InflaRx’s Gohibic (vilobelimab), a monoclonal anti-human complement factor C5a antibody, has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adults.
BioNTech and OncoC4 have announced a worldwide license and collaboration agreement to develop and commercialize OncoC4’s next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications....
Celltrion, one of Korea’s largest biopharma companies, will be Rani’s exclusive supplier of ustekinumab biosimilar, CT-P43, for its oral RT-111 RaniPill program.
Corbus says new data shows its monoclonal antibody demonstrates robust pre-clinical anti-tumor activity alone and in combination with anti-PD-1 therapy.
One dose of an antibody drug protected from malaria infection during the malaria season in Mali, showing up to 88% effectiveness: demonstrating for the first time that a monoclonal antibody can prevent malaria in an endemic region.
Biogen has started a global Phase 2/3 study for litifilimab, a humanized IgG1 monoclonal antibody (mAb), in participants with cutaneous lupus erythematosus (CLE).
Regeneron Pharmaceuticals will purchase Sanofi's stake in their collaboration on Libtayo (cemiplimab) for an upfront payment of $900m, giving Regeneron exclusive worldwide rights to the medicine.
Janssen’s Carvykti, a therapy for multiple myeloma, has been approved for conditional marketing authorization (CMA) by the European Medicines Agency (EMA).
The US Food and Drug Administration (FDA) has approved Enjaymo (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD).
Celltrion Group has reported that data from an in vivo efficacy study shows that its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59), has a strong neutralizing effect against the rapidly spreading Delta variant.
Corbus Pharmaceuticals announced the expansion of its portfolio into immuno-oncology through licensing deals with the University of California San Francisco and Panorama Research Inc for two new monoclonal antibodies (mAbs).
Eli Lilly and Co received a subpoena late last week from the US Department of Justice (DOJ), requesting certain documents, as part of a probe into its manufacturing site in Branchburg, New Jersey.
The first patient has been enrolled in the randomized Phase 3 SILVAR study to evaluate the efficacy and safety of siltuximab in patients with COVID-19 previously treated with corticosteroids, or another respiratory virus infection associated with serious...
Eli Lilly and Company's neutralizing antibody bamlanivimab (LY-CoV555) has received interim authorization from Health Canada as a treatment for COVID-19.
Lilly's monoclonal antibody therapy, bamlanivimab (LY-CoV555), has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the treatment of adults and children with recently diagnosed, mild to moderate COVID-19.
Biogen Inc’s shares tumbled around 30% yesterday with the company hitting a roadblock late last week as it chases regulatory approval for its investigational Alzheimer's treatment.
AbbVie has boosted its immunotherapy pipeline in a global licensing deal with Chinese biotech, I-Mab, for its anti-CD47 monoclonal antibody, lemzoparlimab.
Under an agreement with Zumutor, Catalent Biologics initiates clinical manufacture of the latter’s lead candidate targeting solid tumors, ahead of FDA filing.
Biosana to work collaboratively with the Bioprocessing Technology Institute, aiming to design a highly flexible and cost-effective continuous manufacturing solution.
Samsung continues an agreement formerly signed with Glenmark to manufacture Ichnos’ mAb treatment candidate for atopic dermatitis, as the product enters Phase III clinical trials.
Merck enters a clinical collaboration agreement with Oncologie to evaluate the combination of investigational drug Bavituximab and Keytruda in cancer patients.
The FDA approves targeted biologic, Dupixent, for the treatment of atopic dermatitis in patients 12 to 17 years old, the first treatment of its kind for adolescents.
Avastin biosimilar from Pfizer receives approval from the FDA for the treatment of five forms of cancers, increasing market competition for the originator drug.
SGS’ completed the ₤8.7m expansion of its large molecule testing facility in Glasgow and made room to increase its existing biosafety service and PCR platform capabilities.
Dupixent, Regeneron and Sanofi’s collaborative mAb treatment for eczema, has been approved by the European Commission for a new indication in severe asthma.
The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option.
I-Mab and WuXi Biologics extend their strategic partnership for biologics process development as well as clinical and commercial manufacturing to accelerate drug development in China and abroad.
ABL will use WuXi’s platforms in an extended agreement for the development and commercialization of its bispecific antibodies, using the recently launched WuXiBody platform.
Rubius has announced plans to acquire Alexion’s manufacturing facility in Rhode Island, where the latter made immunosuppressant Soliris before exiting the site last year.
Catalent Pharma Solutions has agreed with the Center for iPS Cell Research and Application (CiRA) at Kyoto University in Japan to advance one of the first regenerative human therapies with induced pluripotent stem (iPS) cells applicable to humans.
