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In Shkreli's wake, KaloBios vows fair pricing. Will others follow?

EVENTSfiercepharma2016-04-14 12:45 Read   46

KaloBios ($KBIO) pledged a fair pricing oath last week as part of its corporate brand-saving maneuver away from one-time CEO and industry bête noire Martin Shkreli.

Amid finger-pointing on native ad rules, pharma gears up to do it right

Commentsfiercepharma2016-04-14 11:18 Read   73

A study this week called out a majority of marketers for violating FTC native advertising rules, noting that only one-third use the proper labels.

Merck KGaA loses FDA nod for fertility drug

R&Dfiercepharma2016-04-14 11:13 Read   84

It's been more than 10 years since the FDA signed off on Merck KGaA's fertility drug Luveris. But now, after the company failed to conduct a postmarketing trial, the FDA has yanked the drug's approval at the German pharma's request.

Drug Pricing, Presidential Politics, and Three Biotechs with Promise PTIE, DRRX, ABEO, AST

EVENTSthelifesciencesreport2016-04-14 11:06 Read   63

While the vagaries of the 2016 political season create uncertainty in the biotech and pharmaceutical sectors, companies are moving ahead with innovative cell therapies, gene therapies and new, safer ways to deliver addictive drugs, and investors find themselves in a position to play the development ideas with varying degrees of risk.

FDA panel says no to quick approval of Clovis' rociletinib

Regulatorpmlive2016-04-14 10:55 Read   92

An FDA advisory committee all but dashed any hopes that Clovis Oncology had for quick approval of its lung cancer drug rociletinib yesterday.

Health Tip: Wear a Bike Helment

Healthdrugs2016-04-14 10:55 Read   68

A helmet is essential for any person who rides a bicycle. Here are guidelines for choosing a safe helmet that should be worn for every ride.

PAREXEL And EMC Form Alliance To Provide Cloud-Based Document And Regulatory Information Management Services

R&Drealwire2016-04-14 10:27 Read   82

PAREXEL enhances its Regulatory Cloud; leverages EMC® Documentum® for Life Sciences software solution suite to offer an end-to-end regulatory solution

Brain on LSD revealed: First scans show how the drug affects the brain

R&Dsciencedaily2016-04-14 10:20 Read   71

For the first time, researchers have visualized the effects of LSD on the human brain. In a series of experiments, scientists have gained a glimpse into how the psychedelic compound affects brain activity. The team administered LSD (Lysergic acid diethylamide) to 20 healthy volunteers in a specialist research centre and used various leading-edge and complementary brain scanning techniques to visualize how LSD alters the way the brain works.

Medivation Said to Have Rebuffed Sanofi Takeover Approach

EVENTSbloomberg2016-04-14 10:14 Read   41

Medivation Inc. rebuffed a recent takeover approach from French drugmaker Sanofi, which is pursuing the U.S. company to expand its cancer treatment business, according to people familiar with the matter.

U.S. docs know scarily little about the FDA process for new drugs

Commentsfiercebiotech2016-04-14 10:04 Read   53

The very people charged with prescribing medicines to patients don’t, as it turns out, know very much at all about how they are approved--and this may be leading them to over-prescribe new drugs.

Kala Pharmaceuticals Announces Closing of $68 Million Series C Financing

EVENTSbusinesswire2016-04-14 09:56 Read   58

Kala Pharmaceuticals, Inc. (Kala), a developer of innovative ophthalmic products based on its proprietary mucus-penetrating particle (MPP) technology, announced that it has closed a highly oversubscribed $68 million Series C preferred stock financing, led by Longitude Capital.

UCSD targets dendritic spines in promising Alzheimer's approach

Trendfiercebiotech2016-04-14 09:51 Read   72

Current Alzheimer’s treatments control symptoms without tackling the underlying disease or delaying its progression. Scientists from the University of California, San Diego have created molecules that may be able to protect neuronal function in people with neurodegenerative disease, a potential new take on Alzheimer's disease.