The European Commission has entered into a supply agreement with GlaxoSmithKline and Vir Biotechnology for up to 220,000 doses of sotrovimab, an investigational mAb for treating COVID-19.

DisperSol and Catalent announce manufacturing collaboration to accelerate DisperSol’s pharmaceutical production.

FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.

Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

FDA has approved Mylan Pharmaceuticals’ Semglee, the first interchangeable biosimilar insulin product for treating diabetes.

Regeneron and AstraZeneca have entered an agreement to create a small-molecule medicine designed to treat obesity.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

Excessive drug pricing is being scrutinized across Europe, as hefty fines are set to send out a clear message of intolerance to anti-competition conduct.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Investments, biologics, and the impact of COVID-19 will continue to shape the bio/pharmaceutical outsourcing industry for the near term.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.

VICO Therapeutics’ drug candidate, VO659, for treating Huntington’s Disease was granted orphan drug designation by FDA.

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

Thermo Fisher Scientific has added a new suite of immune repertoire assays that offers high detection rates of malignant clones, allowing researchers to better assess blood cancers.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

ERS Genomics and Japan SLC have signed a non-exclusive license agreement, allowing Japan SLC access to ERS Genomics’ CRISPR/Cas9 patent portfolio.

Byondis and Glycotope have formed an agreement to discover and develop antibodies that target specific glyco-epitopes.

Summa Equity has acquired a majority stake in science tools business Axion BioSystems with the intent of further entering the CGT market.

Following a deal struck in mid-2018, 908 Devices’ ZipChip and REBEL technology have proven instrumental in facilitating Transcenta’s efficiency and volumetric production.

Through a partnership with the University of Hertfordshire, Ziath discovers means of using AI to detect empty wells in sample tube racks.

Avantor’s newly unveiled J.T.Baker robotic tips is the latest in their line of automated precision plastics.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

Cytiva and Pall reinforce recent expansion efforts with a $1.5-billion dollar investment in new manufacturing facilities.

Sciex’s recently launched accurate mass instrument, the ZenoTOF 7600 system, offers novel ion fragmentation and increased sensitivity for life science research and biotherapeutic development.

Merck announced that FDA approved Vaxneuvance for active immunization for the prevention of invasive pneumococcal disease.