News

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

The company announced the expansion of its global shipping program, which now allows companies to ship dangerous goods between 36 countries.

GE Healthcare continues to ramp up its offerings in the bioprocessing space with the purchase of Asymptote and a continued partnership with Zenith Technologies.

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.

MilliporeSigma’s new high-area cartridge filters and single-use capsules are suitable for feed streams with high levels of particulates.

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

Janssen will have access to PeptiDream’s proprietary Peptide Discovery Platform System technology, which will be used to identify peptides against multiple metabolic and cardiovascular targets.

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.

Sartorius acquired the Swedish company that specializes in data analytics software for biopharmaceutical development and manufacturing.

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.

Philadelphia plays host to the exhibits, conferences, and networking activities of CPhI North America on May 16-18, 2017.

The company received priority review for its investigational CAR-T therapy to treat leukemia.

The mAb is the first approved treatment that targets the progressive form of the disease.

The facility in Britley will now manufacture the company’s automated systems, enabling the company to better serve European markets and shorten the supply chain.

FDA approved Dupixent for the treatment of atopic dermatitis amidst a preemptive lawsuit filed by Sanofi/Regeneron involving the drug and an Amgen patent covering IL-4 inhibitors.

The Mobius MyWay portfolio offers off-the-shelf and configured-to-order single-use assemblies.

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.

The company has signed two separate agreements with the Agency for Science, Technology, and Research (A*STAR) and the Nanyang Technological University (NTU) to progress its therapeutic stem cell pipeline.

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

Permira will acquire LSNE, a CDMO for the pharmaceutical and medical device markets.