Roche announced that its oral BTK inhibitor fenebrutinib met the primary endpoint in the Phase 3 FENhance 1 trial, reducing relapses in relapsing multiple sclerosis by 51% versus teriflunomide, mirroring a 59% reduction seen in the earlier FENhance 2 study. The company plans to file regulatory submissions worldwide for fenebrutinib in both RMS and primary progressive MS, positioning it as a potential first high‑efficacy oral BTK therapy. While the efficacy data are strong, eight fatalities in the fenebrutinib arms and comparable liver enzyme elevations have drawn regulator attention. Roche’s shares fell 1.6% after the announcement.

Genetic Alliance UK’s equity report warns the NHS is falling short for the 3.5 million Britons living with rare diseases. A quarter of patients wait three years for a diagnosis, only 5 % of conditions have approved treatments, and just 10 % of...
Boehringer Ingelheim announced a potential $500 million investment in UK biotech Sitryx to obtain global rights to an undisclosed small‑molecule immunology programme. The partnership covers upfront fees, milestones and royalties, giving Boehringer full responsibility for research, clinical development and commercialization. Sitryx’s...

Japanese conglomerate Asahi Kasei announced a €780 million acquisition of German biotech Aicuris, gaining access to the oral antiviral pritelivir for herpes simplex virus (HSV). The drug, poised for FDA approval later this year, has shown superior lesion healing in phase‑3...

Japanese drugmaker Asahi Kasei announced it will acquire German biotech Aicuris for €780 million, gaining its antiviral therapy pritelivir targeting HSV. The deal expands Asahi Kasei's anti‑infectives portfolio and supports its goal of reaching JPY 300 billion in pharma sales by 2030.

President Donald Trump used a brief four‑minute segment of his State of the Union address to push Congress to codify his Most‑Favoured Nations (MFN) drug‑pricing program. He claimed the voluntary agreements would give Americans the lowest prescription prices worldwide, though...

The FDA has placed Regeneron's anti‑activin A antibody garetosmab under priority review, with a decision expected by August. Phase 3 OPTIMA data showed a 94% reduction in new heterotopic ossification lesions at the lower dose and a 90% reduction at the higher...

A shortage of bone cement from German supplier Heraeus Medical threatens NHS orthopaedic surgeries, potentially lasting two months. NHS England has asked trusts to prioritise emergency joint replacements, leaving elective patients at risk. UK‑based Biocomposites accelerated the launch of its...

Daiichi Sankyo appointed former Novartis chief medical officer John Tsai as its new CMO, succeeding Ken Takeshita after a five‑year tenure. Tsai brings a record of launching 160 projects and 15 regulatory approvals, including Zolgensma and Pluvicto, and recent experience leading biotech...

Novartis announced that its oral BTK inhibitor Rhapsido (remibrutinib) achieved significantly higher complete response rates than placebo in the phase 3 RemIND trial for the three most common forms of chronic inducible urticaria (CINDU). The drug, already approved for chronic spontaneous...
Immedica’s pegzilarginase (Loargys), the first enzyme replacement therapy for arginase‑1 (ARG1) deficiency, has received NICE endorsement for NHS use in the UK. The weekly IV or subcutaneous treatment cuts blood arginine levels by roughly 80% and is recommended for patients...
Roche announced that its anti‑CD20 antibody Gazyva (obinutuzumab) met the primary endpoint in the phase 3 MAJESTY trial for primary membranous nephropathy (pMN). The study showed significantly higher complete remission rates at two years compared with the immunosuppressant tacrolimus, while maintaining...

Quince Therapeutics warned investors it may need bankruptcy protection after its lead drug eDSP failed a pivotal phase 3 trial for ataxia‑telangiectasia. The SEC filing disclosed less than $6 million in cash, $12 million in short‑term investments and a $16 million unsecured line of...

PTC Therapeutics has withdrawn its FDA filing for Translarna (ataluren) as a treatment for nonsense‑mutation Duchenne muscular dystrophy after the agency indicated the data would not meet the threshold for substantial evidence of effectiveness. The decision ends a decade‑long effort...

The U.S. Food and Drug Administration has placed Takeda's orexin‑2 receptor agonist oveporexton (TAK‑861) into a priority review, with a decision expected in the third quarter. If approved, it would become the first drug to target the underlying orexin deficiency...

Swiss pharma giant Novartis announced it will acquire RNA‑drug developer Avidity Biosciences for $12 billion, with the transaction expected to close in the next few months. The deal is part of Novartis' strategy to bolster its pipeline amid significant patent expiries,...

US digital physical therapy specialist Sword Health announced it will acquire competitor Kaia Health for $285 million, creating a combined platform that will dominate the US market and expand into Europe. The deal brings together two digital musculoskeletal care providers,...
Eikon Therapeutics, the biotech startup founded by former MSD R&D head Roger Perlmutter, announced pricing of its Nasdaq IPO at $16‑$18 per share, aiming to raise up to $318 million and achieve a valuation above $900 million. The company will list under...

AstraZeneca has paid $630 million to buy out AbelZeta’s 50 % share of the China development and commercialisation rights to the CAR‑T therapy C‑CAR031, securing full control of the anti‑GPC3 treatment in China. The deal expands AZ’s CAR‑T portfolio following prior acquisitions...