Eli Lilly, Boehringer Ingelheim's Jardiance clinches heart failure edge with FDA nod for wider label Russian invasion of Ukraine could impact more than 200 clinical trials across biotech and pharma DOJ sues to block UnitedHealth-Change Healthcare deal Insulet’s Omnipod insulin pump sales send it past $1B mark for the first time Moderna, after monumental commercial debut, forecasts $22B in COVID shot sales this year AbbVie ditches fibrosis program it paid Morphic $20M for in 2020 Baxter reaches $18M settlement with SEC over decades of allegedly inflating income Lifespan, Care New England call off merger following regulatory roadblocks GlaxoSmithKline, Medicago’s plant-based COVID vaccine, Covifenz, wins first approval Scipher Medicine collects $110M for its drug-matching blood tests Merck cuts ties to Moderna's early-phase KRAS vaccine, leaving mRNA specialist to mull next steps Merck KGaA pledges $550M in manufacturing upgrades after closing buyout of mRNA CDMO Exelead 'Better than Abecma': Slimmed-down 2seventy charts own course after bluebird split Omada Health hits unicorn status with $192M Fidelity-led series E Featured Story | By Fraiser Kansteiner The U.S. FDA on Thursday blessed Lilly and Boehringer’s Jardiance with a label expansion to curb the risk of cardiovascular death and hospitalization for heart failure in adults. The move comes after the partners in November sent off an FDA application for the med to treat adults with heart failure independent of left ventricular ejection fraction. read more |
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Top Stories By Kyle LaHucik,Annalee Armstrong,Max Bayer Russia's invasion of Ukraine could impact clinical studies as there are more than 250 trials with at least one site in the Eastern European nation, according to ClinicalTrials.gov. Karuna Therapeutics noted one of its schizophrenia trials has no clear timeline because 10 of 19 sites are in Ukraine. read more By Paige Minemyer The Department of Justice has filed suit to intervene in UnitedHealth Group's acquisition of Change Healthcare, just days shy of the company's planned consummation date of Feb. 27. read more By Andrea Park Even without the rollout of the latest model of its tubeless insulin pump system—the Omnipod 5, which was originally poised to receive FDA clearance early last year but didn’t secure the agency’s OK until last month—Insulet still broke new ground in its 2021 earnings. read more By Fraiser Kansteiner This year, Moderna expects revenue from sales of its mRNA-based COVID-19 vaccine to clock in at around $22 billion. The company has locked up advanced purchase agreements worth $19 billion, with additional signed options valued at roughly $3 billion, the company said Thursday. read more By Kyle LaHucik AbbVie is ditching work on all the alpha V beta 6 (αvβ6) inhibitors that it paid $20 million to license from Morphic Therapeutic in 2020. The Big Pharma is culling the work because of a suspected on-target "safety signal" from preclinical testing. read more By Andrea Park According to the SEC, from at least 1995 until 2019, Baxter converted its internal foreign transactions, assets and liabilities into U.S. dollars on its financial statements using a method that “was not in accordance with U.S. GAAP or generally accepted accounting principles.” read more By Dave Muoio The federal regulator and Rhode Island's attorney general previously agreed that the deal would lead to "extraordinary" market power, likely raising prices and reducing the quality of care across the state and into some nearby Massachusetts communities. read more By Angus Liu As Sanofi and GlaxoSmithKline's COVID-19 vaccine finally heads to regulators, another shot using GSK’s pandemic adjuvant has taken home its first global approval. read more By Andrea Park Though still hard at work detangling the biology of patient-specific drug response, Scipher Medicine has already solved another very important piece of the startup puzzle: fundraising. read more By Nick Paul Taylor Merck has dumped Moderna’s mutant KRAS vaccine mRNA-5671. The action, which comes shortly after Merck closed enrollment in a phase 1 trial, leaves Moderna pondering the next steps for the program. read more By Kevin Dunleavy Ahead of schedule, Merck KGaA’s subsidiary in the United States, MilliporeSigma, has completed its acquisition of Indianapolis-based Exelead, following regulatory approvals and other clearances, for $780 million. The company will pour an additional $557 million into Exelead over the next 10 years. The deal is part of Merck KGaA’s effort to expand into the booming mRNA market. read more By Max Bayer Less than four months after finalizing its spinoff from bluebird bio, leaders of 2seventy bio say their pipeline's current success stories are not the bar, including FDA-approved Abecma. Instead, those at the helm believe the company's future will be defined by the science it's now chasing. read more By Rebecca Torrence Virtual chronic care management company Omada Health hit unicorn status with a $192 million series E round led by Fidelity, the company announced Wednesday. read more |
