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FDA Sets UDI Compliance Deadline for Class I, Unclassified Devices

  • Post author:Sam
  • Post published:February 15, 2018
  • Post category:The GMP Letter

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

Continue ReadingFDA Sets UDI Compliance Deadline for Class I, Unclassified Devices

2 Biotechs With the Potential of Doubling Investors' Cash

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

Analyst price targets for these two biotechs suggest they could double your money. Here's what you need to know. Source: BioSpace

Continue Reading2 Biotechs With the Potential of Doubling Investors' Cash

Oxford BioMedica Wins $105M Gene Therapy Contract From Bioverativ

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

The deal includes a licence to use OXB's LentiVector Enabled technology and access to its industrial-scale manufacturing technology. Source: BioSpace

Continue ReadingOxford BioMedica Wins $105M Gene Therapy Contract From Bioverativ

Teva Surges After Warren Buffett's Berkshire Reports $358M Stake

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

Teva got a nice shot in the arm after reports that billionaire investor Warren Buffett took a stake in the company. Source: BioSpace

Continue ReadingTeva Surges After Warren Buffett's Berkshire Reports $358M Stake

4 Small Biotech M&A Targets for Gilead

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

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

Continue Reading4 Small Biotech M&A Targets for Gilead

Beleaguered Axovant Begins Cutting Jobs While Exiting CEO Gets $2.6M+ Severance Package

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

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…

Continue ReadingBeleaguered Axovant Begins Cutting Jobs While Exiting CEO Gets $2.6M+ Severance Package

J&J Wins FDA Nod for Erleada, the First Drug for Nonmetastatic Prostate Cancer

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

Janssen got a little love from the FDA on Wednesday. Source: BioSpace

Continue ReadingJ&J Wins FDA Nod for Erleada, the First Drug for Nonmetastatic Prostate Cancer

Vertex Nixes Three Planned Phase III CF Trials in France

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

Vertex has declined to comment, but BioCentury received a copy of the letter the company sent to laboratories explaining. Source: BioSpace

Continue ReadingVertex Nixes Three Planned Phase III CF Trials in France

GT Biopharma Promotes COO to Top Post, Effective Immediately

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:BioPharma

Mr. Cross has held the position of President and COO of GTBP since November 16, 2017. Source: BioSpace

Continue ReadingGT Biopharma Promotes COO to Top Post, Effective Immediately

Guangzhou Facility Warned for Deficient Procedures

  • Post author:Sam
  • Post published:February 14, 2018
  • Post category:Drug Industry Daily

The FDA sent a warning letter to Chinese manufacturer Guangzhou Baiyunshan for failing to follow proper cleaning, validation and storage procedures at its Guangzhou, Guangdong facility. Source: Drug Industry Daily

Continue ReadingGuangzhou Facility Warned for Deficient Procedures
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