GSK hails phase 3 win for RSV vaccine in older adults, sparking race to regulators The hangover: Caribou's allogeneic CAR-T hit by durability doubts as half of patients relapse On the hunt for next FDA nod, ADC Therapeutics scores high response for Hodgkin lymphoma drug Sponsored: Tech-Enabled Trials Don't Have to Mean Loss of Human Connection AACR calls for policy changes to reduce cancer care inequities, improve trial access for minority communities Bluebird gene therapy overcomes safety worries to snag a win at FDA advisory panel Alcon nabs MVP Cooper Kupp as football star joins Pataday allergy eye drop team Brain circuits behind movement and mood could inspire new Parkinson’s disease treatment Can biosimilars tear down AbbVie's Humira rebate wall? Just look at Viatris' Lantus copy: analyst Bristol Myers pays $80M to AI firm Owkin as part of cardiovascular trial accord Oracle, Cerner plan to build national medical records database as Larry Ellison pitches bold vision for healthcare Tempus ties up Eli Lilly collab to bring free genomic testing to lung cancer patients 'The Top Line' podcast: ASCO data that wowed, rising stars blurring the line between traditional and tech-enabled drugs, plus this week’s headlines Chutes & Ladders—Forte taps Chen to be president, CSO amid shareholder dissent Fierce Pharma Asia—Enhertu's standing ovation; Tessa's $126M CAR-T financing; Samsung's manufacturing deal Featured Story By Nick Paul Taylor GSK’s respiratory syncytial virus (RSV) vaccine has hit the mark in a phase 3 trial in older adults, teeing the company up to file for approval by the end of the year. But the data-devoid statement leaves the big question of how the vaccine will fare in a competitive, blockbuster market unanswered. read more |
| |
---|
| Top Stories By Nick Paul Taylor Caribou Biosciences is nursing a hangover. Weeks after celebrating a 100% overall response rate, the CRISPR biotech has revealed 50% of patients relapsed within six months of receiving its allogeneic CAR-T cell therapy, sending its stock suddenly into a 13% dive that largely erased earlier gains. read more By Max Bayer Following the company’s first drug approval in 2021, ADC Therapeutics is looking for FDA nods, and appears to have landed on phase 2 data for a Hodgkin lymphoma drug that could do just that. read more Sponsored by: Vault Health DCTs hold the promise of reducing site and patient burdens but at what cost to human connection? Vault says it doesn't have to be a compromise. read more By Annalee Armstrong The issue is well documented by now: minorities are not getting the same chances to participate in cancer clinical trials as White patients and at the same time face overall disparities in care. The American Association for Cancer Research has put out a call for funding, data collection, cancer control initiatives and access to healthcare in an effort to finally turn things around. read more By Eric Sagonowsky One vote down, another to go: After facing serious safety doubts from FDA reviewers on its gene therapy prospect eli-cel, bluebird bio has convinced an expert panel that the drug's benefits outweigh its risks—at least in some patients. A second bluebird therapy faces scrutiny Friday. read more By Sharon Klahr Coey Alcon's Pataday allergy eye drops are the latest eye care med to enlist a celebrity to help promote the product. This time, Los Angeles Rams wide receiver and Super Bowl LVI MVP, Cooper Kupp, joins the Pataday team. read more By Angus Liu A team led by MIT identified three distinct brain circuits underlying motor and nonmotor symptoms of Parkinson’s disease. The scientists also identified specific receptors on the circuits that could be targeted by drugs. read more By Angus Liu AbbVie’s megablockbuster TNF blocker Humira is about to face biosimilars next year. But will those biosims succeed? According to analysts who examined Viatris and Biocon’s two biosimilar versions of Sanofi’s popular insulin Lantus, both high- and low-list-priced Humira copycats actually could steal market share. read more By Gareth Macdonald Bristol Myers Squibb will work with French biotech AI developer Owkin to design and optimize cardiovascular drug trials under a deal announced June 8. read more By Heather Landi Oracle's chairman Larry Ellison outlined a bold strategy Thursday for the database giant to use the combined tech power of Oracle and Cerner to make access to medical records more seamless. read more By Andrea Park Tempus fugit, but the Chicago medtech of the same name is aiming to stop the clock on cancer with its genomic sequencing tests. read more By Teresa Carey This week on "The Top Line," we discuss our special report on the rising stars in the digital health sector. We also talk about surprising data from this weekend’s ASCO meeting and the week's other big headlines. Plus, we're back in person at the biggest conferences! read more By Max Bayer Forte taps Chen to be new president and CSO amid dissent from top shareholder. Goldstein continues his tour of ocular biotechs, jumping to Aurion. Third Harmonic brings aboard Conner as CMO to guide the development of its hives program. read more By Angus Liu AstraZeneca and Daiichi Sankyo's Enhertu showed strong data in a new breast cancer category: HER2-low. CAR-T specialist Tessa Therapeutics raised $126 million in series A funding. Samsung Biologics and Novartis teamed up for the first time. And more. read more Resources Sponsored by: PwC Don’t miss these critical considerations when evaluating your HCP interactions management program. 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: CG Life Explore the new cell therapy handbook from Thermo Fisher Scientific. Sponsored by: Merit Solutions Quality operations guide your organization through regulatory compliance processes and safeguard your products, processes, and reputation. But your team is capable of so much more. Quality incident data and processes can be a driver of significant business value if shared with other stakeholders. Sponsored by: Blue Matter, strategic consultants in the life sciences Recent trends are driving big changes in Medical Affairs. This paper explores why, and what MA teams can do to stay ahead of the curve. 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? Fierce Digital Pharma Engage June 14-15, 2022 | Huntington Beach, CA @Philly Cell and Gene Therapy Annual Conference 2022 June 17-18th 2022; King of Prussia, PA Fierce Digital Pharma Innovation Week June 21-23, 2022 | Virtual Event Fierce New Product Planning Summit September 20-22, 2022 | Boston, MA Fierce Digital Pharma East October 18-20, 2022 | Philadelphia, PA & October 25-28, 2022 | Virtual Event 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 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 |