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Diagnostic tool reliably predicted obstructive sleep apnea

R&Dhealio2016-04-12 10:56 Read   98

Researchers have validated the use of the Sleep Apnea Clinical Score, according to data published in Mayo Clinic Proceedings.

AZ gets $100m from Lilly as Alzheimer's drug moves into phase III

TrendPmlive2016-04-12 10:26 Read   189

AstraZeneca and Eli Lilly's candidate therapy for Alzheimer's disease (AD) has cleared a phase II/III trial and will now move on to pivotal phase III testing.

FDA Grants Priority Review for Genentech’s Cancer Immunotherapy Atezolizumab in Specific Type of Lung Cancer

Trenddrugs2016-04-12 10:17 Read   193

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) and granted Priority Review for atezolizumab (anti-PDL1; MPDL3280A) for the treatment of people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-containing chemotherapy.

Lilly CEO Lechleiter nabs $16.6M in 2015 pay, with hefty boosts to incentive compensation

R&Dfiercepharma2016-04-11 12:58 Read   94

Eli Lilly CEO John Lechleiter has suffered some tough years this decade, as top sellers such as Zyprexa went off patent and a series of R&D setbacks put a crimp in the company's plans to fill those gaps. But 2015 turned out better than expected--and it shows in Lechleiter's pay.

Venter's HLI valued at $1.2B in Series B round

EVENTSfiercebiotech2016-04-11 11:21 Read   86

J. Craig Venter's Human Longevity, Inc. has refueled in the race to build an industry-leading repository of genomes and associated data. The refueling took the form of a $220 million Series B round, which reportedly valued the company at upward of $1.2 billion and attracted the support of long-time HLI backers Celgene ($CELG) and Illumina ($ILMN).

Five things to know about the flu vaccine

Healthhealio2016-04-11 10:47 Read   98

As the 2015-2016 influenza season is coming to an end, Infectious Disease News has compiled a list of five stories that added new information about the influenza vaccine.

Shock approval for Abiomed but big test to come

Regulatorepvantage2016-04-11 10:19 Read   117

After yesterday’s expanded FDA approval of its Impella line of heart pumps Abiomed is heading for an even more significant event. In a year or so a US study, Shield II, comparing Impella with St. Jude Medical’s HeartMate PHP pump during high-risk percutaneous coronary intervention (PCI) procedures will report data.

FDA staff question efficacy, safety of Clovis' rociletinib in T790M-positive NSCLC

Commentsfirstwordpharma2016-04-11 10:08 Read   144

 In documents posted to the FDA's website Friday ahead of an advisory panel meeting on April 12, agency staff cast doubt on whether Clovis Oncology's experimental lung cancer drug rociletinib is any more effective than existing treatments.

FDA Advisory Committee Unanimously Recommends Accelerated Approval of Ocaliva (obeticholic acid) for the Treatment of Primary Biliary Cirrhosis

Commentsdrugs2016-04-11 09:17 Read   770

Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a clinical stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA)'s Gastrointestinal Drugs Advisory Committee voted 17 to 0 to recommend accelerated approval of Ocaliva (obeticholic acid) for the treatment of patients with primary biliary cirrhosis, recently renamed primary biliary cholangitis (PBC).

FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

RegulatorFDA2016-04-11 09:08 Read   131

Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox to treat swine because the drug may leave trace amounts of a carcinogenic residue.

FDA Flashback: The Top Five New Drug Approvals From 2015

Commentsdrugs2016-04-08 17:23 Read   130

This past year close to 100 new drugs were FDA-approved, so it’s encouraging to look back and see the progress that’s been made as 2015 ends. In fact, more than 40 novel drugs, including a new drug class for patients with high cholesterol, a first-time biosimilar, a life-saving heart failure drug, and a controversial agent to boost women’s libido, all successfully passed through the Agency’s halls.

Shire says Baxalta merger on track despite US tax clampdown

EVENTSPmlive2016-04-08 17:17 Read   110

Shire has said it is confident its $32bn deal to buy Baxalta will go ahead as planned, despite the abandonment of Pfizer's merger with Allergan.