In Wake Of Contaminated Medicines Scandal, India Tightens Standards

Reuters: India Orders New Drug-Making Standards After Overseas Deaths 
Indian pharmaceutical companies must meet new manufacturing standards this year, according to a government notification released on Saturday, although small companies have asked for a delay, citing their debt load. Jolted by a string of overseas deaths linked to Indian-made drugs since 2022, Prime Minister Narendra Modi's government has stepped up scrutiny of pharmaceutical factories to clean up the image of the $50 billion industry. "The manufacturer must assume responsibility for the quality of the pharmaceutical products to ensure that they are fit for their intended use, comply with the requirements of the licence and do not place patients at risk due to inadequate safety, quality or efficacy," said the notification, dated Dec. 28. Companies must market a finished product only after getting "satisfactory results" on tests of the ingredients and retain a sufficient quantity of the samples of intermediate and final products to allow repeated testing or verification of a batch, it says. (1/6)

In other pharmaceutical industry news —

Stat: GSK Is Replacing Its Popular Flovent Inhaler With Authorized Generics, Raising Cost Concerns For Asthma Patients
The timing of the change is telling: Flovent’s price rose nearly 50% since 2014, according to GoodRx, leaving the drug vulnerable to the new Medicaid penalties going into effect as of this year for medications with price increases that outpace inflation. By discontinuing the brand-name inhaler but continuing to earn money from the authorized generic, GSK will be able to avoid paying a penalty. Doctors have warned that the change could make it hard for patients to continue accessing inhalers equivalent to the Flovent ones they have been using, especially at the time of the year when inhalers are most needed. This is because the generic version of Flovent may not be similarly covered by insurance. The trouble lies in the complex system of incentives shaping formularies determining what is and isn’t available to patients, and at what cost. (Merelli, 1/5)

Stat: Allogene Pivoting To New Strategy On Off-The-Shelf CAR-T Therapy 
Allogene Therapeutics is making unexpected changes to development plans for its off-the-shelf cell therapy for a type of blood cancer — a concession that competition from personalized CAR-T treatments, already entrenched in the market, has become more challenging. (Feuerstein, 1/4)

Bloomberg: Bayer’s Menopause Drug Elinzanetant Succeeds In Two Final-Stage Studies
An experimental Bayer AG drug successfully alleviated hot flashes and other disturbances associated with menopause in two studies, clearing a path for a medicine that Bayer says could become a blockbuster. The drug, elinzanetant, lowered the frequency and severity of hot flashes and met all the research goals in studies that included about 800 post-menopausal women, the German company said Monday. Bayer was testing the therapy, which is administered orally once a day, against a placebo. (Loh, 1/8)

Also —

The Wall Street Journal: Elon Musk Has Used Illegal Drugs, Worrying Leaders At Tesla And SpaceX
Elon Musk and his supporters offer several explanations for his contrarian views, unfiltered speech and provocative antics. They’re an expression of his creativity. Or the result of his mental-health challenges. Or fallout from his stress, or sleep deprivation. In recent years, some executives and board members at his companies and others close to the billionaire have developed a persistent concern that there is another component driving his behavior: his use of drugs. ... The world’s wealthiest person has used LSD, cocaine, ecstasy and psychedelic mushrooms, often at private parties around the world, where attendees sign nondisclosure agreements or give up their phones to enter, according to people who have witnessed his drug use and others with knowledge of it. Musk has previously smoked marijuana in public and has said he has a prescription for the psychedelic-like ketamine. (Glazer and Grind, 1/6)

MarketWatch: Elon Musk On WSJ Story: If Drugs Helped My Productivity, I Would Take Them
That was businessman and inventor Elon Musk responding on his X platform, to an article by The Wall Street Journal that discussed alleged illegal drug use by the Tesla CEO. Citing sources, the article that published on Saturday said Musk had used cocaine, ketamine, psychedelic mushrooms and other substances, and that some board members were worried about potential problems for his health and the empire he watches over. ... “If drugs actually helped improve my net productivity over time, I would definitely take them!” Musk responded. (Kollmeyer, 1/8)

The Wall Street Journal: Psychedelics Are Going Mainstream. Investing In Them Hasn’t
Psychedelics spent a half-century in political and medical purgatory. Now they’re starting to go mainstream. Respected academic institutes and billionaires are funding research into their therapeutic benefits, and the Food and Drug Administration could soon approve MDMA (known more commonly as ecstasy) for a treatment for post-traumatic stress disorder. The therapeutic potential of these drugs looks promising, but Wall Street and big pharma are still not convinced of the financial potential. Intellectual property is one big concern. While new compounds discovered in a lab can often lead to over a decade of exclusive profits for a pharma company, psychedelics like LSD and psilocybin, the psychoactive compound in “magic mushrooms,” have been around for a long time. This makes patenting them more controversial. Companies are patenting formulations of the drugs and even things like the cozy furniture in a treatment room, but questions about patent protection abound. (Wainer, 1/5)