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Regulatory
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European flag, vial, syringe

European regulators delay decision on Valneva COVID shot again, asking for antibody data

April 25, 2022
By Richard Staines
Shares in Valneva SE fell sharply after the company said European regulators came back with further queries, including on antibody efficacy data, instead of a recommendation during a rolling review of its delayed COVID-19 vaccine. The company had expected a positive opinion on the vaccine, known as VLA-2001, following the April meeting of the European Medicines Agency’s CHMP committee.
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Regulatory actions for April 25, 2022

April 25, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bayer, Biogen, Direct, Incyte, Lynk, Medac, Medexus, Novartis, Revance.
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Regulatory actions for April 22, 2022

April 22, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bridge to Life, Qvella.
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Silhouette made of crumpled paper illustrating depression

Depression’s era? Axsome squared away with US FDA, Relmada readout near

April 22, 2022
By Randy Osborne
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year.
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Aduhelm product image

Biogen withdraws EU Aduhelm filing amid announcement of latest CHMP opinions

April 22, 2022
By Richard Staines
Biogen Inc. has given up on its attempt to get its Alzheimer’s disease drug Aduhelm (aducanumab) approved by regulators in Europe, deciding to withdraw its filing midway through a review of a previous rejection. The company had asked the European Medicines Agency’s CHMP to reconsider its negative opinion for Aduhelm in December 2021. But its subsidiary in the Netherlands wrote to the EMA this week saying that it had decided to withdraw its marketing authorization application after all.
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Regulatory actions for April 22, 2022

April 22, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ampio, Dragon Boat, Hansa, Moleculin, Nrx, Otsuka, Tvardi, Vertex, Zambon.
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Bottle inside envelope

Idea: Instead of shelving unused opioids, mail them back

April 21, 2022
By Mari Serebrov
The U.S. FDA wants feedback on its latest idea to reduce the number of unused prescription opioids shelved in American homes: requiring prepaid mail-back envelopes to be dispensed with the painkillers.
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The eyes have it: Orasis has an NDA in its sights for presbyopia

April 21, 2022
By Lee Landenberger
Privately held Orasis Pharmaceuticals Ltd. is a step closer to challenging Abbvie Inc.’s Vuity (pilocarpine hydrochloride) ophthalmic solution for treating presbyopia, a version of farsightedness. Orasis plans to submit an NDA to the U.S. FDA in the second half of the year based on phase III results from two studies showing CSF-1 hit its primary and secondary endpoints.
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Blood cells and destruction of cancer cell

More work ahead for PI3K sponsors, US FDA adcom suggests

April 21, 2022
By Mari Serebrov
Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
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Cancer cells

Global paradigm shift needed in cancer care

April 21, 2022
By Mari Serebrov
Citing the flexibilities implemented during the COVID-19 pandemic, the Bloomberg New Economy International Cancer Coalition is pushing to convert those improvements to a permanent paradigm shift in the way cancer patients are diagnosed, treated and cared for across the globe.
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