Here are the latest stories being discussed in biopharma today:
First Keytruda biosimilars move into clinical trials as Merck forges ahead with new formulation
In a bid to create a wave of less costly competitors for Merck’s blockbuster immuno-oncology drug Keytruda, at least three companies have begun or are set to commence trials of Keytruda biosimilars. Samsung Bioepis, Sandoz and mAbxience Research are each conducting trials predicted to conclude by mid-2025. Merck, who earned $25 billion in sales from Keytruda last year, is working on a subcutaneous formula of the drug set to enjoy separate patent protection until 2039. The subcutaneous version is currently in Phase III testing.
Adaptive Biotechnologies cuts jobs ahead of strategic review completion
Diagnostic maker and drug discovery company Adaptive Biotechnologies has cut approximately 49 roles in advance of its impending strategic review completion. The firm, who will be advised by Goldman Sachs during the review, had 790 full-time employees as of the end of 2022.
US’ bankruptcy argument challenges Sorrento Therapeutics’ designated office
In a recent filing for bankruptcy in Texas, Sorrento Therapeutics declared its place of business as a Houston post box, a move the Department of Justice claims misrepresented the company’s true nature. Sorrento, which is based in San Diego, is under scrutiny from US trustee for the Southern District of Texas, Kevin Epstein.
United Therapeutics sues FDA over handling of Liquidia’s new drug application
United Therapeutics is suing the FDA over a new drug application submitted by rival Liquidia for treprostinil, a pulmonary arterial hypertension treatment. United contends the FDA incorrectly handled the application, which was amended during its pending period to include an indication for pulmonary hypertension associated with interstitial lung disease (PH-ILD). The argument states that Liquidia utilized United’s research to support that indication and should have instead carried out its own trials and submitted a separate application for the PH-ILD indication.
J&J social media program to amplify underrepresented voices in lung cancer advocacy
J&J is reaching out to underrepresented members of the lung cancer community inviting them to become digital advocates through its ‘BeLUNG Here’ initiative. The goal is to increase the diversity of voices in lung cancer advocacy, especially among Asian-American, Native Hawaiian, and Pacific Islander communities where a higher proportion of members are affected by the disease.
No longer see benefits, Novartis pulls Adakveo in the UK
Novartis is retracting Adakveo from the UK market, determining that the drug’s clinical benefits no longer surpass its risks. This comes after marketing authorizations for Adakveo were previously annulled in both the MHRA and European Commission. Adakveo remains available on the US market.
House Democrats call for FDA’s clinical diversity action plans
Democrats in Congress appeal for the FDA to make active steps towards more expansive diversity in clinical trials. This comes during a wider conversation surrounding healthcare disparity and how to better serve clinically underrepresented communities.
