A phase III trial of Rafael Pharmaceuticals Inc.’s devimistat in pancreatic cancer has failed, sending shares in its publicly listed holding company through the floor. Shares in Rafael Holdings (NYSE:RFL) closed Oct. 28 down 73% to $8.09, for a loss of $22.08 after an independent data monitoring committee also recommended a separate phase III trial of devimistat in acute myeloid leukemia should be stopped due to lack of efficacy. Read More
Optimism for the potential of a bifunctional fusion protein complex in development at HCW Biologics Inc. for the potential treatment of pancreatic cancer jolted company shares (NASDAQ:HCWB) skyward to $4.73 on Oct. 28, up 62%, though still far short of the company's $8 per share summer market debut. The company, founded and led by former Altor Bioscience Corp. CEO Hing Wong, gained FDA clearance to start a first-in-human phase Ib trial of the candidate, HCW-9218. Read More
As the company unveiled 18-month results from the phase III study called Helios-A, Alnylam Pharmaceuticals Inc.’s president of R&D, Akshay Vaishnaw, said “new exploratory data with the cardiac endpoints are extremely encouraging.” The study is testing RNAi therapy vutrisiran in polyneuropathy associated with hereditary transthyretin-mediated (hATTR) amyloidosis, where Helios-A met all secondary endpoints measured at 18 months. Read More
Fosun Pharmaceutical Group Co. Ltd. has acquired a 73% stake of Antejin Biotech Co. Ltd. in a merger and acquisition deal worth up to ¥4.006 billion (US$626.2 million) to expand its pipeline in the field of bacterial vaccines. To kick off, Shanghai-based Fosun purchased about 32.52% equity interest in Antejin from nine shareholders for about ¥1.108 billion in cash. Read More
DUBLIN – Novadip SA raised €19 million (US$22.1 million) in a first close of a series B round to progress its autologous bone regeneration therapy, NVD-003, on either side of the Atlantic. The company is also working on an allogeneic regenerative approach, which is still preclinical. Read More
LONDON – Four decades of academic research at the University of California, San Francisco, is to be translated through to the clinic with funding from a €1 million (US$1.2 million) European Commission grant. The money, awarded to a Dutch/German consortium will fund the generation and optimization of antibodies designed to neutralize oxidized phospholipids that mediate inflammatory changes in a swathe of diseases. The consortium that won the Eurostars award is led by Oxitope Pharma BV. Read More
Plants could be an alternative vaccine platform for both COVID-19 and future pandemics, shaking up a biologics sector that is currently mostly protein-based. South Korean company Bioapplications Inc., for example, is aiming to have a plant-derived booster shot for COVID-19 in the clinic in 2022. Read More
PERTH, Australia – Investment in regenerative medicine in Australia in 2020 was AU$394.1 million (US295.8 million), accounting for nearly 23% of the overall capital invested in the Australian biotech sector, according to a new report published by Australia’s Regenerative Medicine Consortium. Read More
The U.S. Department of Health and Human Services is proposing to withdraw or repeal a Trump-era rule imposing expiration dates on most of the rules implemented by the department and its agencies, including the FDA. Read More
In an effort to advance a fiscal 2022 spending package through a divided Congress, U.S. President Joe Biden released the framework for his Build Back Better agenda Oct. 28 – minus provisions that would allow Medicare to directly negotiate at least some prescription drug prices. Read More
The EMA and the EU Heads of Medicines Agencies are launching a pilot project to support not-for-profit organizations and academia in the repurposing of an authorized drug for a new indication in an area of public health interest. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adagene, Boehringer Ingelheim, Novartis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Agenus, Axial, Bharat, Biontech, Bio-Path, Eli Lilly, Medicenna, Novartis, Novavax, Ocugen, Pfizer, Quell, Vitti. Read More
