Keytruda trial stopped due to positive results; new bill proposes continuing FDA rare pediatric voucher program; AstraZeneca signs five-year research pact with Harvard Stem Cell Institute
HCV drugs and other specialty medications drove a 13% increase in last year's prescription spending, the CBO overestimated just how much healthcare reform would cost, and an FDA panel voted 17-0 in favor of Kythera's drug that can reduce double chins.
Lilly delays Phase-III cholesterol drug results; PatientsLikeMe and Walgreens team up for "drug reaction reviews"; Roche skin-cancer drug receives Priority Review.
Amgen's Blincyto was approved for a rare form of leukemia after receiving Breakthrough Therapy designation and a Priority Review.
Otsuka acquires Avanir; hackers target pharma; Novartis must give up nicotine patch to finalize GSK consumer deal.
The scoop means the maker of HCV drugs Harvoni and Sovaldi can give any drug an accelerated review time.
A US Senate bill would also make treatments for the disease eligible for priority review vouchers.
For example: Tufts Center for the Study of Drug Development reseachers say it takes 18% longer to develop CNS drugs than it does non-CNS drugs.
It's the second for this cancer drug in two weeks.
The FDA granted priority review for the experimental, all-oral Gaucher's disease treatment.
GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.
An Institutes of Medicine report says doctors are struggling to keep up with cancer tech; AstraZeneca licenses an experimental Merck cancer treatment; Roche tees up for FDA panel review of a new Perjeta indication
Akorn expands, buying Hi-Tech Pharmacal; nursing homes miss their goal to curb antipsychotic-drug use; Bayer cancer drug gets priority review; and Lonza lays off staff
The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.
China's industry investigation widens beyond GlaxoSmithKline; PhRMA's European equivalent rallies patient groups to fight transparency; Biogen Idec says a patient's death is not linked to Tecfidera; parents swap walk-in clinics for office visit; Roche continues its CEO hunt; and Forest logs 6% sales growth.
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- Lawmakers propose allowing pharma companies to share some off-label information
- US pharma market value projected to be $550 billion in five years
- Everyday Health buys rare-disease agency Cambridge BioMarketing
- Biosimilar uptake will require companies to tell a trustworthy backstory
- Apple's ResearchKit: Five Guidelines for Pharma