BioSpace News Archive

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  Drug Development

  Merck May Have Too Many Eggs in Its Keytruda Basket

  Industry watchers and investors have shown some concern that Merck is abandoning other potentially lucrative areas of research to focus on exploiting every last bit of Keytruda’s potential

  April 16, 2018

   · 

  3 min read

   · 

  Mark Terry
• 

  FDA

  Alkermes Gains NDA Acceptance for MDD Treatment That was Previously Rejected by the FDA

  In a stunning about-face the U.S. Food and Drug Administration (FDA) has accepted Alkermes New Drug Application for ALKS 5461. The FDA rejected the NDA at the end of March over a lack of data.

  April 16, 2018

   · 

  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Bristol-Myers Squibb Shares Drop on Positive Lung Cancer Trial

  Bristol-Myers Squibb announced initial positive Phase III data, yet company shares dropped more than six percent.

  April 16, 2018

   · 

  2 min read

   · 

  Mark Terry
• 

  CRISPR Therapeutics Plans to Treat First Patients for Beta Thalassemia in Europe

  The plan is to treat patients with beta thalassemia, a blood disorder that decreases the production of hemoglobin, the iron-containing protein in red blood cells that carries oxygen.

  April 16, 2018

   · 

  3 min read

   · 

  Mark Terry
• 

  Are You Cut Out For Remote Work?

  Remote work, working from home, telecommuting… the number of companies who are offering a flexible work environment or 100% remote jobs is increasing as technology enables employees to, literally, work from anywhere.

  April 16, 2018

   · 

  7 min read
• 

  Job Trends

  Thermo Fisher Scientific Unveils Next Generation Sequencing Assay for Pediatric Cancers

  Less than a week after unveiling its first cloud-enabled biological safety cabinet for contamination control, Thermo Fisher Scientific launched its first NGS panel that specifically targets mutations associated with pediatric and young adult cancers.

  April 16, 2018

   · 

  3 min read

   · 

  Alex Keown
• 

  Deals

  Shire Sells Oncology Business to France’s Servier for $2.4 Billion

  Only a couple weeks after Takeda Pharmaceuticals announced it was interested in buying Shire, Shire sells its oncology business to France’s Servier for $2.4 billion.

  April 16, 2018

   · 

  3 min read

   · 

  Mark Terry
• 

  Drug Development

  With Positive Support from Early Studies Alnylam Looks to File NDA for Second RNAi Therapeutic by the End of 2018

  Fueled by positive Phase I and Phase I/II results from an open-label extension (OLE) study of RNAi therapeutic givosiran, as well as an ongoing Phase III trial, Cambridge, Mass.-based Alnylam said it is eying a possible New Drug Application by the end of the year.

  April 16, 2018

   · 

  2 min read

   · 

  Alex Keown
• 

  Roche Diagnostics Assay Receives FDA Clearance for STD Testing

  Roche said it has gained 510(k) clearance from the U.S. Food and Drug Administration for cobas CT/NG for use on the cobas 6800/8800 Systems for the detection of chlamydia and gonorrhea in both symptomatic and asymptomatic patients.

  April 16, 2018

   · 

  2 min read

   · 

  Alex Keown
• FDA

  Roche receives FDA clearance for cobas® CT/NG for cobas® 6800/8800 Systems

  First moderate complexity molecular test for sexually transmitted infections on fully automated, high throughput platform

  April 16, 2018

   · 

  5 min read