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Ablynx Establishes US Subsidiary, Appoints General Manager
The Belgian biopharmaceutical company has formed a subsidiary in the United States, and appointed Daniel Schneider as its general manager.
Batavia Biosciences Expands Viral Vector Facilities
The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.
FDA Licenses Second Samsung BioLogics Facility
Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity.
FDA and Baxter Work Together to Secure Manufacturing in Puerto Rico
Baxter and FDA are working together to prevent shortages of the company’s sodium chloride 0.9% injection bags after recent hurricanes damaged the island.
FDA Committee Recommends Approval of Spark’s Eye-Disease Gene Therapy
The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.
Sanofi to Expand Influenza Vaccine Production Facility
The company is investing EUR 170 million (US$201 million) to expand its vaccine manufacturing site in France for its newest influenza vaccine.
Promethera and Shibuya Partner on New Cell-Therapy Manufacturing Platform
The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.
Instrument for Continuous Protein and Polymer Aggregation Analysis
Fluence Analytics’ Argen is a protein and polymer stability monitoring product that uses continuous light scattering measurements to produce an information stream.
NIH Partners with Leading Biopharma Companies for Cancer Immunotherapy
NIH has entered a five-year, $215-million collaboration with leading biopharmaceutical companies to advance the development of cancer immunotherapies.
SGS and Bavarian Nordic Form Vaccine Pact
The collaboration will focus on developing a novel and differentiated challenge model for respiratory syncytial virus.
FDA Accepts Amgen’s Application for New Indication of Osteoporosis Biologic
Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.
EMA Accepts AstraZeneca’s Application for Lung Cancer Biologic
AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.
HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic
BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.
CordenPharma Acquires Pfizer API Manufacturing Facility in Boulder, Colorado
CordenPharma will integrate the Hospira Boulder API manufacturing facility into the CordenPharma Colorado network for highly potent and oncology APIs.
PEGylation Reagents for Drug Delivery
Gelest, a manufacturer and provider of silane, silicone, and metal-organic compounds, released a range of dual-function poly(ethylene glycol) (PEG) reagents that enable new approaches to PEGylation for bioconjugates.
EMA Updates Guidelines on Excipients in Labeling
Europe updates the guideline on excipients information in labeling and packaging.
FDA Publishes Antiviral Guidance
The agency published guidance on developing antiviral drugs to treat respiratory syncytial virus infection.
FDA Releases Guidance on Resolving Issues with the Agency
The guidance gives recommendations for resolving scientific or regulatory issues with FDA regarding ANDA applications.
Pfizer Considers Fate of Consumer Healthcare Biz
The company is considering options for a full or partial separation of its Consumer Healthcare business, either through a spin-off, sale, or other transaction.
REMS Guidance Published
FDA published guidance on the format and content of REMS documents.
J&J Invests in Biologic Manufacturing Capacity Expansion in Ireland
Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.
Hitachi Chemical Advanced Therapeutics Solutions Expands Cell Therapy Manufacturing Infrastructure
Hitachi Chemical Advanced Therapeutics Solutions will expand its PCT service platform for cell therapy by adding GMP manufacturing and cleanroom capacity in Allendale, NJ.
ProBioGen and Chiome in Antibody Manufacturing Deal
Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.
Cytel Adds New Clinical Software Site
Cytel, a biometrics CRO and clinical trial software provider, announced that it will be adding a new location for clinical development in Basel, Switzerland.
Storm Impact on Drug Supply
FDA and manufacturers strive to prevent drug shortages from Hurricane Maria.
FDA and EMA Announce Updates to Adverse Event Reporting Systems
Both regulatory bodies are working on enhancements to their respective adverse event reporting systems in efforts to increase transparency and safety monitoring of drugs.
Groninger and Martin Christ Partner at CPhI Worldwide 2017
Groninger will showcase its FlexPro 50 line for small batch production at CPhI Worldwide 2017, and present on up- and downstream processes with freeze-dryer developer and manufacturer Martin Christ.
Aptar Pharma to Exhibit and Present at CPhI Worldwide 2017
Aptar Pharma will be a main exhibitor at CPhI Worldwide 2017 and will deliver three briefings on company drug-delivery developments.
Bavarian Nordic Secures BARDA Contract for Smallpox Vaccine
The Danish biotechnology company has been awarded a sole-source BARDA contract valued at more than $539 million for a freeze-dried smallpox vaccine.
Lonza to Acquire Manufacturing Facility from Shire
Lonza has announced plans to acquire a clinical-stage mammalian manufacturing facility in the United States from Shire.
