| Today's Big NewsJul 13, 2023 |
| By Fraiser Kansteiner Nearly 50 years after norgestrel’s original green light, Perrigo’s oral contraceptive Opill has converted its prescription approval into an OTC nod. The FDA thumbs-up comes two months after the progestin-only tablet won unanimous backing at an FDA meeting of outside experts, paving the way for nonprescription use in patients of all ages. |
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By Annalee Armstrong Caribou Biosciences CEO Rachel Haurwitz, Ph.D., has nothing but praise for the autologous CAR-T cell therapies that have provided another option for lymphoma patients. It’s just that her CRISPR gene editing company would like to do it better with an off-the-shelf approach. |
By Conor Hale The agency was previously leery of some of the devices, recommending alternatives after analyses showed possible increases in long-term death risks. |
By Gabrielle Masson Nymox Pharmaceutical has spoken out against two ex-leaders who formed a rebellion based around the company’s refusal to accept a proposed partnership. The biotech said the proposal would have created debt and blamed the two leaders for pushing the deal for their own personal benefit. |
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Thursday, July 20, 2023 | 12pm ET / 9am PT In this webinar, you will learn how to capture all healthcare services accurately using multiple datasets, the methodology to capture non-traditional HCP visits, what to look for in an affiliations dataset to help identify non-traditional HCP visits, and more. Register now.
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By Angus Liu After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still working out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile. |
By Andrea Park Causaly’s technology is “one of the clearest real-life applications of AI today," according to Carlos Gonzalez-Cadenas, a partner at Index Ventures. |
By Helen Floersh Little is known about the prevalence of Alzheimer's disease in Samoan and other Asian American-Pacific Islander communities. Researchers like Justina Tavana, Ph.D., are hoping to change that. |
By Kevin Dunleavy Five weeks after getting no response from the U.S. Department of Health and Human Services on his request for more information on the potential financial impact of Eisai and Biogen’s newly approved Alzheimer’s treatment Leqembi, Sen. Bernie Sanders (I-Vt.) has sent a follow-up letter to the HHS. The drug has been priced at $26,500 per patient per year. |
By Andrea Park AccurKardia’s software relies on AI algorithms and other technologies to scan readouts collected by a variety of compatible ECG devices. |
By Max Bayer Rupert Vessey will join Flagship Pioneering as the venture firm's first chief scientist. He joins after leading research and early development at Bristol Myers Squibb for four years. |
Fierce podcastsDon't miss an episode |
| | This week on "The Top Line," we discuss new HIV therapies, plus Humira's new biosimilar, foreign pharmaceutical investments, and the rest of the week's headlines. |
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Tuesday, July 25, 2023 1pm ET / 10am PT New methods in scalable compute cloud environments not only accelerate drug discovery in a cost-effective manner, but benefit from reduced deployment time, accelerated GPU speed, and reduced infrastructure costs. Register now to learn more.
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