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ALETH / LIFESCI-BRIEF / 2026-01-23 / SCOTUS TAKES UP HIGH-STAKES GENERICS BATTLE

SCOTUS takes up high-stakes generics battle

Also this week: GSK buys RAPT for $2.2bn, AZ leaves Nasdaq for the NYSE and Moderna pulls back from vaccine trials.

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

In this edition

Weekend catch-up

The US Supreme Court agreed to hear Hikma’s challenge to Amarin over a generic’s “skinny label”.

The court granted certiorari on Friday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), taking up the Federal Circuit ruling that let Amarin’s induced-infringement claim proceed even though Hikma had carved the patented cardiovascular indication out of its generic Vascepa (icosapent ethyl) label. This case impacts branded drugs with secondary uses still under patent and could set how far generics can carve a patented use out of their labelling.

Hellman & Friedman is exploring the sale of med-device maker Cordis at >$9bn, Bloomberg reported.

The PE firm is working with advisers to gauge interest, with about half a dozen listed medtech companies weighing bids, according to the report; talks are early and no sale is assured. H&F bought Cordis, which makes stents and other cardiovascular devices, from Cardinal Health in 2021 for about $1bn.

SpyGlass Pharma and Agomab Therapeutics filed Nasdaq IPOs

SpyGlass is an eye-disease company, whose lead asset is a drug-eluting intraocular lens in phase 3 for glaucoma. It filed its S-1 on Friday to trade under the ticker SGP. Immunology developer Agomab Therapeutics filed for its own Nasdaq listing in the same window. Only a handful of drug developers completed sizeable IPOs in 2025, and several 2026 biotech IPOs are taking shape a week after the JPM conference.

Monday 19 January

US drugmakers are pressing European governments to accept higher prices

The push follows the MFN pricing deals US companies struck with the Trump administration, which they say force them to raise prices abroad to defend the $700bn US market. Pfizer chief executive Albert Bourla, the first to sign such a deal, told reporters at the JPM conference that faced with cutting the US price to France’s level or pulling out, the company would stop supplying France.

Valneva withdrew its chikungunya vaccine after the FDA suspended the shot.

Valneva voluntarily withdrew the US BLA and IND application for Ixchiq, after the FDA suspended the licence in August 2025 following four new reports of serious adverse events; earlier safety concerns had centred mainly on older recipients. The agency has now also placed the IND on clinical hold to investigate a newly reported serious event in a younger adult. This was Valneva’s main commercial launch it its largest market.

Tuesday 20 January

GSK agreed to buy US biotech RAPT Therapeutics for $2.2bn, its first major deal under new chief executive Luke Miels.

GSK will pay $58 a share in cash, an equity value of $2.2bn and about $1.9bn net of cash, for RAPT’s ozureprubart, a long-acting anti-IgE antibody in phase 2b for the prevention of food-allergy reactions. Its once-quarterly dosing would set it apart from Novartis and Roche’s Xolair (omalizumab), which dominates the anti-IgE class.

GSK enters agreement to acquire RAPT Therapeutics

Pfizer agreed to exit the HIV joint venture ViiV Healthcare as Shionogi committed $2.1bn to raise its holding.

GSK, Pfizer and Shionogi agreed to replace Pfizer’s 11.7% interest in ViiV with new shares issued to Shionogi. Pfizer receives $1.875bn and GSK a $250m special dividend, leaving GSK with 78.3% and Shionogi 21.7%. Pfizer, which warned in December that 2026 revenue will fall, exits a business it helped found while Shionogi doubles down.

AstraZeneca will delist from Nasdaq and move its US listing to the NYSE.

AZ gave notice that it will withdraw its ADSs and debt from Nasdaq, effective after the close on 30 January, with its ordinary shares and debt starting to trade directly on the NYSE from 2 February. This will complete a shareholder-approved plan to harmonise its listing across London, Nasdaq Stockholm and New York.

Moderna and Merck’s personalised cancer vaccine sustained a 49% cut in the risk of melanoma recurrence or death at five years when added to Keytruda.

In the phase 2b KEYNOTE-942 trial, intismeran autogene (mRNA-4157) plus Keytruda reduced recurrence or death by 49% (hazard ratio 0.510) against Keytruda alone in resected high-risk stage III/IV melanoma, matching the benefit seen at three years.

Qiagen is weighing strategic options, including sale, Bloomberg reported.

The molecular-testing company is working with advisers and has held talks with several possible buyers, including some US strategics, according to the report; its shares rose about 12%. A 2020 Thermo Fisher approach worth roughly $12bn collapsed after an activist opposed it, and the pending exit of chief executive Thierry Bernard is seen as clearing the way.

Wednesday 21 January

J&J guided to 2026 revenue of $100bn to $101bn, led by Darzalex.

FY2025 sales rose 6.0% to $94.2bn and Q4 sales 9.1% to $24.6bn. Darzalex, its multiple myeloma antibody, delivered $14.4bn in 2025, with $3.9bn in Q4. J&J said pharma sales topped $60bn for the first time and forecast double-digit growth by 2030.

Health-AI company OpenEvidence raised $250m, doubling its valuation to $12bn.

The Series D, co-led by Thrive Capital and DST Global, roughly doubled the valuation of three months earlier and takes total funding to c.$700m. OpenEvidence’s clinical-search tool, used widely by US physicians, joins the wave of capital chasing medical AI.

IntraBio won European approval for Aqneursa in Niemann-Pick type C and a phase 3 win in ataxia-telangiectasia.

The European Commission cleared Aqneursa for the neurological signs of Niemann-Pick type C in patients aged six and over weighing at least 20 kg. Separately, a phase 3 crossover trial in ataxia-telangiectasia, a rare neurodegenerative disease with no approved treatment, showed a statistically significant improvement on the SARA ataxia scale. IntraBio said it would advance regulatory submissions.

The FDA set out draft guidance on using minimal residual disease and complete response to support accelerated approval in multiple myeloma.

The draft recommends MRD negativity in the bone marrow, measured by flow cytometry or next-generation sequencing, and complete response as primary endpoints to support accelerated approval, with clinical benefit confirmed later on survival or progression. Because response rates in myeloma are now so high, traditional endpoints can no longer adequately differentiate between new therapies.

Thursday 22 January

Abbott’s Q4 sales were light and its shares fell sharply.

Q4 sales rose 4.4% to $11.46bn against a consensus of about $11.8bn, as nutrition fell 8.9% and diagnostics slipped 3.6% organically on China’s volume-based procurement. Devices grew 12.3% and pharma 7.0% organically. It guided to 2026 organic sales growth of 6.5-7.5%. Shares fell around 10% on the day.

Corcept’s relacorilant improved overall survival in a phase 3 ovarian cancer trial.

In the ROSELLA trial, relacorilant plus nab-paclitaxel cut the risk of death by 35% (hazard ratio 0.65, p=0.0004) against nab-paclitaxel alone in platinum-resistant ovarian cancer, with median survival of 16.0 months versus 11.9. The win follows the FDA’s rejection of relacorilant in Cushing’s syndrome; the agency has set a decision on the ovarian filing for 11 July, and Corcept has filed in Europe.

Moderna will not fund new late-stage vaccine trials blaming US hostility.

Speaking to Bloomberg TV at Davos, Bancel said regulatory delays and shrinking official support had made the market too small: “You cannot make a return on investment if you don’t have access to the U.S. market.“ This retreat pulls late-stage funding from the core technology Moderna was built on, as U.S. vaccine policy undergoes a major overhaul under Health Secretary Robert F. Kennedy Jr.

China-founded Corxel raised $287m to push an oral GLP-1 pill beyond China.

The Series D1, led by RTW Investments and SR One, funds an ongoing US phase 2 in obesity, a planned global phase 2 in type 2 diabetes and phase 3 preparations for CX11, an oral small-molecule GLP-1 receptor agonist Corxel licensed ex-China from Vincentage. It is one of the larger private rounds for an oral incretin as Eli Lilly, Novo Nordisk and several biotechs race into the pill market.

The United States formally left the World Health Organization.

The exit took effect on Thursday, a year after President Trump ordered it by executive order on his first day back in office and the required 12 months’ notice ran out. Critics warn the departure damages US and global health.

Friday 23 January

Sanofi will file eczema drug amlitelimab despite a mixed set of phase 3 readouts.

The SHORE study met all primary and key secondary endpoints in moderate-to-severe atopic dermatitis, but COAST 2 was mixed: it hit the US co-primary endpoint while missing statistical significance on its EU co-primaries. Sanofi, which has tipped the OX40-ligand antibody as an immunology blockbuster to follow Dupixent (dupilumab), said it will proceed with global submissions in H2 2026.


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