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Novartis’ AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility
The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
FUJIFILM Adds Late-Phase and Commercial Fill/Finish Capabilities
In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.
New “Right-to-Try” Law Challenges FDA Oversight
Right-to-Try bill sent to White House for President’s signature after passage by Congress.
WuXi Biologics to Invest $60 Million in New Singapore Biomanufacturing Facility
WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.
Vectalys, FlashCell Merge to Form Gene Therapy Company
The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.
Gilead’s Kite Expands Cell Therapy Facilities in US, Europe
The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.
FDA Approves First Preventive Treatment for Migraine
The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
Parker Bioscience Expands UK Facilities
Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.
European and Indian Pharmacopoeias Coordinate on Quality Standards
Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.
FDA Commissioner Puts Branded Companies on Notice
The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.
China’s Pharma Growth Potential to Drive Attendance at CPhI China
Internationalization and regulatory reform are driving growth and investment China.
Catalent Adds Capacity at Kansas City Clinical Supplies Facility
The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.
FDA Approves Pfizer’s Epoetin Alfa Biosimilar
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
Novartis Acquires AveXis for $8.7 Billion
The acquisition is expected to strengthen Novartis’ gene therapy pipeline.
Apotex Recalls Product Due to Elevated Levels of Impurities
The company is recalling Piperacillin and Tazobactam for Injection, USP 3.375 Gram/Vial And 4.5 Gram/Vial strengths because of concerns of decreased potency due to elevated levels of impurities.
AuroMedics Pharma Issues Recall Due to Glass Particulates in Vials
The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.
IPEC-Americas Acquires Global Excipient Event
ExcipientFest has been acquired by IPEC and rebranded as Excipient World.
GE Increases Cell Culture Media Production Capacity
The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.
Catalent to Develop Biosimilars for Valerius Biopharma
Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.
Lilly to Acquire ARMO BioSciences for $1.6 Billion
Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.
BIA Proposes New Biotech Fund Structure to UK Government
The BioIndustry Association has called on the British government to introduce a new venture capital fund structure that will enable the public to invest in the United Kingdom’s biotech revolution.
Trump Drug Pricing Plan Outlines Rule Changes Pharma Can Live With
President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.
CGMP Violations Found at India Facility
FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.
GlobalData Reports on Barriers Impeding Biosimilar Entry into US Market
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
Precision Medicines Speed Development and Reduce Healthcare Costs
The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.
Lonza, Proteon Therapeutics Extend API Manufacturing Partnership
The companies have extended a contract agreement for the commercial manufacture of the active pharmaceutical ingredient for vonapanitase, an investigational drug intended to improve hemodialysis vascular access outcomes.
FDA Seeks Permanent Injunctions Against Two Stem Cell Clinics
The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.
Inventory Management Software Designed for Biopharma
InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.
Merck, Moderna Expand mRNA Cancer Vaccines Partnership
The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.
J&J’s Janssen to Acquire BeneVir for $1 Billion
Johnson & Johnson’s Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen’s immunotherapy platform.
