Merck recently announced that its cytomegalovirus (CMV) treatment, Prevymis (letermovir), lowered the odds of CMV reactivation by 88% 100 days after allogeneic hematopoietic cell transplantation...
FDA recently issued a complete response letter (CRL) for Eli Lilly and Company’s biologics license application (BLA) for its combination antibody therapy, sintilimab, to treat nonsquamous...
Pfizer recently announced that its selective sphingosine 1-phosphate (S1P) receptor modulator to treat moderate to severely active ulcerative colitis (UC) significantly improved the primary endpoint of...
Moderna will expand its mRNA vaccine pipeline through two new development programs, including a combination respiratory vaccine candidate and a program against four endemic human coronaviruses...
Novavax recently launched its global, unbranded vaccine programs, 'We Do Vaccines' and 'Know Our Vax' as educational efforts to help protect people's health in the fight against the...
Civica recently announced plans to manufacture and distribute insulin to diabetes patients at significantly lower prices than insulins currently on the market.
Civica, CivicaScript, and the...
Pfizer recently initiated a Phase 2/3 clinical trial to evaluate the safety, pharmacokinetics, and efficacy of its COVID-19 treatment, Paxlovid, in non-hospitalized, symptomatic pediatric...
FDA recently issued a complete response letter (CRL) to Gilead rejecting its New Drug Application (NDA) for HIV-1 treatment, lenacapavir.
The agency cited Chemistry Manufacturing and Controls (CMC)...
The US Patent and Trademark Office (PTAB) recently ruled that CRISPR gene-editing technology belongs to the Broad Institute of Harvard and MIT, according to multiple news sources.
After an...
AstraZeneca Rare Disease and Alexion group recently closed a global collaboration and license agreement with Neurimmune AG for the investigational human monoclonal antibody, NI006.
NI006 is a...
FDA recently accepted Bristol Myers Squibb’s supplemental Biologics License Application (sBLA) for its non-small cell lung cancer (NSCLC) drug, Opdivo, plus chemotherapy.
The agency based its...
Moderna recently expanded its mRNA pipeline with three new development programs, including an HSV mRNA vaccine, a varicella-zoster virus (VZV) vaccine, and a checkpoint cancer vaccine.
First, Moderna...
Moderna and ROVI recently entered into a long-term collaboration to increase capacities for the compounding, aseptic filling, inspection, and manufacturing of mRNA vaccines and medicines over the next...
FDA recently issued emergency use authorization for Eli Lilly and Company’s monoclonal antibody, bebtelovimab, which retains activity against the omicron variant.
The agency authorized the...
AstraZeneca recently announced that its combination chemotherapy treatment improved radiographic progression-free survival (rPFS) compared to standard-of-care for metastatic castration-resistant...
Merck KGaA, Darmstadt, Germany, and Quris recently signed an agreement to assess the Quris BioAI machine learning platform and compare it to traditional in vitro and in vivo approaches.
The Quris...
Biogen and Xbrane Biopharma recently agreed to develop, manufacture, and commercialize a preclinical monoclonal antibody and proposed biosimilar, Xcimzane, referencing Cimzia.
Cimzia is a drug...
Samsung Biologics will acquire Biogen’s stake in Samsung Bioepis for $2.3 billion to accelerate growth in biosimilars and novel therapeutic research and development.
Under the terms of the...
Personalized immunotherapy from an individual’s tumor-fighting immune cells could potentially treat metastatic breast cancer, according to a study from the National Cancer Institute’s...
CVS Health and Medable recently collaborated to expand clinical trial access and engagement for patients at select MinuteClinic locations.
The collaboration will combine Medable’s software...
