Latest News
1 April
Eli Lilly outlays $7.8bn to acquire sleep drug biotech Centessa
Centessa’s lead asset has already demonstrated positive results in Phase II studies across a range of sleep-wake cycle conditions. Credit: Michael Vi/Shutterstock.com
Eli Lilly will acquire neuroscience specialist Centessa Pharmaceuticals in a deal worth up to $7.8bn, solidifying the drugmaker’s status as one of the most dominant players in the pharma deals arena so far this year.
As per the takeover deal, Lilly will acquire UK-based Centessa for $38 a share, representing a 37% premium on the Nasdaq closing price of $27.58 on 30 March. Despite the front-loaded nature of the deal, Centessa could also receive an additional $9 per share in contingent value rights (CVR).
Whether that extra $1.5bn in CVR is added to the deal hinges on three milestones for cleminorexton, Centessa’s lead candidate. The asset, formerly known as ORX750, has already demonstrated positive results in Phase II studies across a range of sleep-wake cycle conditions, including narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
In a research note following the deal, Citi analysts commented: “We think this could be an impactful expansion of Lilly’s neuroscience portfolio, given the large collective total addressable market across the three indications.”
2 April
Eli Lilly wins FDA approval for weight loss pill, tees up Novo rivalry
The US Food and Drug Administration (FDA) has approved Eli Lilly’s orforglipron pill for weight loss, ending Novo Nordisk’s first mover advantage in the US after just three months.
The oral glucagon-like peptide-1 receptor agonist (GLP-1RA) will be branded under the name Foundayo. Lilly expects to launch the drug on its direct-to-consumer channel by 6 April, with retail pharmacy and telehealth provider availability following soon after.
The FDA based its decision on results from the ATTAIN clinical programme, which demonstrated that patients taking the highest dose of Foundayo who remained on treatment lost an average of 12.4% of their body weight.
The approval marks the first new molecular entity (NME) approved under the FDA’s national priority voucher (CNPV) programme. The regulatory pathway was launched by Commissioner Marty Makary to streamline approvals for drugs that showcased a US-centric potential.
26 March
FDA opens door to feedback on ‘unclear’ national priority voucher pathway
The US Food and Drug Administration (FDA) will convene a public hearing intended to obtain feedback on its Commissioner’s National Priority Voucher (CNPV) pilot programme, a framework that has garnered mixed reception since launching in mid-2025.
The hearing, which will take place on 12 June 2026, will see the public offer their opinions across a range of topics related to the CNPV programme. Alongside the in-person event at the FDA’s headquarters in Maryland, those wishing to provide comment can also do so virtually until the end of June.
FDA commissioner Marty Makary launched the CNPV programme in June 2025. The regulatory framework allows biotechs and pharma companies who receive a voucher to have a shortened FDA review time for a new drug application of up to two months, down from the usual 10-12 month timeframe.
17 March
RFK Jr’s vaccine overhaul halted by federal judge’s ruling
US health secretary Robert F Kennedy (RFK) Jr’s ongoing overhaul of the vaccine sector in the US has hit a roadblock, after a judge halted nearly all the changes following a lawsuit from leading medical associations.
At the heart of the court ruling was RFK Jr’s changes to the Advisory Committee for Immunization Practices (ACIP), the US Centers for Disease Control and Prevention (CDC) panel responsible for reviewing vaccine data and issuing official government recommendations on immunisations.
Over the course of 2025, the US Department of Health and Human Services (HHS) chief replaced all existing members with a new slate of advisers. Among the new joiners were well-known vaccine sceptics and individuals who were critical of Covid-19-related countermeasures.
Federal judge Brian Murphy has ruled that the appointments likely violated US law, adding that all votes taken by the panel have been suspended.
11 March
FDA issues warning to Novo Nordisk on unreported semaglutide safety events
Novo Nordisk has received a warning letter from the US Food and Drug Administration (FDA) related to the company’s failure to investigate and flag treatment-emergent adverse events (AEs) associated with its top-selling drug, semaglutide.
According to the letter, an FDA Bioresearch Monitoring Program inspection revealed “serious violations” in Novo’s compliance with post-marketing adverse drug experience (PADE) reporting laws, which require medicine makers to both investigate and inform the FDA of “serious and unexpected” drug-related AEs within 15 calendar days.
Of the violations, two were patient deaths associated with semaglutide use – one of which was invalidated by Novo due to a failure to capture the patient’s identifier, while the other was not reported to the FDA at all. Semaglutide is the active ingredient in Novo’s blockbuster glucagon-like peptide-1 receptor agonist (GLP-1RA) products, Wegovy and Ozempic.