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FDA gives Gilead reprieve on partial hold for cancer drug studies

An FDA safety review has cleared Gilead Sciences to resume five clinical trials that were placed under a partial hold in January. The experimental Gilead drug, magrolimab, is part of a class of cancer immunotherapies that address a hot target for the field.

Gilead Sciences cancer drug hit with partial hold due to adverse event concern

Gilead Sciences did not disclose details about the safety concern that led to an FDA partial clinical hold on five studies evaluating its cancer drug, magrolimab. But this experimental cancer immunotherapy introduces a safety risk that’s a known problem for all drugs in this class.

Former Shire asset becomes Mirum’s first FDA-approved rare disease drug

Mirum Pharmaceuticals drug Livmarli is now approved to treat pruritus caused by Alagille syndrome, a rare liver disease that can worsen to the point of requiring a transplant. Mirum licensed the drug from Shire in 2018.

Gilead and Novo Nordisk advance NASH collaboration to larger clinical study

Clinical tests of drugs from Gilead Sciences and Novo Nordisk have yielded encouraging results in nonalcoholic steatohepatitis (NASH), and the partners now want to see if the drug combinations help patients in a larger mid-stage study. The planned Phase 2b study expands on a 2019 R&D alliance.

Gilead, Galapagos halt IPF study in latest stumble for blockbuster alliance

The decision to discontinue all clinical trials for ziritaxestat is the latest setback in a broad alliance between Gilead Sciences and Galapagos. Last year, the FDA rejected a rheumatoid arthritis drug covered under the partnership.

FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug

While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.

Gilead invests another $145M into expanded oncology pact with Tango Therapeutics

The update to the partnership includes opt-in rights for Gilead on 15 drug targets, up from five under the original 2018 deal. Gilead will pay $125 million upfront and make a $20 million equity investment in Tango, which focuses on synthetic lethality.

Gilead got a boost from a newly approved PrEP drug. Now, a major insurer is dropping coverage

UnitedHealthcare sent a notice to plan members stating that it would no longer cover Descovy to prevent HIV, while Truvada – after it goes generic next month – will be covered for free. Gilead reported that Descovy for PrEP had offset a second-quarter fall in product sales.

Big Pharma plays CMO as Pfizer signs on to produce Covid-19 drug remdesivir for Gilead

Gilead Sciences had said in its second-quarter earnings that it would partner with companies in North America, Europe and Asia to manufacture the antiviral drug, which received an emergency use authorization from the FDA in May.

Gilead Covid-19 drug remdesivir benefited from $6.5B in NIH-funded basic research, study finds

Research on the drug’s molecular target dates back to the 1950s. A spokesperson for Gilead noted that the company anticipates potentially investing more than $1 billion on the drug this year alone.