Europe

EMA poised to be 4th regulator approving Boehringer’s Jascayd lung drug

Fri, 22 May 2026 12:00:00 -0400

As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use also recommended Novartis AG’s Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders.

As IVL technologies advance, Shockwave looks to defend its lead

Fri, 22 May 2026 08:00:00 -0400

As interests and competition in the intravascular lithotripsy (IVL) market heats up, Shockwave Medical Inc. said it believes that its latest coronary IVL catheter, the C2 Aero, and other projects in the pipeline, will help it to maintain its leadership in calcium modification.

Infex has positive phase IIa data in bronchiectasis; preps for next trial

Thu, 21 May 2026 12:00:00 -0400

Infex Therapeutics Ltd. has published positive phase IIa data for its lead program, RESP-X, in the treatment of exacerbations of chronic respiratory infections caused by Pseudomonas aeruginosa and is now laying the ground for phase IIb development, after raising £4.3 million (US$5.8 million) in new capital.

Subgroup analysis of the Champion-AF trial shows age not a factor

Wed, 20 May 2026 12:00:00 -0400

A subgroup analysis of data from Boston Scientific Corp.’s Champion-AF trial, which looked at the outcomes for patients with atrial fibrillation treated with a left atrial appendage closure (LAAC) device compared to direct oral anticoagulants (DOACs), found that the efficacy and safety of LAAC compared to DOAC are not affected by age. The data were presented at the EuroPCR conference in Paris.

All Women data show Allegra edge in female TAVR patients

Wed, 20 May 2026 12:00:00 -0400

Data from the All Women clinical trial, which looked at the Allegra transcatheter aortic valve replacement (TAVR) system compared to balloon-expandable valves (BEV) in women with aortic stenosis, showed that Allegra delivered lower mean gradients and less prosthesis-patient mismatch than BEVs. The data presented at the EuroPCR conference in Paris was the first randomized head-to-head comparison of different TAVR platforms conducted exclusively in women.

Elixir Dynamx system sees lower event rates than drug-eluting stent

Tue, 19 May 2026 12:00:00 -0400

Elixir Medical Corp. reported four-year data from the Bioadaptor randomized controlled trial presented at the EuroPCR conference in Paris, which showed that patients with coronary artery disease treated with its Dynamx coronary drug-eluting bioadaptor system experienced significantly lower event rates compared to those treated with Medtronic plc’s Resolute Onyx drug-eluting stent, including reduction in cardiovascular death.

Boston Scientific reports Seismiq IVL data from Fracture study

Tue, 19 May 2026 12:00:00 -0400

Boston Scientific Corp. reported positive results from the Fracture investigational device exemption trial which evaluated its Seismiq 4CE coronary intravascular lithotripsy (IVL) catheter in patients with severely calcified coronary artery disease. Late-breaking data presented at the EuroPCR conference in Paris showed that the pivotal study met its primary safety and effectiveness endpoints, with high rates of freedom from major adverse cardiac events at 30 days and strong procedural success.

New hypertension option as Astrazeneca’s Baxfendy wins FDA nod

Mon, 18 May 2026 12:00:00 -0400

Patients on antihypertensive medications who still struggle with high blood pressure now have a new treatment option, following the U.S. FDA’s approval of Astrazeneca plc’s baxdrostat. Branded Baxfendy, the drug is a first-in-class aldosterone synthase inhibitor, though it could be joined soon by potential competitor Mineralys Therapeutics Inc., which has a December 2026 PDUFA date for its aldosterone synthase inhibitor, lorundrostat.

EU reaches Critical Medicines Act pact to tackle drug shortages

Fri, 15 May 2026 12:00:00 -0400

In further fallout from the COVID-19 pandemic, the EU has now reached agreement on the Critical Medicines Act, which aims to boost European manufacturing capacity for drugs and their active ingredients, and enable member states to organize joint procurement to improve access to orphan drugs.

Sonomind raises €20M for ultrasound neuromodulation technology

Fri, 15 May 2026 12:00:00 -0400

Sonomind SAS raised €20 million (US$23 million) in a series A funding round for its ultrasound-based neuromodulation technology for depression. The funds will be used for clinical trials of the non-invasive device, which uses a custom-made acoustic lens to precisely target deep regions within the brain to bring relief to patients suffering from treatment-resistant depression.

Andes virus cases rise to 11; Hondius passengers in quarantine to June 21

Thu, 14 May 2026 12:00:00 -0400

The number of cases of hantavirus infection has risen from eight to 11, following the repatriation of passengers from the cruise ship MV Hondius, with World Health Organization (WHO) Director General Tedros Adhanom Ghebreyesus warning the danger is not over. “In fact, it has entered a new phase as the passengers and crew return home,” he told attendees of a meeting at WHO’s headquarters in Geneva on May 13.

Nvision secures $55 million, with backing from Abbott

Wed, 13 May 2026 12:00:00 -0400

Nvision Imaging Technologies GmbH raised $55 million in a series B financing round led by Abbott Laboratories for its quantum-enhanced sensing platform, Polaris, which uses quantum technology to boost the MRI signal of sugar-based imaging agents to enable real-time measurement of metabolism on standard MRI systems. Sella Brosh, CEO and co-founder of Nvision, told BioWorld that the funds are extremely important as the company is scaling the Polaris systems to many more sites worldwide, which is a capital intensive process.

MHRA sets out proposal to redefine gene therapies

Tue, 12 May 2026 12:00:00 -0400

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation on changes it is proposing to the legal definition of gene therapies, to reflect the advances in technology and manufacturing over the two decades since the current legislation was drawn up. The aim is to correct the mismatch between regulatory terminology and modern science, which MHRA says “can lead to uncertainty” over how a product is classified and to “inconsistent oversight and potential barriers for developers."

Commerce gives Rx companies 30 days to submit US onshoring plans

Tue, 12 May 2026 12:00:00 -0400

Companies seeking a break in the soon-to-be-implemented U.S. Section 232 biopharma tariffs have 30 days to apply for a company-specific onshoring agreement with the Department of Commerce, according to the procedures the department laid out in a notice to be published in the May 13 Federal Register.

Roche secures CE mark for Alzheimer’s blood test

Tue, 12 May 2026 12:00:00 -0400

Roche Holding AG secured CE marking for the Elecsys plasma phosphorylated-tau 217 blood test designed to rule in and rule out amyloid pathology, a hallmark of Alzheimer's disease. Developed with Eli Lilly and Co., the test brings to the market another much-needed solution to help clinicians diagnose Alzheimer’s patients following the FDA approval of Fujirebio Diagnostics Inc.’s blood test last year.

First cruise ship hantavirus genome points to zoonotic spillover

Tue, 12 May 2026 09:00:00 -0400

The initial appraisal of the first complete genome sequence of a hantavirus isolated from a patient in Switzerland who was a passenger on the cruise ship MV Hondius is consistent with a spillover from its natural reservoir, rather than the emergence of a markedly altered virus.

First cruise ship hantavirus genome points to zoonotic spillover

Mon, 11 May 2026 12:00:00 -0400

Scarlet raises $4M to take manufactured red blood cells into clinic

Fri, 08 May 2026 12:00:00 -0400

Scarlet Therapeutics Ltd. has demonstrated its manufactured red blood cells (RBCs) act in the same way as their natural counterparts in vivo, opening the way for the cells to be used as drug delivery vehicles and raising the possibility they could replace conventional blood transfusions. To build on this, Scarlet has closed a $4 million seed round to work on the first clinical application, in which RBCs loaded with therapeutic proteins will be used to treat rare metabolic diseases.

Hantavirus is ‘sentinel’ more than acute pandemic threat

Fri, 08 May 2026 09:00:00 -0400

News of eight infections and three deaths so far due to an emerging zoonotic virus has brought back unhappy memories of the early days of SARS-CoV-2. At a press conference on Thursday, officials from the WHO did their best to calm the public’s fears that the MV Hondius, the ship currently heading to the Canary Islands with its remaining passengers plus assorted medical, WHO and European Center for Disease Prevention and Control staff, is the 2026 version of the Diamond Princess.

Roche to acquire Pathai for up to $1.05B

Thu, 07 May 2026 12:00:00 -0400

Roche Holding AG has agreed to acquire Pathai Inc. for up to $1.05 billion in a bid to strengthen its position in digital pathology and enhance its biopharma services. The move builds on a partnership established between the two companies in 2021, and expanded in 2024, to include the development of AI-enabled companion diagnostic algorithms.

Italy’s Angelini pays $4.1B cash for rare disease specialist Catalyst

Thu, 07 May 2026 12:00:00 -0400

Italian family-owned Angelini Pharma SpA is making its first move into the U.S. market, acquiring rare diseases specialist Catalyst Pharma Inc. in an all-cash deal worth $4.1 billion. The acquisition gives Angelini ownership of three marketed drugs for treating epilepsy and neuromuscular diseases that had combined sales of $589 million in 2025, a 19.8% increase over 2024.

Hantavirus is ‘sentinel’ more than acute pandemic threat

Thu, 07 May 2026 07:00:00 -0400

Swiss Biotech reports record private investment, employment in 2025

Wed, 06 May 2026 12:00:00 -0400

Privately-funded biotechs in Switzerland raised a record CHF1.15 billion (US$1.47 billion) in 2025, an increase of 38% over 2024, and 45% of the total capital raised by the sector. This was a significant advance on previous years, when private companies typically attracted about 30% of overall investment.

Bayer buying Perfuse for $300M up front in potential $2.45B deal

Wed, 06 May 2026 12:00:00 -0400

In its first substantial M&A transaction since 2021, Bayer AG is buying Perfuse Therapeutics Inc., a firm that has operated quietly, though it reported positive midstage data last year for PER-001, an endothelin antagonist, in glaucoma and diabetic retinopathy.

UCB onboards more autoimmune TCEs with $2.2B Candid buy

Tue, 05 May 2026 12:00:00 -0400

UCB SA agreed to pay $2 billion up front to acquire bispecific T-cell engager (TCE)-maker Candid Therapeutics Inc. and lead BCMA/CD3 TCE asset cizutamig (CND-106), continuing big pharma’s spree for China-made autoimmune assets in 2026.

USTR calls out trade partners for Rx, med-tech pricing policies

Tue, 05 May 2026 12:00:00 -0400

For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report.

White House looks to expand MFN pricing for $530B-plus in savings

Tue, 05 May 2026 12:00:00 -0400

Amid calls for transparency on the most-favored nation (MFN) pricing deals U.S. President Donald Trump has reached with 17 biopharma companies, the White House Council of Economic Advisers released a report May 5 detailing how the volunteer MFN policy works and touting the $530 billion-plus in savings it’s projected to deliver over the next 10 years.

Cytospire raises £61M series A to target EGFR in solid tumors

Tue, 05 May 2026 09:00:00 -0400

Next-generation T-cell engager (TCE) specialist Cytospire Therapeutics Ltd. has raised £61 million (US$82.7 million) in a series A round, equipping it to advance the lead program CYT-X300 to the clinic in the treatment of EGFR-positive solid tumors. The company’s pan gamma delta (γδ) TCEs are designed to overcome problems with cytokine release syndrome, on-target effects on healthy cells, and the excessive activation of CD3 that have occurred with earlier bispecific antibodies that bind to the CD3 receptor on T cells.

UCB onboards more autoimmune TCEs with $2.2B Candid buy

Mon, 04 May 2026 12:00:00 -0400

USTR calls out trade partners for Rx, med-tech pricing policies

Mon, 04 May 2026 12:00:00 -0400