| Today's Big NewsSep 23, 2022 |
Eli Lilly’s tirzepatide, already approved in type 2 diabetes and carrying high expectations in obesity, could break pharma sales records, an analyst team at UBS says. The also touted the potential for Lilly’s Alzheimer’s candidate donanemab. Six months after the FDA lifted a clinical hold, Pfizer is gearing up to resume dosing in a phase 3 hemophilia A gene therapy trial. Amid Pfizer's pause, rival BioMarin has worked to get its rival back on track. In a new poll, physicians report an increase in emergency department violence. That’s leading to burnout for healthcare providers and hurting patient care, they added. - Eric Sagonowsky |
| By Fraiser Kansteiner With Eli Lilly’s latest Type 2 diabetes launch and obesity hopeful in the running to become “the biggest drug ever,” an approval for donanemab—the company’s experimental antibody effort against Alzheimer’s disease—would simply be “icing on the cake” for investors. That's according to analysts at UBS. |
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By Nick Paul Taylor Pfizer is finally nearly ready to resume dosing in its phase 3 hemophilia A gene therapy trial. Six months after the FDA lifted the clinical hold on the study, trial sites are set to resume enrollment with a view to restarting dosing in October. |
By Dave Muoio A new ACEP poll of emergency physicians found increases in ED assault frequency and physical injury, leading more doctors to agree that the attacks are taking a toll on providers. |
By Conor Hale The company has secured an FDA clearance for its Skout computer vision tech that helps spot suspicious polyps during a colonoscopy. |
By Angus Liu In a decision that has largely flown under the radar, AstraZeneca and Merck & Co. have started pulling Lynparza’s use in heavily pretreated BRCA-mutated advanced ovarian cancer patients, similar to what GSK and Clovis are doing for their own PARP inhibitors. |
By Angus Liu Securo Bio’s Copiktra looks on track to follow other PI3K inhibitors in bowing out of certain blood cancer markets after an FDA expert panel backed a negative review by the agency’s internal team. |
By Nick Paul Taylor Good, but not good enough. That is the verdict AstraZeneca reached after seeing phase 2b data on its Ionis Pharmaceuticals-partnered cholesterol drug ION449, which comfortably beat placebo but fell short of the bar for further development. |
By Teresa Carey This week on "The Top Line," we'll discuss how two Big Pharma companies, GSK and Takeda, made moves this week to bolster their environmental sustainability efforts. We'll discuss their strategies and what we can expect for the future. |
By Paige Minemyer Earlier this week, it was revealed that the District of Columbia Judge Carl Nichols would allow the merger to move forward. But that sealed opinion has now been released in full. |
By Andrea Park The EASEE system developed by Germany’s Precisis is a minimally invasive treatment for drug-resistant epilepsy that can be introduced in its early stages, after multiple drug options fail. |
By Kevin Dunleavy An FDA oncology advisory committee has voted down Oncopeptides' multiple myeloma drug Pepaxto. The drug won approval on an accelerated pathway in February of 2021 but a confirmatory trial raised questions about its safety. The drug remains approved in Europe. |
By Gabrielle Masson An FDA advisory committee has rejected Spectrum’s lung cancer hopeful Pozenveo, citing efficacy concerns. |
By Heather Landi Oracle plans to "rewrite" the VA's Cerner EHR as a cloud application with new capabilities, in order to fix stability issues and ensure a better experience for clinicians and patients. |
By Andrea Park In a ringing endorsement for its cloud-based, artificial intelligence-powered EEG headset, Ceribell has nearly doubled its series C financing after initially closing the round over a year ago. |
Fierce podcasts Don't miss an episode |
| This week on "The Top Line," we chat about this year’s European Society for Medical Oncology meeting, where Merck presented a series of trial flops for Keytruda. We also discuss the lessons learned from the COVID-19 pandemic and how they are being applied to the monkeypox test EUA. |
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