Cardiologists say that up to 15% of their patients could be on PCSK9 inhibitors next year; FDA committee to evaluate new Oxycodone version
Groups urge disclosure of payments to nurse practitioners and physician assistants; Horizon seeks $3-billion acquisition of Depomed; Sanofi closes $245-million agreement to buy priority-review voucher
The FBI is investigating Johnson & Johnson's morcellator; Sanofi purchased another priority review voucher; generic drug prices are falling at a slow rate
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.
Specialty medicines continue to be a hot category, one in which spending has surged behind products that treat medicine's most complex diseases. This eBook lays out the needs and hurdles along the specialty drug pathway, explaining how stakeholders are working to get meds into patients' hands and ease their experience. Click here to download.