Not for sale: Intellia isn't interested in a buyout, but CEO Leonard has an eye out for complementary tech Atea and Roche's COVID-19 antiviral flunks phase 2, prompting switch that will delay pivotal data Dicerna narrows focus for kidney drug after mixed data, setting up head-to-head market battle with rival Alnylam Sponsored: Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction? Biogen, Sage plot 2022 filing for zuranolone approval, furthering turnaround of depression drug Sofinnova bulks out VC shop with a hefty $548M as it zeroes in on early-stage European biotechs Struggling Calithera nabs two cheap cancer assets from Takeda for just $10M upfront Crinetics spins off radiopharmaceuticals into new company with $30M in a page from Roivant's playbook Entasis' antibiotic bests last resort treatment on path to become new weapon against drug-resistant bacteria Takeda spinout Phathom's erosive esophogitis drug bests Prevacid in head-to-head phase 3 trial D&D Pharma snags $51M ahead of Korean IPO for Alzheimer's, Parkinson's Pandemic launch woes: Esperion cuts 40% of workforce, goes all in on cholesterol drug's outcomes trial Natera launches lung DNA test for catching transplant rejections Study shows promise of mobile apps, connected devices to help patients manage hypertension Featured Story | By Annalee Armstrong When Moderna’s CEO Stephane Bancel said he wanted to buy into gene editing, the chatter over the potential target flared to a roar. So you know we had to ask when we had Intellia CEO John Leonard on the line. read more |
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Top Stories By Nick Paul Taylor Atea Pharmaceuticals and Roche have suffered a big blow to their bid to bring an oral antiviral for COVID-19 to market. A phase 2 trial of the candidate missed its primary endpoint, prompting Atea and Roche to consider changes that will delay data from a pivotal study by around one year. read more By Ben Adams Dicerna is still paving a way forward for its troubled late-stage RNAi asset nedosiran as it looks to gun for an FDA approval in just one sub-type of a rare disease after ratcheting up another mixed bag of data. read more Sponsored by: Q2 Solutions Clinical lab testing at home - fact or fiction? Many operational and patient-related considerations must be taken when using a decentralized approach to specimen collection at or near the trial participant's home. read more By Nick Paul Taylor Biogen and Sage Therapeutics’ race to bring depression drug zuranolone to market is entering the home stretch. After talking to the FDA, the partners have outlined plans to start a rolling submission early in 2022 and complete the filing in the second half of the year. read more By Ben Adams Sofinnova Partners has raised 472 million euros ($548 million) to create the largest early-stage healthcare VC fund in Europe. read more By Ben Adams Calithera Biosciences, fresh off axing more than a third of its staff at the start of the year, is tapping Japanese Big Pharma Takeda for two oncology assets targeting lung and blood cancers. read more By Kyle LaHucik Crinetics Pharmaceuticals has partnered with venture capital shops to launch Radionetics Oncology with $30 million in initial fuel. While Crinetics is largely focused on oral treatments for rare endocrine diseases and related tumors, Radionetics' mandate is a much broader scope within oncology. read more By Annalee Armstrong A new antibiotic by Entasis Therapeutics has bested an existing therapy against a pathogen deemed by the CDC to be an urgent threat during a phase 3 clinical trial. read more By Emmy Lucas Phathom Pharmaceuticals' erosive esophagitis drug vonoprazan performed as well as over-the-counter Prevacid in a head-to-head phase 3 clinical trial, potentially teeing up a 2022 application for FDA approval. read more By Kyle LaHucik D&D Pharmatech raised $51 million in a series C to bankroll mid-stage studies in Alzheimer's and Parkinson's. The financing will also fund other assets across the company's five subsidiaries and sets it up for an initial public offering in Korea in the first quarter of 2022. read more By Angus Liu Just as Esperion’s cholesterol sister meds Nexletol and Nexlizet launched at the start of the pandemic, pharma marketing went digital. As its cash dwindles, the company is reaching for the ax to focus on a key cardiovascular outcomes trial. read more By Conor Hale The lung test launch marks Natera's third in as many months for its Prospera DNA test, which recently debuted heart- and kidney-focused diagnostics. read more By Rebecca Torrence Nearly half of all U.S. adults suffer from high blood pressure—and a new study suggests digital health tools used at home can help lower it. Hello Heart's program, which links a wearable blood pressure monitor to a mobile app, helped 84% of users with stage II hypertension reduce their blood pressure over three years, according to a study published last Friday. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. Sponsored by: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. Sponsored by: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. 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