Biopharma News

Novavax has filed its COVID-19 vaccine for authorization in the UK and Australia.

Genentech’s Susvimo (ranibizumab injection) is approved for intravitreal use via ocular implant for the treatment of neovascular age-related macular degeneration.

The $691 million deal will see Vertex use Mammoth’s systems to discover and develop in-vivo gene-editing therapies.

Merck’s agreement with the Medicines Patent Pool (MPP) aims to facilitate affordable global access for molnupiravir.

Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.

Pfizer and BioNTech’s Phase III trial demonstrated 95.6% booster efficacy relative to participants who received placebo.

The EC approved BMS’s Opdivo (nivolumab) as a complementary treatment to chemotherapy for adult patients with certain types of gastric or esophageal cancer.

A new GMP facility in Raleigh, NC, and a starting materials facility in Paris, France, give Cellectis end-to-end, in-house manufacturing capacity for its UCART product candidates.

Crystec and Biosidus have joined forces to enhance the delivery and performance of biotherapeutics.

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

Boehringer Ingelheim’s Cyltezo (adalimumab-adbm) is the first FDA approved interchangeable biosimilar for Humira.

The collaboration between Intellia and SparingVision will work to develop genomic medicines for ocular diseases.

This acquisition grants Bionano access to BioDiscovery’s clinical software solution for variant analysis.

Enzyvant’s Rethymic is the first FDA approved treatment for congenital athymia.

Element’s acquisition of Nanosyn is the latest in a series of moves made to strengthen the company’s North American presence.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

Pacira’s acquisition grants them access to Flexion’s pain management portfolio.

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

Supernus will acquire Adamas’ Parkinson's disease treatment portfolio through a $400 million acquisition.

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

Pfizer may pay up to $630 million for access to Voyager’s novel AAV capsids in transgene research.

Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

The collaboration between Sunovion, Sumitomo Dainippon, and Otsuka will focus on four compounds designed to treat neuropsychiatric health conditions.

Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.

Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.

AstraZeneca’s acquisition of Caelum Biosciences gives them access to CAEL-101, a promising light chain amyloidosis treatment.

Pure Psyence, Pure Extracts and Psyence’s joint venture company, will develop psilocybin-derived treatments.