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Home » Newsletters » BioWorld

BioWorld

April 24, 2024

View Archived Issues
Ozempic-Wegovy boxes and pens2

Move over, Humira, there’s a new mega-blockbuster in town

There was a time not that long ago when Merck & Co. Inc.’s Keytruda (pembrolizumab), with its multiple cancer indications, was seen as the heir apparent to Humira’s title of the biggest blockbuster drug. Not anymore. That title now belongs to Novo Nordisk A/S’ semaglutide, approved as Ozempic in 2017 to treat diabetes and as Wegovy in 2021 to help with weight loss. Read More

China grapples with providing access to CAR T therapies

The process of manufacturing autologous T-cell therapies is technically challenging when compared with other oncology drugs, making the overall cost of developing CAR T therapies significantly higher. A challenging reimbursement environment for drugs listed on China’s National Reimbursement Drug List also means that most patients will have to pay out of pocket to access CAR T therapies. Taken together, complex logistics – production, manufacturing and supply chain – and complicated administration requirements are key bottlenecks that inflate the input costs involved in developing these specialized treatment options. Read More
Marc Tessier-Lavigne, CEO, Xaira

Xaira launches with $1B+ for AI drug development

In one of the biggest startups ever, Xaira Therapeutics has launched with more than $1 billion from investors. The financing, according to BioWorld records, is roughly equivalent to Roivant Sciences Inc.’s $1.1 billion raise in August 2017 and Galderma Inc.’s $1 billion private placement in June 2023. Read More

US FDA approves Pivya for uncomplicated UTIs

The U.S. FDA approved Utility Therapeutics Ltd.’s Pivya (pivmecillinam), an oral prodrug of injectable mecillinam, on its April 24 PDUFA date for female adults with uncomplicated urinary tract infections (UTIs) caused by Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. Read More
cancer-cell-light.png

Flindr’s $21.4M series A advances immune modulators

Flindr Therapeutics BV has raised €20 million (US$21.4 million) in a series A round to advance small-molecule immune modulators aimed at targets it has identified in cancer patients who respond to existing immunotherapies. Read More
Gavel and FTC logo

Attorney predicts ‘all-out battle’ over FTC noncompete rule

The U.S. Federal Trade Commission’s final rule for noncompete clauses in employment contracts would seem to endanger life science patents and trade secrets, but there is a question of whether the agency stepped outside its statutory bounds in forming the rule. The U.S. Chamber of Commerce has already filed suit on the rule, but Joshua Rich of McDonnell Boehnen Hulbert & Berghoff LLP told BioWorld, that the Chamber is unlikely to be the last entity to file suit over the rule. Read More

Big pharma seeks innovation in China despite geopolitical turmoil

Big pharma continues to seek innovation in China despite rising geopolitical tension, speakers said at the Asia Bio Partnering Forum in Singapore April 24. Read More
Lung cancer driven by the Kras oncogene shown in purple

Broader KRAS inhibition methods include chaperoning, gluing, vaccinating

The existence of two approved therapies, Lumakras (sotorasib, Amgen Inc.) and Karzati (adagrasib, Mirati Therapeutics Inc.), has been a triumphant success against KRAS, a protein that was once considered undruggable. Read More

BioWorld Insider Podcast: Mark McKenna storms back with Mirador and eyes the development landscape

In one of the biggest financings of the year so far, former Prometheus Biosciences Inc. CEO Mark McKenna helped raise $400 million to launch a new company, Mirador Therapeutics Inc. He didn’t sit on the sidelines for long after Merck & Co. Inc. bought Prometheus for $10.8 billion in 2023. He recruited key Prometheus executives to focus on Mirador’s genetic approach to drug discovery and precision medicine. McKenna said there was too much left undone to just hang back. In this BioWorld Insider episode, he talks about the new company and the multi-billion-dollar drugs that he believes provide sub-optimal efficacy compared to the tailor-made therapies he wants to develop. Read More

Appointments and advancements for April 24, 2024

New hires and promotions in the biopharma industry, including: Actym, Cel-Sci, Curevac, Evotec, Flare, Harness, Oruka, Pharmaessentia, Recludix. Read More

Financings for April 24, 2024

Biopharmas raising money in public or private financings, including: Contessa, Endeavor, LSL, Scilex, Theralase. Read More

In the clinic for April 24, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alto Neuroscience, Corcept, Curium, Helmholtz Munich, Inmune, Isotope Technologies, Lisata, Neurocrine, Neurogene, Qilu, Regeneration, Response, Sanofi, Theriva, TME, Unity. Read More

Other news to note for April 24, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aubex, Bighat, Biolojic, Endo, Exopharm, Glysious, J&J, Hami, Merck & Co., Moderna, Openai, Nektar, Tetra, Tryp, Tryptamine, Vivoryon. Read More

Regulatory actions for April 24, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abeona, Astrazeneca, Averoa, Beigene, Edgewise, Immunitybio, Innocan, Medivir, Oncoc4, Revive, Tiziana. Read More

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