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Novo Holdings, the Novo Nordisk Foundation’s holding and investment company, declared plans for a $16.5bn acquisition of Catalent as the company expands its manufacturing capabilities.

In the merger, Novo Holdings will receive all outstanding shares of Catalent for $63.50 per share in cash. This price reflects a premium of 39.1% to the closing price of Catalent’s common stock on 28 August 2023. This date was the contract development and manufacturing organisation’s (CDMO) last trading day before announcing Catalent’s new strategic and operational review committee, which assessed the company’s business strategy and operations.

Novo Nordisk has been consistently bulking its manufacturing operations in the last few years, following obesity and diabetes drug shortages in several countries. For example, in December 2023, the Danish company announced the acquisition of Alkermes’ Irish manufacturing plant in a $92.5m deal. Before this, in November 2023, the pharma giant declared plans to expand its manufacturing facility in Chartres, France, to increase capacity for its GLP-1 products such as Ozempic (semaglutide).

Eli Lilly has announced a $2.19bn net income on a reported basis for the fourth quarter of 2023 – a 13% rise compared with $1.94bn in the same quarter of the previous year.

Its earnings per share (EPS) on a reported basis grew from $2.14 to $2.42 in Q4 2022, up 13% during Q4 2023 ending 31 December 2023.

On a non-GAAP [generally accepted accounting principles] basis, the latest quarter’s net income stood at $2.25bn and EPS at $2.49, compared with a net income of $1.89bn and EPS of $2.09 in Q4 2022.

Revenue was $9.35bn, up 28% compared with $7.30bn in the same quarter of the previous year. The revenue growth was attributed to a combination of higher realised prices, increased volume and a favourable impact from foreign exchange rates.

A few days after the US FDA issued letters seeking the addition of black box warnings of secondary T-cell malignancies, the agency updated its website to amend Gilead Sciences’ Tecartus (brexucabtagene autoleucel) warning.

The proposed amendment for Tecartus kept the class-level boxed warning, similar to other CAR-T products: “T cell malignancies have occurred following treatment with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies.” However, the amendment removed “including Tecartus”, which was required for the other five CAR-T therapies.

On 19 January, the US FDA issued letters to all six FDA-approved CAR-T cell therapies asking that the labels for the therapies be updated to include T-cell malignancies in the black box warning section. Following the issuance of the letter, the companies have 30 days to either submit a proposal to add the black box warning proposed by the FDA or to submit a rebuttal.

The US Department for Health and Human Services (HHS) has sent the first offers to participating drug companies eligible for negotiation under the Medicare price negotiation programme as required by the Inflation Reduction Act (IRA). 

The Centers for Medicare and Medicaid Services is managing these talks, with a 30-day window given to involved drug companies to indicate acceptance of the suggested prices or present an alternative offer. Once both Medicare and the drug company agree on a price, the revised prices will become effective within Medicare in 2026.

The IRA allows Medicare to directly negotiate to reduce prescription prices for certain drugs and requires certain companies to pay rebates back to Medicare if the drug prices exceed the rate of inflation. The first ten drugs selected to be negotiated in the programme include those marketed by pharma giants AstraZeneca and Merck & Co’s anti-diabetic drugs, Farxiga (dapagliflozin), and Januvia (sitagliptin), respectively.

The UK’s National Institute for Health and Care Excellence (NICE) has recommended AbbVie’s Tepkinly (epcoritamab) as a third-line treatment option for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

NICE has endorsed Tepkinly in DLBCL patients whose cancer has returned or has not responded to at least two previous treatments. The therapy is only recommended for patients who have already either received Roche’s Polivy (polatuzumab vedotin) or it is either contraindicated or not tolerated.

Tepkinly is a bispecific CD20 CD3 T-cell engager. In May 2023, Tepkinly received accelerated approval from the US Food and Drug Administration (FDA) as a third-line therapy in adult patients with DLBCL. The drug is marketed as Epkinly in the US. The therapy was also granted conditional marketing authorisation from the European Commission (EC) for the same indication as approved by the FDA.