And so, another working week will soon draw to a close. This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is rather modest. Besides hoping to keep cool, we plan to catch up on sundry chores and errands, hang with two of our short people, and take a nap or three. And what about you? This is a lovely time of year to enjoy the outdoors and get a real tan (not one of those orange ones you-know-who has been sporting). You could make time for someone special. Or simply plan the rest of your life. Whatever you do, have a grand time. But be safe. See you soon …
Despite issuing an indefinite ban on a Chinese factory run by Zhejiang Hisun Pharmaceutical last September, the US Food and Drug Administration allowed the plant to continue exporting ingredients for use in finished drugs in the US, Bloomberg News tells us. The agency had found “broad data manipulation,” such as deleted potency and purity information, but allowed shipments to avoid drug shortages.
The European Medicines Agency issued a paper outlining possible revisions to its existing guidelines for first-in-human studies in wake of the French clinical trial in which one man died and others were hospitalized earlier this year. The agency, which issued its guidelines in 2007, hopes to find better ways to respond to adverse events, such as rules for stopping a trial. French authorities last month began an involuntary manslaughter investigation.
Even as the FDA increased scrutiny of India’s drug makers, the agency is approving generic drug applications from Indian companies at a record pace, Bloomberg News reports. The FDA approved 83 new generic applications from India’s publicly listed firms in the last six months of 2015. In the first half of this year, approvals slowed to 72 through June, but this was still among the best six-month periods in dating to 2005.
Valeant Pharmaceuticals says the FDA raised concerns over a new eye drop made at a Bausch + Lomb facility in Florida and issued a complete response letter, Reuters writes. The agency did not identify any efficacy or safety issues with the eye drop, which is being developed to treat a type of glacuoma, but cited problems with good manufacturing practices.
Roche chief executive Severin Schwan says the UK risks losing its lead in medical research if the Brexit vote prompts the country to leave the European Union, SwissInfo tells us.
Amgen and Allergan said a late-stage trial of a biosimilar version of Roche’s Herceptin that they are developing met its primary endpoint, according to the Wall Street Journal.
The European Medicines Agency recommended marketing authorization in the European Union for Truvada, the pre-exposure prophylaxis, or PrEP, treatment for HIV.
Wockhardt received an Establishment Inspection Report from the FDA for three facilities and said a ban on exports from to the US will continue, the Economic Times writes.
Pfizer and Spark Therapeutics say their investigational hemophilia B drug has been awarded breakthrough therapy status by the FDA, according to PharmaTimes.
Merck suffered a setback with its C. difficile medicine as the FDA asked the drug maker for additional data, delaying a decision on a priority review by three months, PharmaTimes says.
More than 400 women have so far opted in to sex-discrimination litigation that was filed on behalf of female sales reps against Merck, the New Jersey Law Journal writes. The sign-up deadline is Aug. 12.