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Johnson & Johnson (J&J) has signed a definitive agreement for the acquisition of Ambrx Biopharma in a $2bn all-cash deal.

Ambrx, a clinical-stage biopharmaceutical company, is recognised for its synthetic biology platform, which is instrumental in designing and developing antibody drug conjugates (ADCs).

The company’s portfolio includes clinical and preclinical programmes that optimise the safety and efficacy of its candidate therapeutics in oncology indications. Among the key candidates in Ambrx’s pipeline is ARX517, an ADC targeting prostate-specific membrane antigen for metastatic castration-resistant prostate cancer.

Another is ARX788, a human epidermal growth factor receptor 2 (HER2)-directed ADC for metastatic HER2-positive breast cancer. ARX305 is also being developed to target CD-70 [cluster of differentiation 70] for renal cell carcinoma.

The US Food and Drug Administration (FDA) has authorised the Agency for Health Care Administration of Florida’s drug importation programme under section 804 of the Federal Food, Drug and Cosmetic (FD&C) Act.

The initiative marks a significant step towards Florida’s goal of importing prescription drugs into the state from Canada. The move is in line with the US Government’s Executive Order on Promoting Competition in the American Economy.

The FDA’s approval of Florida’s Section 804 Importation Program (SIP) proposal is the first such move of its kind. It will be valid for two years from the notification to the regulator of the first shipment.

Florida’s Agency for Health Care Administration must now submit further drug-specific data for review and approval by the FDA. The state should also ensure that the drugs are assessed for authenticity and comply with FDA-approved specifications. Drugs imported to the state are required to be relabelled to align with FDA requirements.

Valneva has adjusted its financial guidance for the 2023 calendar year, after the French vaccine specialist said it had not yet sold a priority review voucher.

The voucher’s sale would have brought in proceeds of €90m-€110m ($70.6m-$86.3m). As such, Valneva said it is now expecting total product sales revenues for the year of €130m-€150m, according to a 29 December press release.

Valneva had originally updated its guidance in November 2023, expecting total revenues and other income between €220m-€260m, assuming sale of its priority review voucher before year-end. 

Valneva secured the voucher upon approval from the US Food and Drug Administration (FDA) of its chikungunya vaccine Ixchiq. As per the Tropical Disease Priority Review voucher programme, the voucher – which cuts four months off FDA review time for any drug application it is redeemed for – can be sold to other companies.

The EC has ruled in favour of Biogen and revoked the centralised marketing authorisations for generic versions of Tecfidera (dimethyl fumarate) held by multiple companies.

These companies include Accord Healthcare, Mylan, Neuraxpharm, Polpharma and Teva Pharmaceuticals. 

Additionally, the EC granted the drug full data and marketing protection until 3 February 2025. Following the decision, Biogen initiated legal action to defend its market protection rights, as per a 19 December press release.

 The drug was approved by the EC as a first-line oral treatment for people with relapsing-remitting multiple sclerosis (RRMS), a common form of multiple sclerosis (MS).

In 2020, Mylan launched a generic version of Tecfidera in the US, and since then other companies have launched generic versions of the drug. The entry of the discounted generics led to a sharp decline in Tecfidera’s revenue.

ImmunityBio has started the year off strong by announcing it has entered into a deal with Oberland Capital involving a $320m revenue interest purchase agreement (RIPA). The investment will advance the company’s commercialisation of its near-approval bladder cancer drug candidate, Anktiva (N-803), and support ImmunityBio’s efforts to expand Anktiva into multiple solid tumour indications.

The deal cemented $210m in funding at closing and will see the biotech receiving an additional $100m pending the US Food and Drug Administration (FDA) approval of an Anktiva/Bacillus Calmette-Guérin (BCG) combination treatment for BCG-unresponsive high grade non-muscle invasive bladder cancer (NMIBC).

As per a 2 January SEC filing, for an upfront $200m, Oberland gained the rights to receive quarterly tiered payments that range from 3%–7% of ImmunityBio’s net sales in all countries excluding China and its controlled territories. Following a successful approval, the royalty rate range will increase to 4.5%–10%.