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Home » Newsletters » BioWorld

BioWorld

Dec. 6, 2023

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Pharvaris turns next page in oral HAE therapy with phase II Chapter-1 readout

Pharvaris NV’s phase II top-line data from the Chapter-1 trial testing oral bradykinin B2 receptor antagonist deucrictibant in hereditary angioedema (HAE) wowed Wall Street and sparked speculation regarding where the drug might fit in the increasingly competitive landscape. Read More

Arvinas, Pfizer broaden scope of ER-targeting therapy after impressive phase Ib breast cancer readout

While early stage and involving a relatively small patient population, the interim phase Ib readout from the combination cohort testing estrogen receptor (ER)-targeting candidate vepdegestrant in combination with CDK4/6 inhibitor Ibrance (palbociclib) in heavily pretreated patients with ER-positive/HER2-negative breast cancer was impressive enough to prompt partners Arvinas Inc. and Pfizer Inc. to expand development work on the program. The results also struck a chord on the Street, with shares of Arvinas (NASDAQ:ARVN) gaining 31% on the day. Read More
Coronavirus, mRNA and syringe

Off-target immune response from modified mRNA impacts future development

The Nobel Prize-winning modification that prevents the innate immune system from recognizing injected mRNA as foreign and blocking transcription of the protein it encodes has been found on some occasions to cause ribosomal frameshifting. Read More

US FDA approves Novartis’ factor B inhibitor for rare blood disease

The U.S. FDA has approved Novartis AG’s Fabhalta (iptacopan) as the first oral monotherapy for adults with paroxysmal nocturnal hemoglobinuria, a rare blood disease that impairs blood cell production. This is the only factor B inhibitor of the immune system’s complement pathway and is expected to be on the market before December ends. Fabhalta has plenty of competition from already-approved therapies and more treatments are in development. Read More
Antibodies

Celltrion, Cyron ink $882M deal for polyspecific antibodies

South Korean pharmaceuticals Celltrion Inc. and Cyron Therapeutics Co. Ltd. are teaming up to discover and develop bispecific and trispecific antibodies, collectively called polyspecific antibodies, under the ₩1.158 trillion (US$882.38 million) joint research agreement inked on Dec. 6. Under the terms, privately held Daegu-based Cyron will discover and develop at least three polyspecific antibodies for blood and solid cancers pre-selected by Incheon-based Celltrion via Cryon’s CD-3 targeting T-cell engager platform that helps engage T cells to attack cancer cells. Read More

China’s NMPA greenlights Jingxin’s dimdazenil for insomnia

China’s National Medical Products Administration (NMPA) approved Zhejiang Jingxin Pharmaceutical Co. Ltd.’s dimdazenil (EVT-201) for short-term treatment of insomnia. Jingxin filed the NDA in China in April 2022. Read More

US senator: New payment model needed for gene therapies

With the number of high-priced cell and gene therapies expected to grow dramatically over the next decade, U.S. Sen. Bill Cassidy (R-La.) is asking for input from patients, doctors, manufacturers, payers and policy wonks on how to pay for the treatments and ensure patient access when they become more mainstream across the ultra-rare disease spectrum. Read More

Topic alerts now available for all BioWorld subscribers

You asked and we listened. Now, in addition to the daily news lineup, you can create topic alerts to be delivered directly to your inbox or via an RSS reader. It’s easy to set up. Instructions can be found here: https://www.bioworld.com/featured-feeds. Read More

Appointments and advancements for Dec. 6, 2023

New hires and promotions in the biopharma industry, including: Abcuro, Alentis, Empress, Myeloid, OM, Renagade, Transgene, Vertex. Read More

Financings for Dec. 6, 2023

Biopharmas raising money in public or private financings, including: Ability, Adcentrx, Coya, Eyepoint, Immunoprecise, Kazia, Pharvaris, Rxcell, Tanai. Read More

In the clinic for Dec. 6, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alentis, Allarity, Alto, Annovis, Aqualung, Aquestive, Ascletis, Aspargo, Bioatla, Bioinvent, Bolt, Cidara, Cybin, Eli Lilly, Esocap, G1, Genentech, Gradalis, Gri, Inventiva, Melinta, Nasus, Neuren, Neurosense, Novadip, Pfizer, Replimune, Ribomic, Trevi, Valneva, Vaxcyte, Zyus. Read More

Other news to note for Dec. 6, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aclaris, BMS, Boehringer Ingelheim, Comera, Coya, Cyprium, Dr. Reddy’s, Formation, Fortress, Hibercell, IGM, Imidomics, Kamada, Kedrion, Mendus, Merck & Co., Naya, Onk, Sentynl, Sun, Taiwan Bio, Ten63, Tract, Trialspark, Vitrivax, Zydus. Read More

Regulatory actions for Dec. 6, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomea Fusion, Bridgebio, Bristol Myers Squibb, Genentech, Hamlet, Immunogen, Johnson & Johnson, Mission, Osteal, Roche, Travere, Vanda. Read More

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