| | | Three unique groups share all they learned about sample collection for COVID-19 testing and research. From a pop-up COVID-19 testing lab to a vehicle catching on fire with COVID-19 samples aboard, read their stories and recommendations. Download Now. 
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Today's Big News Sep 15, 2022 Alnylam, Regeneron hit go on phase 2 trial of genetic NASH therapy after generating signs of efficacy Pfizer gears up to submit meningococcal shot for approval this year after phase 3 success Are biotech SPACs back? Cancer-focused Apollomics next to take blank-check route With Nasdaq delisting threat, IMV drops 3rd of staff in refocus on lead oncology asset Eloxx stock slumps lower on failed phase 2 cystic fibrosis trial Strata Oncology expands pan-tumor clinical collaboration with Pfizer Modeling embryonic circulation, researchers produce elusive precursor blood stem cells Drug metabolism expert BioIVT acquires XenoTech CRO from Sekisui Mallinckrodt scores long-awaited FDA nod to treat life-threatening liver condition Genentech wants people to do a double take the right way when it comes to SMA Healthcare plays by CVS, Walgreens and Amazon will drive more partnerships, tech investment, experts say FDA write-up reveals production flaws behind Alvotech's recent Humira biosim slapdown Horizon plays 'pass the glass' in World Sight Day social media, video campaign Redesign Health scores $65M to create and launch more healthcare startups | By Nick Paul Taylor Alnylam and Regeneron have hit the gas on their RNAi nonalcoholic steatohepatitis program, outlining plans to kick off a phase 2 clinical trial of the drug candidate after generating early evidence of efficacy. |
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By Max Bayer New phase 3 data of Pfizer's pentavalent meningococcal vaccine has the big pharma gearing up to go to regulators before the end of the year. The company found its new shot held up against alternatives, including GSK's offering. By Gabrielle Masson Are we witnessing the return of SPACs? It's worth considering as Apollomics merges with Maxpro Capital Acquisition Corp.—the second such transaction in recent weeks. Sponsored By Danaher Corporation The rapidly evolving field of genomic medicines has manufacturers scrambling to scale up the production of complex medicines. Flexible, automated and integrated technologies are the solution. By James Waldron It’s been a turbulent first year for IMV’s CEO Andrew Hall. In July, the company was threatened with Nasdaq delisting. Now, IMV has initiated a significant strategic reorganization that will allow the biotech to focus on its lead, oncology asset at the expense of a third of his workforce. By Nick Paul Taylor Eloxx Pharmaceuticals’ cystic fibrosis candidate has failed a midphase clinical trial, dragging its battered share price down further still and leaving the future of the program in doubt. By Joseph Keenan Strata Oncology, developer of a range of DNA- and RNA-based tests as well as a genomic and transcriptomic profiling platform, is extending its clinical collaboration with Pfizer. By Helen Floersh Biomedical engineers have tried for decades to create blood stem cells in the lab, with little success. But a new study from a research team at the University of New South Wales in Sydney sheds light on the longstanding mysteries behind how the cells develop as well as how they can be artificially induced for use in patients. By Joseph Keenan BioIVT, a biological specimens and services firm, has snapped up Sekisui Chemical's CRO division XenoTech for an undisclosed price. By Kevin Dunleavy After lots of trial and error, the FDA has finally signed off on Mallinckrodt's Terlivaz as the first approved treatment for hepatorenal syndrome (HRS) with rapid reduction in kidney function. The condition affects between 30,000 and 40,000 annually in the U.S. By Sharon Klahr Coey Fashion is not generally known for its inclusivity, but all that changed with the Double Take fashion show, part of Roche Genentech’s "SMA My Way" program, where participants with the muscle-wasting disease walked and rolled down the runway in fashions adapted especially for them. By Heather Landi CVS, Walgreens and Amazon are ramping up their focus on in-home medical services and primary care and it will cause major disruptions for more traditional brick-and-mortar providers, industry experts say. By Fraiser Kansteiner In a write-up of Alvotehc's Reykjavik, Iceland, manufacturing facility, the FDA laid out 13 observations, including chidings related to procedural controls, management of manufacturing deviations, the presence of bacteria and mold, plus more. By Jacqueline Renfrow Horizon Therapeutics is challenging 5 million people to get their vision checked before World Sight Day on Oct. 13. By Heather Landi Redesign Health has built and launched 40 healthcare startups since 2018, and it nabbed $65 million in fresh funding to jump-start dozens more. Fierce podcasts Don't miss an episode | This week on "The Top Line," we discuss Sarepta's phase 2 Duchenne muscular dystrophy clinical trial that was green-lit earlier this week after a clinical hold in June. We also chat the opposing results on either side of the pond for Illumina quest for Grail. |
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| Tuesday, September 27, 2022 | 11am ET / 8am PT By standardizing core, repeatable IRT modules, clinical trial organizations can realize consistency and efficiency for all trials. Join The Secrets of Successful IRT Standardization and learn how Bayer did it. Register now. 
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