Tariffs nixed by Supreme Court, Trump still has options
U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.

Tariffs nixed by Supreme Court, Trump still has options
U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.
Japan endorses two iPSC drugs for approval under CEA pathway
Japan is backing conditional approvals of Amchepry (raguneprocel, Sumitomo Pharma Co. Ltd./Racthera Co. Ltd.) and Reheart (Cuorips Inc.), positioning them to become the world’s first induced pluripotent stem cell-derived (iPSC) therapies to receive regulatory clearance.
Grail shares plunge after Galleri test misses primary endpoint
Grail Inc.’s share price dropped more than 50% in premarket trading Feb. 20 after it reported late the day before that the NHS-Galleri trial did not meet its primary endpoint. The U.K study, done though the National Health Service with 142,000 individuals enrolled, evaluated the ability of Grail’s Galleri multicancer early detection test to look for cancer-specific methylation patterns in blood.
Today's news in brief
Bioversys tuberculosis combo targets drug resistance
Antibiotics specialist Bioversys AG has reported the first clinical proof-of-concept data for alpibectir (BVL-GSK098) in combination with ethionamide in pulmonary tuberculosis, with phase IIa early bactericidal activity data published in the New England Journal of Medicine.
Report calls for EU members to pull together on biopharma strategy
Hand wringing over what support Europe’s biopharma sector needs to stay competitive has intensified since the European Commission unveiled its proposal for an EU Biotech Act in December 2025, and the latest contribution to the debate is a comparative analysis of how 10 countries have strengthened their biopharmaceutical ecosystems post-COVID-19.
China tops US in January drug approvals
U.S. FDA approvals began 2026 at a slower pace than usual, with eight approvals recorded in January. The total falls below the 2025 monthly average of about 19 approvals and trails every month last year, which ranged from 12 to 27 approvals.

Analysis and data insight

M&A activity drives infectious disease stock rebound
Infection
Infectious disease-focused biopharma companies continued their rebound into year-end, with the BioWorld Infectious Disease Index finishing 2025 up 68.55% after standing at a collective 28.98% at the end of October. The rally underscores a sharp reversal from earlier in the year, when the index had...
US GAO: March-ins not much of a solution for Rx prices
Medical technology
Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the...
Strong start to 2026 signals continued momentum in biopharma deals
Deals and M&A
Biopharma dealmaking continued its momentum into 2026, with January logging $31.16 billion in total value. That figure outpaced January 2025’s $28.63 billion and exceeded the 2025 monthly average of $24.38 billion. In addition, January 2026 ranks as the highest first month in the past eight years.
Relaxin unrest after Astrazeneca phase II HF bid joins failures
Clinical
Wall Street pushback against relaxin player Tectonic Therapeutic Inc. was sharp, but a trial design that differs could save the drug from the fate of Astrazeneca plc’s long-acting relaxin-2 analogue, AZD-3427, which the pharma giant has “removed from phase II,” where it was being tested in a trial...

Financings

2025 report: Spain’s Catalonia region a European life sciences leader
Europe
At a time of global transition for life sciences, with China stepping up the pace of innovation and the U.S. adopting protectionist policies, the health innovation region in Catalonia, Spain, is emerging as one of the most dynamic hubs in Europe. Last year, the region, centered on Barcelona, saw...

Medical technology

Medtronic sees first cases with Hugo robotic platform
U.S.
Medtronic plc this week reported that the first commercial surgical cases using its Hugo robotic-assisted surgery system have been completed in the U.S. Hugo is expected to be a key growth driver for the company, especially with opportunities in the underpenetrated U.S. soft tissue surgical...

AI transforming med tech in 2026; clinical need drives investments
Diagnostics
Med-tech companies with an AI component in their solutions will certainly find investors willing to back them. AI after all, is being used to develop more effective, smarter technologies. However, investors will only deploy capital into innovations that address genuine clinical needs. The aging...
MHRA proposes path forward for CE-marked devices
Regulatory
With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access...

Newco news

Omnigeniq’s journey from space science to drug design
Cancer
A project that started as a bioreactor to assist astronauts in deep space to keep medications safe in a microgravity environment could help pharma companies model how drugs behave in the human body. Omnigeniq unveiled at the J.P. Morgan Healthcare conference the first computer model of a human...
Vesalic targeting toxic muscle exosomes in motor neuron diseases
Neurology/psychiatric
Newco Vesalic Ltd. has formed to take forward research indicating extracellular vesicles secreted by skeletal muscle cells carry toxic payloads that are key drivers of motor neuron diseases, including amyotrophic lateral sclerosis. The discovery of this process, which is largely external to the...
AI meets antibody design: Galux draws $29M series B for drug R&D
Financings
Galux closed a ₩42 billion (US$29 million) series B round Feb. 10, led by Yuanta Investment to bring AI-driven “rational design” to the protein drug development process, already heavily influenced by human engineering.
Vibrant aims to tame EGFR tumors with masked TCEs
Cancer
After raising $61 million in a series B round, Vibrant Therapeutics Inc. is gearing up to begin a U.S. phase I trial with its lead program, VIB-305, a masked T-cell engager (TCE) for treating EGFR-positive solid tumors.
ALTx formed to drug pathway by which cancer cells become immortal
Financings
Newco ALTx Therapeutics Ltd. has launched with a £12.55 million (US$17.1 million) seed round to develop inhibitors of the alternative lengthening of telomeres (ALT) pathway, by which 10% to 15% of cancers become immortal.

U.S.

Moderna’s flu vaccine back in play as FDA shifts course on review
Infection
A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission seeking approval of seasonal influenza vaccine mRNA-1010, now agreeing to review the application and setting an assigned PDUFA date of Aug....

Europe

Investors raise concerns on 2026 financing for early stage med tech
Medical technology
Med-tech companies looking for capital will have to work harder this year to attract investor attention. Even though investment firms have money to deploy, the capital will go toward more targeted opportunities and later-stage companies. For early stage med tech, 2026 is expected to be a tough...

Boston Sci’s Farapulse better than thermal ablation at 4 years
Clinical
Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation platform, which demonstrated that patients with paroxysmal atrial fibrillation achieved better long-term success than those treated with thermal ablation. The data come as sales of the Farapulse...
Microbiotica reports positive phase Ib data for live microbiome therapeutic
Clinical
Microbiome specialist Microbiotica Ltd. announced positive data from a phase Ib study of MB-310, an orally administered live biotherapeutic product for treating ulcerative colitis, with 12 of 19 treated patients achieving clinical remission, compared to three of 10 patients in the placebo arm.

Clinical

Australia launches world-first pediatric mRNA brain cancer trial
Vaccine
A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in...
Dwarfism golden gate? Bridgebio’s infigratinib phase III hits
Musculoskeletal
Bridgebio Pharma Inc. kept the phase III wins coming, this time with positive top-line results from Propel 3, the global phase III pivotal study of oral infigratinib, designed to inhibit FGFR3 signaling in children with achondroplasia.
Upstream’s verekitug boat floats in asthma phase II
Respiratory
Upstream Bio Inc.’s favorable top-line results from the phase II Valiant trial testing verekitug in adults with severe asthma were not enough to charm Wall Street, and shares of the firm (NASDAQ:UPB) closed Feb. 11 at $14.69, down $13.12, or 47%.
Evommune, Nektar soar on atopic dermatitis phase II data
Dermatologic
Marking an important day for those with atopic dermatitis, shares of two biopharmas surged on clinical data suggesting new biologics are on their way to help address 40% of patients with uncontrolled disease.
Bayer’s asundexian cuts stroke risk 26% in phase III win
Cardiovascular
Bayer AG’s oral factor XIa inhibitor asundexian significantly reduced ischemic stroke by 26% in patients following a noncardioembolic ischemic stroke or high-risk transient ischemic attack in the phase III Oceanic-Stroke study.
Priovant’s brepo impresses in phase II cutaneous sarcoidosis trial
Inflammatory
On the heels of an NDA submission for brepocitinib in dermatomyositis, Priovant Therapeutics Inc. disclosed data showing the dual TYK2/JAK1 inhibitor surpassed expectations in a phase II study in cutaneous sarcoidosis, another chronic inflammatory...

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