BioSpace News Archive

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• 

  Business

  Siemens to Slash 6,900 Jobs Worldwide

  The majority of the cuts will be in Germany and about 1,800 will be in the U.S.

  November 20, 2017

   · 

  2 min read

   · 

  Alex Keown
• 

  Drug Development

  Genentech Shows Off Positive Results From Phase III HEMLIBRA, TECENTRIQ Studies

  Data will be submitted to health authorities globally, including the FDA and EMA.

  November 20, 2017

   · 

  17 min read
• Business

  Biohaven Receives Agreement From FDA on Initial Pediatric Study Plan for Rimegepant, a Second Generation Oral CGRP-Receptor Antagonist for the Acute Treatment of Migraine

  Agreement on an iPSP is one of the regulatory requirements that must be met prior to submitting a NDA.

  November 20, 2017

   · 

  4 min read
• Business

  United Therapeutics Announces Additional Six Months of Regulatory Exclusivity for Adcirca

  United Therapeutics today announced that the FDA has granted pediatric exclusivity for Adcirca tablets through May 21, 2018, based on study results submitted by Lilly in response to a written request by the FDA to investigate the use of tadalafil in pediatric patients with Duchenne muscular dystrophy.

  November 20, 2017

   · 

  6 min read
• Business

  CanniMed Therapeutics Announces Director Resignation

  The Company thanks Mr. Duguid for his service on the board since 2001 and wishes him well in the future.

  November 20, 2017

   · 

  1 min read
• Drug Development

  BioLineRx Announces Partial Results of BL-8040 COMBAT Study Accepted for Presentation at ASCO 2018 Gastrointestinal Cancers Symposium

  BioLineRx announced today that an abstract with partial results from the monotherapy portion of BL-8040’s Phase IIa COMBAT study in pancreatic cancer was accepted for presentation at the ASCO 2018 Gastrointestinal Cancers Symposium.

  November 20, 2017

   · 

  6 min read
• Business

  PathoQuest Announces Formation of Scientific Advisory Board

  Members of the Scientific Advisory Board are recognized infectious diseases, microbiology and next-generation sequencing experts.

  November 20, 2017

   · 

  3 min read
• Business

  NanoViricides Files Quarterly Report for Period Ending September 30, 2017

  NanoViricides filed its quarterly report for its first quarter of financial year 2018 in a timely manner with the SEC on Tuesday, November 14, 2017.

  November 20, 2017

   · 

  6 min read
• FDA

  Volpara Receives Regulatory Clearances in Japan and Taiwan

  In Japan, the full Volpara Enterprise suite of products has received regulatory approval as a Class II medical device.

  November 20, 2017

   · 

  3 min read
• 

  Business

  Gamida Cell Taps Former Clal Biotech CSO as New Leader

  Dr. Adams to further advance promising pipeline, including breakthrough therapy, NiCord, in phase 3 development as a universal bone marrow transplant solution.

  November 20, 2017

   · 

  3 min read