Hello, folks, and how are you today? ’Tis the middle of the week, which calls for a celebratory cup of stimulation. After all, you made it this far, so why not forge ahead? Besides, a warm, shiny sun is enveloping the Pharmalot campus, which is a nice thing. Our official mascots seem to agree as they happily snooze nearby. Now, though, the time has come to get cracking. Here are some items of interest. Have a grand day and do keep in touch …
India is revising its Drugs and Cosmetics Act of 1940 to make it easier for companies to do business and improve the safety and efficacy of locally produced drugs, according to Reuters. The government added that, after extensive discussions with stakeholders, draft guidelines have been prepared to regulate the medical devices industry, and these would be issued shortly.
The UK’s National Institute for Health and Care Excellence recommended that five drugs should be covered, but only because the manufacturers agreed to reduce prices to the National Health Services, the Telegraph says. The drugs will be used to treat lung cancer, high cholesterol, melanoma, and a condition called hidradenitis, where sweat glands and cause abscesses, boils and lesions. Novartis sells two of the cancer drugs that were recommended.
The National Institutes of Health issued a policy for using a single Institutional Review Board for multi-site research in hopes of streamlining the IRB review process, Outsourcing Pharma writes. The policy is expected to allow IRBs to focus on reviewing single-site protocols, instead of conducting redundant reviews, which will hopefully yield enhanced oversight.
A growing variety of new apps and websites make it possible to get prescription contraceptives without going to the doctor, the New York Times tells us.
The US Food and Drug Administration withdrew a document that offered new details on how drug makers developing biosimilars might add suffixes to the names of their medicines, Regulatory Focus reports.
After positive Phase 2 results, Merck is taking a novel antibiotic into Phase 3 testing in combination with Primaxin, which is generally reserved to treat serious and resistant infections, PMLive says.
Impax Laboratories agreed to pay $586 million for several generic drugs from Teva Pharmaceuticals, which is closing in on a deal to buy the Allergan generic business, TheStreet notes.
The FDA agreed to review Mitsubishi Tanabe’s application to market a treatment of amyotrophic lateral sclerosis, or ALS, PharmaTimes informs us.
A large observational study suggests that moderate lowering of LDL, or bad cholesterol, may be just as effective as intensive lowering, according to CardioBrief.
Czech regulators say that three drug wholesalers have “seriously violated” guidelines for good distribution practices, according to InPharma Technologist.