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Janssen’s Remicade Biosimilar Infringement Case Against Samsung Bioepis Dismissed

  • Post author:Sam
  • Post published:December 6, 2017
  • Post category:Drug Industry Daily

Janssen Biotech and Samsung Bioepis jointly requested that Janssen’s patent infringement case be dismissed following the Supreme Court’s ruling earlier this year on the biosimilar approval process. The New Jersey…

Continue ReadingJanssen’s Remicade Biosimilar Infringement Case Against Samsung Bioepis Dismissed

PTAB Judge Issues Guidance on Amending Patents Following Circuit Court Decision

  • Post author:Sam
  • Post published:December 6, 2017
  • Post category:Drug Industry Daily

The chief administrative law judge of the PTO’s Patent Trial and Appeal Board issued guidance to holders on how to amend their patents after being challenged with an inter partes…

Continue ReadingPTAB Judge Issues Guidance on Amending Patents Following Circuit Court Decision

Jury Orders Bayer, J&J to Pay $28 Million for Xarelto Claims in First Bellwether Loss

  • Post author:Sam
  • Post published:December 6, 2017
  • Post category:Drug Industry Daily

A Philadelphia jury found Bayer and Johnson & Johnson liable for the injuries of a woman prescribed their prescription blood thinner Xarelto, following three consecutive victories for the drugmakers in…

Continue ReadingJury Orders Bayer, J&J to Pay $28 Million for Xarelto Claims in First Bellwether Loss

FDA Proposes Collaborative Approach for Pediatric Rare Disease Research

  • Post author:Sam
  • Post published:December 6, 2017
  • Post category:Drug Industry Daily

For more efficient development of treatments for pediatric rare diseases, sponsors can implement controlled, multi-arm, multi-company clinical trials, according to a new draft guidance that the FDA says could help…

Continue ReadingFDA Proposes Collaborative Approach for Pediatric Rare Disease Research

FDA Considers ‘Vicarious’ Criminal Liability for Senior Company Officials

  • Post author:Sam
  • Post published:December 6, 2017
  • Post category:Drug Industry Daily

The FDA’s chief counsel said the agency is examining the legal circumstances where a company’s senior personnel and management could be held not only civilly responsible, but also criminally responsible…

Continue ReadingFDA Considers ‘Vicarious’ Criminal Liability for Senior Company Officials

Ex-Employees Accuse Biotech Hedge Fund Founder of Toxic Sexual Harassment Culture

  • Post author:Sam
  • Post published:December 5, 2017
  • Post category:BioPharma

According to the report, Isaly made lewd comments to female employees, subjected them to pornographic images and made "pervasive sexist comments." Source: BioSpace

Continue ReadingEx-Employees Accuse Biotech Hedge Fund Founder of Toxic Sexual Harassment Culture

UK Science Gets More Post-Brexit Love From GlaxoSmithKline, Other Drugmakers

  • Post author:Sam
  • Post published:December 5, 2017
  • Post category:BioPharma

The move is welcome news for Prime Minister Theresa May, who has struggled to win over large sections of industry as Britain prepares to leave the European Union. Source: BioSpace

Continue ReadingUK Science Gets More Post-Brexit Love From GlaxoSmithKline, Other Drugmakers

4 Biotechs Facing Do-or-Die Catalysts in December

  • Post author:Sam
  • Post published:December 5, 2017
  • Post category:BioPharma

As 2018 winds down, it's not over for some biopharma companies. Source: BioSpace

Continue Reading4 Biotechs Facing Do-or-Die Catalysts in December

San Diego's Vital Therapies Names Ex-Jazz Pharma Exec as New Chief Leader

  • Post author:Sam
  • Post published:December 5, 2017
  • Post category:BioPharma

Cox takes over for Vital Therapies CEO Terry Winters who will step down from the Vital Therapies Board and become a consultant to the company. Source: BioSpace

Continue ReadingSan Diego's Vital Therapies Names Ex-Jazz Pharma Exec as New Chief Leader

Bay Area's Carmot Lands $240M+ R&D Tie-Up With Biotech Giant Amgen

  • Post author:Sam
  • Post published:December 5, 2017
  • Post category:BioPharma

Under the deal, Carmot will use its lead-identification technology to identify and advance novel drug leads for Parkinson's disease and other disease areas. Source: BioSpace

Continue ReadingBay Area's Carmot Lands $240M+ R&D Tie-Up With Biotech Giant Amgen
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