Novartis nabbed another FDA win for its Tafinlar and Mekinist cancer combo, this time broadening its label quite widely.

US regulators greenlighted the therapy for any solid tumor in patients with BRAF V600E mutations whose cancers are unresectable or metastatic. Individuals as young as 6 will be eligible to take the drug, making it the first BRAF/MEK inhibitor approved in pediatrics, Novartis said.

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2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

The deeply troubled European biotech Galapagos and its new CEO Paul Stoffels are going the CAR-T route, and they have a new, €225 million buyout designed to give them an inside track over the first-gen therapies that have made their way into the market.

Just weeks after inking an exclusive licensing pact for an anti-BCMA CAR-T out of China, Dutch biotech CellPoint has struck a deal to sell the company to Galapagos, with €125 million coming in cash and another €100 million on the table for potential milestones.

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The Biden administration released its Spring regulatory agenda, offering up plans on which proposed and final rulemakings will be coming down the pike in the not-too-distant future.

For the FDA, many of the draft and final rules are repeats, although the agency will look to clear its plate of remaining 21st Century Cures Act obligations, which have been in the works since 2016.

For instance, although Section 3023 of the Cures Act has a Dec. 2019 statutory deadline, the agenda shows the FDA is still hoping to release two proposed rules related to that part of the bill this September.

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As Merck KGaA continues to boost its manufacturing presence in Europe, most recently in Ireland and France, the company’s US branch is not shying away from stateside expansion.

On Thursday, MilliporeSigma’s production facility in Verona, WI, near the state capitol of Madison, began a new expansion on an existing site to produce highly potent APIs (HPAPIs). The new $65 million, 70,000 square foot addition, will look to bring 50 new jobs to the area, on top of the 350 that are employed already at the site.

Jonathan Weissman and team are out with a cancer-fighting biotech riding the appetite for those so-called “don’t eat me” and “eat me” signals.

The scientific co-founder — alongside fellow Whitehead Institute colleague Kipp Weiskopf and Stanford biologist Michael Bassik — has launched DEM BioPharma with incubator Longwood Fund and a crop of other investors.

In all, the nascent, 10-employee biotech has $70 million to bankroll hematology- and solid tumor-based programs, including a lead asset that could enter human trials in two to three years, CEO David Donabedian told Endpoints News.

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Over the next five years, Novartis is pledging to pour $250 million into R&D for new treatments of neglected tropical diseases and malaria — with the ultimate goal of eliminating these diseases.

“Over the past decade, great progress has been made against NTDs, but there is still a lot more work to be done,” CEO Vas Narasimhan said in a statement.

About 1.7 billion people still suffer from NTDs around the world, mostly in impoverished areas, and while malaria doesn’t fall in the NTD category, it still affects 241 million people and kills hundreds of thousands of children every year.

In the nearly eight years since Christophe Weber tapped Andy Plump as the new R&D chief at Takeda, the two top execs have been on a mission to elevate the company into a top-15 global giant, with a pipeline to match. And now they’ve set out to create a sprawling, 600,000 square-foot R&D and office HQ to complement this vision and fly their multinational flag over the heart of the Cambridge, MA biotech hub.

More than four months after Eric Lander, the famous founding director of the Broad Institute of MIT and Harvard, resigned from his top White House spot after bullying staff, President Joe Biden has nominated Arati Prabhakar to serve as the next director of the Office of Science and Technology Policy (OSTP), which is a Senate-confirmed position.

Prabhakar is the first woman, immigrant, or person of color nominated to serve as the director of OSTP, and if confirmed, she would also take the role of Assistant to the President for Science and Technology.

Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas

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