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Fujifilm Biotechnologies takes lessons from Denmark as debut of massive NC cell culture facility loomsWith several high-profile drugmakers already lining up for manufacturing space, Fujifilm Biotechnologies is on the cusp of kicking off operations at a much-anticipated mega plant in North Carolina. M2025/6/17
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Regeneron, playing catch up with J&J and Pfizer, wins FDA approval for Lynozyfic in multiple myelomaAnother BCMA-targeted agent has arrived for the treatment of multiple myeloma. The new option, Regeneron’s linvoseltamab, haswon an FDA approvalfor treating myeloma patients who have received at leas2025/6/12
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Sandoz, on a $1.1B investment spree in Slovenia, breaks ground at new $440M biosimilar plantGeneric and biosimilar specialist Sandoz is strengthening its footprint in Slovenia, pledging $440 million to set up a new biosimilar facility for sterile product manufacturing some 24 miles from the2025/6/12
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FDA weighs regulatory action on argenx's Vyvgart Hytrulo amid reports of 'severe worsening' of diseaseThe FDA’s regular communications based on reports from its drug safety report database don’t always rattle investors’ cages. But that was not the case with a regulatory update Monday on argenx’s auto2025/6/10
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Sobi agrees to pay up to $300M to reduce royalty payments to Apellis on EmpaveliApellis and Sobi haveamendedtheir partnership agreement for paroxysmal nocturnal hemoglobinuria (PNH) treatment Empaveli, or Aspaveli as it is known in Europe. With the new deal, Stockholm-based2025/6/10
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Bayer gains key FDA expansion for fast-rising prostate cancer drug NubeqaBayer has taken another step toward achieving its €3 billion peak sales estimate for androgen receptor inhibitorNubeqa, scoring an FDAapprovalto expand its use to all patients with metastatic castrat2025/6/5
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Novo Nordisk signs on to support ADA’s obesity advocacy divisionAlmost exactly a year after launching its Obesity Association, the American Diabetes Association (ADA) has recruited Novo Nordisk for support. The ADA’s obesity division went live last June, with a m2025/6/5
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CDC vaccine expert resigns amid shifting COVID guidance: ReutersWith U.S. recommendations for COVID-19 vaccines in flux, a leading member of the CDC's COVID vaccine advisory group is reportedly jumping ship. Lakshmi Panagiotakopoulos, M.D., a nearly 10-year CDC e2025/6/3
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ASCO: Bristol Myers CMO brushes off LAG-3 concern in lung cancer after Opdualag's adjuvant melanoma flopDespite its success in advanced melanoma, Bristol Myers Squibb’s fixed-dose PD-1/LAG-3 combo, Opdualag, failed to move the needle in resected skin cancer. Afterrevealingin February that Opdualag fail2025/6/3
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ASCO: J&J's Akeega gives PARP a novel prostate cancer win, but FDA path in patient subset unclearThe FDA has already approved PARP inhibitors in certain patients with metastatic castration-resistant prostate cancer (mCRPC). Now, Johnson & Johnson’s Akeega is giving the class a win in castrat2025/5/29