Life science news 9 November 2026: two US regulatory decisions, three UK updates, two licensing deals and one acquisition.
The FDA granted accelerated approval to Rybrevant Faspro for head and neck cancer. AbbVie licensed an oral IBD candidate from Nxera in a deal worth up to $1.47bn. Boehringer Ingelheim took options on six preclinical cancer programmes from SBP Group.
The FDA granted accelerated approval to Rybrevant Faspro on 5 November 2026. The product is amivantamab and hyaluronidase-lpuj. Janssen Biotech, Inc. is the sponsor. It is approved for adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The indication applies where disease has progressed on or after platinum-based chemotherapy and immunotherapy. The agency says the approval rests on overall response rate and duration of response. Confirmatory studies are required to verify clinical benefit. The FDA granted Breakthrough Therapy designation for this indication. The drug is not indicated for HPV-associated oropharyngeal squamous cell carcinoma. The FDA describes it as the first approval in 10 years of a drug for this group. The group is patients with recurrent or metastatic HNSCC who previously received platinum-based chemotherapy.
The approval draws on an open-label, multicentre trial of 102 patients. The overall response rate was 42%. Of those who responded, 56% had responses lasting six months or longer. The FDA says currently approved therapies have a response rate of around 20% or less. The data come from a single trial, so that comparison is indirect. Angelo De Claro, M.D., is director of the FDA’s Oncology Center of Excellence. He called it “a meaningful step forward for patients with head and neck squamous cell carcinoma.” The FDA lists warnings for hypersensitivity, interstitial lung disease, dermatological reactions, ocular toxicity and harm to an unborn baby. Its announcement describes no boxed warning. See pending decisions in the FDA drug approval decisions tracker.
AbbVie has licensed an investigational inflammatory bowel disease (IBD) candidate from Nxera Pharma. The agreement was announced on 4 November 2026. The compound is NXE0033744, an oral EP4 receptor agonist. AbbVie receives exclusive worldwide rights to develop and commercialise it in IBD. Nxera receives $100m upfront. It is also eligible for up to $1.37bn in development and commercial milestones. Together, the payments could reach $1.47bn. Nxera would also receive tiered royalties on net sales. The deal is subject to customary antitrust clearances, including under the Hart-Scott-Rodino Act.
Trade reports say the candidate has completed Phase 1. They describe a study group of patients with ulcerative colitis. No Phase 2 data have been disclosed. Efficacy in IBD is therefore unproven. This is a licensing deal, not a regulatory decision. Milestone payments depend on clinical, regulatory and commercial progress. They may never be paid in full. The agreement extends an existing collaboration between the two companies in neuroscience. The terms above are consistent across the reports reviewed.
Boehringer Ingelheim has signed a multi-programme option and licence agreement with SBP Group. The company announced it on 4 November 2026. SBP Group is Sino Biopharmaceutical Limited (01177.HK). The deal covers six preclinical biologic programmes. They use antibody-drug conjugate and T-cell engager technologies. Five come from LaNova Medicines in Shanghai. One comes from Beijing Tide Pharmaceutical. Both are SBP Group subsidiaries. SBP Group will carry out early development. Boehringer holds options, not rights. It may exercise them after agreed clinical milestones.
SBP Group receives $358m in upfront and near-term payments. It is eligible for about $7bn in option-exercise, development, regulatory and commercial milestones. Tiered royalties of up to double digits would follow on sales. Some outlets give the total as $7.4bn. That is the $358m plus the milestones, so the figures do not conflict. For four programmes, rights would cover territories outside mainland China, Hong Kong and Macau. For two, they would be worldwide. Theresa Tse, chairwoman of SBP Group, called the deal “an important milestone.” Targets and indications were not disclosed.
The MHRA has extended the UK marketing authorisation for Joenja (leniolisib). Pharming Group announced the change on 6 November 2026. Joenja is now authorised for children aged 4 to 11 years. They must weigh at least 27kg and have activated PI3K delta syndrome (APDS). The earlier UK indication covered adults and adolescents aged 12 and older. The approved doses for the new group are 40 mg and 50 mg twice daily. Pharming expects Joenja to be available under the expanded indication in February 2027. It says it will work with the NHS to support timely access. Pharming describes it as the first treatment approved in the UK specifically for children with APDS.
Pharming says the decision relied on its paediatric clinical programme. That programme ran under a Paediatric Investigation Plan agreed with the MHRA. The company also cites clinical pharmacology and safety assessments. The release gives no paediatric efficacy figures and no comparator data. It says leniolisib was “generally well-tolerated” in patients aged 4 and older. For adults and adolescents, it cites a randomised, placebo-controlled Phase 3 trial. The company says the trial showed statistically significant improvement in its co-primary endpoints. Dr Austen Worth, a paediatric immunology consultant at Great Ormond Street Hospital, said the extension “provides an important new option.”
In further life science news 9 November 2026: NICE guidance, a generic HIV approval, MHRA rules and a Lonza deal.
Rhythm Pharmaceuticals says NICE has updated its guidance on Imcivree (setmelanotide). The company announced it on 4 November 2026. The update covers adults with genetically confirmed Bardet-Biedl syndrome (BBS). Earlier NICE guidance, issued in May 2024, covered patients aged 6 to 17. Rhythm says the update allows funded NHS treatment for adults in England, Wales and Northern Ireland. Children aged 2 to 5 in England and Wales are funded through NHS England specialised commissioning. Rhythm says that arrangement is unchanged. The company says NICE considered additional clinical, real-world and disease-burden evidence, including longer-term treatment data.
The release does not link to the NICE guidance document. The scope above is therefore Rhythm’s own account. The release does not mention Scotland. Imcivree is authorised in the EU and UK for obesity and hunger control in genetically confirmed BBS. It covers adults and children aged 2 and older. Rhythm says the NICE assessment reflected the effect of BBS on quality of life, mental health, mobility, education and independence. Professor Philip Beales is emeritus professor of molecular genetics and genomic medicine at University College London. He called the update “welcome news for adults in England, Wales and Northern Ireland living with Bardet-Biedl syndrome.”
Dr. Reddy’s Laboratories has secured FDA tentative approval for a generic version of lenacapavir. The announcement came on 2 November 2026. Lenacapavir is a twice-yearly injection for HIV prevention. Unitaid, which published the release, calls this the first generic injectable lenacapavir. The release says tentative approval is the FDA’s standard designation for generics while the originator remains under patent. Dr. Reddy’s developed it with support from Unitaid, Wits RHI and the Clinton Health Access Initiative. The support was financial, technical and regulatory.
The partners say the product will cost $40 per person per year. That price applies in the 120 low- and middle-income countries covered by Gilead’s voluntary licence. Initial supplies are expected by the end of 2026. Broader availability is expected in 2027. The release’s headline says the FDA approves the product. Its body text specifies tentative approval. This report follows the body text. Deepak Sapra is chief executive officer of API and Services at Dr. Reddy’s Laboratories. He said the approval “brings us a significant step closer.”
The MHRA has published guidance on non-clinical safety data generated outside the OECD Mutual Acceptance of Data (MAD) system. The news story is dated 4 November 2026. It covers UK clinical trial authorisation applications. Data generated within the OECD MAD framework remain the expected default. Non-OECD data can be considered only case by case. The MHRA says it will weigh the participant population and the seriousness of the condition. It will also weigh unmet medical need and the trial’s stage and design. In limited cases, it may apply an enhanced non-clinical assessment. First-in-human trials in patients with advanced cancers are one example it gives.
The MHRA will also run a risk-based programme of inspections. These will target non-clinical test facilities that often appear in UK applications. The regulator says the approach “does not change the standards expected for the quality, safety or integrity” of pivotal non-clinical data. It encourages developers planning to use non-OECD data to engage with the MHRA early. It says the approach will evolve with regulatory experience, compliance intelligence and inspection outcomes. The announcement names no spokesperson. Its quotes are therefore attributed to the MHRA, not to an individual.
Lonza has agreed to acquire five US contract development and manufacturing (CDMO) sites from Merck KGaA, Darmstadt, Germany. The agreement was announced on 3 November 2026. Lonza will pay cash. It puts the total enterprise valuation in the low- to mid-triple-digit millions of Swiss francs. The release gives a range, not an exact price. Closing is expected in mid-2027, subject to customary closing conditions. The sites are in St. Louis, Missouri; Madison and Verona, Wisconsin; Carlsbad, California; and Indianapolis, Indiana.
Lonza lists a different focus for each location. St. Louis covers bioconjugates. Madison and Verona cover high-potency payload-linkers. Carlsbad offers end-to-end viral vector solutions, including aseptic fill-finish. Indianapolis offers lipid nanoparticle, liposome and PEGylated protein solutions, also including aseptic fill-finish. Wolfgang Wienand, chief executive officer of Lonza, said the acquisition is “a strong fit with our One Lonza Strategy.” The deal is an acquisition of manufacturing sites. It is not a drug licensing or regulatory decision.
That’s your life science news digest for 9 November 2026, back next Monday with the latest from pharma, biotech and healthcare at www.lifesciencedaily.news.
Catch up on the 2 November news roundup
