Rise and shine, another busy day is on the way. And this looks to be a delightfully sunny day as well here on the Pharmalot campus, where the shortest of short people is sleeping in. As for us, we are pursuing the usual routine of juggling meetings, calls, deadlines, and whatnot. No doubt, you may relate. So please join us for a needed cup of stimulation as we dig in. And, of course, here are some tidbits. Have a great day and do keep in touch …
The Drug Controller General of India is inspecting 200 drug makers, including leading manufacturers such as Cipla and Pfizer, for allegedly selling poor-quality medicines and failing to comply with manufacturing standards, the Times of India tells us. This is the first time that inspections on this scale have been undertaken by the regulator and follows ongoing concerns about quality-control problems at Indian facilities.
Meanwhile, the US Food and Drug Administration has banned Phalanx Labs from shipping products to the United States after the Indian company, which makes pharmaceutical ingredients, refused to let inspectors visit its site in Visakhapatnam, InPharma Technologist reports. The refusal suggests the company makes products under insanitary conditions, according to an FDA notice.
Some Valeant Pharmaceuticals documents concerning its accounting practices are being withheld from public scrutiny by the US Securities and Exchange Commission, according to Wells Fargo analyst David Maris. He suggests the move means the drug maker’s accounting may have been “more problematic than previously thought or that broader regulations on (the) use of (non-standardized) accounting may be forthcoming.”
Takeda Pharmaceuticals has begun the world’s first field test of a norovirus vaccine, which will be compared to placebo in healthy volunteers who are recruited from US military training installations, PMLive says.
Leading cancer doctors in the US are pushing pediatricians and other health care providers to help increase use of the HPV vaccine, the Washington Post tells us.
Inovio Pharmaceuticals and GeneOne Life Sciences received FDA approval to start an early-stage human trial testing their Zika vaccine, STAT writes.
The FDA released draft guidance for recommendations on better reporting and evaluating the age, race, and ethnicity data in clinical trials for medical devices, Regulatory Focus reports.
The Indian government plans to release widely anticipated revised guidelines for approving biosimilars during the first week in July, according to the Economic Times.
The first proposed testing of the CRISPR gene-editing technology in humans is being funded by Internet billionaire Sean Parker, according to the MIT Technology Review.
The European Medicines Agency is recruiting patient organizations for its management board in a bid to broaden input on product reviews, according to PMLive.
The Nasdaq Biotechnology Index fell last Friday for a ninth straight day, marking its longest selloff since June 1996, according to Bloomberg News.
GlaxoSmithKline reported its experimental combination therapy for chronic obstructive pulmonary disease topped AstraZeneca’s Symbicort in Phase 3 trial, Reuters says.
Drug makers asked the Russian government to ease conditions for running clinical trials in Russia, according to the Pharma Letter, citing recent statements from the Russian Ministry of Health.
The Scottish Medicines Consortium rejected Amgen’s Repatha, a PCSK9 inhibitor for lowering cholesterol, due to a lack of robust outcomes data, PMLive tells us.