BioSpace News Archive

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• BioMidwest

  ANI Pharma Enters Five-Year $125M Senior Secured Credit Facility with Citizens Bank

  The Facility is comprised of a $75M five-year term loan that was closed today in support of ANI’s acquisition of four NDAs acquired from Astra for $46.5M in cash as previously announced this morning.

  December 29, 2017

   · 

  4 min read
• Policy

  Avadel Pharmaceuticals Issues 2018 Corporate Outlook

  The company announced its 2018 corporate objectives and financial expectations, including the commercial launch of Noctiva.

  December 29, 2017

   · 

  14 min read
• Deals

  Galena Biopharma Stockholders Approve Business Combination With SELLAS Life Sciences Group Board Sets Reverse Stock Split Ratio

  The failure of stockholders to approve this proposal has no impact on the Merger.

  December 29, 2017

   · 

  4 min read
• Business

  Alpha Pro Tech Names Lloyd Hoffman as President; Appoints Donna Millar to Board of Directors

  The appointments are effective immediately.

  December 29, 2017

   · 

  4 min read
• Pharm Country

  Delcath Announces Exit From Convertible Note

  The number of shares of the Company’s issued and outstanding common stock immediately following issuance of the initial Shares to the investors is 114,054,852.

  December 29, 2017

   · 

  5 min read
• Policy

  Progenics Pharmaceuticals Announces FDA Acceptance of New Drug Application for AZEDRA (iobenguane I 131) in Pheochromocytoma and Paraganglioma

  The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA).

  December 29, 2017

   · 

  5 min read
• Pharm Country

  Recro Pharma Reports Inducement Grants for New Staff - Dec. 29, 2017

  The equity awards are subject to the individual’s continued service with Recro Pharma through the applicable vesting dates.

  December 29, 2017

   · 

  4 min read
• Policy

  GW Pharmaceuticals Submits Marketing Authorisation Application in Europe for Epidiolex (cannabidiol) in the Treatment of Lennox-Gastaut Syndrome and Dravet Syndrome

  In October 2017, GW completed the submission of its rolling Epidiolex NDA to the FDA, also for seizures associated with LGS and Dravet syndrome.

  December 29, 2017

   · 

  6 min read
• Drug Development

  Atara Biotherapeutics Announces FDA Clearance to Initiate Two Phase III Clinical Studies to Evaluate Tabelecleucel in Patients With Rituximab-Refractory Epstein-Barr Virus Associated Post-Transplant Lymphoproliferative Disorder (EBV+PTLD)

  Tabelecleucel is Atara’s off-the-shelf T-cell immunotherapy in development for the treatment of EBV+PTLD.

  December 29, 2017

   · 

  9 min read
• Mylan Adds to U.S. Women’s Healthcare Portfolio With FDA Approval of First Generic for Estrace Cream

  Mylan N.V. today announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan’s Estrace Cream.

  December 29, 2017

   · 

  5 min read