Featured Story | By Nick Paul Taylor MacroGenics has closed a phase 2 clinical trial of its anti-cancer antibody enoblituzumab after learning of seven deaths potentially associated with hemorrhagic events. The setback means two of MacroGenics’ three attacks on B7-H3 have hit setbacks but the biotech is forging ahead with the third candidate. read more |
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Top Stories By Annalee Armstrong More than 100 women in biotech have signed on to a letter decrying the Supreme Court's ruling overturning Roe v. Wade. They say this is only the beginning of their activism. read more By Max Bayer Just a week after Vertex’s stem cell therapy to treat type 1 diabetes was released from an FDA clinical hold, the company is clearing out potential competition by buying ViaCyte for $320 million. read more Sponsored by: Lonza AG Advance your AAV-based therapeutics by leveraging Lonza expertise, using the same tools and technologies used for our platform processes. Balance risk and speed, while maintaining high AAV productivity read more By Annalee Armstrong Sanofi presented data on its broad bleeding disorder pipeline at the International Society on Thrombosis and Haemostasis 2022 Congress Sunday, showcasing key late-stage data on two therapies: efanesoctocog alfa and fitusiran. read more Sponsored by: Parexel The rise of clinical trial complexity has been well-documented but the impact on logistics is not well understood. Here, we look at decentralized trials, patient experience and the role of logistics. read more By James Waldron Emerald Health Pharmaceuticals’ CEO and CFO have both stood down as the CBD-focused company battles fraud allegations from the SEC. read more By Nick Paul Taylor Pliant Therapeutics’ idiopathic pulmonary fibrosis (IPF) candidate has impressed investors. With phase 2 data supporting more development, the biotech boasted a 60%-plus stock surge on Monday morning. read more By Gabrielle Masson Researchers have discovered that quelling astrocytes—star-shaped brain cells—might fight long-term effects of traumatic brain injury, pointing to a protein involved in the process that could serve as a potential therapeutic target. read more By Kevin Dunleavy With sales of blood pressure medicine Giapreza lagging, La Jolla has sold out to royalty management company Innoviva for $149 million. The Waltham, Massachusetts, company intends to pay $5.95 per share, which is a 70% premium on La Jolla’s 30-day share price. read more By Angus Liu Bristol Myers Squibb's Opdivo and Yervoy and Exelixis' Cabometyx have their own newly diagnosed kidney cancer nods. Now, Exelixis showed that adding its drug to the immuno-oncology duo can confer additional benefits, but so far only on stalling tumor progression. read more By Fraiser Kansteiner Following a preapproval inspection at one of the drugmaker's formulations manufacturing sites, Dr. Reddy’s says the FDA slapped the company with a two-observation Form 483. read more By Heather Landi Primary care company Forward, reportedly worth more than $1 billion, is the latest digital health company to feel pressure from the current market downturn. read more By Andrea Park Lumos Diagnostics’ FebriDx point-of-care test will have to wait a bit longer to see the light of day in the U.S., as the Australian company announced Monday that its 510(k) submission to the FDA has been rejected. read more Resources Sponsored by: Triangle Insights Group, LLC Discover how the new partnership between TrialCard and Triangle Insights Group can help you bridge the critical gap between strategy and execution, ensuring commercialization success of your product or therapy. 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Sponsored by: Thermo Fisher Scientific Sponsored by Thermo Fisher Scientific The journey for starting or expanding a lab can be exhilarating, while also being challenging--learn how this free program provides savings and solutions to support your goals. Sponsored by: Catalent 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: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Catalent 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 Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities Sponsored by: Catalent What are key considerations for intranasal delivery in the treatment of acute and chronic conditions? Decentralized Clinical Trials Forum July 26, 2022 | Free Virtual Event Fierce Biotech Summit September 19-20, 2022 | Boston, MA Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Health Payer Forum October 12, 2022 | Free Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event Fierce Biotech Cell & Gene Therapy Forum October 19, 2022 | Virtual Event Clinical Quality Oversight Forum: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia PA | Presented by: Fierce Pharma Decentralized Clinical Trials Summit: Part of the Fierce Clinical Collective Oct 24-26, 2022 | Philadelphia, PA | Presented by: Fierce Pharma Fierce Pharma Meeting Professionals Summit November 2-3, 2022 | Atlantic City, NJ Fierce European Trial Master File Summit November 14-16, 2022 | London, UK Fierce Diversity, Equity & Inclusion Forum November 15-16, 2022 | Free Virtual Event Fierce Launch Readiness for Medical Affairs & Communications Teams Summit November 30-December 1, 2022 | Virtual Event Fierce JPM Week 2023 January 2023 | San Francisco, CA & Virtual Fierce Clinical Trial Billing & Research Compliance Summit February 2023 | Location TBD Fierce BD&L Summit for Life Sciences March 14-15, 2023 | San Francisco, CA | 
