Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.

Smart, accurate, science-based messaging is needed to advance bio/pharma science.

COVID-19 has placed bio/pharma in the spotlight of global media, but away from vaccines there are other prospective pipeline treatments that will be worth watching.

The White House’s American Jobs Plan includes investment in new technologies for rapid scale up of vaccine production, in expanded emergency production capacity and enhanced US infrastructure for biopreparedness, and in greater production onshore of APIs.

Human error at an Emergent BioSolutions facility cited as cause for the loss of a large batch of COVID-19 vaccines.

The business, which has been renamed Woodstock Sterile Solutions, will operate out of a single site in Woodstock, IL, and will support clinical- to commercial-stage formulation and manufacturing.

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.

The acquisition will give Amgen access to Rodeo's 15-prostaglandin dehydrogenase program, which will strengthen its inflammation portfolio.

NewAge Industries received B Corp certification from B Lab, a nonprofit organization that creates standards, policies, and tools for businesses.

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

BIA and Clarivate have released data showing that UK biotech companies are set to experience another strong year for fundraising in 2021.

NICE has issued a positive recommendation for Sobi's Kineret (anakinra) to be used as a first-line biologic therapeutic option for Still’s disease.

EMA's CHMP has issued a positive opinion for Diurnal's second product in Europe, Chronocort (Efmody), to treat CAH.

The EC has approved Roche's treatment for 5q spinal muscular atrophy (SMA), Evrysdi (risdiplam).

UK's Ofwat and Nesta Challenges have called on pharmaceutical innovators to collaborate with water companies for the new Water Breakthrough Challenge.

NICE has recommended carfilzomib in combination with lenalidomide and dexamethasone (KRd) as a treatment for adult patients with multiple myeloma who have already had one previous therapy.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

GSK will provide filling capacity at its Barnard Castle facility in England.

Celonic will manufacture CvnCoV at its facility in Germany.

The partnership will combine Cold Chain Technologies thermal packaging with B Medical Systems’ stationary refrigeration solutions for temperature-critical pharmaceuticals.

Celltrion Group has revealed that EMA's CHMP has issued a positive scientific opinion for regdanvimab (CT-P59)—an anti-COVID-19 monoclonal antibody treatment candidate.

The Janssen Pharmaceutical Companies of Johnson & Johnson revealed that EMA's CHMP has issued a positive opinion for Ponvory (ponesimod) for the treatment of RMS.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.

The companies will use Ajinomoto’s AJICAP proprietary site-specific bioconjugation technology for the development of Bright Peak’s Immunocytokines.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices.

The company is recalling the product because of crystallization in vials.