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This whitepaper provides insight into the basic principles of longitudinal qualitative research, which can guide development efforts and inform communication strategies for a patient centric approach in any therapy area. Learn More.
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Today's Big NewsSep 23, 2022 |
| 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. |
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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 Gabrielle Masson An FDA advisory committee has rejected Spectrum’s lung cancer hopeful Pozenveo, citing efficacy concerns. |
By James Waldron Ferring Pharmaceuticals’ biotherapeutic passed an FDA committee vote despite some skepticism from a handful of members, setting up the asset for potential approval to treat C. difficile infection. |
By Gabrielle Masson The botulinum toxin family of treatments may be best known for aesthetic applications like Botox. But in Aeon Biopharma's case, its candidate ABP-450 hit its main goals in a phase 2 trial for a rare neck muscle disorder. |
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 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. |
By Conor Hale The watchdog office reviewed the FDA’s embrace of “regulatory flexibility” and its use of emergency use authorizations during the first months of 2020, at a time when no coronavirus tests were available anywhere in the country. |
By Zoey Becker,Kevin Dunleavy,Fraiser Kansteiner,Angus Liu CDC data show that a new variant called BF.7 has doubled its incidence nationally over the last two weeks. Pfizer is updating a vaccine order with the U.S. Plus more. |
By Anastassia Gliadkovskaya The Long COVID Research Initiative aims to hasten research and clinical trials for long COVID by soliciting private backers and connecting researchers and clinicians with patients. |
By Gabrielle Masson,Fraiser Kansteiner Maxwell Biosciences has added three new senior executives to its team as it aims to shed its preclinical status. |
By Angus Liu Moderna is considering building a manufacturing plant in Japan, its CEO says. Takeda has offloaded an unwanted cancer drug to Puma Biotechnology. Everest Medicines hired Gilead's former China head as its new CEO. And more. |
Fierce podcastsDon't miss an episode |
| | 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. |
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