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PharmaJet Releases Positive Phase I Results for Hantavirus Vaccines

  • Post author:Sam
  • Post published:March 13, 2018
  • Post category:BioPharma

PharmaJet released positive interim results from the U.S. Army’s Phase I clinical trial of two hantavirus vaccines to prevent hemorrhagic fever with renal syndrome (HFRS). Source: BioSpace

Continue ReadingPharmaJet Releases Positive Phase I Results for Hantavirus Vaccines

European Commission Finds Fewer Pay-for-Delay Deals

  • Post author:Sam
  • Post published:March 13, 2018
  • Post category:Drug Industry Daily

Pay-for-delay deals between branded and generic drugmakers in the European Union continued to decline in 2016, according to the latest update from the European Commission. Source: Drug Industry Daily

Continue ReadingEuropean Commission Finds Fewer Pay-for-Delay Deals

President’s Panel Calls for Value-Based Pricing, Increased Competition to Lower Cancer Drug Prices

  • Post author:Sam
  • Post published:March 13, 2018
  • Post category:Drug Industry Daily

The President’s Cancer Panel highlighted the sharp increase in U.S. cancer drug prices in a 70-page report to President Trump, calling for more value-based pricing, more competition in the drug…

Continue ReadingPresident’s Panel Calls for Value-Based Pricing, Increased Competition to Lower Cancer Drug Prices

FDA Adopts Final ICH M7(R1) Mutagenic Carcinogen Guideline

  • Post author:Sam
  • Post published:March 13, 2018
  • Post category:Drug Industry Daily

Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.…

Continue ReadingFDA Adopts Final ICH M7(R1) Mutagenic Carcinogen Guideline

FDA Plans More Research Into Drug Advertising

  • Post author:Sam
  • Post published:March 13, 2018
  • Post category:Drug Industry Daily

The FDA announced plans for additional research into the impact of drug promotion on consumers’ understanding of prescription drug risks and benefits, and said a more targeted presentation of risks…

Continue ReadingFDA Plans More Research Into Drug Advertising

AbbVie’s Elagolix Dazzles in Phase III Trial

  • Post author:Sam
  • Post published:March 12, 2018
  • Post category:BioPharma

AbbVie and Neurocrine Biosciences announced that its Phase III ELARIS UF-II trial of elagolix for uterine fibroids met its primary endpoint. Source: BioSpace

Continue ReadingAbbVie’s Elagolix Dazzles in Phase III Trial

Protalix BioTherapeutics Treatment for Ulcerative Colitis Shows Positive Data

  • Post author:Sam
  • Post published:March 12, 2018
  • Post category:BioPharma

Protalix BioTherapeutics believes it’s on the right track in developing an oral medicine for ulcerative colitis that could potentially replace current TNF-inhibitor therapies that are administered via injection or infusion.…

Continue ReadingProtalix BioTherapeutics Treatment for Ulcerative Colitis Shows Positive Data

Proteostasis Therapeutics Snags Breakthrough Designation

  • Post author:Sam
  • Post published:March 12, 2018
  • Post category:BioPharma

The U.S. Food and Drug Administration granted Proteostasis Therapeutics' investigational cystic fibrosis add-on therapy the Breakthrough Therapy Designation. Source: BioSpace

Continue ReadingProteostasis Therapeutics Snags Breakthrough Designation

Are Life Science Companies Falling Behind Tech Companies?

  • Post author:Sam
  • Post published:March 12, 2018
  • Post category:BioPharma

Tech companies have been making significant forays into the life sciences and a new report suggests that life science companies are in danger of falling behind their tech brethren.. Source:…

Continue ReadingAre Life Science Companies Falling Behind Tech Companies?

FDA Grants Merck's Keytruda Priority Review for Cervical Cancer

  • Post author:Sam
  • Post published:March 12, 2018
  • Post category:BioPharma

The FDA accepted Merck & Co.’s supplemental Biologics License Application and granted Priority Review for Keytruda in advanced cervical cancer. Source: BioSpace

Continue ReadingFDA Grants Merck's Keytruda Priority Review for Cervical Cancer
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