Industry News

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

Public health authorities and the biomedical research community are seeking new strategies to address global health threats.

FDA sent a warning letter to Lijiang Yinghua Biochemical and Pharmaceutical Co., Ltd. for failure to follow current good manufacturing practices.

After a review of public comments, USP will not move forward with nomenclature proposal without further FDA collaboration.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2018 season.

EMA and its new host country have finalized the terms of the agency’s relocation to Amsterdam.

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

The agency has released new guidance on the development of new medication-assisted treatments for opioid dependence.

FDA’s Center for Drug Evaluation and Research has published its second annual report on key safety programs and activities.

The new document answers questions regarding implementation of the ICH Q7 guidance on GMPs for APIs.

A new report gives an overview of the work of the International API Inspection Program.

Premier Pharmacy Labs is voluntarily recalling multiple products because of the potential lack of sterility assurance.

Thermo Fisher Scientific and the University of Pittsburgh have established a new pharmacogenomics center of excellence to support translational research that demonstrates the value of PGx in precision medicine.

FDA sent a warning letter to Tris Pharma Inc. after investigators found the company had failed to properly investigate batch failures and establish quality control procedures.

The agency has assigned new EU member state rapporteurs and co-rapporteurs to medicines previously assigned to the UK’s Medicines and Healthcare products Regulatory Agency.

A new study by the Business Research Company reveals prominent contract research organization outsourcing trends.

David Weingarten, PhD, and Mark Feldstein, PhD, will present ways to optimize pharma patent protection to avoid generic competition and increase return on investment at CPhI North America 2018.