Roche's TIGIT flop prompts GSK, iTeos to reevaluate next steps for rival drug BridgeBio adds another $110M to coffers with voucher sale a day after mega BMS deal FDA tags Editas' thalassemia cell therapy an orphan drug as it rounds final bend in race to clinic Checkmate details bleak future if $250M Regeneron merger does not close Adagio still hopes to build omicron offense for lead COVID-19 therapy 'The Top Line' podcast: Big Pharma's M&A lull, the shake-up in top 10 highest paid R&D execs, plus this week's headlines Human Cell Atlas initiative makes strides as scientists piece together 'Google Map' of human cells As Siemens AG leaves Russia over Ukraine war, Siemens Healthineers will stay GSK's ViiV, Horizon and Pfizer earn top scores from U.S. patient groups: survey Healing the heart: Moderna cofounder, researchers near ‘Holy Grail’ for heart regeneration Chutes & Ladders—Moderna CFO Gomez departs after just one day following unearthed investigation Fierce Pharma Asia—Takeda's patent cliff and rare disease setback; FDA's censure of Sun, Aurobindo Featured Story | By Nick Paul Taylor That was fast. Just 39 hours after the bombshell failure of Roche’s TIGIT trial, iTeos Therapeutics revealed it and GlaxoSmithKline are assessing “how best to proceed with additional clinical development” of their rival asset in light of the phase 3 flop. read more |
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Top Stories By Annalee Armstrong A day after getting a nice fat—and sorely needed—paycheck from Bristol Myers, BridgeBio has sold off a priority review voucher, adding $110 million to its coffers. read more By Nick Paul Taylor Editas Medicine has picked up more regulatory privileges for its ex vivo gene-edited medicine, securing FDA orphan-drug designation in beta thalassemia ahead of the start of a clinical trial in the indication. read more By Annalee Armstrong Checkmate Pharmaceuticals has detailed a difficult future in a regulatory filing if the $250 million merger with Regeneron does not close. read more By Annalee Armstrong Hoping to still make the case for an FDA authorization for its COVID-19 antibody, Adagio Therapeutics is making modifications and exploring higher doses in search of an omicron offense. read more By Teresa Carey This week on "The Top Line," we talk about why Big Pharma is resisting the temptation to go on a biotech M&A spree. We also discuss the 10 biggest earners among R&D chiefs and the drastic changes from last year's list, plus the week's biggest headlines. read more By Angus Liu The Human Cell Atlas consortium has added important pieces to the creation of the full map of human cells, offering new insights into gene activity in specific cell types and how immune cells behave in various human tissues and organs. read more By Conor Hale Siemens AG’s decision to exit Russia does not include Siemens Healthineers, according to the company, which previously said it would continue to support healthcare providers and patients in the country. read more By Natalie Missakian When it comes to sizing up pharma’s corporate reputation, U.S. patient groups put GlaxoSmithKline’s ViiV Healthcare, Horizon Therapeutics and Pfizer on top. read more By Gabrielle Masson Healing a broken heart has taken on new meaning—researchers led by Moderna's cofounder have a new approach that may repair heart function after damage, closing in on the long-awaited “Holy Grail” for patients awaiting heart transplant. read more By Max Bayer Gomez steps down as Moderna CFO after just one day following an unearthed investigation at his former employer. Seagen puts Siegall on leave after domestic violence arrest. Inovio taps new leader following "particularly challenging period" and persistent COVID vax failures. read more By Angus Liu Takeda is preparing for the patent loss of its third-largest product and called it quits on a rare disease therapy. Sun Pharma and Aurobindo Pharma received new Form 483s from the FDA. Eisai has completed the rolling submission of its second Alzheimer's disease candidate. And more. read more Resources Sponsored by: Catalent In this executive summary, we describe the benefits of controlled release, look at how to determine whether a drug is suitable for controlled release, review the application of PBPK modelling in controlled release formulation development and discuss how modified release products can be developed to deliver optimal patient outcomes. 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