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BioWorld

Sun, Jul 27, 2025
Breaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Trump administration impacts continue to roil the life sciences sectorBreaking News: Self-amplifying mRNA technology underscored for next big pandemic
  • EU flag, syringe, capsules

    CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla

    After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.
  • Memo's potravitug reduces BK viral load in kidney transplant

  • Brandon Capital closes sixth life sciences fund at AU$439M

  • Today's news in brief

  • CHMP rejects Sarepta’s Elevidys, changes mind on Lilly’s Kisunla

    After a tough few weeks for Sarepta Therapeutics Inc., the EMA dealt another blow on July 25, announcing it will not be approving the Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec). Re-examination of the file led to a happier outcome for another drug that has attracted considerable controversy, Eli Lilly and Co. Inc.’s Kisunla (donanemab) for treating the early stages of Alzheimer’s disease.
  • Memo's potravitug reduces BK viral load in kidney transplant

    Memo Therapeutics AG is laying plans to advance its BK polyomavirus neutralizing monoclonal antibody potravitug into phase III development after reporting positive phase II results in treating infections in immunocompromised kidney transplant patients.
  • Brandon Capital closes sixth life sciences fund at AU$439M

    Brandon Capital Partners Pty Ltd., Australia’s largest life sciences venture capital firm, announced the final close of its sixth fund at AU$439 million (US$288 million), the VC’s largest fund to date.
  • Today's news in brief

    BioWorld briefs for July 25, 2025.
  • Device, drug makers weigh in on Janssen’s FCA case

    Janssen Pharmaceutical’s loss in a False Claims Act (FCA) case for the company’s HIV treatments resulted in judgments of roughly $1.6 billion – an outcome the company appealed to the Court of Appeals for the Third Circuit.
  • Two cancer drugs combined modify Alzheimer’s disease in mice

    Current treatments for Alzheimer’s disease have limited effects. While they can slow cognitive decline or alleviate symptoms, they do not reverse this complex neurodegenerative condition caused by multiple factors. Researchers from the Gladstone Institutes and the University of California, San Francisco (UCSF) have screened FDA-approved drugs in search of agents that could potentially modify the disease.
  • Biopharma busy with numerous clinical successes last month

    In June 2025, BioWorld tracked 254 clinical trial updates across phases I to III, up from 223 in May, 151 in April and 197 in March. Of the June updates, 24 trials reported positive phase III results, while only one was reported as a failure.

BioWorld Insider Podcast

Play buttonRobert Williamson, CEO of Triumvira Immunologics, and Hernan Bazan, CEO of South Rampart Pharma, discuss bracing for tariffs, NIH grant cuts and gifting China a biopharma leadership position.
Listen now

Analysis and data insight

  • Tablets on conveyor belt

    South Korea hits record $23B pharma production; 2024 exports up 28%

    Biosimilar
    South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.
  • Silhouette of child and brain

    Rett bet set includes Neurogene, Taysha gene therapies

    Clinical
    Neurogene Inc.’s disclosure June 30 of its registrational trial design in Rett syndrome (RS) added spice to the space, where Taysha Gene Therapies Inc. is another closely watched player. The New York-based firm said Embolden will test NGN-401, a gene therapy for the treatment of females age 3 and...
  • Opportunity compass with Chinese flag

    For big pharma, China is a shopper’s dream

    Deals and M&A
    Big pharma is increasingly shopping in China to fill its pipelines as it faces looming patent cliffs on major blockbusters coupled with growing pricing pressures on drugs. China’s out-licensing deals grew to represent 32% of global deals in the first half of 2025, according to a Jefferies report...
  • June FDA approvals jump, led by three new NMEs

    Regulatory

    The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it the third-highest total for this period in BioWorld’s records, trailing 118 approvals in 2024 and...

More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for July 25, 2025

  • Financings for July 25, 2025

  • In the clinic for July 24, 2025

  • Other news to note for July 25, 2025

  • Regulatory actions for July 25, 2025

Deals and M&A

  • Sanofi expanding vaccine portfolio in $1.6B Vicebio buyout

  • Biopharma deal value surges past $138B in first half of 2025

  • Sino to acquire Lanova and pipeline for up to $950M

  • JCR’s third deal with Alexion gives rights to AAV capsids

  • Biopharma deals hit $35B in June, highest month of 2025 so far

  • Chugai and Gero partner to tackle age-related diseases

  • Abbvie gains rights to IGI’s trispecific ISB-2001 in $1.9B+ deal

  • JCR’s third deal with Alexion gives rights to AAV capsids

  • In a $10B deal, Merck buys cardio developer Verona

  • Veritas, Mitsubishi Gas Chemical partner for new ASO candidates

Financings

  • Amplia raising AU$27.5M to advance FAK inhibitor narmafotinib

    Cancer
    Amplia Therapeutics Ltd. is raising AU$27.5 million (US$18.12 million) to advance lead compound narmafotinib (AMP-945), a focal adhesion kinase (FAK) inhibitor, into new indications beyond pancreatic cancer.
  • Newco sends up Flare in bid to Dispatch solid tumors

    Newco news
  • Avalyn secures $100M for inhaled pulmonary fibrosis candidates

    Respiratory
  • 34 mainland China biotechs file for Hong Kong IPO in H1 2025

    Analysis and data insight
  • Illimis $42M series B to spur study of Aβ-clearing fusion protein

    Immune
More in Financings

Science

  • Illustration of group of people with chromosomes floating above

    A fresh look at 1000 Genomes is more detailed, and more panoramic

    Genomics
    The human genome has yielded another round of secrets with the publication of two back-to-back papers in Nature on July 23, 2025. Both studies re-sequenced probands from the open-access 1000 Genomes Project, which was one of the first projects to sequence individuals from diverse populations. While...
  • Coinfections and diversity paint the many shades of HIV cure

    Conferences
    We all look different to HIV, a virus that destroys the immune system. The defensive cells record every interaction with foreign agents, infections from viruses and bacteria, but also with mechanisms occurring within the body, such as microbiome metabolism, the effects of aging, or the development...
  • IAS 2025: Cheat, parasitize, break the virus – fresh ideas fuel HIV research

    Conferences
    There is still no effective vaccine or cure for HIV. Scientists are considering options ranging from longer-term antiretroviral therapy (ART) that space out injections by several years to long-lasting pre-exposure prophylaxis (PrEP) that acts as a vaccine while immunization is achieved. What else...
  • New non-opioid approach for pain: Tafalgie reports phase I data

    Clinical
  • Eight babies born after successful mitochondrial transfer

    Clinical
  • UK Biobank project complete, supports research with 100,000 scans

    Clinical
  • IAS 2025: All eyes still on the HIV reservoir

    Conferences
More in Science

Newco news

  • Single strand RNA

    In ongoing mRNA evolution, SML Biopharm sights new cancer vaccines

    Clinical
    SML Biopharm Co. Ltd. is harnessing mRNA technology to develop novel immunotherapy-based cancer vaccines, including two candidates for cervical and head and neck cancers caused by human papillomavirus (HPV) infection.
  • Illustration of kidney with DNA structures

    Renasant launches with $54.5M to develop drugs for a genetic kidney disease

    Financings
    Launched out of 5AM Ventures’ 4:59 Initiative, Renasant Bio Inc. has secured $54.5 million in seed funding to support development of treatments for autosomal dominant polycystic kidney disease (ADPKD), a genetic disease caused by mutations in the PKD1 and PKD2 genes, which encode polycystin...
  • Circode executives

    Circode applies circRNA to heart disease drug R&D, in vivo CAR T

    Cancer
    Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
  • Actithera raises $75M series A for FAP-targeted radiopharmaceuticals

    Financings
    Actithera A/S is poised to bring small-molecule pharmacokinetics to radiopharmaceuticals after closing a $75.5 million series A that will fund initial clinical development of a candidate targeting the elusive fibroblast activation protein (FAP).
  • Hand holding money plant

    Abvance Therapeutics secures seed funding to limit glucose lows

    Financings
    Abvance Therapeutics Inc. secured an undisclosed amount of capital in a seed round led by Zubi Capital to support development of an insulin and glucagon combination product that the company has been in the process of developing for approximately 18 months.
More in Newco news

Regulatory

  • US FDA approves first hand eczema treatment: Leo Pharma’s Anzupgo

  • PTAB to return to pre-pandemic hearing practice

  • Ridding US vaccines of thimerosal prioritized over RSV prep

  • Apnimed loses no sleep over new phase III apnea results

  • Sarepta yields to FDA request, pauses Elevidys shipments

  • Replimune says it didn’t see this CRL coming

  • Makary chooses new CDER director from industry ranks

  • Sarepta confronts FDA, won’t stop Elevidys shipments

  • Biocon wins first FDA interchangeable label of Novolog biosimilar

  • EFPIA urges action to improve Europe’s clinical trials ecosystem

U.S.

  • Stock chart, upward arrow

    Abivax’s obefazimod wows investors; stock climbs 500%+

    Clinical
    Abivax SA is positioning to change the treatment landscape in ulcerative colitis after delivering positive results and a favorable safety profile in two phase III trials of its orally available miRNA-124 enhancer, obefazimod. Abivax stock rocketed in Europe and the U.S. on news of the data. Shares...
  • Diamedica’s DM-199 shows promise for serious pregnancy disorder

    Clinical
  • Sarepta CEO: Third same-vector gene therapy death ‘not material’

    Clinical
  • Adcom agrees with FDA: Otsuka’s PTSD treatment needs more study

    Regulatory
  • Med tech helps boost J&J to strong 2Q beat

More in U.S.

Europe

  • United Kingdom flag, map

    Life sciences strategy to reduce UK approval costs by 25%

    Regulatory
    The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
  • Rx tariffs a few weeks away?

    Regulatory
    “Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said, as he provided a few more details about his proposed global biopharma sector tariff. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build. And...
  • NIH capping science journal fees for open access published research

    Regulatory
    The National Institutes of Health has opened another front in its cost cutting drive, saying it will cap the fees science journals charge for publishing papers authored by researchers it funds.
  • Nuclidium’s radiopharma approach draws $99M in series B

    Clinical
  • Optimism prevails despite talk of 200% biopharma tariff

    Registered direct offering
  • UK industry encourages renewal of rare disease framework

    Science
  • EU unveils new ‘Choose Europe for life sciences’ strategy

    Regulatory
More in Europe

Clinical

  • Phase III MG settee: Astrazeneca perched pretty with gefurulimab

    Immune
    Astrazeneca plc seems on the way to expanding its presence in myasthenia gravis (MG) with positive “high-level” results from a global, randomized, double-blind, placebo-controlled phase III trial with once-weekly, self-administered gefurulimab in...
  • Livzon’s IL-17A/F meets phase III endpoints in plaque psoriasis ​

    Immune
    Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized,...
  • Still no scare for Ohtuvayre: Roche IL-33 COPD data mixed

    Respiratory
    The fate of IL-33-targeting astegolimab will be determined by talks with regulators, after Roche AG’s Genentech unit rolled out mixed results from a pair of studies testing the compound vs. placebo on top of standard-of-care (SOC) maintenance...
  • Australia awards AU$100M in grants to biopharma/med-tech incubators

    Regulatory
    The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.
  • Imugene’s allogeneic CD19 CAR T sees 75% response rate

    Cancer
    Immuno-oncology company Imugene Ltd.’s allogeneic, off-the-shelf CD19 CAR T, azercabtagene zapreleucel (azer-cel), has resulted in seven complete responses and three partial responses in a phase Ib trial in relapsed diffuse large B-cell lymphoma...
  • Hengrui/Kailera obesity asset delivers solid weight loss in phase III

    Endocrine/metabolic
    A glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptor dual agonist developed by Jiangsu Hengrui Pharmaceuticals Co. Ltd. and licensed by Kailera Therapeutics Inc. has shown a mean weight loss of 19.2% at the 6-mg dose...
More in Clinical

BioWorld Insider Podcast

One-on-one with medical innovators

podcast microphone, sound waves on purple backgroundBreakthrough medicines, billion-dollar deals, spectacular clinical successes and crushing failures all play a part in biopharma’s dynamic story. Developers make scientific advancements with the potential to change everything, only to face regulatory conundrums and ever-fluctuating markets. BioWorld tracks key events in the fast-moving sector every business day. Now, the BioWorld Insider podcast lets you hear directly from the movers and shakers whose collective work is changing how we all live. Join us each week for a new conversation.


Recent episodes:

  • The importance of balancing AI and people in drug development
  • Two CEOs discuss bracing for tariffs, NIH grant cuts and
    gifting China biopharma leadership position
  • As biopharma investments stumble, med tech surges
  • Mega money well spent? Mammoth mergers fall short of the dream
  • Healing the health divide for women
  • Modifi gets creative on the rocky road to a multibillion-dollar buyout
  • A quantum leap into the future of drug development
  • Gene and cell therapies will propel innovation, says Astellas CCO
  • Capricor’s CEO pursues a BLA and talks rare disease
  • The first half of 2024 was strong as M&As and financings dominate

View all

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