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BioMarin Shoots Up on Roche Takeover Rumor

  • Post author:Sam
  • Post published:July 8, 2016
  • Post category:BioPharma

<IMG SRC"http://enewsletters.biospace.com/images/news/biospace-breaking-news-boardroom.jpg" NAME"BioMarin Shoots Up on Roche Takeover Rumor" ALT"BioMarin Shoots Up on Roche Takeover Rumor"July 7, 2016By Alex Keown, BioSpace.com Breaking News StaffSAN RAFAEL, Calif. Shares of <A HREF...…

Continue ReadingBioMarin Shoots Up on Roche Takeover Rumor

Week In Review

  • Post author:Sam
  • Post published:July 7, 2016
  • Post category:Drug Industry Daily

Source: Drug Industry Daily

Continue ReadingWeek In Review

NICE Backs Pfizer’s Bosulif After Cancer Fund Restructuring

  • Post author:Sam
  • Post published:July 7, 2016
  • Post category:Drug Industry Daily

The UK’s price watchdog is backing coverage for Pfizer’s Bosulif at a new discounted price, broadening access to the drug that was previously only available through the now-revamped Cancer Drugs…

Continue ReadingNICE Backs Pfizer’s Bosulif After Cancer Fund Restructuring

FDA Issues Rebuttal to AstraZeneca Exclusivity Suit

  • Post author:Sam
  • Post published:July 7, 2016
  • Post category:Drug Industry Daily

AstraZeneca’s lawsuit against the FDA over the exclusivity of one of its drugs is a “transparent” effort to stifle generic competition for the blockbuster anti-cholesterol drug Crestor, the FDA said…

Continue ReadingFDA Issues Rebuttal to AstraZeneca Exclusivity Suit

FDA Sets Compliance Framework for Compounding Near Replicas of Approved Drugs

  • Post author:Sam
  • Post published:July 7, 2016
  • Post category:Drug Industry Daily

The FDA is laying out compliance parameters for outsourcing facilities that compound near replicas of approved drugs, urging them not to distribute such products to patients that could use an…

Continue ReadingFDA Sets Compliance Framework for Compounding Near Replicas of Approved Drugs

Pfizer Signs Code of Conduct for Opioid Marketing Under Deal With Chicago

  • Post author:Sam
  • Post published:July 6, 2016
  • Post category:Drug Industry Daily

Pfizer has pledged to communicate all the risks associated with opioids in future ads under an unusual accord it reached with the city of Chicago. Source: Drug Industry Daily

Continue ReadingPfizer Signs Code of Conduct for Opioid Marketing Under Deal With Chicago

FDA Recalls and Import Alerts

  • Post author:Sam
  • Post published:July 6, 2016
  • Post category:Drug Industry Daily

Source: Drug Industry Daily

Continue ReadingFDA Recalls and Import Alerts

Legislative Update

  • Post author:Sam
  • Post published:July 6, 2016
  • Post category:Drug Industry Daily

Source: Drug Industry Daily

Continue ReadingLegislative Update

Protocol Deviations Prompt 483s for Clinical Investigators

  • Post author:Sam
  • Post published:July 6, 2016
  • Post category:Drug Industry Daily

Three clinical investigators were cited for deviating from their investigational plans recently by the FDA for a litany of different reasons. Source: Drug Industry Daily

Continue ReadingProtocol Deviations Prompt 483s for Clinical Investigators

Croatian Regulator Slams Indian API Maker for 32 Alleged GMP Violations

  • Post author:Sam
  • Post published:June 17, 2016
  • Post category:International Pharmaceutical Regulatory Monitor

Indian API maker Dhanuka Laboratories could lose its EU GMP certificate after an inspection turned up 32 violations. Source: International Pharmaceutical Regulatory Monitor

Continue ReadingCroatian Regulator Slams Indian API Maker for 32 Alleged GMP Violations
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