A first-of-its-kind organization launched on May 13 unifying the voices of life science companies committed to delivering desperately needed treatments to rare disease patients. The Rare Disease Company Coalition’s 10 founding members have brought 22 treatments to market and have more than 160 rare disease programs in the works.
Pivotal data from Amgen’s and AstraZeneca’s NAVIGATOR Phase III trial show tezepelumab, a potential first-in-class human monoclonal antibody, reduced asthma aggravations and exacerbations requiring hospitalizations better than placebo in patients with severe asthma.
Merck announced positive results from the late-stage KEYNOTE-522 study for Keytruda as a neoadjuvant treatment for triple negative breast cancer, which should support the company’s previous attempt for U.S. approval that was stymied by a regulatory advisory committee in February and rejected by the Food and Drug Administration in March.
Biopharma companies Gennao Bio and Juno Diagnostics raised a combined $65 million in Series A funding rounds.
Biogen Inc. exercised the company’s option to acquire TMS-007, an investigational drug for acute ischemic stroke, from TMS Co. Ltd.
2021 is shaping up to be another banner year for biotech companies. According to BioSpace, funds appear to be in near-endless supply as companies advance next-gen technologies and therapeutics for the health of all. BioSpace reviews a few raking in cash for their programs.
In a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for Covid-19, researchers found when a new monoclonal antibody drug was added to treatments being given to hospitalized Covid-19 patients who were still breathing on their own, Humanigen Inc.’s lenzilumab significantly improved their odds of not needing invasive mechanical ventilation.
Building on the success of the company’s mRNA research, BioNTech will establish its first regional hub in the Asia Pacific region. The company will open a state-of-the-art manufacturing facility to support a global supply of mRNA-based vaccines and therapeutics in Singapore.
Six months after receiving Emergency Use Authorization from the U.S. Food and Drug Administration for Covid-19 vaccines, Pfizer/BioNTech and Moderna are seeking full approval for the preventative medications. Pfizer and BioNTech announced on May 7 that they initiated a rolling submission of a Biologics License Application with the FDA for full approval of their mRNA vaccine in individuals 16 years and older.
The U.S. Food and Drug Administration approved Merck’s Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the first anti-PD-1 therapy approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients.
