Biopharma News
GSK Agrees to Sell Thrombosis Brands and Manufacturing Site to Aspen
GlaxoSmithKline?s sale of its thrombosis brands is part of a focus on its late-stage pipeline.
Merck Cuts 8,500 Positions, Moves Headquarters
Merck announced plans to reduce its workforce by 8,500 and move its headquarters in order to sharpen its commercial and R&D focus.
Merck & Co. Receives Complete Response Letter From FDA Regarding Sugammadex Sodium Injection
Merck & Co. has received a Complete Response Letter from FDA for the resubmission of its new drug application for sugammadex sodium injection.
J&J's Janssen and PATH Partner to Develop Rilpivirine Formulation
J&J's Janssen and PATH partner to improve drug formulation that could help prevent HIV infection.
Cell Medica Opens Commercial Manufacturing Facility
Cell Medica, a T cell therapeutics company, has opened a European manufacturing facility in Berlin-Buch, Germany to develop, manufacture, and market treatments of infections and cancers related to oncogenic viruses.
AstraZeneca, Bristol-Myers Squibb Recall Certain Lots of Bydureon
AstraZeneca, Bristol-Myers Squibb recall certain lots of of their antidiabetes drug Bydureon (eventide) due to manufacturing records that batches may contain underfilled vials.
Unilife Signs Supply Contract with Sanofi for Prefilled Syringes
Unilife grants Sanofi long-term exclusivity for the use of Unilife?s prefilled syringe with Sanofi?s Lovenox.
Myriad Genetics Expands Companion Diagnostic Pact with AstraZeneca
Myriad Genetics and AstraZeneca expand their companion diagnostic pact for AztraZeneca?s investigational drug candidate olaparib.
California State Senate Passes Biosimilars Bill
Following passage in the California Assembly, the California State Senate passes legislation to specify requirements for dispensing biosimilars.
Zealand Announces Collaboration with Eli Lilly
Zealand will join efforts with Eli Lilly to design and develop therapeutic peptides for Type 2 diabetes and obesity.
Amarin Targets Novasep as Fourth Supplier of Vascepa API
Amarin released the submission of an sNDA to FDA seeking approval for Novasep Group.
Sanofi Pasteur Selects Freeslate to Improve Formulation Development
Sanofi Pasteur has purchased Freeslate?s Biologics Formulation System for accelerating research in vaccine and protein formulation development.
Shire, and Santaris Extend Alliance to Develop LNA-drugs
Santaris Pharma and Shire have extended their partnership in the rare genetic disease space.
Vical Restructures and Reduces Staff
Vical's restructuring will leave the company with approximately 74 employees.
Amgen and Servier Complete Product Collaboration Transaction
Amgen, Servier collaborate ivabraline and other cardiovascular products.
ScinoPharm, Sundia MediTech Partner for Pharma Outsourcing in China
ScinoPharm Changshu Pharmaceuticals and Sundia MediTech form an alliance for contract research and manufacturing services in mainland China.
uniQure to Build Therapy Production Plant in US to Leverage AAV Manufacturing Strength
uniQure B.V. announced it has commenced build-out of a 55,000 ft2 US manufacturing plant in Lexington, Mass.
Pfizer Licenses Potelligent CHOK1SV Cell Line
The licensed cell line combines BioWa's engineered glycosylation Potelligent Technology with Lonza's GS Gene Expression System.
Immunovaccine Secures $5 Million Loan to Support Clinical Stage Cancer Vaccines
A loan from the Province of Nova Scotia will support Immunovaccine's clinical studies through 2016.
iQur Leads Major European Project to Develop a Universal Influenza Virus Vaccine
iQur announced that it has been granted 5 million EUR ($6.6 million) by the European Union Framework 7 fund to develop a universal influenza vaccine.
Immunocore Signs Research and Licensing Agreement with GSK
Immunocore Limited has entered into a partnership with GlaxoSmithKline for multiple novel targets not addressable using antibody-based technologies.
Aspen to Acquire Select API Assets and Finished Products from Merck
The $1-billion deal includes select parts of Merck?s manufacturing site in Oss, The Netherlands and Sioux City, Iowa as well as 11 finished products.
MorphoSys and Celgene Sign Monoclonal Antibody Pact
The companies agree to jointly develop and promote MOR202, an oncology mAb in a deal potentially valued at more than $800 million.
FDA Discovers Microbial Contamination in Compound Pharmacy Products
Novartis Receives FDA Warning Letter for cGMP Violations at Austrian Plant
The company is cited for using unapproved visual-inspection methods for finished parenteral drugs and conducting inadequate visual inspections.
Celerion Adds Containment Room
Modular containment room at Belfast facility allows studies of biologics and vaccines.
MorphoSys and GlaxoSmithKline Partner in Antibody Pact
-
AbbVie and Alvine Will Collaborate on Celiac Disease Therapy
Program aims to develop a novel oral treatment.
