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. | Today's Big News Sep 16, 2022 AstraZeneca's Alexion bet continues to pay off as danicopan improves hemoglobin levels in phase 3 Intellia's gene editing therapies both post early successes as evidence grows for CRISPR potential With 70% staff gone, Nordic Nanovector board members jump ship amid 'strategic review' With cash evaporating quickly, Palisade Bio cuts staff to save money and focus on sole GI med Amgen CEO Robert Bradway warns Biden's Inflation Reduction Act could blunt future biotech success stories 'The Top Line': What Merck trial flops at ESMO may portend, lessons from COVID for monkeypox test EUAs and more Novartis headquarters raided in Swiss competition authority's patent probe NYU puts forward cancer test to help predict the success and toxicity of checkpoint inhibitor immunotherapies 'Unsustainable' losses are forcing hospitals to make 'heart-wrenching' cuts and closures, leaders warn Chutes & Ladders—Biden lands on leader for new agency that will oversee 'cancer moonshot' initiatives Fierce Pharma Asia—Takeda's €300M production boost; Daiichi, Dizal ESMO wins Featured | By James Waldron AstraZeneca’s $39 billion acquisition of Alexion last year continues to look like money well spent. The latest good news is that the oral factor D inhibitor danicopan can improve hemoglobin levels when added to the approved drugs Ultomiris or Soliris. |
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| Top Stories By James Waldron Intellia Therapeutics is closing out the week strong, reporting good news for a duo of gene editing trials. Both are early-stage, but the company is already prepping to move the transthyretin amyloidosis therapy, NTLA-2001, into what it hopes will be a pivotal study. By James Waldron Nordic Nanovector is shedding board members as the Norwegian biotech continues to seek out options for survival in the wake of discontinuing its lymphoma trial. 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 Max Bayer Just a month after raising nearly $14 million through a public offering, Palisade Bio is cutting 20% of staff to shore up dwindling funds. The company is directing all resources towards its sole GI-focused asset. By Fraiser Kansteiner In an era of abundant pharma buyouts, small and midsized biotechs may find it increasingly difficult to go their own way, Amgen’s CEO Robert Bradway figures. And new drug cost legislation in the U.S. certainly won’t help, the helmsman added. By Teresa Carey This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA. By Angus Liu Some guests recently “visited” Novartis’ headquarters in Basel, the company said. But according to Switzerland’s anti-competition watchdog, it was a raid. By Conor Hale Researchers at NYU have developed a single test they say can help determine which patients may see their cancer return after treatment with immunotherapies, as well as who may be at risk for severe side effects. By Dave Muoio A new report warns that anywhere from 53% to 68% of the nation's hospitals will finish 2022 with red operating margins. For systems large and small, this means service line closures or outright shutdowns that threaten patients' access to care, hospital leaders warned Thursday. By Max Bayer,Gabrielle Masson President Joe Biden has landed on a leader for his new federal biotech agency aimed at overseeing his ambitious “cancer moonshot” initiatives. By Angus Liu Takeda is investing heavily in plasma-derived therapy amid rapid growth. Daiichi Sankyo and AstraZeneca spinout Dizal Pharma are moving their respective lung cancer prospects ahead based on promising clinical data. President Joe Biden has launched a biomanufacturing initiative, which is widely viewed as a response to China's growing industry. And more. Fierce podcasts Don't miss an episode | This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA. |
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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. | Resources eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx Whitepaper Supporting your product development programme through experience, expertise, and efficiency. Sponsored by: Almac Pharma Services eBook Improve patient engagement, adherence, and outcomes Sponsored by: Health Catalyst Whitepaper Learn how IT and facility security professionals are collaborating on key initiatives to mitigate digital and physical security risks and build resilience healthcare system-wide. Sponsored by: Everbridge Video Learn how a centralized platform for pathology images, metadata, and analysis results can connect previously siloed research initiatives and advance our collective understanding of tissue. Sponsored by: Proscia Video Can an optimized research process--including AI-powered workflow and process automation tools--help get breakthrough drugs to market faster? Sponsored by: Proscia Whitepaper What is the most suitable dosage form technology for the Oral Delivery of Lipid-Based Formulations? Sponsored by: Catalent Research Learn more about how the versatility of Softgel Technology helped a customer with a volatile compound. Sponsored by: Catalent Whitepaper How can Lipid-Based Drug Delivery System help bring poorly soluble drugs to market? Sponsored by: Catalent Whitepaper Learn how formulation development for a PFS affects manufacturing to drive the industry toward optimizing delivery of injectable products and, ultimately, improving patient care. Sponsored by: Catalent Biologics Webinar Ypsomed and Catalent Biologics experts discuss strategies for integrated PFS manufacturing and auto-injector assembly to accelerate timelines and more in this webinar. Sponsored by: Catalent Biologics Whitepaper How can we predict the ability of a preclinical drug to inadvertently cause or intentionally inhibit cytokine secretion and T cell activation Sponsored by: ReachBio | The Cell Biology Experts™ Custom Resource Center Read through this library of resources to find out how you can strengthen innovation and efficiency, improve safety and quality, and prioritize resources to support your long-term goals. Sponsored by: JLL Whitepaper Read our whitepaper and dive into the way healthcare providers can digitally transform day-to-day work by streamlining costs and increasing agility by removing manual paper burdens. Sponsored by: DocuSign Research Learn how a private health insurance company uses analytics to deliver exceptional service to its employees and members Sponsored by: Genpact Executive Summary How a new app brings the power of CRM to a leading lab instruments provider’s field service engineers Sponsored by: Cognizant Whitepaper Clarus Therapeutics (Clarus) is a men’s specialty pharmaceutical company that partnered with Catalent to develop a unique and convenient drug delivery form for their hormone replacement therapy. Sponsored by: Catalent Whitepaper Learn more about how the transition from early to late phase of a small molecule program plays a pivotal role in a program’s ultimate success. Sponsored by: Catalent Whitepaper This paper explores how Medical Affairs is increasingly playing a key leadership role in evidence planning and generation (part 3 in a series). Sponsored by: Blue Matter, strategic consultants in the life sciences Whitepaper Explore how Thermo Scientific’s Process Liquid Preparation Services can help you plan for scalable buffer preparation. Sponsored by: Thermo Fisher Scientific Research TwinRCTs require fewer patients and shorten trial timelines for rare neurodegenerative diseases. Sponsored by: Unlearn AI eBook Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent Whitepaper Did you know Catalent has newly expanded in-house capabilities spanning clinical and commercial scale manufacturing for DPIs, unit-dose, bi-dose and preserved multi-dose nasal sprays? Sponsored by: Catalent Whitepaper What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Sponsored by: Catalent Multimedia ZS helps life sciences companies shape the future of medicine by turning healthcare data into transformative insights. Discover the power of R&D innovation Sponsored by: ZS Industry Events Virtual U.S. Healthcare Compliance Certificate Program October 10-13, 2022 European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Drug Development Boot Camp® 2022 November 16-17, 2022 |