CAR-T’s commercial challenge is making thousands of patient-specific manufacturing runs behave like one reliable system. "In vivo" production techniques could be one solution.

Original title: “The hidden scale-out problem behind CAR-T’s growth”

The FDA’s primary review team found that Replimune hadn’t sufficiently addressed deficiencies that had been pointed out in the two prior rejection letters for the melanoma therapy Tudriqev.

Original title: “Replimune’s melanoma drug would have been rejected again if not for senior CBER official”

In this episode of Denatured, you’ll hear from Christina Takke, managing partner at V-Bio Ventures and Mariette van der Velden-Roesink, founding partner at Curie Capital. We explore why the Benelux region remains scientifically strong, but investment fragmented, and what it will take to turn it into a more unified biotech investment corridor.

Original title: “Breaking borders: Building biotech scale in Benelux”

With U.S. data science jobs projected to grow 35% over the next decade, a recruiter and talent strategy director discuss the qualifications, technical skills and mindset needed to land these coveted positions.

Original title: “Biopharma needs more data scientists. Who's getting hired?”

Wall Street analysts believe that a more cautious approach to manufacturing, study enrollment and side effect management could help developers avoid future safety hazards.

Original title: “Autoimmune CAR-T faces tough questions after Novartis, Bristol Myers study halts”

Teva believes the therapy has “pipeline-in-a-product” potential. Elsewhere, a high-stakes trial was paused and GSK advanced a competitor to Moderna’s flu shot.

Original title: “Teva claims success in celiac study; BioMarin, Ascendis settle patent dispute”

Funding announcements can signal future hiring activity, giving biotech professionals a chance to build relationships before positions are posted. Industry experts share how to identify the funding events, milestones and company indicators most likely to lead to new jobs.

Original title: “Follow the money: How funding announcements can help identify jobs before they’re posted”

BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers.

Original title: “Stripped of AstraZeneca safety net, BMS could face ‘carnage’ if high-risk clinical trial fails”

The National Institute of Diabetes and Digestive and Kidney Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the invention embodied in the patents and patent applications listed in the Supplementary Information section of this notice to Nulyn Science ("Nulyn"), a company located in Paris, France.

Original title: “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance Disorders”

FDA's RFA-FD-25-020 funds rare disease clinical trials up to $900,000 per year for 4 years. Deadlines, eligibility, IND requirements, and how startups win. FDA is funding the human trial data that moves a product closer to an approved label. There are more than 10,000 known rare diseases affecting roughly 30 million Americans, and only a few hundred of those diseases have approved treatments. The Orphan Products Grants Program has funded clinical trial research since 1983, and more than 80 of the studies it has funded have gone on to facilitate marketing approval of a rare disease product. RFA-FD-25-020 is an FDA grant that pays for rare disease clinical trials. It provides up to $650,000 in total costs per year for up to four years, and up to $900,000 per year if you use an innovative or efficient trial design. The money is non-dilutive, meaning you give up no equity and no intellectual property. Clinical trials in any phase of development, meaning Phase 1, Phase 2, and Phase 3 are all eligible · Drugs, biologics, medical devices, and medical foods · Studies of already approved products being evaluated for a new orphan indication · Studies assessing multiple rare diseases at once, provided prevalence data is supplied for each disease The criteria include proposing a clinical trial that provides safety or efficacy data for a rare disease, using the generic name of the product, requesting no more than four years, documenting rare disease prevalence, explaining how the trial supports a new indication or labeling change, meeting the IND and IDE requirements under 21 CFR 312 for drugs and biologics or 21 CFR 812 for devices, providing the required appendices and letters, and complying with page and formatting limits.

Original title: “RFA-FD-25-020: FDA Orphan Products Clinical Trials Grant — BW&CO”

Roche has tapped Simcere Zaiming for a new T cell engager that could have broad application in B cell–mediated diseases including lymphoma and autoimmune conditions.

Original title: “Roche finds another oncology gem in Asia with $1.5B B cell disease partnership”

After downsizing by 50% last year, Arsenal Biosciences is again laying off employees. This time, 99 people are getting cut as part of a strategic shift to focus the company’s R&D efforts on in vivo CAR T therapies.

Original title: “ArsenalBio sacrifices ‘majority’ of staff in pivot to in vivo CAR T”

Earlier in his career, he led global ... of rare-disease therapies, with earlier commercial leadership roles at Acorda Therapeutics, Takeda Pharmaceuticals and Johnson & Johnson. Mr. Benecchi holds an MBA from Duke University's Fuqua School of Business and a BA from Colby College. Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients ... Earlier in his career, he led global launch readiness for UCB's BIMZELX® (bimekizumab) and, at Alexion, directed global commercial excellence and launch readiness across a portfolio of rare-disease therapies, with earlier commercial leadership roles at Acorda Therapeutics, Takeda Pharmaceuticals and Johnson & Johnson. Mr. Benecchi holds an MBA from Duke University's Fuqua School of Business and a BA from Colby College. Inventiva is a clinical-stage biopharmaceutical company focused on the research and development of an orally administered small molecule for the treatment of patients with MASH. Inventiva appoints Chris Benecchi as Chief Operating Officer to lead operational readiness for lanifibranor Phase 3 study results and potential commercialization, enhancing MASH treatment approach The Company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for the treatment of adult patients with MASH, a common and progressive chronic liver disease. These statements include, but are not limited to, forecasts and estimates with respect to Inventiva’s NATiV3 Phase 3 clinical trial with lanifibranor in patients with MASH, including the quality of trial results, design, duration, timing, costs, and funding, timing of clinical trial data releases and publications, the information, insights and impacts that may be gathered from clinical trials, the potential therapeutic benefits of lanifibranor, potential regulatory submissions, approvals and commercialization, Inventiva’s pipeline and development plans, and Inventiva's future activities, expectations, plans, growth and prospects.

Original title: “INVENTIVA (EPA:IVA) |”