The flop that is Aduhelm (aducanumab) made itself felt in Biogen Inc.’s executive suite as CEO Michael Vounatsos is leaving the company. He had the job for five and a half years and for less than a year after the controversial Alzheimer’s treatment was approved. He will stick around until a successor is found. Read More
The U.S. Centers for Medicare & Medicaid Services’ (CMS) decision last month restricting coverage of a class of Alzheimer’s drugs to clinical trials meeting the agency’s standards still isn’t sitting well with some lawmakers. Read More
Switzerland’s biotechnology sector maintained its strong investment performance in 2021. The final tally for the year came to CHF3.33 billion (US$3.4 billion), which is almost equivalent to its record-breaking total of CHF3.4 billion for 2020. Read More
Health care private equity investor Patient Square Capital has launched Enavate Sciences, a new portfolio company with an initial capital commitment of $300 million devoted to "enabling innovation through both capital and company-building experience," CEO Jim Boylan told BioWorld. The firm, which plans to invest in both therapeutics startups and enabling technologies, plans to raise $200 million to $300 million more in 2022. Read More
Dianthus Therapeutics Inc. has, appropriately, flowered in springtime. The Waltham, Mass.-based company emerged from stealth with $100 million in series A funding and lofty ambitions to rewrite the rules of targeting the complement system with a pipeline of antibodies that bring new levels of selectivity to an area of innate immunity that has proved difficult to target. Read More
Tubulis GmbH has added considerable momentum to its effort to build a pipeline of novel antibody-drug conjugates (ADCs) by closing a €60 million (US$63.2 million) series B round. CEO and co-founder Dominik Schumacher told BioWorld the cash would enable the Munich-based firm to generate clinical proof of concept, build a clinical pipeline and continue development of its platform technologies. Read More
Xbiome Inc. acquired M-201, a clinical-stage program from Assembly Biosciences Inc., to treat patients with mild to moderate ulcerative colitis as it looks to develop products to address the growing incidence of bowel disease throughout Asia. The company expects to start a phase Ib trial of the oral live biotherapeutic product in the U.S. in 2022 and also plans to run clinical trials in China. Read More
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC). Read More
Engimmune Therapeutics AG has raised CHF15.5 million (US$16.7 million) in a seed round, as it prepares to address efficacy and safety shortcomings that currently constrain T-cell receptor and soluble TCR cancer therapies. The Basel, Switzerland-based company’s technology brings together genome editing, functional screening, deep mutational sequencing and machine learning, to engineer synthetic T-cell receptors that are highly specific to a chosen tumor antigen, increasing affinity and safety and avoiding off-target effects. Read More
In an ongoing sibling saga of biopharma trade secret theft, Gongda Xue, a Swiss resident and Chinese citizen, has been convicted, following a U.S. trial, of charges related to a conspiracy to steal trade secrets from Glaxosmithkline plc over a six-year period beginning in 2010, the U.S. Attorney’s Office for the Eastern District of Pennsylvania reported May 2. Read More
In launching the European Health Data Space May 3, the European Commission (EC) heralded it as “a fundamental game-changer for the digital transformation of health care in the EU.” Read More
Could investments in biopharmaceutical companies in 2022 be as aggressive as 2021, which saw a record 1,968 biopharma deals worth about $213.5 billion? So far, 2022 may be the lowest financing year since 2017 overall. But, drilling down to venture capital, private companies raised $5.7 billion in Q1 through 129 transactions, making it the second-best first quarter in history with 2021 at the top. BioWorld Senior Analyst Karen Carey explores the data with staff writer Lee Landenberger, explaining what happened in Q1 and where Q2 is headed. Read More
New hires and promotions in the biopharma industry, including: Adcendo, Alentis, Apellis, Ellipses, Glycoera, Ilya, Integra, Intellia, Oncotelic, Pionyr, Plexium, Seismic. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adverum, Aptorum, Kala, Milestone, Sorrento, Tarsus, Vertex, Zynerba. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abcellera, Biogen, Byondis, Cero, Cognition, Curative, Empirico, Hansoh, Haya, Immunicum, Ingenia, Medac, Mosaic, Nikeng, Oryzon, Scribe, Sesen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Axsome, Biogen, Coherus, Horizon, Hutchmed, Ideaya, Junshi, Moderna, Myovant, Novavax, Regeneron, Sage, Supernus, Vaxxinity, Vertex, Vitti. Read More