The Aleth Briefs trace each story to its original source and show how the week unfolded.
The week in five lines
The UK cut its drug rebate to win back pharma.
Lilly‘s retatrutide posted significant 28.7% weight loss.
Novartis and Relation strike AI deal worth up to $1.7bn.
The Biosecure Act cleared the US House.
The EU agreed its biggest pharma overhaul in decades.
In this edition
Weekend catch-up: Natera-Foresight MRD; BioNTech lung cancer
Monday: UK biotech fund; Mirum-Bluejay; Dyne Duchenne; FDA CAR-T bar
Weekend catch-up
Natera bought Foresight Diagnostics for up to $450m, entering blood cancer.
Announced on Friday, the all-stock deal pays $275m upfront with up to $175m more tied to revenue and reimbursement milestones. Foresight’s ultrasensitive PhasED-Seq platform detects molecular residual disease (MRD) in lymphoma from a blood sample, complementing Natera’s Signatera MRD testing in solid tumours. Natera plans to fold the phased-variant technology into Signatera, with a clinical launch expected in 2026.
BioNTech / OncoC4’s gotistobart more than halved mortality risk in a phase 3 lung-cancer trial.
Reported on Saturday, the non-pivotal dose-confirmation stage of the phase 3 PRESERVE-003 trial showed gotistobart cutting the risk of death by more than half versus chemotherapy in squamous non-small cell lung cancer (NSCLC) that had progressed after immunotherapy and chemotherapy. Median overall survival was not reached at 15 months, versus 10 months for chemotherapy, although tolerability was demanding. BioNTech is pushing beyond Covid vaccines into oncology.
Monday 8 December
The British Business Bank agreed a $100m commitment to SV Health’s SV8 biotech fund.
The cornerstone commitment to the $500m SV8 Biotech Fund is the state bank’s biggest since it was formed in 2014, and takes its life-sciences fund commitments past £560m across 15 funds. The government widened the bank’s capacity this year to speed backing for UK growth companies.
Mirum Pharmaceuticals agreed to buy Bluejay Therapeutics for $620m, adding a phase 3 hepatitis D antibody.
Mirum will pay $250m in cash and $370m in stock, with up to $200m more in sales milestones, for brelovitug, a monoclonal antibody in the global phase 3 AZURE programme for chronic hepatitis delta, a liver infection with little approved treatment in the US. Topline data are expected in H2 2026. The purchase extends Mirum’s existing rare liver disease business rather than opening a new one.
Dyne Therapeutics’ Duchenne drug hit its goal in a registrational study and is heading to the FDA.
In the registrational expansion cohort of the phase 1/2 DELIVER trial, z-rostudirsen (DYNE-251) raised muscle-adjusted dystrophin to 5.46% of normal at six months (p<0.0001) in Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, with functional gains. Dyne plans to seek US accelerated approval in Q2 2026 and targets a possible Q1 2027 launch if granted priority review. DMD approvals have historically relied on surrogate data, so a clean registrational read strengthens its case.
The FDA said new cancer CAR-T therapies should beat those already approved.
In a JAMA paper, CBER director Vinay Prasad and colleagues set randomised trials showing superiority over standard care, including approved CAR-Ts, as the agency’s preferred route to approval, a move beyond the single-arm studies behind all seven marketed CAR-T therapies. Single-group trials would still be considered where a randomised one is not feasible, as in rare or heavily pre-treated groups. Head-to-head studies cost more and take longer, and several programmes were not built for them.
Tuesday 9 December
Novartis struck an atopic-disease discovery deal with UK biotech Relation Therapeutics worth up to $1.7bn.
Relation will receive $55m upfront through equity investment and research funding, with up to $1.7bn in additional milestones, along with tiered royalties. The collaboration pairs Relation’s AI-led, patient-data discovery platform with Novartis’s immuno-dermatology expertise to identify first-in-class targets for allergic diseases. It represents another major pharma investment in AI-led target discovery.
A softened Biosecure Act was folded into US defence bill and cleared the House.
Text released on Tuesday wrote the measure into the 2026 National Defense Authorization Act, and the House passed the bill on Wednesday, with the Senate still to act. It would bar named Chinese contract research and manufacturing firms, and companies that work with them, from federal contracts from 2026. Unlike last year’s version it targets firms tied to China’s military rather than naming WuXi AppTec or WuXi Biologics. Many US biopharma companies rely on Chinese suppliers.
S. 1071 (119th Congress): Biosecure Act - all actions - US Congress
House Committee Print 62380: 2026 National Defense Authorization Act text - US House of Representatives
Pfizer paid $150m upfront for a Chinese GLP-1, expanding its obesity pipeline.
The exclusive global licence for YP05002, an oral small-molecule GLP-1 in phase 1 from YaoPharma, a Shanghai Fosun Pharmaceutical unit, carries up to $1.935bn in milestones and tiered royalties. Pfizer discontinued danuglipron in April 2025 and completed its acquisition of Metsera in November. This is another instance of big pharma sourcing obesity assets from China rather than building them in-house.
The FDA approved the first gene therapy taken through approval by a nonprofit.
Waskyra (etuvetidigene autotemcel), from Italy’s Fondazione Telethon, treats Wiskott-Aldrich syndrome, an inherited immune and bleeding disorder, by adding working copies of the WAS gene to a patient’s own blood stem cells. As stated by the foundation, it is the first gene therapy a nonprofit has taken through FDA approval, a route that sidesteps the commercial return a company must show, at a time when developers have pulled approved rare-disease gene therapies from the market.
Fondazione Telethon announces FDA approval of Waskyra (etuvetidigene autotemcel) for Wiskott-Aldrich syndrome - Fondazione Telethon
Medline set terms for one of largest US healthcares IPOs of up to $5.4bn.
The medical-supplies group, taken private in 2021 by Blackstone, Carlyle and Hellman & Friedman, is offering 179 million shares at $26 to $30. At the top of the range, it would rank among the largest US healthcare IPOs on record.
Medline sets terms for a massive $5.37bn Nasdaq IPO - Fierce Biotech
Wednesday 10 December
The UK cut the headline new-medicines payment rate to 14.5% and lifted its NHS drug bill.
The government set the newer-medicines payment rate under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) at 14.5% for 2026, down from this year’s record 22.9%, honouring the cap agreed in the UK-US trade deal last week. Including a separate 1% investment contribution, the total payment is 15.5%. The government expects the package to produce up to £1bn of additional medicines spending over three years. The ABPI called it a first step back towards competitiveness.
Biotechs sold a record $3.2bn of follow-on stock in a single day.
Eight companies raised the money between Tuesday evening and Wednesday morning, with Structure Therapeutics, Terns Pharmaceuticals and Kymera Therapeutics each taking more than $600m off recent data. With the IPO window still shut, this is a leading indicator that public investor appetite for the sector is returning.
Thursday 11 December
The EU struck a deal on its biggest overhaul of pharma law in two decades.
Council and Parliament negotiators agreed to set regulatory data protection at eight years plus one year of market protection, and to shorten the EMA review from 210 to 180 days, alongside new shortage-notification duties. Industry body EFPIA called the package encouraging but “not strong enough to move the needle“ on European competitiveness. The provisional deal still needs formal sign-off.
‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector - Council of the European Union
Background note: pharmaceutical package - European Parliament
Lilly’s triple agonist retatrutide posted significant 28.7% weight loss.
In phase 3 TRIUMPH-4, 12 mg retatrutide reduced weight by 28.7% and WOMAC pain by 74.3% in adults with obesity and knee osteoarthritis; treatment-regimen estimates were 23.7% and 62.6%. The GIP, GLP-1 and glucagon receptor agonist is Lilly’s follow-on to Mounjaro. Adverse-event discontinuations were 18.2% versus 4.0% on placebo, while mostly mild dysesthesia affected 20.9%. Reuters cited analysts describing the weight loss as the highest yet, but the overall result as mixed because of side effects.
GSK’s Blujepa won FDA approval for gonorrhoea, the first new-class oral antibiotic for it in three decades.
The FDA cleared Blujepa (gepotidacin), a first-in-class oral antibiotic, for uncomplicated urogenital gonorrhoea in patients aged 12 and over weighing at least 45 kg who have limited or no alternative treatment options. Approval was based on the phase 3 EAGLE-1 trial, in which Blujepa was non-inferior to injectable ceftriaxone plus oral azithromycin. Rising resistance has reduced treatment options for gonorrhoea. GSK is one of the few large pharma companies still developing antibiotics.
Blujepa (gepotidacin) approved by US FDA as an oral option for uncomplicated urogenital gonorrhoea - GSK
The FDA approved Amgen’s Uplizna in generalised myasthenia gravis.
Uplizna (inebilizumab), a CD19-targeted B-cell depleter, is cleared for adults with the autoimmune neuromuscular disease who carry anti-AChR or anti-MuSK antibodies, dosed twice a year after two loading doses. It is the first CD19 therapy in the indication, entering a market already crowded with newer biologics.
GSK’s outgoing chief said the US is still the best place to invest, warning the UK risks falling behind.
Speaking as she prepares to leave GSK at the year’s end, Emma Walmsley said the US remained the leading market in the world for launching new drugs and vaccines, reiterating that GSK will invest >$30bn into the US by 2030. She called improvement in the UK’s life-sciences commercial environment, “absolutely critical” to growth.
UK still at risk of falling behind in life sciences, says Emma Walmsley - The Times
GSK to invest $30bn in R&D and manufacturing in the US over next 5 years