| 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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Featured | | By Ben Adams Welcome to this year's Fierce Biotech's Fierce 15. Join us in celebrating 2022's best of the best biotech startups. This year, we focused more than ever before on diversity in management and geography across the biotech world, highlighting a broader range of teams, leaders and science. |
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Top Stories By Max Bayer In a race to design the next era of checkpoint inhibitors, AstraZeneca PD-L1 and CTLA-4 bispecific show efficacy rivaling data against Keytruda in first line lung cancer patients. But the dose level eliciting strong durability also came with significant toxicity, spurring a dose reduction. By Gabrielle Masson Scorpion Therapeutics has signed on another big pharma exec, tapping Sanofi’s Michael Streit, M.D., to be its first CMO and guide the biotech as it works to advance two clinical candidates to clinic in 2023. 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 EZH2 inhibitors have shown their potential—already with one approved therapy and a few in the pipeline—and Pfizer is one of the latest biopharmas to add the tool to its clinical belt. And phase 1 data presented at the European Society of Medical Oncology congress 2022 point to a positive safety profile, with glimpses of benefit for some cancer patients, though not all. By Max Bayer Fresh off head-turning new phase 2 data, AstraZeneca spinout Dizal says its planning to launch a phase 3 trial of its niche NSCLC treatment in the U.S. before the end of the year. The news comes as the small biotech hopes to keep up with larger pharmas that nabbed approval for the same indication in 2021. By Nick Paul Taylor BioNTech has shared a fresh cut of data from a phase 1/2 clinical trial of its CAR-T cell therapy candidate BNT211, revealing a decline in the all-comer response rate but cementing the asset’s credentials as a potential treatment for testicular cancer. By Max Bayer Regeneron is bullish on its efforts to treat ovarian cancer and new data has provided a boost to its ambitions. A taste of phase 1 findings from one of the company's bispecific antibodies showed a 14.3% objective response rate in a heavily pretreated population. By Max Bayer Relay Therapeutics is walking away from ESMO with strong response data in a new cohort of patients testing the company's bile duct cancer med. The company reported a nearly 90% objective response rate among 17 patients taking the recommended phase 2 dose. By Nick Paul Taylor Another successful antibody-drug conjugate looks set to roll off Daiichi Sankyo’s production line. After teasing early data on the B7-H3-directed candidate one year ago, the Japanese drugmaker has now linked DS-7300 to a 58% response rate in small cell lung cancer and responses in other tumors. By Gabrielle Masson Investors such as Pfizer have flooded Nimbus Therapeutics with $125 million in private financing, money that will go toward three clinical inflammatory and autoimmune disorder programs, including a phase 3 psoriasis launch. By Angus Liu In a closely watched competition among KRAS inhibitors, Amgen leads the pack with a randomized trial win in lung cancer. Now, the California drugmaker is giving a first look at the detailed data that could set the bar for all others to come, including Mirati Therapeutics, Roche and Novartis. By Andrea Park Artificial intelligence has increasingly become a go-to tool—rather than a novelty—for drugmakers looking to build the next generation of groundbreaking therapeutics. By Angus Liu Merck’s Keytruda has long established itself as standard of care in newly diagnosed non-small cell lung cancer. But now Roche aims to carve out a market for Tecentriq by targeting a neglected group of patients. By Paige Minemyer When the CVS Caremark team geared up to take on health disparities, it quickly realized that any initiative would require a significant basis in data to succeed. 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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Resources 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 eBook Improve your congress competitive intelligence and cut down costs by 50% Sponsored by: Ferma.AI, a Product of ZoomRx 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 European Healthcare Compliance Certificate Program Septemeber 19-23, 2022 Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Free Virtual Event Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Drug Development Boot Camp® 2022 November 16-17, 2022 | 