FDA Drafts Guidance on Replacing Reagents for IVD Devices
The FDA issued draft guidance to provide updates on in vitro diagnostics’ replacement reagents. Source: The GMP Letter
IMDRF Updates Device Safety and Performance Assessment Guidelines
The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction. Source:…
FDA Sets UDI Compliance Deadline for Class I, Unclassified Devices
The FDA issued “immediately in effect” guidance for manufacturers of Class I and unclassified medical devices on compliance dates for meeting unique device identification requirements. Source: The GMP Letter
2 Biotechs With the Potential of Doubling Investors' Cash
Analyst price targets for these two biotechs suggest they could double your money. Here's what you need to know. Source: BioSpace
Oxford BioMedica Wins $105M Gene Therapy Contract From Bioverativ
The deal includes a licence to use OXB's LentiVector Enabled technology and access to its industrial-scale manufacturing technology. Source: BioSpace
Beleaguered Axovant Begins Cutting Jobs While Exiting CEO Gets $2.6M+ Severance Package
When David Hung abruptly left Axovant Sciences this week, he walked away with a hefty severance package of $2.26M as well as a discretionary bonus of $300,000, according to a…
4 Small Biotech M&A Targets for Gilead
Investors and analysts had been encouraging Gilead to acquire something for a long time, so they were mostly happy when it bought Kite Pharma in September. Source: BioSpace
Teva Surges After Warren Buffett's Berkshire Reports $358M Stake
Teva got a nice shot in the arm after reports that billionaire investor Warren Buffett took a stake in the company. Source: BioSpace
J&J Wins FDA Nod for Erleada, the First Drug for Nonmetastatic Prostate Cancer
Janssen got a little love from the FDA on Wednesday. Source: BioSpace
Vertex Nixes Three Planned Phase III CF Trials in France
Vertex has declined to comment, but BioCentury received a copy of the letter the company sent to laboratories explaining. Source: BioSpace
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