The U.S. FDA’s guidance to COVID-19 vaccine manufacturers, announced June 30, that they should develop modified bivalent boosters that include an omicron BA.4/5 spike protein component marks the beginning of a new era in the pandemic in which manufacturers are no longer driving the development of the vaccines. Read More
More than five years after agreeing to collaborate in a deal that had the potential to top $1 billion, Akebia Therapeutics Inc. executed an agreement to terminate its troubled partnership to develop vadadustat with Otsuka Pharmaceutical Co. Ltd. Otsuka will pay Akebia a $55 million settlement fee. Read More
Recently published real-world data with Firazyr (icatibant), the selective B2 bradykinin receptor antagonist from Takeda Pharmaceutical Co. Ltd. to treat acute hereditary angioedema (HAE) attacks, trained a spotlight on the space, where a handful of players compete. Among the prospects is the early stage but intriguing Star-0215 from Astria Therapeutics Inc., which could be the next advance in the kallikrein-inhibitor class. Read More
With vaccines now authorized for children as young as six months, omicron boosters in development for the fall, and the nation’s first protein subunit vaccine for COVID-19 pending authorization, the U.S. appears to be well on its way to exiting the turmoil caused by the deadly SARS-CoV-2 virus. Globally, there is reason for optimism as well. Read More
Genmab A/S, of Copenhagen, Denmark, said it intends to file a BLA with the U.S. FDA for its subcutaneous bispecific antibody epcoritamab, for patients with relapsed/refractory large B-cell lymphoma in the second half of 2022. Read More
Japan is establishing a centralized infectious disease crisis management agency that will be under direct control of the prime minister. One of the goals is to better clarify the chain of command and to bring together resources and COVID-19 task forces from the Cabinet Secretariat and the Ministry of Health, Labor and Welfare. Read More
Researchers at the Institute for Cancer Research have demonstrated that in pancreatic tumors, the balance between a more aggressive mesenchymal and a less aggressive epithelial state is constantly in flux, depending on an interplay of different regulatory proteins. Read More
As an ever-increasing share of companies seek signs of efficacy for investigational drugs in early stage studies, single-arm trials to confirm those effects and support marketing applications are also becoming more common. Now, China’s Center for Drug Evaluation has released draft guidelines on how single-arm trials can be regulated, used to support the new drug application for cancer drugs, and accelerate oncology drug development. Read More
New hires and promotions in the biopharma industry, including: ADC, Affimed, Centessa, Clover, Fate, Infant Bacterial, Nektar, Newron, Protalix, Revir, Teva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amarin, Bavarian Nordic, Biontech, Emergex Vaccines, Essa, Immunome, Oncodesign, Pfizer, Regeneron, Rome, Sanofi. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: ABVC, Ascentage, Aura, Bavarian Nordic, Nurix, Pfizer, Phanes, Skye. Read More
