Pharmalot, Pharmalittle: Merck drug wins FDA nod as first-line lung cancer treatment

Hello, everyone, and how are you today? We are just fine, thank you, despite overcast skies hovering above the Pharmalot campus. Our shortest person has trotted off to the local schoolhouse, the official mascots are happily snoozing here and there, and we are quaffing cups of stimulation. What could be better? We hope your own day is getting off to a good start and, on that note, here are some tidbits to help you along. Hope all goes well and do keep in touch …

Merck won earlier-than-expected US regulatory approval for its Keytruda drug as a first-line treatment in lung cancer patients, cementing its lead over rivals. Separately, the National Comprehensive Cancer Network rejected Merck’s bid to list a combination of Keytruda and chemotherapy in its compendia of treatment guidelines. Sanford Bernstein analyst Tim Anderson wrote the decision was not a surprise, since Merck submitted a small Phase 2 study.

The pharmaceutical industry trade group is requiring members to pay an additional $100 million per year to fund a post-election battle over drug prices, Politico reports. The Pharmaceutical Research and Manufacturers of America is hiking membership dues by 50 percent in order to have $300 million on hand annually. The trade group is gearing up to spend hundreds of millions on ads pushing back against politicians from both parties who have attacked pricing.

Pharmaceutical and alcohol companies are donating to anti-marijuana campaigns in five states — Arizona, Massachusetts, Maine, Nevada and California — where votes will be held next month on whether to legalize marijuana, the Guardian writes. Drug makers fear that fewer prescriptions may be written for their painkillers. One recent study found fewer Medicare prescriptions were written in states where marijuana is legalized.

The Sarepta Therapeutics drug for Duchenne muscular dystrophy has provided “a worrisome model for the next generation of molecularly targeted therapies,” write two Harvard Medical School professors in JAMA. The FDA approval may embolden drug makers to “demonstrate a slight difference in a laboratory test, activate the patient community, win approval, and charge high prices, while relying on limited regulatory follow-up.”

Pfizer cut the price of its Enbrel rheumatoid arthritis and psoriasis treatment by 20 percent in Ireland, the Irish Times reports. The move is part of a agreement reached between the government and the pharmaceutical industry to cut prices for biologics by 20 percent once they lose patent protection and face direct competition. Enbrel lost patent protection in Europe earlier this year, and Biogen introduced Benepali into the Irish market in September.

The Food and Drug Administration is planning a study to determine whether animation may distort how consumers perceive the risks and benefits of a medicine, but some drug makers are unhappy with the questions the agency plans to ask, according to Regulatory Focus. Remarks filed by some companies suggest they are hesitant to see how such limited research could actually lead to new policies or guidance.

Concordia International, which has gained a reputation for aggressively hiking prices of its medicines, says its chairman and chief executive, Mark Thompson, is resigning, Pharmafile writes. The drug maker, whose stock has been plummeting, drew attention last May for increasing the price fourteenfold of eye drops that the UK’s National Health Service relies on to treat bacterial conjunctivitis.

India’s Supreme Court will hear the government’s petition to transfer cases filed against its ban on hundreds of fixed dose combination drugs, the Economic Times tells us. The government, which banned drugs that were alleged to be irrational, unsafe for patients, and lacking scientific validation, filed petitions against several drug makers that are contesting the ban. A hearing is set for Nov. 7.

Indian regulators caught Wanbury relabeling the diabetes drug metformin hydrochloride that was made at a third-party site and illegally exporting it as its own product to Bangladesh, Pakistan, Brazil, and Mexico, the Economic Times tells us. The Maharashtra Food and Drug Administration says it is looking into other companies that could be engaging in the same practice.