News

The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

World Health Organization’s Ebola ring vaccination uses Merck & Co.’s investigational rVSV-ZEBOV vaccine to protect high-risk communities in the Democratic Republic of the Congo from Ebola.

The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.

In adding a Vanrx Pharmasystems aseptic filling isolator, FUJIFILM adds fill/finish for gene therapies and viral vaccines.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.

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 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.

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.