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Home » Newsletters » BioWorld

BioWorld

Sep. 16, 2024

View Archived Issues
Woman itching wrist

Lilly’s Ebglyss enters US atopic dermatitis market with FDA nod

Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.). Read More

Daily grind: Ascendis achondroplasia win not grate for Biomarin

Predictably, weekly vs. daily subcutaneous injections made a big difference in the achondroplasia space, where shares of Copenhagen, Denmark-based Ascendis Pharma A/S (NASDAQ:ASND) closed Sept. 16 at $139.57, up $20.35, or 17%, on favorable, pivotal top-line data with Transcon CNP (navepegritide), as competitor Biomarin Pharmaceutical Inc.’s stock (NASDAQ:BMRN) ended the day at $69.86, down $15.04, or 17.7%. Read More
FDA-approved-stamp3.png

Genentech’s new multiple sclerosis treatment reduces admin time

Genentech’s newly approved multiple sclerosis (MS) injection takes about 10 minutes to administer, dramatically reducing the four to six hours required by its intravenous predecessor. The U.S. FDA approved the humanized monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for relapsing MS and primary progressive MS on Sept. 13. Read More
Doctor and patient

The massive, untapped opportunity in women’s health

Biocom California’s most recent edition of its Let's Talk About series covered the future of women’s health. The panel of executives from companies and investors in women’s health were frustrated about the state of funding for the space. “Only about 1% of health care R&D dollars go [specifically] to women’s health outside of oncology,” Jenn Kiang, director of corporate affairs and development at Daré Bioscience Inc. told the audience. But the opportunity is huge, she said. Read More
Cancer cells under magnifying glass

ESMO 2024: For T-cell target antigens, lots to see, but what to show?

Metastatic solid tumors may be curable now. Among the most profound results presented over the weekend at the European Society for Medical Oncology (ESMO) 2024 Congress were the 10-year data from the Checkmate-067 and Keynote-006 trials, the phase III trials that tested Opdivo (nivolumab, Bristol Myers Squibb Co.) and Keytruda (pembrolizumab, Merck & Co. Inc.) as first-line agents in advanced or metastatic melanoma. Read More

US FDA: Context matters in cancer trials

Putting in writing what it’s been saying at advisory committee meetings, the U.S. FDA is issuing a draft guidance on multiregional clinical trials for cancer drugs that underscores the need for applicability to the U.S. population and medical practices. Read More

ESMO 2024: Immvira’s MVR-T3011 shows early efficacy in bladder cancer

Immvira Group Co.’s oncolytic herpes simplex virus product, MVR-T3011, showed early efficacy via intravesical administration in patients with high-risk BCG-failure non-muscle invasive bladder cancer. Read More

Senators send stern message to US FDA on animal testing

While it’s called the FDA Modernization Act (FDAMA) 3.0, the short bipartisan bill introduced in the U.S. Senate Sept. 15 is basically a message to the FDA: “The move away from animal testing in FDAMA 2.0 wasn’t a congressional suggestion. It’s a mandate, so get it done.” Read More

ICYMI: Week in review, Sept. 9-13, 2024

A quick look back at top stories. Read More

Biggest gainers and losers for Sept. 9-13, 2024

The top 10 biopharma stock gainers and losers for the week. Read More

Appointments and advancements for Sept. 16, 2024

New hires and promotions in the biopharma industry, including: Kalm Therapeutics. Read More

Financings for Sept. 16, 2024

Biopharmas raising money in public or private financings, including: Base, Centessa, Inmune, Terns, Valneva, Xencor. Read More

In the clinic for Sept. 16, 2024

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atea, Curevac, Hotspot Therapeutics, Immuneering, Moberg, Neurocrine, Vico, Zambon. Read More

Other news to note for Sept. 16, 2024

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cidara, Emergent Biosolutions, Nona, Omrx Oncology, OS Therapies, Umoja. Read More

Regulatory actions for Sept. 16, 2024

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Arcturus, Bavarian Nordic, CSL Vifor, Halozyme, Nanoscope, Roche. Read More

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