FDA staff endorse Moderna, Pfizer COVID-19 vaccines for young kids Bipartisan gun violence deal supports 'major investments' for behavioral health, telehealth programs Another biotech SPAC bites the dust as Blade Therapeutics’ planned merger is cancelled Rune Labs translates Apple Watch data into Parkinson's insights with FDA nod In short reprieve for AbbVie and J&J, FDA extends BeiGene's Brukinsa review in blockbuster leukemia realm Experts say broad FTC probe could bring new crackdown and laws on PBM industry After $750M bet, AbbVie lays down marker in fiercely competitive bispecific niche BD pairs up with Mayo Clinic’s real-world data platform for device development Novartis' Kymriah posts strong 5-year data in ALL after setback in label expansion bid Daiichi Sankyo’s survival data means it may finally be ready to compete with Novartis’, Astellas’ marketed AML meds Ekso Bionics nabs FDA exoskeleton clearance for multiple sclerosis rehabilitation Amid FDA delay, Amylyx scores conditional ALS drug nod in Canada A new day for pediatric cancer patients: Day One's share price doubles on initial data for brain tumor drug FDA clears digital tool to help diagnose autism in children as young as 16 months Survey: 13% of Medicare Advantage claims, prior authorization requests denied Featured Story | By Zoey Becker As Pfizer and Moderna's COVID-19 vaccine applications in young children move through the FDA's regulatory process, parents may soon be able to line their children up for shots. At an advisory committee this week, independent experts will vote on whether to endorse Moderna’s vaccine in a wide range of children and adolescents and Pfizer’s in children 6 months through 4 years old. read more |
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Top Stories By Dave Muoio New community, school and virtual behavioral health program investments are at the core of a gun violence deal that's likely to pass through both chambers of Congress. read more By James Waldron Blade Therapeutics set out plans for a blank-check deal in November 2021 that would have given Blade about $255 million to bankroll trials in fibrosis and neurodegenerative conditions. But the move to join the NASDAQ by merging with SPRIM Global Investments' special purpose acquisition company have hit a dead end. read more By Andrea Park With the importance of accurate self-reporting for Parkinson's treatment, a spate of apps and other digital tools have cropped up to help patients keep track of their symptoms. One such tool newly cleared by the FDA takes the concept a step further, bringing in the Apple Watch’s movement-analysis abilities to take on some of the tracking itself. read more By Angus Liu AbbVie and Johnson & Johnson’s Imbruvica just nabbed a three-month reprieve before a potential face-off against BeiGene’s rival med Brukinsa in chronic lymphocytic leukemia, a key battleground for BTK inhibitors. read more By Robert King Experts say a wide-ranging FTC study into the PBM industry could spark new legislative efforts in Congress and future enforcement actions such as fines on anti-consumer practices. read more By Nick Paul Taylor AbbVie and Genmab have posted more clinical data on their potential blockbuster rival to Roche’s newly approved Lunsumio, linking the CD20xCD3 bispecific epcoritamab to a 39% complete response rate that fell away somewhat in patients previously treated with CAR-T. read more By Conor Hale BD teamed up with the Mayo Clinic and its patient data-sharing program to help track real-world performance of its current medical devices and help develop new ones. read more By Kevin Dunleavy Novartis' presented impressive long-term survival data for its gene therapy Kymriah. Of 79 children and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL), 55% of them survived during the five-year study. read more By James Waldron Daiichi Sankyo’s challenger to Novartis’ Rydapt looks like it may get another shot at FDA approval, with quizartinib posting positive survival data from a phase 3 trial. read more By Conor Hale To help patients with multiple sclerosis that may have trouble walking, Ekso Bionics is taking a leap forward with the first FDA clearance in the condition for a robotic exoskeleton suit that provides power and balance to the legs. read more By Eric Sagonowsky After some skepticism from the U.S. FDA and its expert advisers, Amylyx Pharmaceuticals has scored the first worldwide approval for its ALS drug, AMX0035. The conditional nod requires the company to deliver phase 3 data from its PHOENIX trial, which is underway. read more By Gabrielle Masson Day One Biopharmaceuticals appears to be living up to its namesake, unveiling positive initial data for its oral drug tovorafenib, which aims to treat a brain tumor in children that currently has no approved treatment. read more By Andrea Park The rise of digital diagnostics may be the key to speeding up autism diagnoses, which can be even further delayed for girls and for children from low-income and nonwhite families. read more By Robert King A recent survey of Medicare Advantage enrollees found that 13% had a claim or prior authorization request denied by their plan as scrutiny of the program heats up. read more | 