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Home » Newsletters » BioWorld

BioWorld

March 8, 2023

View Archived Issues
Women handshake with virology graphics

Modex codex may read out new story in EBV with Merck vaccine pact worth $922M-plus

Another step forward in the quest for an Epstein-Barr virus (EBV) vaccine took the form of Merck & Co. Inc.’s deal with Modex Therapeutics Inc., owned by Opko Health Inc., to advance MDX-2201 worldwide, an arrangement that brings $50 million up front for Opko plus as much as $872.5 million in milestone payments along with royalties. Read More

Redx halts biliary tract cancer treatment monotherapy program

Top-line results of a phase II study of RXC-004, a porcupine inhibitor for treating certain Wnt ligand-dependent cancers, are not good enough to continue development as a monotherapy for biliary tract cancer, according to Redx Pharma plc. Despite the monotherapy arm not hitting progression-free survival at six months, the Porcupine2 study continues with its other treatment arm, this one using Keytruda (pembrolizumab, Merck & Co. Inc.). Data from that arm are set to come in the second half of 2023. Read More
Makena

Covis makes second offer to withdraw Makena

Noting that the FDA had rejected its previous proposal last year to voluntarily withdraw Makena from the U.S. market, Covis Pharma BV is again offering to voluntarily withdraw the drug, which is the only drug approved to reduce the risk of preterm birth. Along with its offer, the company asked the agency “to allow for an orderly wind-down that would best serve the interests of the patients,” according to a March 6 letter from Covis’ attorney to FDA Commissioner Robert Califf and Namandjé Bumpus, the agency’s chief scientist. Read More

CFIUS finally clears merger with F-star and Invox

After placing a temporary hold on the merger between F-star Therapeutics Ltd. and Sino Biopharmaceutical Ltd.’s Invox Pharma Ltd., citing “unresolved national security risks,” the Committee on Foreign Investment in the United States (CFIUS) has finally cleared the merger to proceed. Read More
DNA, fetus illustration

Prenatal gene-editing treatment offers curative potential for serious inherited disease

The researcher who pioneered prenatal surgery to correct neural tube defects has turned her attention to using CRISPR-edited gene therapies to correct severe monogenic diseases in utero. The availability of prenatal genetic diagnosis and advances in treating fetuses, and also in gene therapy/gene editing, make it possible to repair almost any defect in the genetic code. At the same time, there is a clear rationale for intervening before birth, Tippi MacKenzie, professor of surgery at UCSF’s School of Medicine, told attendees of the third International Human Genome Editing Conference in London on March 7. Read More

Zhejiang Medicine’s anti-HER2 ADC positive in phase III; possible new drug submission up next

Zhejiang Medicine Co. Ltd.’s subsidiary, Novocodex Biopharmaceuticals Inc., reported positive phase III study results for its humanized anti-HER2 monoclonal antibody-drug conjugate, ARX-788, in the treatment of patients with HER2-positive locally advanced or metastatic breast cancer in China. Read More

Appointments and advancements for March 8, 2023

New hires and promotions in the biopharma industry, including: Alnylam, Artax, Biogen, Combined, Editas, Freya, Hepatx, Varmx, Venatorx. Read More

Financings for March 8, 2023

Biopharmas raising money in public or private financings, including: Betterlife, Bridgebio, Cidara, ONL, Revolution. Read More

In the clinic for March 8, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ab2, Dyadic, Enthera, Indaptus, Infectious Disease Research Institute, Janssen, Maia, Merck & Co., Panbela, Protagonist, Small. Read More

Other news to note for March 8, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akston, Oncopeptides, Stelis. Read More

Regulatory actions for March 8, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biomarin, Genethon, Ionis, Novan, Regeneron, Sanofi, Shorla, Siga, Takeda. Read More

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