BioSpace News Archive

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  Drug Development

  Sarepta Plunged After Adverse Event Forces Trial Halt in the UK

  But the biotech swiftly indicated that it doesn’t expect the halt to last for long.

  February 12, 2018

   · 

  2 min read

   · 

  Mark Terry
• 

  Policy

  Amicus Investors Cheer as the FDA Shaves Four Months Off Its Fabry Drug Review Date

  Amicus announced that the FDA accepted its NDA for migalastat to treat Fabry disease in patients with amenable mutations.

  February 12, 2018

   · 

  2 min read

   · 

  Mark Terry
• 

  Business

  Philips Healthcare to Shutter Manufacturing at Cleveland Plant

  The Dutch healthcare giant said that it also plans to invest in a service training program in Cleveland.

  February 12, 2018

   · 

  1 min read
• 

  Policy

  Pentax Medical Recalls Duodenoscopes Over Fluid Leakages

  The federal watchdog has cleared the updated design and labeling for the duodenoscope.

  February 12, 2018

   · 

  1 min read
• 

  Policy

  Insulet to Pay $19.5M to End Investor Lawsuit

  The lawsuit alleged that Insulet misrepresented the success of its OmniPod Eros roll-out in 2013.

  February 12, 2018

   · 

  1 min read
• 

  Scottish Medtech Vascutek Gets £33M Investment

  The company plans to build two new cleanrooms and a sterilisation suite at its manufacturing base at Inchinnan.

  February 12, 2018

   · 

  1 min read
• 

  FDA

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

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

  February 12, 2018

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  Genentech Shows Off New Mid-Stage DME Data

  The study assessed two doses of RG7716 versus ranibizumab standard of care given as monthly intravitreal injections.

  February 12, 2018

   · 

  2 min read

   · 

  Alex Keown
• 

  Business

  Ramaswamy’s Roivant Inks $650M R&D Deal With This Tiny Diabetes Biotech

  With the deal in hand, Roivant has stepped into the world of metabolic diseases.

  February 12, 2018

   · 

  2 min read

   · 

  Alex Keown
• 

  Business

  Biotech Startup Rubius to Double Footprint With New Kendall Square Lease

  The fast-growing company will anchor 399 Binney St., an Alexandria Real Estate Equities property.

  February 12, 2018

   · 

  1 min read