Biopharma News

Kala’s acquisition of Combangio expands its clinical-stage biologic pipeline.

Under the expanded agreement with Agios, Centogene will provide global clinical trial support for thalassemia and sickle cell diseases.

AbbVie will pay REGENXBIO up to $1.75 billion for the rights to develop and commercialize its treatment of various eye conditions.

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

Flagship Pioneering has officially launched Alltrna, a company planning to combat genetic diseases with transfer ribonucleic acid (tRNA) medicine.

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

Element’s acquisition of JMI Laboratories will increase their North American service offerings.

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.

Janssen Sciences Ireland was honored for its project execution of a large-scale expansion of biologics drug substance fed-batch capacity.

Novartis’ scemblix (asciminib) is designed to provide a single treatment option to patients struggling with chronic myeloid leukemia.

Aceragen’s acquisition of Arrevus adds key treatment candidates to its rare disease pipeline.

Takeda’s acquisition of GammaDelta Therapeutics expands their immuno-oncology and innate immune cell therapy portfolio.

Abbvie’s Vuity (pilocarpine HCI ophthalmic solution) is the first and only eye drop to receive FDA approval for the treatment of presbyopia.

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.