| |   | Hi! Today we talk about bringing base editing to the cholesterol-laden masses, and the intricacies of bringing prescription-only meds over the counter.
- Meghana | | | Base editing therapy enters human trials Base editing, one of the newfangled forms of CRISPR, is now being tested in humans.
Verve Therapeutics announced this morning that the first patient has been dosed in the trial of its lead therapy, VERVE-101. That treatment takes aim at familial hypercholesterolemia, an inherited disease that triggers high levels of LDL cholesterol in millions of people. In studies with non-human primates, the base editing approach slashed cholesterol levels by nearly 60% — and those levels were maintained for up to six months. “What we’re trying to do is really disrupt the way this disease is cared for and move it from chronic care ... to one and done,” Verve CEO Sekar Kathiresan said. “And this is really the first step in that journey.” Read more. | An OTC birth control pill? A drugmaker yesterday asked the FDA for permission to sell a birth control pill that wouldn’t require a health provider’s prescription.
France-based HRA Pharma’s application comes in the wake of the recent dissolution of Roe v. Wade, though the company says the timing is unrelated to the Supreme Court’s decision. It has compiled years of research intended to convince the FDA that women can safely weigh the risks a hormone-based pill might carry, and use the pill as intended.
“For a product that has been available for the last 50 years, that has been used safely by millions of women, we thought it was time to make it more available,” one executive said. Read more. | From trials to triumph: The 2022 STAT Summit Join us as we host silo-breaking discussions on the most important topics in health care. Over two days this November, you’ll hear from some of the leading minds in the industry. Don’t miss out, and enjoy early-bird pricing on your pass until July 22. | What happens to pharmacies if prescription drugs go OTC? Just recently, the FDA proposed a rule that would allow pharma companies to switch products from prescription-only to over-the-counter, while still offering a prescription version. This would mean the OTC version could have the same active ingredient, dosage, strength, and route of administration as its prescription-only counterpart. This would allow patients to sidestep office visits and prescriptions, while payers could benefit from fewer medical and prescription claims.
The market could open up considerably for pharmaceutical companies — leading to massive new profits. But not everyone thinks that's a good idea. “The FDA’s proposed rule has important ramifications as it will decrease the number of prescriptions written and dispensed,” opines Martha M. Rumore, an intellectual property expert specializing in food, drug, and cosmetic law. The proposed rule doesn’t account for drugs that are “behind-the-counter,” she says, a concept in which drugs are dispensed a pharmacist’s approval. Should drugmakers begin selling statins, for instance, over-the-counter, the demand could be massive — leaving many pharmacies and pharmacists suddenly left out of the decision-making process for distributing potent medications. Read more. | Teva lied about role in opioid crisis, NY says New York Attorney General Letitia James said that Teva Pharmaceutical Industries helped fuel the state’s opioid crisis, but attempted to evade accountability, Reuters writes. She said a senior Teva executive made “demonstrably false” claims in a sworn affidavit that the Israel-based company didn’t sell or promote opioids in the U.S., despite evidence to the contrary. “This new evidence shows an even greater disregard for the pain and destruction that this company fueled,” and may entail a “fraud on the court,” she said, adding that the company’s use of offshore accounts to shelter potentially large amounts of money from its American business created “real concern” that Teva may not pay damages. Teva said in May it might have to pay $2.6 billion to settle U.S opioid lawsuits around the country. | More reads - Biotech stocks are up by double digits. It’s still a bear market Barron's
- Vertex absorbs ViaCyte and its stem cell-based diabetes treatment for $320M, clearing out competition Fierce Biotech
| Thanks for reading! Until tomorrow,  | | | |
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