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‘It’s Time for Trodelvy’: Charity launches petition against Gilead for drug access

The charity Breast Cancer Now has launched a petition calling on Gilead to provide free-of-charge access to its new treatment Trodelvy (sacituzumab govitecan) for eligible patients with triple negative incurable secondary breast cancer – once the drug is licensed and ahead of a decision being made around its routine use on the NHS next year.

Jubilant’s oral remdesivir formulation shows positive results in human trial

Image credit: Pexels/Pixabay

Jubilant Pharma has announced the successful completion of studies in human volunteers for their oral formulation of remdesivir - an FDA-approved treatment for COVID-19.

Gilead’s bladder cancer drug gets FDA approval

Gilead sign

The FDA have granted accelerated approval to Gilead’s Trodelvy drug for the treatment of metastatic urothelial cancer (UC).

FDA approve Gilead’s breast cancer treatment after Phase III trial

Gilead sign

The FDA has approved Gilead’s Trodelvy therapy for the treatment of metastatic triple-negative breast cancer (TNBC).

Gilead and MSD partner to develop and commercialise two-drug HIV regimen

Gilead and MSD, known as Merck in the US and Canada, have entered into an agreement to co-develop and co-commercialise long-acting HIV treatments.

The treatments will combine Gilead’s investigational capsid inhibitor, lenacapavir, and MSD’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen for people living with HIV.

Galapagos and Gilead halt Phase III trials for idiopathic pulmonary fibrosis drug

Galapagos and Gilead have halted the ISABELA Phase III clinical studies for their autotaxin inhibitor ziritaxestat in patients with idiopathic pulmonary fibrosis (IPF).

The decision is based on the Independent Data Monitoring Committee (IDMC)’s recommendations which, following a regular review of unblinded data, concluded that ziritaxestat’s benefit-risk profile no longer supported the continuation of the studies.

NICE recommends rheumatoid arthritis drug Jyseleca for NHS use

NICE has issued a final appraisal determination (FAD) recommending the use of Jyseleca (filgotinib) on the NHS in England for adults with moderate to severe active rheumatoid arthritis (RA).

The decision marks the first time in the UK that an advanced therapy has been recommended in people with moderate RA, offering thousands more the chance to achieve remission earlier – potentially slowing the irreversible damage and life-limiting symptoms RA can cause.

European approval for Kite's CAR-T therapy Tecartus in elapsed or refractory mantle cell lymphoma

Gilead-owned Kite Therapeutics has secured marketing authorisation from the European Commission for its chimeric antigen receptor (CAR) T cell therapy Tecartus (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19) in relapsed or refractory mantle cell lymphoma, a rare form of non-Hodgkin lymphoma.

The approval is conditional, awarded because, according to the Commission, “the benefit of immediate availability outweighs the risk of less comprehensive data available.”

Gilead's lenacapavir meets primary goal in heavily treated and multidrug resistant HIV-1

Gilead has pulled back the curtain on promising new data for its long-acting HIV-1 capsid inhibitor lenacapavir for heavily treated and multidrug resistant HIV-1 infection, an area of great unmet need.

The Phase 2/3 data was generated from 36 recruited patients with multi-class HIV drug resistance and detectable viral load who were not seeing their disease controlled with their current regimen.

WHO warns regulators to consider all available evidence before approving remdesivir for COVID-19

The World Health Organization’s Chief Scientist Soumya Swaminathan has warned that experts and regulators assessing the use of Gilead’s remdesivir should consider all the available evidence before awarding marketing authorisation to treat COVID-19, and not just the FDA’s approval last week. 

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