Drugs approved through the accelerated approval pathway, as well as psychiatric drugs, were more likely to have a safety issue following FDA approval.
The FDA to require black-box warnings for hep.-C drugs; AstraZeneca's Brilinta fails to meet study goals; ICER says PD-1s are too pricey
And why the stories behind thalidomide, Naprosyn, AZT, cardiology stents, and Zaltrap still resonate.
Darzalex may interfere with blood testing; Kaine scrutinized for ties to pharma; medical societies are in support of bill exempting CME reporting
EpiPen price hikes led to syringe use; states with medical marijuana laws have drops in drug spending; Pfizer and Merck KGaA start ovarian cancer trial
The FDA issues warning for certain antipsychotics; Shkreli may face more securities charges; Genentech and Stand Up to Cancer launch campaign
While it's made great strides, the healthcare industry is still behind in some technology and information safeguards.
Critics question the FDA's decision to approve OxyContin for children; AstraZeneca temporarily stops to lung-cancer trials; Sanders will oppose Califf's nomination as FDA commissioner
New analysis says Paxil is not safe or effective for teens; some FDA reviewers voted against Addyi approval over side effects; HHS partners with AstraZeneca on antibiotic development
The FDA encourages clinical testing of testosterone; Google spins out its life-sciences business; Novartis buys remaining rights to Arzerra
Sanofi plans immuno-oncology collaboration with Regeneron; Merck considers hard-to-treat patient populations for its experimental hepatitis-C therapy; drugmakers did not report 10% of adverse events to the FDA within required timeframe
UnitedHealth looks for refunds when drugs don't work; the European Medicines Agency recommends Sanofi's and Regeneron's PCSK9 inhibitor, Praluent, for approval; Biogen's multiple-sclerosis drug, Tecfidera, reports lower-than-expected sales growth
Gilead will limit financial assistance to patients to pressure payers; Biogen reports another PML case related to Tecfidera; Valeant buys Egyptian drugmaker
Celgene announces $7.2-billion bid for Receptos; Cytokinetics is using Ice Bucket Challenge donations to test experimental drug; GlaxoSmithKline conducts media review for its consumer health brands
The FDA approves AstraZeneca's Iressa as a first-line lung-cancer therapy; Mylan and Dr. Reddy's launch generic versions of dementia treatment Namenda; health insurer consolidation may lead to pressure on drug prices
Dr. Stephen Ostroff took over as the FDA's acting commissioner when Dr. Margaret Hamburg stepped down in March.
- Study: One-third of docs trust pharma content on HCP sites
- Five things for pharma marketers to know: Wednesday, May 17, 2017
- Five things for pharma marketers to know: Monday, May 22, 2017
- Five things for pharma marketers to know: Tuesday, May 23, 2017
- Five things for pharma marketers to know: Friday, May 19, 2017
- Five things for pharma marketers to know: Wednesday, May 24, 2017
- The FDA cites risk info in warning letter over Contrave DTC ad
- Nearly every $100,000 drug approved in the last three years was for a rare disease
- Alexion hires new chief commercial officer
- Otsuka, Proteus refile their sensor-enabled drug
Live at MM&M Transforming Healthcare
In his keynote address at the MM&M Transforming Healthcare conference, Dr. Gautam Gulati says the industry is being outpaced by its innovation.
One executive referred to AI as a "black box" and as the "Tower of Babel."
Execs stressed the importance of collaboration, consumer-mindedness.
The artificial pancreas can provide value to the health system.
MM&M honors 40 upstarts and veteran innovation gurus.
For the first time MM&M honors a group of 10 agency execs.