BioWorld. Link to homepage.

Clarivate
  • BioWorld
  • BioWorld MedTech
  • BioWorld Asia
  • BioWorld Science
  • Data Snapshots
    • BioWorld
    • BioWorld MedTech
    • Infographics: Dynamic digital data analysis
  • Special reports
    • Infographics: Dynamic digital data analysis
    • Trump administration impacts
    • Biopharma M&A scorecard
    • BioWorld 2024 review
    • BioWorld MedTech 2024 review
    • BioWorld Science 2024 review
    • Women's health
    • China's GLP-1 landscape
    • PFA re-energizes afib market
    • China CAR T
    • Alzheimer's disease
    • Israel
    • Rise of obesity
    • Radiopharmaceuticals
    • Biosimilars
    • Aging
    • IVDs on the rise
    • Coronavirus
    • Artificial intelligence

BioWorld. Link to homepage.

  • Sign In
  • Sign Out
  • My Account
Subscribe
BioWorld - Friday, May 9, 2025
Breaking News: 100 days of uncertaintyBreaking News: 100 days of uncertaintyBreaking News: 100 days of uncertainty
  • Deal handshake with coin, chart background

    Shionogi to acquire Japan Tobacco pharma companies for $1.1B

    Shionogi & Co. said it plans to acquire Japan Tobacco Inc. (JT) subsidiaries Torii Pharmaceutical Co. and Akros Pharma Inc. for ¥160 billion (US$1.1 billion) to expand its global R&D business. The two companies have been negotiating since early 2024, and the deal is structured such that a tender offer will begin on June 18 with an offer price of ¥6,350 per share to buy at least 11.89% of the minority stake, JT told BioWorld.
  • Gyre widening in pancreatic? Revolution offers lung data, too

  • Haya doing well with a $65M series A for precision medicine

  • Today's news in brief

  • Shionogi to acquire Japan Tobacco pharma companies for $1.1B

    Shionogi & Co. said it plans to acquire Japan Tobacco Inc. (JT) subsidiaries Torii Pharmaceutical Co. and Akros Pharma Inc. for ¥160 billion (US$1.1 billion) to expand its global R&D business. The two companies have been negotiating since early 2024, and the deal is structured such that a tender offer will begin on June 18 with an offer price of ¥6,350 per share to buy at least 11.89% of the minority stake, JT told BioWorld.
  • Gyre widening in pancreatic? Revolution offers lung data, too

    Revolution Medicines Inc. followed the results offered last month with zoldonrasib (RMC-9805), a RAS G12D (ON) inhibitor, with plenty more about pipeline progress – “an embarrassment of riches,” CEO Mark Goldsmith said – during the firm’s first-quarter update. Shares of the firm (NASDAQ:RVMD) closed May 8 at $41.91, up $4.25, or 11%.
  • Haya doing well with a $65M series A for precision medicine

    Following last fall’s $1 billion development deal with Eli Lilly and Co., precision medicine company Haya Therapeutics SA has raised $65 million in a series A. It’s all part of increased validation from big pharmas that long noncoding RNAs, such as those being developed by Haya, have a strong future.
  • Today's news in brief

    BioWorld briefs for May 8, 2025.
  • US legal issues to track in pharma, biotech: Bio Korea 2025

    Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.
  • Organoids plus gene editing bring insights into pediatric metabolic disease

    “I’m a pediatrician in metabolic diseases, and every day in my clinical work I’m confronted with our lack in effective therapies for our patients.” That was the sobering introduction by Sabine Fuchs in her talk at the 2025 Congress of the European Association for the Study of the Liver in Amsterdam this week. The nature of metabolic diseases makes it difficult to develop treatments for them. “There are over 1,500 diseases known by now, and it is just very difficult to develop therapies for each and every individual rare disease.”
  • Sun shines on Leqselvi at Federal Circuit

    Planting seed money and “wishing” is not enough to claim “irreparable harm” to secure a preliminary injunction or to establish the standing required to appeal a patent board decision, the U.S. Court of Appeals for the Federal Circuit ruled May 7 in two decisions involving Incyte Corp. and Sun Pharmaceutical Industries Ltd.

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

  • Trump tariff EO signing

    South Korea urges US to exempt pharma, allies from tariffs

    Regulatory
    South Korean government and biopharmaceutical industry representatives urged American policymakers May 7 to refrain from imposing tariffs on pharmaceutical imports, and to spare allies if pharma tariffs are deemed necessary. Both Korea’s Ministry of Health and Welfare on May 4 and the Korea...
  • Hand pointing to IPOs on line graph

    Three Korea biotechs prep for May IPOs

    Financings
    Among three Korean biotech companies slated to sell shares on the Korea Exchange this month, Immuneoncia Therapeutics Inc. is the latest to price a ₩33.9 billion (US$24 million) Kosdaq IPO for May 19. Regenerative cell therapy maker Organoid Sciences Ltd. and antibody-drug conjugate specialist...
  • Bar chart, downward arrow

    Biopharma funding drops 71% from 2024, but in line with prior years

    Financings
    Total biopharma financings for the first four months of 2025 reached $15.48 billion, a 71% decline from $53.49 billion in 2024. Biopharma companies raised $2.4 billion in April 2025, reflecting a 37% drop from March's $3.82 billion.
  • Digital globe illustrating pharma trade, tariffs

    Navigating the Trump tariffs: Biopharma execs weigh in

    Europe
    First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks. BioWorld reporters have listened in to the analyst meetings and...
More in Analysis and data insight

Today's news in brief

  • Appointments and advancements for May 8, 2025

  • Financings for May 8, 2025

  • In the clinic for May 8, 2025

  • Other news to note for May 8, 2025

  • Regulatory actions for May 8, 2025

Deals and M&A

  • Dimerix strikes $601M Amicus deal for kidney disease drug DMX-200

  • With new leadership, Creyon enters a $1B-plus deal with Lilly

  • Regulus’ rare kidney disease drug draws Novartis in potential $1.7B buyout

  • Ono terminates development of Chordia’s cancer drug candidate

  • Shock value: Merck’s $3.9B Springworks grab provides jolt

  • US capital crunch pushes China biotechs to roundabout financings

  • Go ask Alis? New fund aims to rescue biopharma’s trapped cash

  • Chinabio 2025: Europe-China pharma deals rise as US markets shut

  • Tessellate signs $570M Boehringer deal targeting ALT-positive cancers

  • Veraxa through a SPAC heads to Nasdaq

Financings

  • Heart, DNA and ECG

    Nuevocor draws $45M series B for gene therapy in rare heart disease

    Science
    Nuevocor Pte. Ltd. has closed a $45 million series B, enabling it to move lead gene therapy NVC-001 into the clinic in the treatment of an inherited form of cardiomyopathy.
  • ‘Everything is possible’: Pharmas navigate US market uncertainties

    Europe
  • China pharma migration: Hengrui greenlighted for Hong Kong IPO

    Analysis and data insight
  • Granite Bio emerges with $100M raised and two immunology assets

    Newco news
  • Synthetic Design emerges with $20M and next-gen ADC platform

    Newco news
More in Financings

Science

  • AI generated, 3D rendering of protein degradation

    AACR 2025: Induced proximity strategy, beyond degraders

    Conferences
    Targeted protein degradation has yet to notch its first approval. But with more than two dozen agents now in clinical trials, the strategy’s ultimate clinical validation appears to be a matter of time.
  • AACR 2025: Nouscom reports early but promising response in Lynch syndrome

    Conferences
    Off-the-shelf cancer vaccine specialist Nouscom AG announced positive final results for its lead product, Nous-209, showing there was a “highly potent” and durable immune response in carriers of Lynch syndrome, a common hereditary condition that can increase the lifetime risk of cancer by as much...
  • Vaccine Integrity Project launched to tackle ‘unfortunate reality’

    Regulatory
    Nervousness about the Trump administration’s attitude to vaccines has spurred the formation of the Vaccine Integrity Project, which has the aim of safeguarding the use of vaccines and ensuring vaccine policy “remains grounded in the best available science,” and is “free from external influence.”
  • PIKfyve enzyme is target to ‘starve’ pancreatic cancer cells

    Cancer
  • Harvard fighting back with lawsuit against Trump administration

    Infection
  • M42 enters R&D with investment in longevity firm Juvenescence

    Deals and M&A
  • Stem cell therapies show safety in clinical trials in Parkinson's

    Stem cells
More in Science

Newco news

  • Genetic editing with CRISPR

    Brink’s recombinase enzymes offer new gene editing approach

    Financings
    Newco Brink Therapeutics SAS is poised to work on the next chapter in genome editing after raising €3.5 million (US$4 million) in seed funding to discover and develop programmable recombinase enzymes.
  • Illustration of antibodies attacking neurons

    Aiming for autoimmunity, Merida Bio launches with $121M series A

    Financings
    When an autoimmune disease disrupted the life of someone close to scientist Dario Gutierrez, an idea emerged for a new company called Merida Biosciences focused on removing misdirected antibodies and their negative effects using Fc biotherapeutics.
  • Feet on scale

    Antag aiming to fill therapeutic gaps in obesity space

    Clinical
    The latest obesity contender, Antag Therapeutics A/S, has dosed the first participants in a phase I trial of a glucose-dependent insulinotrophic polypeptide (GIP) agonist it said will address key gaps in the current treatment options, not least the gastrointestinal side effects seen with GLP-1...
  • Hillstar launches with $67M series A to target TRBV9+ T cells

    Financings
    Hillstar Bio came out of stealth mode, announcing a $67 million series A financing round with investors including Droia Ventures, Frazier Life Sciences, Novo Holdings A/S and Lifearc Ventures.
  • 3D dollar sign

    Augustine Therapeutics closes $85M series A for HDAC6 inhibitors

    Science
    Eight months after announcing the $18.5 million first tranche of its series A, Augustine Therapeutics has closed the oversubscribed round at $85 million and is now ready to begin clinical development of its novel histone deacetylase-6 (HDAC6) inhibitors.
More in Newco news

Regulatory

  • Congress poised to revisit two legislative proposals for patents

  • US-funded gain-of-function research paused for stiffer oversight

  • Some unshod by Prasad nod as CBER change socks stocks

  • EO offers US onshoring relief, FDA steps up foreign inspections

  • US states seek to undo HHS reorg, terminations

  • More stringency expected under new CBER head

  • Australia follows Canadian lead; Labor win a sharp rebuke to Trump

  • Oral GLP-1 Wegovy chases approval in obesity

  • Annual US 301 trade report has louder bark

  • Oh them REMS: Cytokinetics heart-hit with FDA delay

U.S.

  • Illustration of cancer in the pancreas

    Theriva’s VCN-01 improves survival in phase IIb pancreatic cancer trial

    Clinical
    Theriva Biologics Inc.’s stroma-targeting oncolytic virus approach yielded positive findings in metastatic pancreatic ductal adenocarcinoma, with the top-line readout of phase IIb data showing VCN-01 (zabilugene almadenorepvec) in combination with chemotherapy bested chemotherapy alone on primary...
  • US HHS touts NIH-developed universal vaccine platform

    Regulatory
  • FDA clears Satsuma’s Atzumi for migraine

    Regulatory
  • AUA hoorays in bladder cancer for J&J, Urogen, more

    Clinical
  • Filling the NIH funding gap to protect biopharma research

    Analysis and data insight
More in U.S.

Europe

  • Vyvgart Hytrulo

    Argenx’s Vyvgart, Camurus’ Oczyesa among 16 recommended by CHMP

    Regulatory
    Argenx NV is now well on the way to establishing a Vyvgart (efgartigimod alfa) franchise in severe autoimmune diseases, after getting the nod from the EMA in the treatment of progressive or relapsing chronic inflammatory demyelinating polyneuropathy.
  • Roche follows other pharmas, committing $50B in US investment

    Financings
    Roche AG has become the latest pharmaceutical company to respond to the Trump administration’s threat to impose tariffs, saying it will invest $50 billion in drug and diagnostics manufacturing in the U.S. over the next five years. That figure matches a similar commitment by its Basel,...
  • Cyprumed, Merck ink $493M peptide pill licensing deal

    Deals and M&A
    Oral peptide delivery specialist Cyprumed GmbH is about to find out if the high bioavailability of its tablet formulations seen in animal models will translate across to humans, after signing a $493 million license and option agreement with Merck & Co. Inc.
  • New UK law aims for ‘faster, fairer and more inclusive’ clinical trials

    Regulatory
  • Novartis boosting US manufacturing with $23B investment

    U.S.
  • UK government invests £500M in health data research service

    Clinical
  • Many US tariffs paused, pharma warned, EU put on notice

    Regulatory
More in Europe

Clinical

  • Marea looks to a phase IIb study in cardiovascular disease

    Cardiovascular
    With positive phase IIa cardiovascular disease results in hand, Marea Therapeutics Inc. said it is ready to move on to a phase IIb study sometime in the second quarter of 2025. MAR-001, a monoclonal antibody targeting the protein coding gene...
  • Actuate posts improved phase II data in pancreatic cancer

    Cancer
    Actuate Therapeutics Inc. said its lead candidate, elraglusib, in pancreatic cancer demonstrated a substantial improvement in median overall survival compared to data from the same phase II study released in December 2024, but it wasn’t enough to...
  • Aldeyra DED phase III hits but reproxalap field goal fumbled

    Ocular
    Aldeyra Therapeutics Inc. is making another run at U.S. FDA clearance for reproxalap in dry eye disease (DED) after nailing the primary endpoint in a phase III randomized, double-masked, vehicle-controlled dry eye chamber trial of 0.25% ophthalmic...
  • Immutep’s efti shows strong survival data in head and neck cancer

    Cancer
    Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in...
  • Associate degree: PTC’s hints of phase II HD efficacy studied

    Neurology/psychiatric
    PTC Therapeutics Inc. CEO Matthew Klein said the firm “achieved all we set out to [achieve] in phase II” with PTC-518 in Huntington’s disease (HD), but it wasn’t enough to excite Wall Street, as some questioned whether the level of associations...
  • AACR 2025: D3 Bio, Immvira present solid tumor, brain cancer data

    Conferences
    Shanghai-based D3 Bio (Wuxi) Co. Ltd. showed positive results for its lead candidate, next-generation KRAS G12C inhibitor, D3S-001, also known as elisrasib, in patients with KRAS G12C mutation cancers, including patients previously treated with...
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:

  • 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
  • The cost of delays in development and sales: It’s probably not what you think

View all

BioWorld

The news source of record covering the development of innovative human therapies for 25+ years
Subscribe

BioWorld MedTech

Actionable and timely intelligence on advances in medical devices and technologies for 20+ years
Subscribe

BioWorld Asia

A weekly monitor of biopharmaceutical news from the industry’s fastest-growing region
Subscribe

BioWorld Science

Essential discovery and preclinical research news to support crucial drug R&D decisions at the earliest stages
Subscribe

BioWorld Premium

Enjoy extended coverage for the most complete market view with BioWorld, BioWorld MedTech, and BioWorld Asia in a single, easy to access subscription
Subscribe
  • BioWorld
    • Today's news
    • Analysis and data insight
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld MedTech
    • Today's news
    • Clinical
    • Data Snapshots
    • Deals and M&A
    • Financings
    • Newco news
    • Opinion
    • Regulatory
    • Science
  • BioWorld Asia
    • Today's news
    • Analysis and data insight
    • Australia
    • China
    • Clinical
    • Deals and M&A
    • Financings
    • Newco news
    • Regulatory
    • Science
  • BioWorld Science
    • Today's news
    • Biomarkers
    • Cancer
    • Conferences
    • Endocrine/Metabolic
    • Immune
    • Infection
    • Neurology/Psychiatric
    • Patents
  • More
    • About
    • Advertise with BioWorld
    • Archives
    • Article reprints and permissions
    • Contact us
    • Cookie policy
    • Copyright notice
    • Data methodology
    • Infographics: Dynamic digital data analysis
    • Podcasts
    • Privacy policy
    • Share your news with BioWorld
    • Staff
    • Terms of use
    • Topic alerts
Follow Us

Copyright ©2025. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing