Drugs and medicine – Scuba Dive Talks http://scubadivetalks.com/ Thu, 24 Nov 2022 02:06:48 +0000 en-US hourly 1 https://wordpress.org/?v=5.9.3 https://scubadivetalks.com/wp-content/uploads/2021/07/scuba.png Drugs and medicine – Scuba Dive Talks http://scubadivetalks.com/ 32 32 New FDA Pilot Project Offers Accelerated Drug Program Sponsors Expanded FDA Meeting Opportunities on Manufacturing Issues | Hogan Lovells https://scubadivetalks.com/new-fda-pilot-project-offers-accelerated-drug-program-sponsors-expanded-fda-meeting-opportunities-on-manufacturing-issues-hogan-lovells/ Thu, 24 Nov 2022 01:08:49 +0000 https://scubadivetalks.com/new-fda-pilot-project-offers-accelerated-drug-program-sponsors-expanded-fda-meeting-opportunities-on-manufacturing-issues-hogan-lovells/ Background FDA-regulated drug and biologic development programs intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need may have accelerated clinical development timelines, including designation for the breakthrough therapy, accelerated and advanced regenerative medicine therapy (RMAT) programs. Yet applications to market products in these programs must still […]]]>

Background

FDA-regulated drug and biologic development programs intended to diagnose, treat, or prevent a serious disease or condition where there is an unmet medical need may have accelerated clinical development timelines, including designation for the breakthrough therapy, accelerated and advanced regenerative medicine therapy (RMAT) programs. Yet applications to market products in these programs must still meet FDA approval standards, including manufacturing facility compliance with current Good Manufacturing Practices (CGMP). Products with accelerated clinical development activities may experience difficulty in accelerating CMC development activities to align with accelerated clinical timelines. Successful acceleration of CMC preparation may require additional interactions with the FDA during product development and, where appropriate, justify the use of science-based and risk-based regulatory approaches that allow streamlining of development activities of the CMC, so that the clinical benefits of early patient access to these products can be realized.

Due to the accelerated review timelines established for expedited programs for drugs and biologics intended to address unmet medical needs for serious conditions, CMC and GMP issues have often become limiting factors that have resulted in to complete response letters and prevented the FDA from approving drugs that are important advances in public health and that patients urgently need. The CMC and GMP challenges have been particularly important for complex biological products. To some extent, the Breakthrough and RMAT programs were intended to address these challenges, but FDA and industry have recognized that additional FDA interactions and assistance are needed to expedite the resolution of CMC issues. and GMP earlier in the application review cycle associated with accelerated program designation(s).

In response to these concerns and as described in Prescription Drug User Fee Act (PDUFA) Commitment Letter VII, the FDA is implementing this pilot program to facilitate the preparation of CMC for certain drug evaluation and research centers. biologics (CBER) and the center for drug evaluation and research. (CDER)-regulated products with accelerated clinical development timelines. For sponsors participating in the pilot, the FDA will provide product-specific CMC guidance during product development, to include two additional CMC-focused Type B meetings, as well as a limited number of additional CMC-focused discussions, based on readiness and defined CMC milestones. .

Who is eligible for the program?

Participants in the CDRP pilot program must have an active commercial IND clinical program that has not yet reached the end of Phase 2, to allow the pilot sufficient time to impact CMC readiness (for example, 2 years from the planned filing of the marketing application). However, in extenuating circumstances, requests for exceptions may be considered, where development programs would still benefit from the pilot.

When selecting INDs for the pilot program, the FDA intends to consider factors such as:

(1) the expected clinical benefits of facilitating earlier patient access to the product,

(2) product novelty,

(3) the complexity of the product or its manufacturing process, including technology,

(4) Sponsor’s overall manufacturing experience, as well as

(5) Sponsor’s experience with the particular product type, class or type of manufacturing process.

The FDA may also give additional consideration to less experienced sponsors.

What must a participation request contain?

Prospective applicants to the pilot program should describe in their “Application for Participation” as a modification to their IND:

(1) the current state of development of the CMC, including all ongoing activities not already included in the IND.

(2) an expected schedule for product development that aligns with the planned clinical development schedule, showing CMC tasks and activities intended to produce comprehensive CMC data and information for inclusion in the marketing application. This part of the plan should cover the following areas related to the CMC:

  • Characterization of available product and preliminary identification of critical quality attributes.
  • Description of the drug substance and drug product’s current manufacturing process and control strategy (including identification and development of assays), and a description and plan of the manufacturing and control strategy proposed commercial scale, including any necessary microbial control strategies.
  • Identification of manufacturing facilities, including all contracted facilities, as well as recent facility inspection history (including foreign regulatory inspections, if applicable).
  • Plans to ensure product availability for commercial launch.
  • Drug Substance and Drug Product Stability Evaluation Plan.
  • Overall process validation plan.

(3) potential challenges in completing CMC activities within the time frame that is typically required during CMC development.

The CMC development plan should also include the proposed schedule for the two additional CMC-specific Type B meetings offered by the pilot, as well as any other planned meetings and discussions.

Next steps

Beginning April 1, 2023, the FDA will accept applications to participate in the CDRP program. Although the first year of the pilot is limited to nine applications (6 designated for CBER products), the FDA will continue the program for three additional years, and the number of participants for those years has not yet been disclosed. During this CDRP program, sponsors will have the opportunity to discuss their product development strategies and goals with FDA review staff in predefined Type B meetings and a limited number of additional discussions focused on the CMC. The FDA also said it may hold a public workshop and release a strategy document incorporating lessons from the CDRP. Additionally, CDER/OPQ has released a new Policy and Procedures Manual (MAPP 5015.13) effective December 7, 2022, which provides additional details on how CDER will support and implement the pilot program, as well as than the use of regulatory flexibilities under 21 CFR 314.105(c). As further described in PDUFA VII Commitment Letter, no later than April 30, 2026, FDA will release a strategic document outlining the agency’s plans for developing guidance and process documents to integrate lessons learned from the pilot project and related experience with accelerated clinical development timelines.

In a similar vein, CBER’s Office of Tissue and Advanced Therapies (OTAT) announced a virtual public meeting on December 7, 2022 to answer questions from stakeholders regarding CMC cell therapy issues, including for products tissue-engineered medicinal products regulated by OTAT.

]]>
Div Admin Kashmir issues notice for sale of drugs X, H and H1 https://scubadivetalks.com/div-admin-kashmir-issues-notice-for-sale-of-drugs-x-h-and-h1/ Mon, 21 Nov 2022 13:34:58 +0000 https://scubadivetalks.com/div-admin-kashmir-issues-notice-for-sale-of-drugs-x-h-and-h1/ SRINAGAR, 21 NOVEMBER (KNS): Under Nasha Mukht Bharat Abhiyan, Divisional Administration of Kashmir has today issued notice of sale of X, H and H1 drugs. In an official document, the administration mentioned the do’s and don’ts for the sale of these scheduled drugs. It makes it mandatory to mention on the prescription the date of […]]]>

SRINAGAR, 21 NOVEMBER (KNS): Under Nasha Mukht Bharat Abhiyan, Divisional Administration of Kashmir has today issued notice of sale of X, H and H1 drugs.

In an official document, the administration mentioned the do’s and don’ts for the sale of these scheduled drugs.

It makes it mandatory to mention on the prescription the date of issue, the number of tablets issued as well as the pharmacist’s stamp for drugs in Schedules H, H1 and X.

The instructions state that all records and records are to be kept as required by law/rules, in addition to being made available to the Commissioner of the Food & Drugs Control Administration or any other officer authorized by him in this regard. .

Similarly, pharmacists dispensing scheduled drugs should ensure security checks such as video cameras and the prescription should only be issued if presented within 07 days of issuance.

For each medicine in Appendices H1 and X dispensed, the pharmacist must record: the name, the address, the date of birth of the patient, the name of the medicine dispensed and the quantity dispensed, the date of prescription and the date of issue, the name and address of the prescriber.

When storing or archiving records and data, pharmacies should ensure that they are able to locate and retrieve individual documents or information when needed.

The notice orders to dispense drugs if the prescription is incomplete, includes modifications without doctor’s countersign, to dispense tramadol, buprenorphine, tapentadol, codeine, methylphenidate for any online prescription.

Also dispense psychotropic drugs to unaccompanied minors and issue a prescription when you have reasonable grounds to believe the prescription has been tampered with or obtained fraudulently and if it is tampered with, keep the prescription and report it to authorities.

Moreover, it orders to dispense drugs if you do not have a required license for drugs like Schedule X.

Breach of confidentiality – misuse of personal information of the patient as well as the doctor.

Get involved in helping others evade laws such as the Drugs and Cosmetics Act 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic Substances Act 1985; Magical Medicines and Remedies Act 1954 (Improper Advertising).

The divisional control room in charge, Tahir Magray, said it was among the initiatives taken under Nasha Mukth Bharat by the government, including the toll-free helpline No. 18001807202.

In addition, the government ensures strict compliance with applicable laws and regulations relating to Schedule X, H and H1 drugs to prevent diversion of these drugs into dangerous hands and anti-social elements. (KNS)

]]>
Diabetes drug may benefit patients at risk of dangerous heart disease – WISH-TV | Indianapolis News | Indiana Weather forecast https://scubadivetalks.com/diabetes-drug-may-benefit-patients-at-risk-of-dangerous-heart-disease-wish-tv-indianapolis-news-indiana-weather-forecast/ Tue, 15 Nov 2022 18:01:00 +0000 https://scubadivetalks.com/diabetes-drug-may-benefit-patients-at-risk-of-dangerous-heart-disease-wish-tv-indianapolis-news-indiana-weather-forecast/ INDIANAPOLIS (WISH) — A common diabetes drug could benefit patients at risk of dangerous heart disease, a new study suggests. Metformin is one of the drugs most widely prescribed by doctors for type 2 diabetics. Researchers say it’s a possible cure for atrial fibrillation. Atrial fibrillation is a condition in which a person’s heart beats […]]]>

INDIANAPOLIS (WISH) — A common diabetes drug could benefit patients at risk of dangerous heart disease, a new study suggests.

Metformin is one of the drugs most widely prescribed by doctors for type 2 diabetics. Researchers say it’s a possible cure for atrial fibrillation.

Atrial fibrillation is a condition in which a person’s heart beats irregularly, abnormally, or rapidly. This can lead to blood clots, strokes, and heart failure, among other heart complications.

Researchers say there is a significant need for new treatments, as no new drugs have been approved for more than a decade.

Cleveland Clinic scientists used an advanced genetic sequencing method to study metformin. They found that the drug targeted 30 genes associated with atrial fibrillation, with direct effects on gene expression for eight.

“Our electrophysiology section is one of the most advanced in the field,” study author Dr. Oussama Wazni said in a statement. Press release. “We are thrilled to see important research contributing so quickly to the field, especially since metformin is so safe and readily available.”

The study was published in the latest issue of Medicine Reports Unit.

]]>
Uttarakhand government overturns ban on five Patanjali drugs https://scubadivetalks.com/uttarakhand-government-overturns-ban-on-five-patanjali-drugs/ Sat, 12 Nov 2022 15:54:17 +0000 https://scubadivetalks.com/uttarakhand-government-overturns-ban-on-five-patanjali-drugs/ On November 12, 2022, the government of Uttarakhand revoked the ban imposed on five drugs by Patanjali. Earlier on Wednesday, November 9, 2022, Uttarakhand Ayurveda and Unani Licensing Authority ordered Divya Pharmacy, the maker of Patanjali products, to halt production of its five drugs viz. BPgrit, Madhugrit, Thyrogrit, Lipidom and Eyegrit Gold tablets. The ban […]]]>

On November 12, 2022, the government of Uttarakhand revoked the ban imposed on five drugs by Patanjali.

Earlier on Wednesday, November 9, 2022, Uttarakhand Ayurveda and Unani Licensing Authority ordered Divya Pharmacy, the maker of Patanjali products, to halt production of its five drugs viz. BPgrit, Madhugrit, Thyrogrit, Lipidom and Eyegrit Gold tablets. The ban was imposed after the allegation that these drugs are falsely promoted for the treatment of blood pressure, diabetes, goiter, glaucoma and high cholesterol.

In a letter to Divya Pharmacy, the Licensing Officer of Uttarakhand Ayurveda and Unani Services wrote, “Please take the reference from the management letter dated 09.11.2022 in which the drugs Divya Madhugrit Tablet, Divya Eyegrit Gold, Divya Thyrogrit Tablet, Divya BPgrit Tablet and Divya Lipidom Tablet manufactured by your company are designed to stop the manufacture of. In this regard, in accordance with the provisions mentioned in the Law on Medicines and Cosmetics, the firm has 15 days instead of a week to submit its response.

Letter from the Government of Uttarakhand

The letter further read: “Amending the erroneously imposed ban on the manufacture of the above drugs in accordance with the letter dated November 9, 2022, permission is granted to maintain production intact.”

Press statement

Divya Pharmacy issued a press release about this after receiving this letter. In this press release, it is written: “The Patanjali Institute is the first in the world to gain acceptance of Ayurvedic medicines as research and evidence-based medicine with 30 years of continuous effort and research.

“The Honorable Prime Minister is also working to establish pride in his heritage by erasing the signs of all kinds of slavery in the country. Uttarakhand’s ignorant, insensitive and inept Ayurveda license officer not only tarnishes the wise tradition of Ayurveda but the misguided work and mistakes of an officer made a grossly condemnable act of questioning of the tradition and authentic research of Ayurveda, tarnishing it. And maliciously defamed Patanjali. Such conspiracies are made by people opposed to Yoga-Ayurveda and Indian tradition,” he added.

The statement further stated, “It is our duty to make Ayurveda victorious by countering them with facts and scientific research evidence. The department whose job it was to establish Ayurveda as a national system of medicine while bringing glory to Ayurveda is engaged in the eradication of Ayurveda by defaming Ayurveda. We can never accept this unfortunate act. Patanjali is the first institution in the world to have published the most research papers in the world. It has two NABH accredited hospitals and several NABL accredited research laboratories of international standards. More than 500 world-class scientists provide services here.

The press release added, “In these 75 years of independence, no government or other institution has done the work to bring Yoga-Ayurveda to the world. We are deeply hurt by the kind of actions committed by an officer. Patanjali will continue his fight against any conspiracy in any way in the establishment of Ayurveda and Yoga or join any medical mafia or anti-Sanatan conspirators, against him within the law.

“We are grateful to the government for how the government of Uttarakhand corrected the error upon learning of this reckless act of defamation of Ayurveda and this error was corrected when the government became aware of it,” said said the press release, also shared by Acharya. Balkrishna – the managing director of Patanjali Ayurved Limited.

Patanjali’s five drugs were banned on November 9, 2022, in response to a complaint filed by Kerala eye doctor KV Babu in July earlier this year. Babu sent another complaint to the State Licensing Authority (SLA) on October 11 via email. Meanwhile, Dr. GCN Jangapangi has requested in a letter to the joint director of the Divya Pharmacy and the state health authority’s drug controller that the pharmacy immediately and in the future remove “misleading and objectionable advertisements”. of the media space.

Citing misleading advertisements, the regulator also ordered Patanjali to submit updated formulation sheets and label claims for each of the five formulations for a new round of product certification. The company could only resume manufacturing, according to the health authorities’ prohibition order, if the updated indications were authorized.

]]>
New weight-loss drugs work, but who pays? https://scubadivetalks.com/new-weight-loss-drugs-work-but-who-pays/ Wed, 09 Nov 2022 18:01:31 +0000 https://scubadivetalks.com/new-weight-loss-drugs-work-but-who-pays/ Comment this story Comment After decades of failure, weight-loss drugs finally seem poised to become Big Pharma’s new blockbuster category. According to Bloomberg Intelligence, the U.S. obesity drug market alone will be worth $12 billion in 2028. Morgan Stanley Research recently made a much more optimistic prediction, predicting that global obesity drug sales could hit […]]]>

Comment

After decades of failure, weight-loss drugs finally seem poised to become Big Pharma’s new blockbuster category. According to Bloomberg Intelligence, the U.S. obesity drug market alone will be worth $12 billion in 2028. Morgan Stanley Research recently made a much more optimistic prediction, predicting that global obesity drug sales could hit $54 billion. billion dollars by 2030.

The enthusiasm is deserved. These new drugs offer deeper, more sustained weight loss than any drugs that have come before them, and many people could benefit from them: according to the US Government Accountability Office, between 2013 and 2016, only 3% of people eligible for a obesity medicine were taking one.

But these lofty sales goals will only be achieved if the medical field manages to overcome the structural barriers to their use.

The new drugs are usually weekly injections that mimic gut hormones that regulate feelings of fullness. The approach appears to solve the domain’s problems with safety and efficiency. Data on Novo Nordisk’s Wegovy, approved in June 2021, and Eli Lilly & Co.’s Mounjaro, which is expected to be approved next year, suggests that these drugs can help people lose, on average, up to 15 20% of their body weight. We only have a snippet of data on Amgen’s early-stage weight-loss drug AMG 133, but it’s already garnered strong investor interest in hopes it might offer similar or potentially greater weight loss than Mounjaro with single treatment. stroke of month. Amgen said this week that people taking a high dose of the drug lost an average of about 14.5% of their body weight around three months after the start of its Phase 1 trial. Full data from this study will be disclosed at a a conference early next month.

Such findings would make the new drugs 2-3 times more effective than the old diet drugs, which also carried a litany of side effects ranging from unpleasant (leaky stool) to downright dangerous (increased risk of heart attack or cancer).

People are eager to try new treatments. At an obesity conference last week, experts in the field swapped stories about the long waits for new patients seeking an appointment with weight loss specialists. The Massachusetts General Hospital Weight Center, for example, has more than 4,000 people on its waiting list, says Fatima Cody Stanford, a doctor who specializes in obesity medicine.

“Demand is overwhelming the workforce,” says Robert Kushner, obesity medicine specialist at Northwestern Medicine.

Pharmaceutical companies are also struggling to keep up with demand. Lilly has struggled to maintain its supply of Mounjaro, even though it is currently only approved for diabetes. When it receives expected Food and Drug Administration approval as an obesity treatment in the second half of 2023, at least one analyst believes it could quickly become one of the best-selling drugs in history. Of the industry. And although Novo Nordisk’s Wegovy has been on the market for over a year, it has been in a constant state of shortage, first due to surprisingly high demand and then due to manufacturing issues.

Novo expects this supply constraint to be resolved by the end of this year, a situation that could finally provide answers to key market questions. On the one hand, the magnitude of the demand could become clearer; currently, it’s complicated by people turning to diabetes treatments that use the same ingredients as weight-loss drugs. And once the supply is stable, it should be easier to gauge how long people stick to those once-a-week injections, a factor that will affect how big of a blockbuster drug they’ll get. become.

But all of this excitement implies that the field will overcome fundamental challenges that could hold back the widespread use of these weight-loss drugs.

A major problem ? Primary care physicians have been reluctant to prescribe the drugs. One of the problems is that doctors today are generally not trained to treat obesity, and some continue to believe that the disease is just a way of life rather than a medical problem. Until this group feels more comfortable with these treatments, “I’m afraid all of these advancements will sit on the shelf,” says Kushner, who consults for Novo Nordisk and led a Phase 3 study on Wegovy.

Affordability is also a huge issue. Wegovy launched with a monthly price of over $1,600 and insurance coverage has been spotty. A patchwork of laws dictates access to weight-loss drugs nationwide, making them more accessible in some states than others. In Massachusetts, for example, private insurers will pay for obesity drugs, but Stanford says it has remained difficult to get Medicaid to cover the drugs for its patients. In Pennsylvania, meanwhile, a bill that would allow treatments to be covered for state Medicaid recipients has moved closer to passage after languishing for years. And Medicare currently completely excludes coverage for obesity drugs.

Also to consider: The long-term safety story of this new generation of drugs is still being written. Past experience in the field of weight loss has shown that side effects can appear after the drugs have been marketed. This concern is compounded by the fact that the drugs are potentially used in situations where there is no evidence of their effectiveness or safety, namely in people who are not considered medically obese, but who want help to lose weight. (Elon Musk, for example, recently made headlines when he attributed his fitness to fasting and Wegovy, though it’s unclear if he would actually qualify for the treatment.)

The demand for treatments is unquestionable. But getting there — and therefore reaching the high end of all those high sales projections — will require structural changes in how these drugs are prescribed and covered by insurance.

More from Bloomberg Opinion:

• Psilocybin studies risk being skewed by hype: Lisa Jarvis

• If you’ve had Covid, watch out for stroke symptoms: Faye Flam

• Pfizer’s RSV vaccine succeeds where others have failed: Lisa Jarvis

This column does not necessarily reflect the opinion of the Editorial Board or of Bloomberg LP and its owners.

Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, healthcare, and pharmaceuticals. Previously, she was the editor of Chemical & Engineering News.

More stories like this are available at bloomberg.com/opinion

]]>
Overdose deaths have increased by 54% in the past five years https://scubadivetalks.com/overdose-deaths-have-increased-by-54-in-the-past-five-years/ Fri, 04 Nov 2022 22:04:00 +0000 https://scubadivetalks.com/overdose-deaths-have-increased-by-54-in-the-past-five-years/ Deaths caused by drug overdoses increased by 54% between 2017 and 2021, according to a new report from the NZ Drug Foundation. Generic image of drugs. (Source: Getty) The report shows that 171 people died from overdoses in 2021, a significant increase from 111 in 2017. According to the report, the increase is due to […]]]>

Deaths caused by drug overdoses increased by 54% between 2017 and 2021, according to a new report from the NZ Drug Foundation.

The report shows that 171 people died from overdoses in 2021, a significant increase from 111 in 2017.

According to the report, the increase is due to the increasing number of deaths caused by opioids, alcohol and benzodiazepines.

The report also shows that drug mixing was a significant cause of death, with 42% of overdose deaths in the past five years involving five or more drugs.

Over-the-counter prescription drugs also played a significant role in overdose deaths, with one drug listed in the report being present in 77% of cases.

Drug Foundation executive director Sarah Helm said the numbers are extremely concerning and that public policy has overlooked the issue of preventable deaths.

“Each overdose death is tragic and has a huge impact on whānau and communities. The fact that we have seen overdoses increase over the past five years is simply unacceptable,” she said.

“There are so many things we could and should be doing to prevent these deaths. The growing number of people dying from overdoses should ring alarm bells for policy makers.

The report also shows that Maori are disproportionately affected by overdoses being three times more likely to die from them than Pākehā.

Drug law reform

Helm calls for fundamental reform of our drug laws and says a health-based approach is essential to reducing overdoses.

While she acknowledges that these changes will likely take some time, she suggested some short-term solutions that could quickly kick in now.

These changes include increased funding for naloxone, a type of drug for overdoses, and the trial of an overdose prevention center where addicts can practice while under medical supervision while receiving harm reduction treatment and support services.

“The data shows that opioids are present in nearly half of overdose deaths over the past five years, and deaths are increasing,” Helm said.

“Naloxone is an incredibly effective drug that reverses the effects of an opioid overdose. We want it to be in the hands of as many people as possible. The Drug Foundation has tried to better prepare New Zealand for a widespread opioid crisis like the one we see in other parts of the world.

The proposed drug abuse center trial has also been backed by Auckland Central MP Chlöe Swarbrick and the Green Party, who say it will reduce the harm caused by drug addiction and make the city center safer .

“When I stood up to represent my community of Auckland Central, I did so pledging to confront the harsh and complicated realities of the issues that arise in our neighborhoods – many of which do not come from our neighborhoods,” she said earlier this year. .

“That means implementing practical, carefully considered solutions like this overdose prevention center.”

Helm said the Drug Foundation was working to acquire injectable naloxone and the nasal spray version Nyxoid.

Restrictions around injectable naloxone have also eased following a request from the Drug Foundation.

“According to our legal advice, the changes mean that organizations like ours will now be able to distribute injectable naloxone, so we are taking steps to procure it,” says Helm.

“This week we also submitted a funding request to Pharmac for the nasal spray form of naloxone, Nyxoid, which is easier to use and therefore preferred by people who use drugs, their loved ones and first responders like the police.”

“Currently, Nyxoid is $92 for a box of two. We decided to take matters into our own hands because we couldn’t keep waiting for this to come out.

The Drug Foundation hopes these changes will help reduce the number of people suffering from overdoses and reduce harm in vulnerable communities, especially those who are homeless.

]]>
Expert Interview: The Billion-Dollar Boon in Marijuana Drugs https://scubadivetalks.com/expert-interview-the-billion-dollar-boon-in-marijuana-drugs/ Tue, 01 Nov 2022 10:07:48 +0000 https://scubadivetalks.com/expert-interview-the-billion-dollar-boon-in-marijuana-drugs/ Welcome to my interview with Scott Chan, chief analyst for Investing in the real world and The complete investor. Scott is an expert at identifying emerging global “megatrends” in investing, and just days before the U.S. midterm elections, I decided it was time to get a sense of … marijuana. Yes, marijuana. Cannabis mainstreaming is […]]]>

Welcome to my interview with Scott Chan, chief analyst for Investing in the real world and The complete investor. Scott is an expert at identifying emerging global “megatrends” in investing, and just days before the U.S. midterm elections, I decided it was time to get a sense of … marijuana.

Yes, marijuana. Cannabis mainstreaming is one of the most profitable investment trends you will see in your lifetime. On November 8, proposals to legalize weed will be on five state ballots.

First, a quick word about my colleague Scott (photo).

Scott Chan moved to the United States from China with his family when he was 10 years old. He received undergraduate degrees from New York University, followed by an MBA from the Zicklin School of Business at Baruch College. Scott reads and speaks Mandarin and Cantonese Chinese fluently. My questions are in bold.

Scott, from your perspective, how popular is marijuana legalization with the American public?

Who said Americans can’t agree on anything? According to the latest polls, public support in the United States for marijuana legalization has reached almost 70%, including the majority of Republicans and Democrats.

Given the political divisions in this country, support north of 60% is quite broad. In the United States, the use of cannabis for medical purposes is legal in 38 states. When the November 8 midterm elections are over, we will see legal pot in a few more states, due to ballot initiatives.

Efforts to legalize marijuana federally for medical and recreational use have stalled in Congress. What are the short-term chances of federal legalization?

Hope is not lost. The Democratic-controlled US House of Representatives is sympathetic to the cause. The roadblock, the 50-50 Senate, is currently working on several bills to lift restrictions against pot at the federal level.

Of course, if the GOP takes one or both chambers in the election, pot legalization will face a more difficult road. But states are not waiting for Uncle Sam to act. And in the long term, I would say federal legalization of weed is inevitable.

Regardless of your opinion on recreational use, cannabis has been clinically shown to have medical benefits. There is a lot of money to be made in the field of pharmaceutical cannabinoids, which are drugs derived from marijuana ingredients. Can you suggest a case study along these lines?

Yes I can. GW Pharmaceuticals made history in 2018 when its epilepsy drug Epidiolex became the first cannabinoid to be approved by the United States Food and Drug Administration (FDA).

GW Pharmaceuticals was acquired by Jazz Pharmaceutical (NSDQ: JAZZ) last year for $7.2 billion, a pivotal deal that sent shockwaves throughout the marijuana industry and sparked a wave of consolidation among cannabis companies.

Epidiolex generated over $460 million in sales in 2021. It treats epileptic seizures associated with Lennox-Gastaut Syndrome (LGS), Dravet Syndrome (DS), and Tuberous Sclerosis Complex (TSC).

The drug contains cannabidiol (CBD), which is a purified substance extracted from marijuana, and it has been deemed safe enough by the FDA to be used by even toddlers.

Both LGS and DS are genetic disorders causing epilepsy that usually start showing symptoms in early childhood. They are very difficult to treat, but the use of Epidiolex turns out to significantly reduce the frequency of seizures.

TSC is another genetic disease. It causes non-malignant tumors to grow on the brain or other vital organs, which can lead to seizures, intellectual and behavioral problems, and other serious health problems. Epidiolex helps manage seizure symptoms.

What other major marijuana-related drugs are occupying the pipeline?

Jazz is currently working on treating other disorders with cannabinoids, including schizophrenia and autism. For the price it paid, Jazz will certainly be looking to squeeze more money from GW’s assets.

So far, Epidiolex is the only FDA-approved drug that contains marijuana-derived ingredients, but with ongoing research, there will likely be more such drugs on the market in the years to come.

Additionally, there are two FDA-approved synthetic cannabinoid drugs on the market. This means that they are man-made chemical drugs designed to mimic the effects of real cannabis.

There is Cesamet, owned by Bausch Health (NYSE: BHC), which treats nausea and vomiting in cancer patients caused by chemotherapy.

The second drug, Marinol, is owned by an Indian company Alkem Laboratories, also treats nausea and vomiting caused by chemotherapy. Additionally, it is approved to treat anorexia and weight loss in HIV patients.

It seems that lucrative opportunities in marijuana investing await us.

Oh yes. As Epidiolex shows, cannabinoids derived directly from the plant can be lucrative. It’s almost halfway to $1 billion in sales per year and could very well become a blockbuster (i.e. $1 billion or more).

There are around 30 late-stage clinical trials looking at cannabinoids, so over the next few years we could see an explosion in the market. Note that the most common medical use of marijuana is to manage pain, and so far there is no approved marijuana medicine for pain yet.

So, the marijuana market is not just about planting and supplying the plant. Derivative products, including drugs, are also poised to become billion-dollar opportunities. The time has come for investors to embark on the “green rush”.

Editor’s note: My colleague Scott Chan has just provided you with valuable information on the earning potential of marijuana.

On November 1, I’m hosting a special investment town hall called “The Marijuana Millionaire Countdown.”

As the U.S. midterm elections loom on the calendar, I’ll explain why federal legalization of marijuana is inevitable…and why so many states are on the verge of creating new legal markets.

The state’s new legal markets equal new growth for well-positioned marijuana companies. Now is the time to invest in marijuana stocks, before political catalysts propel them higher.

During my online Town Hall, I will reveal the one simple marijuana trade that could dump tons of money into your brokerage account, before midterm votes are even counted.

There’s still time to jump on board for this event, which after November 1st will be archived for easy 24-hour access. Click here to get your free spot!

John Persinos is the editorial director of Invest daily.

To subscribe to John’s video channel, click this icon:

]]>
Miracle Diabetes Curing Diet Nets Biggest Deal in Shark Tank History! https://scubadivetalks.com/miracle-diabetes-curing-diet-nets-biggest-deal-in-shark-tank-history/ Sat, 29 Oct 2022 22:20:18 +0000 https://scubadivetalks.com/miracle-diabetes-curing-diet-nets-biggest-deal-in-shark-tank-history/ () – It was the most watched episode in Shark Tank history when sisters Anna and Samantha Martin won the Shark Tank panel Anna and Samantha Martin, sisters and chemists from MIT, landed the biggest deal in Shark Tank history as the 6 Sharks teamed up to launch the company with a staggering $2.5 million! […]]]>




() – It was the most watched episode in Shark Tank history when sisters Anna and Samantha Martin won the Shark Tank panel

Anna and Samantha Martin, sisters and chemists from MIT, landed the biggest deal in Shark Tank history as the 6 Sharks teamed up to launch the company with a staggering $2.5 million! In just 6 months, their product has completely disrupted the diabetes industry in the United States, and with the help of the Sharks, they are now ready to take on the global market.

After a complete brand overhaul and repackaging, the sisters are now ready to launch their new brand, StrictionD Advanced Formula. Watch the incredible demonstration below that prepared the sharks to feed instantly!

Apparently, the Kim sisters have invented a new chemical compound that can lower blood sugar and lower bad cholesterol. More importantly, it can effectively reverse high blood sugar.

Although there are a number of “supplements” on the market that claim to cure diabetes, the Kim sisters created the first reuptake inhibitor (RI), making it particularly more effective at permanently lowering blood sugar.

The judges were amazed that one product was able to do all of the following:

– Regulates blood pressure

– Balances blood sugar levels

– Lowers bad cholesterol (LDL)

– Increases good cholesterol (HDL)

– Reverses insulin resistance

– Made from 100% natural and organic ingredients

RI works by blocking inhibition of the plasmalemmal transporter-mediated reuptake of a neurotransmitter from the synapse into the pre-synaptic neuron. What this means for men without a PhD in chemistry: a permanent cure for diabetes.


The sisters were the first candidates in Shark Tank history to receive investment offers from all six panel members.

The diabetes industry is a huge market, but it is rarely reported. Studies have shown that 32% of American adults have high blood sugar and only about 54% of people with high blood sugar have their condition under control.

In order to test the validity of sister Kim’s product, Shark Tank decided to take on a volunteer among its production teams. Meet Kathy Rhodes, a 54-year-old mother of 3 who jumped at the chance to try StrictionD Advanced Formula.

Kathy is a 54 year old professional who had clinical hypertension for over 13 years. We had to wait 2 weeks to get a bottle to test as it was sold out almost everywhere we looked. We asked her to track her progress for the 14-day test.

What were the results ?

Day 1 :“I took two StrictionD Advanced Formula capsules and forgot all about it. About 1-2 hours later I started to feel strangely better. I can only describe it by saying it was easier to breathe somehow I was walking in a mall and usually I would have been a bit dizzy with headaches, and I would also have been nauseous at the time, but I I was absolutely fine. For a while I felt like my blood sugar was absolutely normal. I got really curious about what was going to happen next – that was awesome.”

Day 5:“Over the next 5 days I started to feel better and better! I found myself bouncing out of bed and feeling ready to take on the day – usually I have to hit the snooze button at minus twice. I felt motivation like I hadn’t felt in years. I had consistently higher energy levels, rather than the ups and downs I was used to. I was also able to sleep through the night!I was shocked at the drastic results.

Day 14:“After 14 days, not only were all my doubts and skepticism completely gone – my high blood sugar was completely normal and I no longer needed to check it 10 times a day. I had no idea about two secret ingredients little known in a natural supplement could make a big positive difference in how I felt. I’m so grateful to Shark Tank for sharing their findings with us and trying StrictionD Advanced Formula!”

What talk show host Oprah Winfrey has to say about StrictionD Advanced Formula!

Oprah suffers from high blood sugar due to her unhealthy lifestyle. She linked this to her excess salt intake. Oprah has been using StrictionD Advanced Formula for 5 months.

“The pills arrived much faster than expected. I couldn’t wait to see if StrictionD Advanced Formula lived up to the hype. I took a pill every night before bed. In less than 6 days, my blood sugar returned to the stable range for the first time in years.” – Oprah Winfrey.

Will StrictionD Advanced Formula work for you?


There are many remedies for high blood sugar that you can try. Some of them include taking drugs with dangerous side effects. Others involve putting needles into your body. With so many options, it’s normal to be skeptical about the results. So instead of promising our readers anything, we challenge you to follow in Oprah’s footsteps and try it yourself!

The Sharks said the pills were designed to lower blood sugar, and that’s exactly what happened to Oprah. When contacted for comment, the Sharks graciously provided our readers with their promotional package: special bottles + FREE delivery of StrictionD Advanced Formula! You can find these links below.

Remember that it is important that you use the to get the full healing results.

This SPECIAL offer won’t last long, so be sure to follow the link below and save up your BENEFITS today before it runs out!

READER RESULTS

“If there was ever a ‘miracle pill’ it was this one. After the first week, I started noticing that my blood sugar readings were starting to drop. The StricctionD advanced formula gave me no only helped lower my high blood sugar but also helped me. I started taking StrictionD Advanced Formula about a month ago and haven’t felt this good in a long time.

Before taking them, I always felt fatigue and pain in my chest. These pills are excellent and easy to take without any side effects.”

Lacey Brown,
Cronull


“I decided to try StrictionD Advanced Formula just out of curiosity and because they offered special bottles so nothing to lose. I didn’t think any pills other than Vasotec or Prinivil could lower blood sugar.

After you got my bottle, you might not believe my high blood sugar was completely cured.”

Andrea Taylor,
Golden Coast

“My blood sugar and blood pressure are now in the normal range, and my husband is happy for me,

Kelly Smith,
Melbourne CBD

Special offer

Step 1:


The special offer is limited.
Expired :


]]>
So far, reuse of excess drugs saves €600,000 https://scubadivetalks.com/so-far-reuse-of-excess-drugs-saves-e600000/ Thu, 27 Oct 2022 10:26:13 +0000 https://scubadivetalks.com/so-far-reuse-of-excess-drugs-saves-e600000/ Photo: Depositphotos.com An experiment to reuse leftover drugs by donating them to other patients has saved €600,000 so far, news site Nu.nl reported. The cancer drugs were given to other patients after thorough quality control in trials conducted by Radboud University’s Radboudumc Teaching Hospital. Researcher Charlotte Bekker told NOS that 100 million euros worth of […]]]>

Photo: Depositphotos.com

An experiment to reuse leftover drugs by donating them to other patients has saved €600,000 so far, news site Nu.nl reported.

The cancer drugs were given to other patients after thorough quality control in trials conducted by Radboud University’s Radboudumc Teaching Hospital.

Researcher Charlotte Bekker told NOS that 100 million euros worth of medicines are thrown away every year – often in regular waste or down the toilet.

Often, medications are over-prescribed, but patients may also be over-medicated because their treatment has changed or because they have suffered side effects. Medications can also be left out if a patient dies.

Medicines can currently only be reused under strict conditions. Medicines that were in patients’ homes, for example, should be destroyed because they may have been stored in places that are too hot or too cold. Packages that have been opened should also be discarded.

The test uses a special seal that indicates whether the package has been opened and a chip that measures the temperature at which it was stored. The trial also focuses on expensive drugs, costing at least €100 per packet.

Once pharmacists have assessed whether the drugs are still safe, they can then give them to other patients who have been banned from the same drug.

The experiment, which is still ongoing, involves around 1,000 cancer patients at four hospitals in the Netherlands. It is expected to be completed next year, but the results are very promising, Bekker said.

Thank you for your donation to DutchNews.nl

The DutchNews.nl team would like to thank all the generous readers who have donated over the past few weeks. Your financial support has helped us extend our coverage of the coronavirus crisis into evenings and weekends and ensure you are kept up to date with the latest developments.

DutchNews.nl has been free for 14 years, but without the financial support of our readers, we would not be able to provide you with fair and accurate information on all things Dutch. Your contributions make this possible.

If you haven’t donated yet, but would like to, you can do it via Ideal, credit card or Paypal.

]]>
Many children live in homes with leftover prescription drugs, survey finds https://scubadivetalks.com/many-children-live-in-homes-with-leftover-prescription-drugs-survey-finds/ Tue, 25 Oct 2022 04:59:00 +0000 https://scubadivetalks.com/many-children-live-in-homes-with-leftover-prescription-drugs-survey-finds/ Many children are living in homes with unused prescription drugs and expired drugs, according to a new national survey. Nearly half of parents say they have leftover prescription drugs at home, according to the National Child Health Survey from CS Mott Children’s Hospital at University of Michigan Health. Four out of five parents report throwing […]]]>

Many children are living in homes with unused prescription drugs and expired drugs, according to a new national survey.

Nearly half of parents say they have leftover prescription drugs at home, according to the National Child Health Survey from CS Mott Children’s Hospital at University of Michigan Health.

Four out of five parents report throwing away over-the-counter medication after the expiration date.

We have found that it is common for parents to store medicines long after they are expired or no longer needed, creating an unnecessary health risk for children.


Young children entering home medicine are a major source of unintentional poisonings. For older children, access to these drugs carries the risk of experimentation, diversion to peers, or other intentional abuse.”


Sarah Clark, MPH, Co-director of Mott Poll

The nationally representative poll was based on 2,023 responses from parents of children 18 and under who were surveyed between August and September 2022.

Less than half of parents think over-the-counter medicines are less effective after their expiry date, while one in five think they are unsafe.

“Parents may not realize the medicine is out of date until they need it to treat their child’s symptoms,” Clark said. “At this point, parents have to decide whether they will give the expired medicine to their child or go out to buy new medicine.”

More than a third of parents say it is never okay to give their child expired medicine. But one in three parents think it’s okay to do it up to three months after the expiration date, and about the same number say it would be OK after six months or more.

“The expiry date is the manufacturer’s guarantee that a drug is completely safe and effective; over time, the drug will lose its effectiveness,” Clark said. “Parents who plan to give their child medication well past its expiry date should consider how well it will work.”

Proper disposal of medications

More than three in five parents say they are more careful when disposing of leftover prescription medicine than over-the-counter medicine. Most also believe that disposing of expired or leftover medicines properly is important to prevent children from getting into medicines and to protect the environment.

Yet many parents struggle to figure out how to get rid of them. Nearly three-quarters say they don’t know which medications should be mixed with coffee grounds or kitty litter and one in seven have flushed medication down the toilet.

The safest choice, Clark said, is to drop off the drugs at a permanent collection site at a doctor’s office, pharmacy or hospital, or at a community site in conjunction with the US National Drug Take-Back Day. Drug Enforcement Administration.

“Unused and expired medicines are a public safety issue and pose health risks to children,” Clark said. “It’s important that parents dispose of them properly when they are no longer needed to reduce the risk of illness to children as well as the negative impact on the environment.”

How to properly protect children from unused drugs

  • Limit the amount of medication you take home. Avoid buying over-the-counter medications in excess of your family’s needs. For medications prescribed for “as needed” use, such as painkillers, consider filling only part of the prescription and returning to the pharmacy for additional doses only if needed.
  • Store over-the-counter and prescription medications in their original packaging that includes dosage and expiration information. Check the expiration dates of your child’s over-the-counter medications twice a year, especially before allergy and/or flu season.
  • Lock out or at least watch certain medications that can be misused, including painkillers and sleeping pills, especially if there are older children in the home.
  • Safely dispose of unused or expired medicines by dropping them off at a permanent collection site (such as a local hospital, pharmacy, or doctor’s office) or at a periodic take-back event. Some pharmacies also offer mail-in return options.
  • If you are unable to return medicines to a collection site, a secondary option is to dispose of them in the household waste. Medicines should be placed in a plastic bag, dissolved with water, and mixed with kitty litter or coffee grounds to make them unappealing to children or pets. Sealing the bag will prevent the medicine from leaking.
  • Avoid flushing expired or unused medications down the toilet or sink, which could lead to medications entering the water supply and exposing residents to chemicals in drinking water.

Source:

Michigan Medicine – University of Michigan

]]>