Rise and shine, everyone, another busy day is on the way. And so far, this is a quieter day than expected. The local water company, such as it is, has been drilling in the vicinity of the usually serene Pharmalot campus, but perhaps this is their day off. We will find out soon enough. Meanwhile, time for a cup of stimulation and some tidbits. As always, we wish you a smashing day and hope you will remember to pass along interesting secrets …
Cigna will become the latest payer to strike a deal with drug makers to receive discounts if certain medicines don’t help patients as expected, the Wall Street Journal writes. The insurer will get extra price discounts from Amgen, Regeneron Pharmaceuticals, and Sanofi for their pricey, new cholesterol medications known as PCSK9 inhibitors, which can greatly lower the LDL, or bad cholesterol, but cost roughly $14,000 a year.
A majority of Americans oppose federal regulatory changes to speed up the development and approval of new drugs and devices, according to a new poll from STAT and the Harvard T.H. Chan School of Public Health. The findings suggest the public has serious doubts about the 21st Century Cures legislation moving through Congress. Lawmakers from both parties want to change regulatory standards they blame for slowing the approval process for products.
The National Institutes of Health grants hundreds of exclusive licenses each year to small drug makers and biotechs, but releases little to no information about how any of the startups are vetted and licenses are awarded, according to Regulatory Focus. In fact, the decisions appear shrouded in secrecy. In some cases, the companies awarded these licenses do not have office space or websites.
Medivation is exploring a sale following a $9.3 billion offer from Sanofi and interest from other drug makers, Reuters reports. Among the companies that have signed non-disclosure agreements are Pfizer and Amgen. Medivation had recently spurned the Sanofi bid as undervalued, triggering speculation that other drug makers would quickly consider making higher offers.
Hundreds of doctors from Germany are helping establish a “No Free Lunch” campaign in India to blunt promotional influences from drug makers, the Economic Times tells us.
The UK’s National Institute for Health and Care Excellence backed a GlaxoSmithKline lupus drug called Benlysta under a managed access scheme five years after first rejecting the medicine, Pharma Times writes.
Allergan is reworking its executive team and buying back up to $10 billion in stock as the drug maker reported sales that fell short of analysts’ expectations, according to the Wall Street Journal.
The Indian government asked IMS Health to conduct a study to explore whether India should become a member of a global forum that sets standards for good manufacturing practices, The Economic Times reports.
The FDA is requiring updated labels for all drugs containing the olanzapine antipsychotic to warn about a possible risk of a serious and potentially fatal skin reaction, Pharmacy Times says.
Chimerix reported that its experimental antiviral had not improved the survival rate of infected patients in an ongoing clinical trial, the News & Observer writes.