CVS Health

Viatris faces FDA import restrictions at Indian facility

24 December 2024

Aficamten attracts more interest as Sanofi buys China rights

24 December 2024

Positive Phase III trials results with BMS’ Sotyktu

24 December 2024

FDA approves first generic of Victoza

24 December 2024

RAPT obtains worldwide rights ex-China to Jemincare MAb

24 December 2024

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Pfizer's rollercoaster ride and what comes next

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Latest News & Features of interest to CVS Health

AstraZeneca withdraws EU submission for lung cancer drug

AstraZeneca and development partner Daiichi Sankyo have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer. 24 December 2024

Viatris faces FDA import restrictions at Indian facility

Viatris has disclosed that its oral finished-dose manufacturing facility in Indore, India, is subject to regulatory action from the US regulator, after an inspection earlier this year. 24 December 2024

Aficamten attracts more interest as Sanofi buys China rights

Cytokinetics has sold Sanofi exclusive rights to develop and commercialize aficamten in China. 24 December 2024

Positive Phase III trials results with BMS’ Sotyktu

US pharma major Bristol Myers Squibb has announced positive results from POETYK PsA-1 (IM011-054) and POETYK PsA-2 (IM011-055), the pivotal Phase III trials evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). 24 December 2024

FDA approves first generic of Victoza

The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024

RAPT obtains worldwide rights ex-China to Jemincare MAb

USA-based immunology company RAPT Therapeutics has entered into an exclusive license agreement with Shanghai Jemincare Pharmaceutical for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. 24 December 2024

Shionogi to acquire full ownership of joint ventures with Ping An

Japanese drugmaker Shionogi has announced that it will acquire full ownership of its joint ventures with subsidiaries of Ping An Insurance. 23 December 2024

FDA approves Lilly drug for obstructive sleep apnea

US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024

AstraZeneca’s Tagrisso gains new European approval

AstraZeneca has secured European Commission approval for Tagrisso (osimertinib) to treat certain people with locally advanced, unresectable non-small cell lung cancer (NSCLC). 23 December 2024

FDA priority review for Nuvation Bio's taletrectinib

New York-based Nuvation Bio today announced that the FDA has accepted the company’s new drug application (NDA) for taletrectinib, an investigational next-generation ROS1 tyrosine kinase inhibitor (TKI) for the treatment of advanced ROS1+ NSCLC (line agnostic), for priority review. 23 December 2024

Latest In Brief for CVS Health

BRIEF—Mexican approval for Alzheimer’s drug Leqembi

The Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody Leqembi (lecanemab) for the treatment of early Alzheimer’s disease (AD). 5 December 2024

BRIEF—Eisai launches Alzheimer’s drug Leqembi in South Korea

28 November 2024

argenX spinoff secures series A extension to fight blood cancer

22 November 2024

BRIEF—Eisai updates Leqembi outlook

11 November 2024

BRIEF—Eisai completes rolling submission to US FDA for Leqembi maintenance dosing

1 November 2024

BRIEF—EMA re-affirms non-renewal of masitinib and Translarna authorizations

18 October 2024