Europe

Enterobiotix raises $25.7M for phase IIb of microbiome pill in IBS

Wed, 29 Apr 2026 12:00:00 -0400

Microbiome specialist Enterobiotix Ltd. has raised £19 million (US$25.7 million) to fund phase IIb development of its lead program EBX-102-02 in the treatment of irritable bowel syndrome with constipation (IBS-C).

Chiesi snags on-demand HAE drug in $1.9B Kalvista buy

Wed, 29 Apr 2026 12:00:00 -0400

In its largest acquisition to date, Chiesi Group is buying Kalvista Pharmaceuticals Inc. for $27 per share, a roughly 40% premium to the previous day’s closing price, putting the total deal value at about $1.9 billion. In return, the Italian pharma firm adds to its rare disease franchise Kalvista’s recently approved hereditary angioedema (HAE) drug, plasma kallikrein inhibitor Ekterly (sebetralstat), which has gotten off to a strong commercial launch as the only orally available, on-demand treatment for HAE.

Sun Pharma to acquire Merck spinoff Organon for $11.75B

Tue, 28 Apr 2026 12:00:00 -0400

Sun Pharmaceuticals Industries Ltd. will pay $11.75 billion cash to acquire Organon & Co. The transaction is expected to close in early 2027. The addition of Organon’s women’s health products, legacy drug brands and biosimilars are expected to boost Mumbai, India-based Sun’s global reach. The all-cash buy is also expected to relieve Jersey City, N.J.-based Organon of an $8.6 billion debt pile, accumulated after its debt-laden 2021 spinout from Merck & Co. Inc.

Pilatus PLT-012 takes immunometabolic approach to reprogram TME

Tue, 28 Apr 2026 12:00:00 -0400

Pilatus Bio Inc. is working to address a major under-addressed target of current checkpoint inhibitors: metabolic stress within solid tumors. “Traditional immunotherapies release immune ‘brakes,’ but they do not address the underlying metabolic stress in tumors,” Pilatus CEO and cofounder Raven Lin said. “That’s why more than 60% of solid tumor patients do not respond to treatment.”

Biggest overhaul of UK clinical trials rules in 20 years comes into force

Tue, 28 Apr 2026 12:00:00 -0400

New U.K. clinical trials regulations coming into force today, April 28, aim to reduce the time taken to get approval for studies and introduce a category of lower risk trials which will be automatically assessed in 14 days. The key measure to cut timelines is the Combined Review, under which sponsors will be able to submit a single application for regulatory review by the Medicines and Healthcare products Regulatory Agency and ethics review by the Health Research Authority, the body responsible for managing ethics committees.

UK biotech funding in Q1 2026 hints a recovery is in the offing

Mon, 27 Apr 2026 12:00:00 -0400

The funding momentum that was building at the end of 2025 was maintained in the first quarter (Q1) of 2026, with a rebound in venture capital (VC) investment in U.K. biotech. Overall investment in the sector during Q1 was £552 million (US$748 million), of which £516 million was in VC.

Sun Pharma to acquire Merck spinoff Organon for $11.75B

Mon, 27 Apr 2026 12:00:00 -0400

Neuro deals aplenty: UCB’s $1B+ takeover of Neurona the latest

Fri, 24 Apr 2026 12:00:00 -0400

A flurry of deals focused on the neurological disease space in 2026 suggest large biopharma companies are searching for the next best therapeutics for everything from epilepsy and narcolepsy to post-traumatic stress disorder and hyperphagia.

CHMP gives nod for Sanofi’s Cenrifki for multiple sclerosis

Fri, 24 Apr 2026 08:00:00 -0400

Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.

Dupi whoopie: Sanofi/Regeneron cheered for sales, new approval

Thu, 23 Apr 2026 12:00:00 -0400

As Sanofi SA gets ready to welcome a new CEO, the company along with partner Regeneron Pharmaceuticals Inc. said a happy hello as well to robust sales of Dupixent (dupilumab, dupi) and gained U.S. FDA clearance for the IL-4 receptor alpha antagonist to treat children, ages 2 to 11, with chronic spontaneous urticaria who remain symptomatic despite histamine-1 antihistamine treatment.

Netrin-1 inhibitor blocks chemo resistance in pancreatic cancer

Wed, 22 Apr 2026 12:00:00 -0400

Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy.

Xeltis secures CE mark for Axess, its hemodialysis conduit

Tue, 21 Apr 2026 12:00:00 -0400

Xeltis BV has secured CE mark approval for Axess, its restorative vascular access conduit for hemodialysis. The company also released 12-month data from its EU pivotal trial on the technology, which showed strong durability outcomes, including 79% secondary patency and a very low patency‑related reintervention rate of 1.3 per patient-year, as well as a substantial reduction in infection burden.

Whole genome sequencing unveils blood cancer trajectory

Mon, 20 Apr 2026 12:00:00 -0400

A new study tracking the genomic evolution of chronic myeloproliferative neoplasms has shown that progression to myelofibrosis or acute myeloid leukemia is encoded in mutations that occur years before the transformation is clinically evident.

Novo’s Forma acquisition pays off with mitapivat competitor

Mon, 20 Apr 2026 12:00:00 -0400

Novo Nordisk A/S reported top-line results from the phase III Hibiscus study of its pyruvate kinase-R activator, etavopivat, which was acquired through the 2022 buyout of Forma Therapeutics Holdings Inc. The results set up a potential competition for patients afflicted by sickle cell disease with fellow PKR activator mitapivat from Agios Pharmaceuticals Inc.

Ebenbuild’s tech for predicting lung drug deposition validated

Fri, 17 Apr 2026 12:00:00 -0400

The ability of Ebenbuild GmbH’s digital twin technology to predict the deposition of inhaled drugs across the lungs has been validated in a study published in Nature Communications Medicine. The platform, which combines AI-driven image analysis and physics-based computational modeling, demonstrated strong agreement with in vivo imaging data across multiple inhalation scenarios.

Roche plots route to EMA approval for DMD gene therapy

Fri, 17 Apr 2026 12:00:00 -0400

Roche Holding AG is making good on its promise to try and convince the EMA of the benefits of Elevidys (delandistrogene moxeparvovec), announcing a further global phase III trial of the Duchenne muscular dystrophy gene therapy.

Meta-analysis: Anti-amyloid Alzheimer’s drugs not ‘clinically meaningful’

Thu, 16 Apr 2026 12:00:00 -0400

The ongoing controversy over the effectiveness of anti-amyloid drugs is about to get more heated, after a review of clinical trials showed statistically significant results do not read across to clinical benefit for patients with Alzheimer’s disease.

Storm raises $56M series C for phase II RNA inhibitor trial in sarcoma

Thu, 16 Apr 2026 08:00:00 -0400

RNA epigenetics specialist Storm Therapeutics Ltd. has closed a $56 million series C to fund phase II development of its lead RNA enzyme inhibitor, STC-15, in treating myo- and liposarcomas, and announced that the first patient has been treated in the trial.

Alivecor receives CE mark for AI-powered, portable ECG system

Wed, 15 Apr 2026 12:00:00 -0400

Alivecor Inc. has secured CE marking for its Kardia 12L electrocardiogram (ECG) system, which is powered by its KAI 12L AI technology and can detect life-threatening cardiac conditions. Kardia 12L is a portable, AI-guided, 12-lead ECG solution that delivers measurements and interpretations similar to standard 12-lead ECG solutions, right at the point of care. The company said the simplified design will enable faster acquisition of complete ECG data while leading to better patient outcomes.

Biologics in development outnumber small molecules for the first time

Tue, 14 Apr 2026 12:00:00 -0400

More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.

Cortec prepares to implant BCI tech into third stroke patient

Tue, 14 Apr 2026 12:00:00 -0400

Cortec GmbH is preparing to implant its brain-computer interface (BCI) technology into a third stroke patient, with early clinical data showing that the device leads to significant improvement in hand and arm function. The company believes its Brain Interchange system could transform the lives of millions of patients.

Revenio speeds up growth acquiring Visionix for €290M

Mon, 13 Apr 2026 12:00:00 -0400

Revenio Group Oyj has agreed to acquire ophthalmic diagnostics company Visionix International SAS for an enterprise value of €290 million (US$339 million) as it looks to become a leading player in the global eye care market. The deal expands Revenio’s offering with a highly complementary product and software portfolio, including optical coherence tomography equipment, an important and growing segment which is new to the company.

Fit and fat: Study shows no such thing as metabolically healthy obesity

Mon, 13 Apr 2026 09:00:00 -0400

There are new data to chew over in the ongoing controversy about obesity being diagnosed as a disease from a study tracking 157,159 participants in the UK Biobank over 13 years. This shows that even in the absence of any metabolic disturbance such as elevated lipids, high blood pressure or diabetes, there is an increased risk of heart attack, stroke, peripheral arterial disease, heart failure and liver disease in people with a body mass index over 30.

Fit and fat: Study shows no such thing as metabolically healthy obesity

Fri, 10 Apr 2026 12:00:00 -0400

Biologics in development outnumber small molecules for the first time

Fri, 10 Apr 2026 09:00:00 -0400

More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline. At the start of the biotech industry, progress was slow. Between 1983 and 1995, the U.S. FDA approved an average of two biologics each year. Now, biologics have taken the lead by the smallest of margins, accounting for 50.1% of drugs in development at the start of 2026, according to the Pharma Annual Review 2026, published by Pharmaprojects, a firm that tracks global pharma R&D.

Biologics in development outnumber small molecules for the first time

Thu, 09 Apr 2026 12:00:00 -0400

More than four decades on from the approval of the first biologic drug, the industry has reached a tipping point, and biotech drugs now outnumber small molecules in the global R&D pipeline.

C4 yourself: $1B second Roche deal evidence of DAC faith

Thu, 09 Apr 2026 12:00:00 -0400

C4 Therapeutics Inc.’s degrader-antibody conjugate (DAC) strategy gathered more steam with a new collaboration between the firm and Roche AG that brings $20 million up front with the potential for more than $1 billion in discovery, regulatory and commercial milestone payments.

UK formalizes zero tariffs deal with US, will pay more for drugs

Wed, 08 Apr 2026 12:00:00 -0400

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

J&J introduces Varipulse Pro to Europe after CE mark

Wed, 08 Apr 2026 12:00:00 -0400

Johnson & Johnson launched its latest pulsed field ablation (PFA) catheter, Varipulse Pro, in Europe following CE mark approval, bringing another option to electrophysiologists looking to adopt PFA technology. The system features a new pulse sequence with a lower temperature profile and enables ablation that is five times faster than the previous sequence, while achieving equivalent lesions. It represents another significant development in the rapidly evolving PFA market that has transformed cardiac ablation treatment.

Gilead buying Tubulis and its ADCs in $5B takeover bid

Tue, 07 Apr 2026 12:00:00 -0400

German company Tubulis GmbH, which emerged with a $12.3 million series A round and a next-generation antibody-drug conjugate (ADC) platform about six years ago, has commanded up to $5 billion in a buyout offer from Gilead Sciences Inc.