“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia. Read More
Shares of Ionis Pharmaceuticals Inc. (NASDAQ:IONS) fell 21.7% to $43.59 on March 23 after its longtime partner, Roche Holding AG, decided to stop dosing the antisense oligonucleotide tominersen in a global phase III manifest Huntington's disease (HD) study. Roche subsidiary Genentech Inc. said the move was based on an independent data monitoring committee's preplanned assessment of the drug's risk-benefit profile. Read More
A phase IIa study of Frequency Therapeutics Inc.’s lead candidate in treating hearing loss showed it fared no better than placebo, but the company said its faith in the candidate is bolstered by the belief the study was hampered by trial design issues and by data from another study. Read More
Asher Biotherapeutics Inc. raised $55 million in a series A financing round to take forward a series of engineered cytokines designed to selectively activate T cells or other immune effector cells, in order to eliminate both the toxicities and the loss of efficacy that can result from indiscriminate activation. Read More
LONDON – Astrazeneca plc promised to publish the primary analysis of the phase III U.S. trial of its COVID-19 vaccine by the morning of March 25, after chastisement from the data safety monitoring board (DSMB) for using “outdated” information in the interim results published on March 22. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) has approved Australian manufacture of Astrazeneca plc’s COVID-19 vaccine (ChAdOx1-S), which is being manufactured by CSL Ltd. Read More
If the biopharma industry thought its round-the-clock efforts and considerable financial investments in tackling COVID-19 would earn it good will in the U.S. Congress, those hopes were dashed March 23 when both Democrats and Republicans serving on a Senate Health, Education, Labor and Pensions subcommittee reverted to blaming drug companies for much of what’s wrong with the U.S. health care system. Read More
Like its distinctive name, Dragon Boat Biopharmaceutical Co. Ltd., of Shanghai, raced to victory with the Chinese IND approval for its anti-CSF-1R monoclonal antibody candidate BC-006, marking an important milestone for the company as it embraces a growing focus on innovative medicines. Read More
The latest global regulatory news, changes and updates affecting biopharma, including: End of the road for ‘standing’ case; TGA gives labeling guidance; Trial fraud leads to prison sentences. Read More
New hires and promotions in the biopharma industry, including: Acepodia, Allovir, Arrakis, Maze, Medivir, Pharming, Poseida, Sutro, Translate. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Anokion, Frequency, Ideaya, Incyte, Ionis, Lineage, Neoimmunetech, Novartis, Omeros, Oramed, Precigen, Recordati, Regeneron, Roche, Sojournix. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Augustine, Celonic, Cipla, Cure, Curevac, Devpro, Evelo, Eyenovia, Eversana, Fairjourney, Hepion, Hoth, Immunome, Intervivo, Iontas, JSR, Lead Discovery, Life Edit, Lyell, Maze, Mindset, Novo Nordisk, Organicell, Plus, Point, Sangamo, Scholar Rock, Siga, Tallac, Viracta, Xoma, Zenas. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amryt, Cansino, Incyte, Insmed, JCR, Merck, Protagonist, RDIF, Zealand. Read More
