Carmot Therapeutics Inc. has raised $160 million in series D financing to support a trio of early to midstage clinical programs focused on treating diabetes and obesity with peptide-based small-molecule incretin receptor modulators. Read More
Neurofront Therapeutics Ltd. has picked up an option to acquire exclusive Asia rights to a phase II non-opioid drug from Novaremed AG. Under terms of the deal, Novaremed is eligible to receive more than $130 million in option and exercise fees as well as development, regulatory and sales milestone payments plus royalties on net sales. Read More
An expert panel of Japan’s Ministry of Health, Labour and Welfare (MHLW) pushed back on recommending conditional approval for a second time for Shionogi & Co. Ltd.’s orally administered COVID-19 antiviral 3CL protease inhibitor, S-217622, also known as ensitrelvir. Read More
Although Pfizer Inc. has the only drugs approved in the U.S. to treat a rare, progressive heart disease, the U.S. Court of Appeals for the Second Circuit agreed this week with the Department of Health and Human Services, and a lower court, that Pfizer’s proposed copay assistance program for middle-income Americans covered by Medicare would violate the federal Anti-Kickback Statute – even if the company has no “corrupt” intent. Read More
Wall Street apparently wants to see longer-term data from Bridgebio Pharma Inc. with oral infigratinib in children with achondroplasia (ACH) before deciding about the drug’s chances against the approved therapy Voxzogo (vosoritide) from Biomarin Pharmaceutical Inc. Read More
The U.S. FDA has approved fewer drugs and biologics in the first half of 2022 than in each of the five prior years and only one new molecular entity has received clearance since the end of May. While the volume of regulatory news is slightly down from last year, FDA approvals are showing a much deeper decline of 19.8%. Read More
There is no drug that will halt the inevitable process of getting older each year. But biopharmaceutical research can have a positive impact on preventing diseases that come with aging, thereby extending life for the masses, and more importantly, extending quality of life. Part one of BioWorld’s multipart series on extending the human lifespan looks at the increasing development and investment in the space. Read More
In Extending the human lifespan, a BioWorld special report, the team examined the latest science, the key biological drivers that can be targeted pharmacologically and the companies developing potential “Fountain of Youth” candidate drugs. In this episode of the BioWorld Insider Podcast, the team discussed the report’s highlights and key takeaways.
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Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aligos, Ashvattha, Inmed, Nanoscope, Philogen, Revelation, Revive, Sling.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Altamira, Cantargia, Cinrx, Iama, Ginkgo, Navidea, Pluristem, Pluri, Psychogenics, Sanofi, Rona, Serb, Soligenix, Vtv and Zymergen. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, B.More, Bridgebio, Hookipa, Lepu, Matinas, Medexus, Qbiotics, Veru. Read More
