BioPharm International Editors

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

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.

In collaboration with the Singapore Economic Development Board, the new site will supply the Asian region and will include multiple fully digitalized modules for the production of three to four vaccines simultaneously

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.

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.

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.

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 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.

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 company has introduced Opto Assure, a series of assays that provide yield and product quality data at an earlier stage in cell-line development.

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.

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.

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.

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.

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.

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

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

Celonic will manufacture CvnCoV at its facility in Germany.

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

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.

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 agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.

Abecma is the first B-cell maturation antigen-directed chimeric antigen receptor T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.

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.