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Better Late Than Never: Novartis, Momenta Win FDA Approval for Delayed MS Drug

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

Teva and Mylan are looking over their shoulders this morning after the FDA gave Novartis and Momenta the green light for their Copaxone copycat drug. Source: BioSpace

Continue ReadingBetter Late Than Never: Novartis, Momenta Win FDA Approval for Delayed MS Drug

Vertex Scores FDA Nod for CF Combo Drug, Sets $292,000 Price Tag

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

The FDA approved Vertex's Symdeko for cystic fibrosis in patients ages 12 and older with two copies of the F508del mutation. Source: BioSpace

Continue ReadingVertex Scores FDA Nod for CF Combo Drug, Sets $292,000 Price Tag

Booming Lakepharma to Create 100 New Jobs in Massachusetts Expansion

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

The company plans to add approximately 100 positions at the Center by 2020. Source: BioSpace

Continue ReadingBooming Lakepharma to Create 100 New Jobs in Massachusetts Expansion

Charles River Slams Down $800M Cash for Global CRO

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

The acquisition will strengthen Charles River's position as a global early-stage CRO, expanding its client base and service portfolio. Source: BioSpace

Continue ReadingCharles River Slams Down $800M Cash for Global CRO

It's Confirmed: Celgene's Former CEO and Chairman is Making a Run for the Senate

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

Bob Hugin announced his campaign on Monday in an email. Source: BioSpace

Continue ReadingIt's Confirmed: Celgene's Former CEO and Chairman is Making a Run for the Senate

AI Biotech, BioXcel Therapeutics, Files for $69M IPO

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

The Branford, CT-based company was founded in 2017 and plans to list on the Nasdaq under the symbol BTAI. Source: BioSpace

Continue ReadingAI Biotech, BioXcel Therapeutics, Files for $69M IPO

Purdue Pharma Cuts More Than Half of U.S. Sales Staff Amid Opioid Crisis

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

That announcement is a big change in the way Purdue has aggressively marketed OxyContin in the past. Source: BioSpace

Continue ReadingPurdue Pharma Cuts More Than Half of U.S. Sales Staff Amid Opioid Crisis

Walgreens Makes a Takeover Play for Drug Distributor AmerisourceBergen

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

AmerisourceBergen is one of the biggest drug distributors in the U.S. Source: BioSpace

Continue ReadingWalgreens Makes a Takeover Play for Drug Distributor AmerisourceBergen

Administration Requests Huge Hike in FDA Budget for FY2019 — Increased User Fees

  • Post author:Sam
  • Post published:February 12, 2018
  • Post category:Drug Industry Daily

President Trump’s proposed budget for FY 2019 calls for a major increase in budget authority for the FDA along with a significant increase in user fees. Source: Drug Industry Daily

Continue ReadingAdministration Requests Huge Hike in FDA Budget for FY2019 — Increased User Fees

New FDA Guidance Outlines Trial Design for BCG-Unresponsive NMIBC Drugs

  • Post author:Sam
  • Post published:February 12, 2018
  • Post category:Drug Industry Daily

Sponsors of drugs for treatment of bacillus Calmette-Guérin (BCG)-unresponsive nonmuscle invasive bladder cancer should use complete response rates in carcinoma in situ patients as their primary endpoint, the FDA said…

Continue ReadingNew FDA Guidance Outlines Trial Design for BCG-Unresponsive NMIBC Drugs
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