Why Novavax Could be a Millionaire-Maker Stock
If you had a crystal ball, you probably would have invested in Berkshire Hathaway in 1964, or Apple in the 1980s. Source: BioSpace
Drug Giant Roche Buys Former Google Execs' Flatiron in $1.9B Deal
Roche will plunk down $1.9M to acquire Flatiron Health, which has previously been backed by GV, as well as Roche. Source: BioSpace
FDA Advisory Panel Spurns Pacira's Request for Expanded Use of Pain Drug Exparel
Shares of Pacira plunged more than 15 percent this morning after the company revealed the FDA panel's decision. Source: BioSpace
Amag Investors Cheer as Biotech Wins Second Drug Approval This Month
Makena was approved by the FDA in February 2011 and remains the first and only FDA-approved treatment option currently available for pregnant women who have had a prior spontaneous preterm…
Illumina Leaves Mission Bay for New Campus in the Peninsula
The new campus will consolidate some 400 employees in one place and give more space to the startup companies it helps. Source: BioSpace
Superstar Investors Jump in on Celgene Spinout Celularity's $250M Funding Round
Celularity is a biotech founded by stem cell pioneer Robert Hariri, MD, PhD. Source: BioSpace
FDA Tackles Neurological Disorders in Five Guidances, Flags Patient Input
The FDA released five guidances on treatments for a variety of neurological disorders including Duchenne muscular dystrophy and Alzheimer’s disease, offering suggestions for trial designs and methods of measuring effectiveness.…
FDA Clarifies Process to Obtain Informal Feedback Prior to Marketing Submissions
The FDA used a Q&A format to issue final guidance on an informal, non-binding process for sponsors to obtain preliminary feedback before submitting marketing applications. Source: Drug Industry Daily
Expert Committee Votes Down Nerve Block Indication for Exparel
An FDA advisory committee narrowly voted against recommending an additional nerve block indication for Pacira’s Exparel, a local analgesic approved in 2011 for post-surgical pain management. Source: Drug Industry Daily
Gottlieb Outlines FDA Plans for Compounding Enforcement
In Jan. 30 testimony before a House subcommittee, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s…
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