Alleging “untrue statements” included in the approval application for vasculitis drug Tavneos (avacopan), the U.S. FDA’s Center for Drug Evaluation and Research is proposing to withdraw the NDA for small-molecule C5aR antagonist at the center of Amgen Inc.’s 2022 buyout of Chemocentryx Inc. for $3.7 billion.
Sun Pharmaceuticals Industries Ltd. will pay $11.75 billion cash to acquire Organon & Co. The transaction is expected to close in early 2027. The addition of Organon’s women’s health products, legacy drug brands and biosimilars are expected to boost Mumbai, India-based Sun’s global reach. The all-cash buy is also expected to relieve Jersey City, N.J.-based Organon of an $8.6 billion debt pile, accumulated after its debt-laden 2021 spinout from Merck & Co. Inc.
After a hiatus of more than nine months, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) will meet April 29 to discuss two Astrazeneca plc applications – an NDA for camizestrant used in combination with a CDK4/6 inhibitor to treat HR+HER2- locally advanced or metastatic breast cancer and an sNDA for Truqap (capivasertib) to treat metastatic castration-resistant prostate cancer.
A patient death marred Erasca Inc.’s phase I dose-escalation efforts with pan-RAS molecular glue ERAS-0015 in cancer, and shares (NASDAQ:ERAS) ended April 28 at $9.90, down $9.25. ERAS-0015 is being tested in RAS-mutant solid tumors, specifically non-small-cell lung and pancreatic ductal adenocarcinoma.
Soligenix Inc. intends to spend the next weeks further analyzing data and reviewing strategic options in the wake of a disappointing interim analysis from a pivotal phase III study testing Hybryte, its synthetic hypericin, in cutaneous T-cell lymphoma.
Eli Lilly and Co. is acquiring Ajax Therapeutics Inc. for up to $2.3 billion in cash, gaining access to next-generation JAK inhibitors for patients with myeloproliferative neoplasms.
Sun Pharmaceuticals Industries Ltd. will pay $11.75 billion cash to acquire Organon & Co. The transaction is expected to close in early 2027. The addition of Organon’s women’s health products, legacy drug brands and biosimilars are expected to boost Mumbai, India-based Sun’s global reach. The all-cash buy is also expected to relieve Jersey City, N.J.-based Organon of an $8.6 billion debt pile, accumulated after its debt-laden 2021 spinout from Merck & Co. Inc.
Shares of Veradermics Inc. spiked as the first top-line readout from its registrational program for VDPHL-01 showed the oral, extended-release version of minoxidil surpassed expectations in men with mild to moderate pattern hair loss, setting up commercial aspirations as a potential best-in-indication treatment option.
Four months after receiving a complete response letter from the U.S. FDA for tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis, Sanofi SA received a positive opinion recommending approval in the EU.
Grace Therapeutics Inc.’s hopes of becoming the first company in decades to update the standard of care in aneurysmal subarachnoid hemorrhage were delayed after the U.S. FDA issued a complete response letter (CRL) for its GTx-104 NDA, citing manufacturing and nonclinical deficiencies rather than concerns over efficacy or safety.
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