News

The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.

The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.

Parker Bioscience will expand laboratory, cleanroom, office, and warehouse facilities at its Birtley, UK manufacturing site.

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

Internationalization and regulatory reform are driving growth and investment China.

The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.

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).

The acquisition is expected to strengthen Novartis’ gene therapy pipeline.

The company is recalling Piperacillin and Tazobactam for injection, USP 3.375 g because of glass particulates found in a vial.

ExcipientFest has been acquired by IPEC and rebranded as Excipient World.

The company is increasing its cell culture media production capacity at its facilities in Pasching, Austria, and Logan, Utah.

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.

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.

President Donald Trump announced his strategy for making prescription medicines more affordable and accessible in the United States.

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

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.

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.

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.

InstantGMP INV is a validated software for real-time material tracking and inventory control in biopharmaceutical manufacturing.

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.

Johnson & Johnson’s Janssen Biotech will acquire biotechnology company BeneVir Biopharm to strengthen Janssen’s immunotherapy platform.

Takeda expands its global and therapy base with announced acquisition of Shire.

The company received a complete response letter from FDA in response to the biologics license application for a proposed rituximab biosimilar.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.