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

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

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

Internationalization and regulatory reform are driving growth and investment China.

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 ÄKTA pilot 600 from GE Healthcare is a lightweight bench-top chromatography system suited to streamline both GMP and non-GMP everyday operations.

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.

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

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.

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

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.

Huber Kältemaschinenbau presents new temperature control solutions for research, laboratories, and production in Frankfurt.

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.

Telstar has a dedicated process analytical technology (PAT) corner at its booth to display new developments for pharmaceutical freeze drying systems and aseptic manufacturing processes.

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.

The technology, known as Verifi, is available with the ChargePoint’s range of valves that ensure safe and contamination-free handling of API and other formulation ingredients.

The tablet tooling manufacturer will showcase its products and services, which include an online training package and a tool management system for proactive monitoring of tooling rotations, inventory, and maintenance.

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.

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

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.