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Redefining what success looks like in PSC: The evolution of clinical trial endpoints
As understanding of rare cholestatic liver diseases has evolved, endpoint science and patient engagement may help shape future PSC research.
Latest medical news · page 284
The latest headlines across every section, pulled from official and open-access sources.
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How data-driven diagnostic lab services drive precise clinical trial enrollment
Drug commercialization depends on reaching the right physicians at the right moment.
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FDA Breakthrough Therapy and RMAT: Strategic Decisions That Can Accelerate Oncology Development
Explore how FDA Breakthrough Therapy and RMAT designations can create opportunities for oncology programs when backed by the right development strategy.
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Insilico lands heavily backloaded $2.5B AI drug discovery deal with SK Biopharm
Insilico Medicine and SK Biopharmaceuticals have teamed up on an AI-enabled search for drug candidates targeting neuroimmune disorders in a deal that could be worth more than $2.5 billion.
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A 5-month sprint: Behind Pfizer’s $10B deal and Innovent’s global pharma ambition
Despite its massive $10.5 billion size and 12-drug scope, Pfizer’s oncology deal with Innovent Biologics took less than five months to forge, but not without undergoing some stress tests.
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Sanofi's R&D chief Ashrafian to hit the exit as new CEO seeks to fix stuttering pipeline with Roche alum
Recently appointed Sanofi CEO Belén Garijo has stamped her mark on the organization, hiring Paulo Fontoura, M.D., Ph.D., to replace Houman Ashrafian, Ph.D., as the head of the company’s stuttering R&D group.
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Helmed by Sanofi vet, Bionyra emerges with $165M and three licensed I&I assets
Bionyra is emerging from stealth with an oversubscribed Series A round of $165 million co-led by Jeito Capital and Sofinnova Partners. Arkin Bio, Sanofi Ventures, Sixty Degree Capital, Vives Partners and Apollo Health Ventures also participated in the round after the company received seed financing from Sofinnova Partners.
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Definium’s LSD formula produces ‘best data ever seen’ in a pivotal depression trial, CEO says
From its headquarters in the heart of New York City, Definium Therapeutics has dropped topline phase 3 data for its psychedelic answer to depression that is almost certain to keep the field’s hype train rolling.
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For biopharma manufacturing at speed and scale, the future is flexible
Biopharma development has long trended toward specialized and personalized therapies such as cell and gene therapies, antibody-drug conjugates, and monoclonal antibodies (mAbs), among others.
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AbbVie inks $10.9B Apogee buyout to bag hotly tipped eczema prospect
AbbVie has struck a deal to buy Apogee Therapeutics for $10.9 billion. The deal will give AbbVie control of a late-phase eczema drug candidate that could pose a threat to Eli Lilly, Regeneron and Sanofi.
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Sanofi, Pangaea ink AI partnership deal to detect underdiagnosed genetic disease
French biopharma Sanofi inked a partnership deal with Pangaea Data to use its AI platform that helps detect Alpha-1 Antitrypsin Deficiency (AATD) that will be distributed to select healthcare systems and low-income community care clinics.
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Merck’s anti-TL1A antibody from Prometheus buyout passes ph. 3 test in ulcerative colitis
Merck is making advances in the lucrative ulcerative colitis field with the key prize of its $11 billion buyout from several years ago.
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In another reversal for rare disease field, FDA to reconsider Regenxbio gene therapy
In another sign that the FDA is easing its stance toward rare disease drug candidates under new leadership, the agency will reconsider Regenxbio’s gene therapy for an ultra-rare childhood disease, a reversal coming just about four months after a rejection.
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Rethinking controls: The rise of VCGs in drug development
Virtual control groups are redefining study design—cutting animal use while advancing rigor and regulatory momentum.
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Federal health agencies unveil plan to speed up phase 1 clinical trials by 6 to 12 months
As the biotech world flocks to San Diego today for the BIO International Convention, the Department of Health and Human Services has provided plenty of conversation fodder with the announcement of a series of efforts to regain ground on China’s surging early-stage clinical development capabilities.
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Exelixis’ Cabometyx successor fails primary endpoint in colorectal cancer trial amid FDA review
Exelixis’ next franchise drug, zanzalintinib, has hit a clinical setback, although at least two groups of analysts suggested that an FDA approval is still on the table.
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Pfizer’s first new ADC from Seagen acquisition fails phase 3 NSCLC trial
Pfizer announced Monday that sigvotatug vedotin, the first new ADC to read out pivotal data following its $43 billion acquisition of Seagen, has stumbled in a phase 3 study in non-small cell lung cancer.
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FDA issues early alert for J&J’s Abiomed catheter introducer over manufacturing issues, bleeding risk
The FDA has sent out an early alert to J&J’s Abiomed unit and its manufacturing partner, Oscor, for their catheter introducer kits that are used with Impella heart pumps amid manufacturing concerns.
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Corxel gears up for global pivotal push after oral GLP-1 posts ‘competitive’ ph. 2 results
With a balance of competitive efficacy and tolerability, Corxel figures it has a potential winner to take into late-stage development.
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Big obesity bets and China's rise fuel potential $2T in 2032 drug sales: Evaluate
While dealmaking and investment dollars may be flowing across biopharma once again, acute challenges tied to policy, pricing and more continue to dog the industry, even as pipelines bring massive sales opportunities to bear.
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Merck KGaA pledges $50M to build new cardio biotech with eye to later acquisition
Merck KGaA has committed $50 million to build a new biotech with prolific life science investor Versant Ventures, with the ultimate goal of devouring the NewCo down the line.
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Sangamo to put ‘substantially all’ assets for sale in bankruptcy, lines up Lilly and Astellas as buyers
Eli Lilly and Astellas have emerged as “stalking horse bidders” for certain assets as part of Sangamo’s bankruptcy process.
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Serapha Bio takes flight from Boundless merger with $230M and gene-editing prospect from China
The focus of the company is SERP-01, an in vivo base editing program targeting AATD developed in China and licensed from YolTech Therapeutics.
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Discreet biotech Osanni Bio starts making noise with $190M series B for clinical push
An under-the-radar Bay Area biotech has brought in a $190 million series B with the goal of hatching a clutch of new companies to fly its drug candidates forward.