Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

The deal will give Sanofi access to Tidal’s novel mRNA-based approach for in-vivo reprogramming of immune cells, which will expand Sanofi’s research capabilities in immuno-oncology and inflammatory diseases.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

The China National Medical Products Administration has given the company the green light to begin manufacturing commercial supply of its approved anti-PD-1 antibody, tislelizumab, at its biologics facility in Guangzhou, China.

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

The Phase III study will evaluate nemvaleukin alfa, Alkermes' novel investigational engineered interleukin-2 variant immunotherapy, in combination with Merck’s Keytruda (pembrolizumab), in patients with platinum-resistant ovarian cancer.

The UK's National Horizons Centre has been confirmed as a National Training Centre that will deliver on-site advanced therapies and vaccine manufacturing specific training.

CrystecPharma has opened a new subsidiary, Nantong Crystec Pharmaceutical R&D Co. Ltd., and research facility in Haimen City, Jiangsu Province, China.

Sterling Pharma Solutions has acquired ADC Biotechnology, a bioconjugation development services business specializing in antibody drug conjugates.

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

The availability of materials is a critical factor when it comes to vaccine capacity.

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.

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

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.