Good morning, everyone, and how are you today? We are just fine, thank you, especially since we plan to take an extended weekend. This means that our usual dispatches will not return until next Monday. But a respite, however brief, is always welcomed. Yes, we will miss you, but we will return soon enough. Meanwhile, here are some tidbits to get you going. Hope your week is productive and see you soon …
Groups that advocate for patients and doctors are working with big drug makers, which fund their efforts, to fight a proposed overhaul of Medicare Part B reimbursement fees, USA Today reports. A key issue is the independence of these groups, which claim they represent the interests of patients, but simultaneously receive much of their financial support from companies dependent on the continued flow of federal money.
A US Food and Drug Administration advisory panel voted unanimously to recommend that Amgen should be allowed to market a biosimilar version of the best-selling Humira medicine, the Associated Press writes. Sold by AbbVie, Humira generated nearly $15 billion in sales last year. But legal fights over patents are expected to delay the biosimilar launch until at least March 2017, and possibly as late as 2022.
Juno Therapeutics was allowed to resume testing an experimental cancer treatment by the FDA, just days after the agency closed the trial because of three patient deaths, STAT reports. Juno blamed the deaths on an unforeseen interaction between re-engineered blood cells, called CAR-Ts, and a chemotherapy drug used to prepare patients for treatment. Juno proposed resuming the trial without using the chemotherapy drug.
Allowing patients to choose among different medications that do the same thing may increase the effectiveness of the chosen drug and reduce potential side effects, the Wall Street Journal writes, citing a study in Annals of Behavioral Medicine. Participants who were able to choose between two different formulations of a medication reported significantly fewer side effects after 24 hours, compared with those not allowed to choose.
Sage Therapeutics stock rose 40 percent Tuesday after the drug maker announced positive mid-stage trial data for its treatment for postpartum depression, the Wall Street Journal tells us. After 60 hours, the women treated with the drug had a 20-point reduction in a depression score, or more than 12 points greater than the women receiving a placebo, a highly statistically significant difference, TheStreet notes.
The FDA expanded the use of Pfizer’s Prevnar 13 pneumococcal vaccine to treat adults aged 18 to 49 years, according to PharmaTimes.
The Medicines Patent Pool signed manufacturing licenses with six Indian pharmaceutical companies to produce generic versions of anti-retrovirals and hepatitis C treatments, the Financial Express says.
To revive its oncology business, Sanofi is hunting for assets ranging from approved cancer drugs to experimental ones that mine new expertise, a move typified by its bid for Medivation, Bloomberg News writes.
The UK’s National Institute for Health and Care Excellence published draft guidance recommending UCB Pharma’s Cimzia as an option for treating severe rheumatoid arthritis, PharmaTimes says.
About the Author Reprints
Juno took a play from the pharma book called “hedging your bets with the FDA”. The hold was reversed in 2 days, which is less than the time necessary even to get an expedited review with the IRB. So they probably submitted two protocols to the IRB, one with and one without the chemotherapy. When the protocol with the chemo was put on IND hold the approved backup protocol would be ready to send to the FDA within the same day. There is no other rational explanation for FDA approving a brand new protocol and lifting the hold within 2 days.