AstraZeneca and Merck have announced that the FDA has approved Lynparza in combination with bevacizumab as a first-line maintenance treatment of advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in certain adult patients whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by BRCA mutation and/or genomic instability. Regulatory reviews are […]

WuXi Biologics and the Worcester Business Development Corporation (WBDC) have announced the successful signing of a land deal for WuXi Biologics’ clinical and commercial manufacturing facility (MFG11) in Worcester at The Reactory, a 46-acre master-planned biomanufacturing campus. The approximately 107,000-square-foot, two-story facility will be operational in 2022 and create 150 new jobs. Craig Blais, the […]

AbbVie has completed its acquisition of Allergan plc following receipt of regulatory approval from all government authorities required by the transaction agreement and approval by the Irish High Court. “We are pleased to reach this important milestone for the Company, its employees, shareholders and the patients we serve,” said Richard A. Gonzalez, chairman and chief […]

AstraZeneca and Daiichi Sankyo drug Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of certain patients with HER2-positive metastatic gastric cancer. In March 2019, AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialize Enhertu worldwide, except in Japan where Daiichi Sankyo maintains […]

The FDA has granted Fast Track designation for Moderna’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2). In explanation, Moderna’s Chief Medical Officer Tal Zaks said, “Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus. As we await the full set of clinical data from the NIAID-led Phase 1 […]

Moderna and Lonza have announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future. Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the U.S. and Switzerland for the […]

Alexion has announced it will acquire Portola, a commercial-stage biopharma focused on life-threatening blood-related disorders. Portola’s commercialized medicine, Andexxa  (marketed as Ondexxya in Europe) is the first and only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in […]

Pfizer and BioNTech have dosed the first participants in the U.S. and Germany in the Phase 1/2 clinical trial for the BNT162 COVID-19 vaccine program. The Phase 1/2 study is designed to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates evaluated in a single, continuous study. Pfizer and BioNTech’s development […]