| Webinar: Removing Antibody Drug Discovery's DNA Bottleneck Tuesday, September 14 | 2pm ET / 11am PT GPCRs have proven to be one of the most challenging targets for antibody drug development. In this webinar, we describe the use of next-generation DNA synthesis tools to overcome the DNA bottleneck in antibody-based GPCR drug discovery. Learn More. | Biogen's Aduhelm label far exceeds clinical trial population, study says. That could bring real-world surprises DuPage Medical Group hit with data breach that may affect 600,000 patients The mRNA era has arrived thanks to COVID-19. What's next in the pipeline? JAK inhibitors from Pfizer, AbbVie and Lilly hit with dreaded FDA heart safety, cancer warnings Fitness tech company Whoop hits $3.6B valuation after SoftBank-led funding boost After cutting dose because of deaths, Astellas pauses gene therapy trial as new liver issue arises Moderna reveals source of COVID-19 vaccine contamination as Japan finds yet another suspect vial Thermo Fisher, AstraZeneca team up on multiyear companion diagnostic project for drugmaker's precision medicine pipeline As NNU blames hospital cost cutting for labor shortage, industry groups keep the focus on COVID-19 Expect a surge in employer vaccine mandates, Willis Towers Watson survey says Philips gets green light to begin repairing millions of recalled sleep apnea machines COVID-19 tracker: Mesoblast's Novartis-backed drug hits FDA wall; U.S. has tossed 15M vaccine doses since March Featured Story By Noah Higgins-Dunn There's "room for surprises" when it comes to the safety of Biogen's Aduhelm because of the company's tightly controlled clinical trials, which recruited a narrower group of Alzheimer's patients compared to the treatment's FDA label, RBC Capital Markets wrote on Wednesday, citing a recent study. read more |
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| Top Stories By Emmy Lucas The July cyberattack of Illinois' largest independent physician group could affect 600,000 patients. read more By Annalee Armstrong COVID-19 wasn’t even in the picture when mRNA was developed, but with the regulatory runway cleared, biotechs that have been working on the tech for years are ready for liftoff. Yes, Moderna and BioNTech are the rock stars in the business—launched to household name status with the COVID-19 vaccines at the end of 2020. But there's more to the pipeline than just these headliners. read more By Angus Liu The safety problem for Pfizer’s arthritis drug Xeljanz has caused collateral damage across its drug class. The FDA is now requiring new heart safety and cancer warnings for Xeljanz, AbbVie’s Rinvoq and Eli Lilly’s Olumiant and is pushing back their use behind TNF blockers. read more By Anastassia Gliadkovskaya Whoop, which makes wearable fitness tracking technology, raised $200 million in a series F funding round as the company looks to grow internationally. read more By Nick Paul Taylor Astellas’ $3 billion bet on Audentes Therapeutics has hit yet another setback. Months after getting a clinical hold lifted, Astellas has voluntarily paused a gene therapy clinical trial after a patient suffered liver problems at the lower, supposedly safer dose. read more By Kevin Dunleavy Amid the discovery of foreign material in another vial of Moderna’s COVID-19 vaccine in Japan, the company said it has identified the source of contamination found last week. Stainless steel is the material and it was produced from friction between two pieces of metal on a Rovi manufacturing line. read more By Conor Hale Currently, more than 90% of AstraZeneca’s clinical drug candidates are based on a targeted approach, spanning its work in cancer and cardiovascular disease as well as kidney, metabolic and respiratory conditions. read more By Dave Muoio The national nurses union said hospitals have "deliberately" failed to staff units with enough nurses, leading many to quit out of safety concerns. One hospital group's CEO responded that the union "must be experiencing a different reality than the rest of us." read more By Paige Minemyer A growing number of employers are rolling out some kind of COVID-19 vaccine mandate as they grapple with reopening worksites amid a surge of cases due to the delta variant. read more By Conor Hale Philips is preparing to launch what it expects to be a year-long process of repairing and replacing the recalled components in millions of machines. read more By Noah Higgins-Dunn,Kevin Dunleavy,Fraiser Kansteiner The U.S. has tossed just over 15 million doses of COVID-19 vaccines since March 1, NBC News reports. An Illinois woman was caught using a fake vaccine card with a blatant typo on her trip to Hawaii. Plus more headlines. read more |