Biopharma News
Merck KGaA Invests in Research Partnerships in Israel
Additional companies join Merck KGaA and Neviah Genomics in the Israel BioIncubator.
Merck KGaA Invests in China, Global HQ
Merck KGaA plans to build a new biomanufacturing facility in Nantong, China.
Shire To Acquire Rare-Disease Company ViroPharma
Shire's agreement to acquire ViroPharma will strengthen its rare-disease portfolio.
Novartis Announced as Facility of the Year Awards Overall Winner
ISPE names Novartis' US Flu Cell Culture facility as award winner.
FDA Grants KaloBios Pharmaceuticals Orphan Drug Designation for KB001-A
KaloBios Pharmaceuticals receives FDA Orphan Drug Designation for KB001-A in treatment of cystic fibrosis patients.
GSK, Gates Foundation Seek Heat-Stable Adjuvants for Vaccines
GSK and the Gates Foundation will invest a combined $1.8 million in early stage research into vaccine thermostability.
FDA Approves Extended-Release, Single-Entity Hydrocodone Product
Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.
Novartis, Amgen, and Bristol-Myers Squibb Report Sales Up in Third Quarter
Big pharma companies Novartis, Amgen, and Bristol-Myers Squibb announce positive third-quarter 2013 results.
Amarin Cuts Staff Following FDA Vote
Amarin cuts staff in half after an FDA committee rejects its product label expansion.
Abbott Reports Third-Quarter 2013 Results
Abbott?s third-quarter 2013 global sales increased slightly but were affected by a disruption in the International Nutrition business.
Johnson & Johnson Reports Third-Quarter 2013 Results
J&J announces 2013 third-quarter sales increased 3% over 2012 third-quarter sales.
AstraZeneca's MedImmune Acquires Spirogen and Strengthens Antibody-Drug Conjugate Capability
MedImmune expands its antibody-drug conjugate capability through acquisition and collaboration.
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.