| FDA hits pause on Protagonist's blood cancer med after mouse study turns up skin tumors AstraZeneca taps Dana-Farber's Rahma to lead its GI oncology work ESMO: Novartis links prostate cancer drug to improved pain, quality of life as regulatory filings near Sponsored: Four Steps to Smarter, More Dynamic Deployment Elevian snags $40M for stroke recovery and age-related diseases ESMO: Daiichi unveils first early peek at next-gen ADC as analysts see strong data against rivals Everest adds to base camp with $561M biobucks deal for Sinovent-SinoMab's renal disease treatment Vifor doles out $55M upfront to license Travere's late-stage kidney asset slated for US filing next year Pyxis Oncology names new CMO to lead development of next-gen antibody-drug conjugates Excision's CRISPR gene editing therapy for HIV is heading into human testing after FDA clearance First witnesses in Elizabeth Holmes' fraud trial say Theranos manipulated lab data, inflated revenue projections How do faulty genes drive cancer? There's a surprising immune connection, study finds Fierce Pharma Asia—Takeda's lung cancer nod; 4th death in Astellas' gene therapy trial; Everest's mRNA play Chutes & Ladders—AltruBio snags new CMO with resume at Sublimity, Ardea, Amgen and Abbott Featured Story | By Amirah Al Idrus Protagonist Therapeutics’ treatment for a rare, slow-growing blood cancer is under an FDA clinical hold after the company reported safety concerns in a nonclinical mouse study. The mice in the study developed benign and malignant skin tumors, the company announced in a statement on Friday. read more |
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Top Stories By Ben Adams AstraZeneca is following suit of many other pharmas and tapping academic and cancer organizations to fill out its oncology research team. read more By Nick Paul Taylor Novartis is building the case for its radioligand therapy. With positive phase 3 primary endpoint data in the bag, Novartis arrived at the European Society of Medical Oncology Congress 2021 armed with evidence of the therapy’s effect on quality of life and pain. read more Sponsored by: IQVIA Are you using data and analytics to design smarter campaigns and more effective sales rep deployment? read more By Kyle LaHucik Elevian has picked up another $40 million to bankroll its work in age-related diseases. The funding will bankroll phase 1 trials, slated for 2023, testing its lead program for stroke recovery. read more By Ben Adams Daiichi Sankyo has seen some great successes in the clinic, the deal room and commercially when it comes to antibody-drug conjugates, but it’s not resting on its laurels. read more By Kyle LaHucik Everest Medicines bought into the COVID-19 vaccine and mRNA space earlier this week, and, now, the biopharma is paying up to $561 million to reach the summit in renal disease treatments. read more By Kyle LaHucik Sparsentan has gone through the wringer in recent months after the FDA denied an accelerated approval in May. Now, just one week after a successful meeting with the regulatory agency, Travere has a licensing agreement with Vifor Pharma that includes $55 million upfront and up to $135 million in biobucks. read more By Emmy Lucas Pfizer darling Pyxis Oncology will advance its lineup of oncology antibody-drug conjugates with the help of a newly-appointed chief medical officer. read more By Annalee Armstrong A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application. read more By Andrea Park The first two witnesses took the stand this week in former Theranos CEO Elizabeth Holmes’ federal fraud trial, both former employees of the disgraced blood-testing startup who mapped out the corners they say were regularly cut in the lab, the boardroom and beyond. read more By Arlene Weintraub A study out of Howard Hughes Medical Institute found that more than 100 mutated cancer-suppressor genes don’t act directly on cancer cells to cause them to grow, but rather block the immune system from recognizing and destroying tumors. They believe further research into those immune pathways could inspire new treatments. read more By Angus Liu Takeda snagged an FDA nod for a niche lung cancer med to challenge Johnson & Johnson's bispecific antibody. The FDA slapped another clinical hold on Astellas' gene therapy trial after a patient death. China's Everest Medicines bought its way into the mRNA sector. And more. read more By Kyle LaHucik After pivoting to immunology, AltruBio picked up a new chief medical officer from Sublimity Therapeutics who also held director-level roles at Ardea and Amgen. Rusty Williams is back from Prime time, this time leading Walking Fish Therapeutics as CEO. And ViaCyte filled its vacant chief scientific officer role with an academic. read more | | The life-changing potential of cell & gene therapy demands lab services that are just as transformative. LabConnect® leads the evolution of lab services with customized solutions that simplify clinical trial complexity. Let us help with your next study so you can focus on the research. Learn more. |
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