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Home » Newsletters » BioWorld

BioWorld

March 11, 2025

View Archived Issues
Breast cancer illustration

Arvinas phase III wild card turns over in breast cancer

Mixed clinical results led shares of Arvinas Inc. (NASDAQ:ARVN) to close March 11 at $8.30, down $9.26, or 52%, after the company and Pfizer Inc. disclosed results from the phase III Veritac-2 study testing vepdegestrant monotherapy vs. fulvestrant in adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. Enrolled were subjects whose disease progressed after treatment with CDK4/6 inhibitors and endocrine therapy. Read More

Cervomed serves up positive extension data in dementia phase IIb study

Positive 16-week extension data from Cervomed Inc.’s phase IIb in dementia with Lewy bodies followed a failure from December. New results from the Rewind-LB trial testing neflamapimod, a brain-penetrant, orally administered small molecule that inhibits the intracellular enzyme p38MAP kinase alpha, have encouraged the company to pursue a phase III study. Read More
Dermatologic-atopic-dermatitis2

Kyowa Kirin, Amgen’s rocatinlimab ignites positive response in Rocket study

Analysts were pleasantly surprised by the positive phase III data reported for Kyowa Kirin Co. Ltd./Amgen Inc.’s rocatinlimab, a T-cell rebalancing therapy, in moderate to severe atopic dermatitis. Read More

Leyden Labs raises $70M for intranasal flu drugs, acquires Covbio

Leyden Laboratories BV added a fresh $70 million in financing to advance Panflu, its phase II-ready intranasal pan-influenza prophylactic medicine, while acquiring Cov Biotechnology Pte. Ltd. (Covbio) and its zoonotic virus-targeting portfolio to prepare for the next pandemic. Read More
HIV infected cell

At CROI, HIV cure trials raise hopes for broader applicability

At the 2025 meeting of the Conference on Retroviruses and Opportunistic Infections (CROI) it was the best of times, it was the worst of times. On the first full day of the conference, reports from the first HIV cure trial conducted in Africa, the RIO trial and others showed that perhaps, a broadly useful cure is on the horizon. Read More
Pills spilling out of prescription bottle

Ending ‘pill penalty’ challenges sacred cow status of IRA

Getting the Ensuring Pathways to Innovative Cures (EPIC) Act through the U.S. Congress to do away with the “pill penalty” in the Medicare drug price negotiations could require an epic effort, given the current politically fueled atmosphere on the Hill. With the Inflation Reduction Act (IRA), which created the negotiations, considered a signature achievement of the Biden administration, the negotiations have become, for many lawmakers, almost a sacred cow that can’t be touched. If anything, some of them want to expand the negotiations to more drugs and to the commercial market. Read More
Art concept for inflamed human tissue

Time nigh for I&I? Key data points ahead

Yesterday’s first part of this two-part series surveyed bispecific antibodies for immunological and inflammatory (I&I) disease. Apart from bispecifics, Leerink analyst Thomas Smith lately has proven interested in I&I overall, unveiling his “five for 2025” in a January report that listed five indications with “potential for disruption” in the year ahead. Read More

Valo raises €19M for immunotherapy work

Finnish cancer immunotherapy specialist Valo Therapeutics Oy has raised €19 million (US$20.7 million) in a round that attracted Italian and Australian investors, and funding the company to the completion of the ongoing phase Ib trial of its lead program in the treatment of solid tumors. Read More
Gavel-and-scales.png

Clinical trial fraud ends with guilty pleas

In another real-life episode of “sponsor beware,” the owners of a clinical research facility pleaded guilty March 10 in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs. Read More

Appointments and advancements for March 11, 2025

New hires and promotions in the biopharma industry, including: Haya, Madrigal, Matinas, Psyence, Seaport, Tenpoint. Read More

Financings for March 11, 2025

Biopharmas raising money in public or private financings, including: Alvogen, Beam. Read More

In the clinic for March 11, 2025

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agomab, Alumis, Arrowhead, Beam, BMS, Eli Lilly, Incyte, Innocare, Johnson & Johnson, Leo Pharma, Mineralys, Novo Nordisk, Organon, Regeneron, Sanofi, SFA, Trevi, Urogen. Read More

Other news to note for March 11, 2025

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocon, Inozyme, Sunshine. Read More

Regulatory actions for March 11, 2025

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Celltrion, Ionis, Vertex. Read More

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