Industry News

April 24–30, 2017 is European Immunization Week in Europe, and in a statement on the European Medicines Agency (EMA) website dated April 25, 2017, Executive Director Guido Rasi stressed the importance of vaccinations in preventing and controlling disease. Rasi acknowledged that fear created from incorrect information presented by unreliable sources has created a lack of trust in vaccines. But he highlighted that Europe monitors and records information on the safety of medicines, including vaccines.

On April 24, 2017, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and a group of executives from several big pharma companies composed an open letter to the European Medicines Agency (EMA) regarding its relocation.

A new study from the United States National Institutes of Health (NIH) found that pairing the antidepressant amitriptyline with drugs designed to treat central nervous system diseases, enhances drug delivery to the brain by inhibiting the blood-brain barrier in rats. The blood-brain barrier serves as a natural, protective boundary, preventing most drugs from entering the brain. The research, performed in rats, appeared online April 27, 2017 in the Journal of Cerebral Blood Flow and Metabolism.

Companies believe that biologics and biosimilars would experience the fastest growth over the next year; there is also interest on increasing market penetration of generic drugs.

The dispute over who has the rights to key CRISPR-Cas9 patents continues. On April 12, 2017 the University of California, Berkeley, in conjunction with the University of Vienna and Emmanuelle Charpentier, filed an appeal to overturn an earlier decision by the United States Patent Trial and Appeal Board (PTAB).

The agency issued its recommendation for the influenza virus strains European vaccine manufacturers should include for 2017.

The new guide offers guidance on how to ensure data and records are complete, consistent, secure, accurate, and available throughout their lifecycle.

The agency cited the company’s India facility for batch failures and data integrity problems.

The conference has partnered with Mercy Ships, a non-profit organization using hospital ships to deliver health care to developing nations.

In a new study, researchers from Boston Children’s Hospital study responses to pneumococcal vaccine in infant monkeys.

Pharmaceutical Technology spoke with Ben Locwin and Tom Fox ahead of their CPhI North America presentation to discuss drug pricing, compliance challenges, and corporate social responsibility in the bio/pharmaceutical industry.

A drop in US drug approvals was noted but this trend was not yet seen in Europe.

The agency released guidance on single assessments of PSURs to improve safety and benefit-risk assessment of medicines.

The role of patient advocates in shaping regulations and policy has put attention on financial and operational links between drug companies and independent health organizations.

FDA is in the center of the debate over developing and pricing new cancer therapies.

A new study in NEJM compares the regulatory review processes of FDA and EMA.

Scott Gottlieb answers Senators' questions at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee.

EMA has developed a framework and action plan to foster relationships with the academic community.

The company announced that Meridian Medical Technologies is extending a recall of EpiPen and EpiPen Junior to the United States.

The agency sent a warning letter to Opto-Pharm Pte Ltd. after deficiencies in sterile manufacturing procedures were found at the company’s Singapore facility.

A new report states that wider access to new antivirals for HCV and better screening of patients would help avert 90,000 deaths by 2030.

Manufacturers and regulators are working to reach consensus on the harmonization of management of postapproval changes.

The agency recommended six drugs for approval in March 2017 including treatments for neuroblastoma, heart failure, and more.

The agency is recommending the suspension of a variety of medications because of unreliable bioequivalence studies conducted by Micro Therapeutic Research Labs

The taskforce will be evaluating how data can be used to support pharmaceutical research, innovation, and development.

Will new generic drugs bring the cost of medicines down in the way policy makers hope?

In a FDAVoice blog post, CBER Director Peter Marks discusses the new designation for cell therapies that treat life-threatening diseases.

FDA issued a warning letter to USV Private Limited citing CGMP violations that include data integrity and microbiological contamination issues.

The two pharmacopeias signed a Memorandum of Understanding as recognition of their collaboration for developing international science-based standards.

Human antibody for Zika virus could help in the treatment and prevention of the infection.