Good morning, everyone, and how are you today? We are just fine, thank you, especially since an extended holiday weekend is imminent on this side of the pond. In our case, we will return next week, which means we will begin our weekend daydreaming sooner than usual. Our agenda is rather modest. We hope to spend time with two of our short people, sample the great outdoors, and catch up on our reading. And you? This is a wonderful time to connect with special people, connect with nature, or you could try something completely different. Whatever you do, have a grand time. But be safe. See you soon…
Bill Gates supports US drug pricing despite intensifying criticism of high costs. “The current system is better than most other systems one can imagine,” he told Bloomberg Television. “The drug companies are turning out miracles, and we need their R&D budgets to stay strong. They need to see the opportunity.” He also backs tiered pricing for developing nations, in which drugs sold in low- and middle-income countries cost less than in developed nations.
Some big drug makers are returning to developing new antibiotics after decades of largely ignoring the business due to the meager returns offered by such medications, Bloomberg News tells us. Of 80 companies that pledged at the World Economic Forum to fight antimicrobial resistance, 18 expect to boost antibiotic research spending by an average of 36 percent this year, while expanding research staff by 6.5 percent.
The sharp fall in the British pound thanks to Brexit is hurting traders that sell cut-price drugs to the UK’s National Health Service after importing them from other parts of Europe, the Wall Street Journal reports. The UK is the second-largest parallel importer in the European Union and parallel imports may normally shave as much as 10 percent off the cost of innovative medicines in the country.
The US Centers for Medicaid & Medicare Service will revise a proposal to change how drugs are reimbursed under Medicare Part B before publishing the final rule, the Hill writes. CMS Deputy Administrator Patrick Conway told the Senate Finance Committee “we are reviewing the comments now and plan to make adjustments.” But he defended the overall approach and indicated the administration will proceed with finalizing the rule despite the controversy.
Tesaro stock popped yesterday after the company reported its PARP inhibitor slowed ovarian cancer progression in a late-stage study, STAT writes. The news boosted shares in Medivation, which is developing a PARP inhibitor, suggesting Sanofi may have to raise its bid for the company. One catch: Ovarian cancer rates may remain high, because patients who aren’t treated at well-trafficked oncology centers tend to receive sub-optimal treatment.
Cempra submitted an application to the European Medicines Agency to market its solithromycin to treat community-acquired bacterial pneumonia, or CABP, according to a regulatory filing. The drug maker hopes to win US regulatory approval for its antibiotic, which is billed as a safer alternative to fluoroquinolones, later this year. Cempra plans to price the medication at $400 to $500 for a treatment course.
Merck formed a partnership with Moderna Therapeutics to develop and commercialize personalized cancer vaccines that includes an upfront payment of $200 million, the Philadelphia Business Journal says. The goal is to find a tumor’s specific mutations and use those to form the basis of a vaccine to elicit a specific immune response, which would then recognize and destroy cancer cells.
The biotech industry and the Food and Drug Administration agreed on a draft commitment to support the latest version of the Biosimilar User Fee Act, a five-year funding deal to support agency reviews, Regulatory Focus reports.
The FDA warned two Chinese manufacturers of pharmaceutical ingredients for problems with data integrity and flimsy oversight of quality control, InPharma Technologist writes.
The FDA and European Medicines Agency are making significant progress toward mutually recognizing each other’s manufacturing inspections, according to Regulatory Focus.
India’s Union Health Ministry issued revised draft guidelines that create a regulatory pathway to obtain marketing authorization for biologics, PharmaBiz tells us.