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  • Acrosian launches AI-focused biometrics CRO targeting pharma and biotech
    Acrosian has been introduced as a new contract research organization built for the AI era. The firm is founded by Benjamin Jackson, Soumitra Chowdhury and Vladimir Mats, who previously created the…
    Fierce Biotech · 1mo agoPositive↗ source
  • Guardant Health partners with Patrick Dempsey for emotional colorectal cancer screening video
    Guardant Health, maker of the Shield blood test for colorectal cancer, released a new video featuring actor Patrick Dempsey to raise awareness of the disease. In the one‑minute clip, Dempsey watch…
    Fierce Biotech · 1mo agoPositive↗ source
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WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
raps · 1mo agoRegulatoryNeutral↗ source
  • Senate Republicans, led by Rand Paul, compel Dr. Fauci to testify at hearing on COVID-19 response
    Senate Republicans, especially Rand Paul, have long criticized the government’s handling of the COVID-19 pandemic and are using a Senate hearing to question Dr. Anthony Fauci. Paul, who has accuse…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • CDC survey shows racial gaps in diagnosis of endometriosis, PMOS and uterine fibroids among US women
    A recent CDC National Center for Health Statistics report based on a 2022-2023 survey of about 5,000 women ages 20 to 49 provides new insight into how often certain gynecologic conditions are diagn…
    STAT · 1mo agoNeutral↗ source
  • Whoop appoints new chief medical officer, discusses health tech plans and CMS initiative
    STAT Health Tech’s latest newsletter features a brief interview with Whoop’s newly appointed chief medical officer. The CMO fielded three questions about the company’s direction, wearable data use…
    STAT · 1mo agoNeutral↗ source
  • FDA clears Freenome's SimpleScreen CRC blood test, Abbott to market it in U.S.
    The U.S. Food and Drug Administration has given clearance to Freenome’s SimpleScreen CRC, a blood-based test for colorectal cancer. Abbott will be the exclusive U.S. marketer and will pay Freenome…
    Fierce Biotech · 1mo agoApprovalPositive↗ source
  • Global HIV funding drops 18%, raising fears of epidemic resurgence
    A new UNAIDS report warns that the world could see a rebound of HIV infections after donor financing fell sharply last year. Government contributions dropped by more than $1.5 billion to $7.3 bill…
    STAT · 1mo agoNegative↗ source
  • Claris Biotherapeutics raises $118M Series B to advance corneal stem-cell eye drop
    Claris Biotherapeutics announced a $118 million Series B financing round led by Novo Holdings and supported by several venture firms. The funding will be used to move its lead candidate, CSB-001, i…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • RA Capital backs Oak Hill Bio's Nasdaq debut via $175 million SPAC merger
    RA Capital announced that its SPAC, Research Alliance Corporation III, will merge with Oak Hill Bio, creating a new Nasdaq-listed rare-disease company. The combined entity will start with $175 mil…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, securing phase-2 vitiligo antibody FB102
    Argenx announced it will buy Forte Biosciences for $2.2 billion, gaining access to FB102, an anti‑CD122 antibody currently in phase‑2 trials for vitiligo and celiac disease. In a recent phase 1b s…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • PhRMA pushes back as prescription drug spending continues to rise, according to STAT+ newsletter
    STAT+ Health Care Inc. newsletter author Bob Herman reports on the growing concern that prescription drug spending is rising despite industry attempts to downplay it. The piece appears in the July…
    STAT · 1mo agoNegative↗ source
  • FDA doubts efficacy of Capricor’s Duchenne stem-cell therapy after Phase 3 miss
    The U.S. Food and Drug Administration said Monday that Capricor Therapeutics’ stem‑cell treatment for Duchenne muscular dystrophy failed to meet the primary goals of its Phase 3 trial, contradictin…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA advisory panel backs broader compounding of six peptide drugs despite limited safety data
    An FDA advisory panel reviewed seven peptide therapies and voted to ease access to six of them. The recommendation would let compounding pharmacies manufacture these peptides, expanding how they ca…
    STAT · 1mo agoRegulatoryPositive↗ source
  • RA Capital leads $175 million round for Oak Hill Bio to revive Roche’s Angelman syndrome drug
    RA Capital and other investors have committed $175 million to Oak Hill Bio, a new biotech aiming to revive a previously shelved experimental therapy for Angelman syndrome originally developed by Ro…
    STAT · 1mo agoDealNeutral↗ source
  • Apnimed targets up to $160 million IPO to fund launch of Oxnimbi, its oral sleep apnea pill
    Apnimed, a Massachusetts biotech, filed with the SEC indicating it will seek an IPO of up to $160 million to finance the commercial launch of its oral obstructive sleep apnea therapy, Oxnimbi (AD10…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • MapLight shares tumble over 60% after mixed Phase 2 schizophrenia trial results
    MapLight Therapeutics reported mixed outcomes from its Phase 2 Zephyr trial of the experimental schizophrenia drug ML-007C-MA, causing its stock to fall sharply. The trial enrolled 307 patients wi…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • InnoCare’s oral TYK2 inhibitor fadeucravacitinib meets primary endpoint in phase 3 psoriasis trial
    InnoCare Pharma announced that its oral TYK2 inhibitor fadeucravacitinib (also known as ICP-488) achieved the primary endpoint in a phase 3 study of adults with moderate-to-severe plaque psoriasis.…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • Argenx to acquire Forte Biosciences for $2.2 billion, bolstering its autoimmune drug pipeline
    Argenx announced it will purchase Dallas-based Forte Biosciences for $2.2 billion in cash. The transaction values Forte at $77 per share, a 41 percent premium to its closing price on Friday. The a…
    STAT · 1mo agoDealPositive↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 1mo agoCRLNegative↗ source
  • WHO publishes first interim list of medical device authorities; AstraZeneca explores AI to reduce late-stage risk
    The World Health Organization has issued its first interim list of medical device authorities, marking a step toward greater transparency in device regulation. The list is intended to guide manufac…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA commits to safeguarding stakeholder data; FDA advisory panel expands compounding peptide list
    The European Medicines Agency announced that it will assume ultimate responsibility for protecting information submitted by stakeholders through online meeting registrations and surveys, in line wi…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA issues three new guidances to expand eligibility criteria for cancer trials
    The FDA's Oncology Center of Excellence has released three final guidance documents aimed at widening the pool of patients who can enroll in oncology clinical trials. The guidances focus on three…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Sarepta Therapeutics appoints Michael Severino, former Tessera CEO, as new chief executive
    Sarepta Therapeutics announced that Michael Severino will become its chief executive, effective Tuesday. Severino previously led Tessera Therapeutics. He replaces Doug Ingram, who said he will ret…
    STAT · 1mo agoNeutral↗ source
  • Gossamer ends $486M PAH partnership with Chiesi after phase 3 miss
    Gossamer Bio announced it is terminating its collaboration and licensing agreement with Italy's Chiesi, regaining worldwide development and commercial rights to its pulmonary arterial hypertension…
    Fierce Biotech · 1mo agoDealNegative↗ source