Life science news 12 October 2026: three deals, three US approvals and two UK regulatory updates.
Shionogi agreed to buy IntraBio for $2bn. Viatris offered $1.65bn for Pacira BioSciences. The FDA approved Tecentriq for Stage III dMMR colon cancer.
Shionogi will acquire the US rare disease company IntraBio for $2bn. The company announced the agreement on 5 October 2026. Shionogi Inc, its New Jersey subsidiary, will buy all outstanding IntraBio shares. IntraBio will then become a wholly owned subsidiary. The $2bn is upfront consideration payable to IntraBio shareholders. Shionogi expects the transaction to complete between November and December 2026. Closing depends on competition-law waiting periods and clearances from relevant regulators. IntraBio’s lead product is Aqneursa (levacetylleucine). The FDA approved it in September 2024 for neurological manifestations of Niemann-Pick disease type C. A second FDA approval followed on 18 September 2026, for ataxia in patients with Ataxia-Telangiectasia.
Shionogi’s release gives IntraBio net sales of $67.9m for its 2025 financial year, up from $3.5m in 2024. Net loss for 2025 was $35.8m. The figures are prepared under US GAAP. The European Medicines Agency approved Aqneursa for Niemann-Pick disease type C in January 2026. It is reviewing the product for Ataxia-Telangiectasia. IntraBio also has clinical programmes in Pompe disease, Fragile X syndrome and Jordan’s syndrome. Shionogi chief executive Isao Teshirogi said the company is applying “that same focus and determination to rare diseases”. Shionogi says the effect on its results for the year ending March 2027 is under review.
Viatris has agreed to acquire Pacira BioSciences for $36.50 per share in cash. The companies announced the deal on 8 October 2026. The equity value is $1.65bn. Viatris will launch a tender offer for all Pacira common shares. A second-step merger at the same price will cover any shares not tendered. Both boards approved the deal unanimously. Pacira’s board recommends that stockholders tender. Viatris plans to fund the purchase mainly from excess cash, with the rest from short-term borrowings. Completion needs a majority of Pacira shares to be tendered and the expiry of the applicable regulatory waiting period. Viatris expects to close by the end of 2026.
Pacira’s revenue for the twelve months to 30 June 2026 was about $746m. Its adjusted EBITDA was about $177m. The release gives no premium or enterprise value. Pacira markets Exparel (bupivacaine liposome injectable suspension) for postsurgical pain. It also markets Zilretta (triamcinolone acetonide extended-release injectable suspension) for osteoarthritis knee pain. Its most advanced candidate is PCRX-201, a gene therapy in Phase 2 development for knee osteoarthritis. Viatris says the deal will be immediately accretive to its financial guidance metrics. Pacira chief executive Frank D. Lee said the company’s mission has been “to deliver innovative, non-opioid pain therapies”.
CSL and Alentis Therapeutics have formed a global partnership on lixudebart. The release is dated 5 October 2026. Lixudebart is an investigational monoclonal antibody that targets claudin-1. It was formerly known as ALE.F02. CSL will pay Alentis $355m as an upfront payment. Alentis is eligible for up to $1.2bn in commercial milestones, a potential total of $1.555bn. The companies will develop and promote the drug jointly. After launch, global profits are split 55% to CSL and 45% to Alentis. CSL will fully fund the ongoing Phase 2 RENAL trial. It will also fund the planned Phase 3 trial in ANCA-associated vasculitis with rapidly progressive glomerulonephritis.
CSL will also fund Phase 2 trials in focal segmental glomerulosclerosis and primary sclerosing cholangitis. An interim analysis of 26 patients in RENAL showed improved kidney function and proteinuria at 24 weeks. A Phase 1b study in 41 patients with F3 or F4 fibrosis showed improved liver function at six weeks. The release gives no comparator group for either result. Alentis chief executive Dr Mark Pruzanski said it will “dramatically accelerate the development of lixudebart in several indications in parallel”. Dr Bill Mezzanotte, EVP and Head of R&D at CSL, cited CSL’s “commitment to building a leading global nephrology franchise”.
The FDA approved Tecentriq (atezolizumab) on 8 October 2026 for Stage III mismatch repair deficient (dMMR) colon cancer. The approval covers adjuvant use with a fluoropyrimidine and oxaliplatin. It applies to adult and paediatric patients two years of age and older. The FDA also approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) for the same use. Hybreza is for patients 12 years of age and older who weigh 40 kg or greater. Genentech, part of Roche, is the sponsor. The review ran under priority review and Project Orbis. LSDN logs such decisions in its FDA drug approval decisions tracker.
The approval rests on the ATOMIC trial. It was randomised, open-label and active-controlled, with 711 adults and one paediatric patient. Patients received atezolizumab plus mFOLFOX6, or mFOLFOX6 alone. Disease-free survival was the primary endpoint. The hazard ratio was 0.50 (95% confidence interval 0.35 to 0.73; p=0.0001). Median disease-free survival was not reached in either arm. Roche reports 36-month disease-free survival of 86% with Tecentriq plus mFOLFOX6, against 76% with mFOLFOX6 alone. The FDA lists warnings for immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic stem-cell transplantation and embryo-fetal toxicity. In Roche’s release, Frank A. Sinicrope of the Mayo Clinic, the trial’s US principal investigator, called it a “practice-changing regimen”.
In further life science news 12 October 2026, the FDA approved Tukysa and Hovilpri, and UK regulators issued two updates.
The FDA approved Tukysa (tucatinib) on 7 October 2026 for maintenance treatment of HER2-positive breast cancer. The notice names Seagen, a Pfizer subsidiary, as the sponsor. The indication is for adults with unresectable locally advanced or metastatic HER2-positive breast cancer. Patients receive Tukysa with trastuzumab and pertuzumab after induction treatment. The recommended dose is 300 mg orally twice daily. Treatment continues until disease progression or unacceptable toxicity. The approval is based on the HER2CLIMB-05 trial. It was randomised, double-blind and placebo-controlled. The efficacy evaluation included 654 adult patients. Patients with or without brain metastases were eligible.
Eligible patients had no progression after four to eight cycles of trastuzumab, pertuzumab and a taxane. The comparator was placebo plus trastuzumab and pertuzumab. Patients on endocrine therapy for hormone receptor-positive disease could continue it. Median progression-free survival was 24.9 months with Tukysa, against 16.3 months with placebo. The hazard ratio was 0.64 (95% confidence interval 0.51 to 0.80; p<0.0001). Overall survival data were not yet mature. Tukysa carries a boxed warning for hepatotoxicity. The FDA also lists warnings for diarrhoea, embryo-fetal toxicity and increased serum creatinine without affecting renal function. The notice does not give adverse event rates.
The FDA announced its approval of Hovilpri (pritelivir) tablets on 9 October 2026. The notice describes use in adults with weakened immune systems. They have mucocutaneous lesions caused by herpes simplex virus infection. They have not responded to acyclovir, valacyclovir or famciclovir. The FDA gave the application priority review. Asahi Kasei Therapeutics announced the approval the same day. Aicuris, which Asahi Kasei acquired in April 2026, developed pritelivir. The approval is based on part C of the PRIOH-1 Phase 3 trial (NCT03073967). It was randomised, open-label and comparator-controlled, with a superiority design. It treated 101 immunocompromised adults.
The comparator was the investigator’s choice of available treatments. Treatment ran for up to 28 days. It was extended to 42 days if lesions were improving but not fully healed. The primary endpoint was healing of all lesions by day 28. That occurred in 63% of patients on Hovilpri, against 34% on the comparator. Headache was the most common adverse reaction. The notice refers readers to the prescribing information for drug interactions. It does not mention a boxed warning. Asahi Kasei’s release describes the lesions as refractory, with or without resistance, to standard antiviral treatment.
The MHRA has approved catumaxomab, brand name Korjuny, to treat malignant ascites in adults. It granted the marketing authorisations on 2 October 2026 and announced them on 7 October. Atnahs Pharma UK Limited is the company. The MHRA used the International Recognition Procedure. The approval applies when standard cancer treatment is no longer feasible. Malignant ascites is a build-up of cancer-containing fluid in the abdomen. Patients often need repeated drainage. Catumaxomab is a monoclonal antibody that targets EpCAM, a protein on certain cancer cells. It activates immune cells to help destroy those cells. A doctor experienced in cancer treatment gives it through a catheter into the abdomen.
The main study enrolled 258 patients with malignant ascites and EpCAM-positive cancer. They had no further chemotherapy options or were unsuitable for chemotherapy. Patients given catumaxomab after paracentesis went about 46 days without further drainage. Patients given paracentesis alone went about 11 days. Treatment is four infusions, with the dose raised at each one. Listed side effects include nausea, vomiting, diarrhoea, abdominal pain, fever, chills, fatigue and cytokine release syndrome. Julian Beach is the MHRA’s Interim Executive Director of Healthcare Quality and Access. He said the agency will “continue to monitor catumaxomab’s safety closely”.
The government has accepted all 44 recommendations of the National Commission into the Regulation of AI in Healthcare. The MHRA issued the response on 6 October 2026. The Commission published its report on 10 September 2026. The response sets out ten priority areas for delivery across the UK. The Commission’s view is that AI-enabled medical devices should be assessed and monitored throughout their working life. The government commits to a lifecycle-based regulatory framework. The MHRA will issue draft guidance on managing changes to AI-enabled devices in December 2026. It will begin consulting on how to qualify and classify such devices in 2027. A full implementation roadmap is due in spring 2027.
The MHRA has also opened applications for Phase 3 of AI Airlock, its regulatory sandbox for AI-enabled medical devices. The programme has secured three years of additional government funding. Phase 3 focuses on post-market surveillance and lifecycle regulation. A webinar for applicants takes place on 22 October 2026. The first wave of innovators will be selected in November 2026. Health Innovation Minister James Frith said “innovation must never come at the expense of patient safety”. MHRA Chief Executive Lawrence Tallon said the Commission has given the agency “a clear and ambitious blueprint”. Scotland will set out its own response later.
That’s your life science news digest for 12 October 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news.
Catch up on the 5 October news roundup
