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. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. Sponsored By: H1 More than 570 clinical trials in Ukraine have been disrupted. Unanticipated disruptions to medical testing and clinical trials impede progress toward new breakthroughs and new therapies that millions of patients around the world hang their hope on. What role do rescue sites play? Sponsored by: United Cargo The United Cargo team has made a commitment to pharmaceutical and medical partners that we are equipped to support their vaccine transportation needs safely and effectively across our expansive global and domestic network. The safety and security of these commodities is our priority, and we are proud to be a trusted partner in these efforts. Download infographic now. |