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STAT+: Gilead gets a boost from California court in a case over slow-walking an HIV drug

STAT

In a boost for Gilead Sciences, the California Supreme Court agreed to review a contentious legal theory that thousands of HIV patients have used in a closely watched case to argue drugmakers can be held negligent for failing to develop a medicine. Continue to STAT+ to read the full story…

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STAT+: Pharmalittle: FDA flags safety concerns with CRISPR-based sickle cell treatment; FDA warns about eye drop infection risk

STAT

We hope your day is productive and meaningful. Food and Drug Administration disclosed some safety concerns about an experimental CRISPR-based treatment for sickle cell disease, citing methods used to evaluate a risk of inadvertently making unwanted changes to patient DNA , STAT explains. And please do stay in touch. … The U.S.

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When Worlds Collide: The Theory of Real-World Evidence Meets Reality

FDA Law Blog: Biosimilars

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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STAT+: Pharmalittle: We’re reading about Pfizer’s DTC platform, Sandoz’s feud with a U.K. trade group, and more

STAT

We hope that your day is meaningful and productive, and that you will keep in touch when you hear something saucy. made vaccine was tested in clinical trials but never approved for use. Brianne Dressen, 42, a former teacher from Utah, says she developed a severe neurological condition after taking part in a vaccine trial in 2020.

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STAT+: Pharmalittle: We’re reading about a 486% drug price hike, AstraZeneca CEO pay, and more

STAT

 A small company called Harrow argues that it can make the case for an injectable eye treatment that has been used to combat several serious conditions. Novartis plans to cut up to 680 jobs in its product development organization , Reuters notes. Around 440 jobs will go in Switzerland and up to 240 in the U.S.

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FDA Approves First Over-the-Counter Naloxone Nasal Spray

LifeProNow

FDA approved Narcan, 4 milligram (mg) naloxone hydrochloride nasal spray for over-the-counter (OTC), nonprescription, use – the first naloxone product approved for use without a prescription. The timeline for availability and price of this OTC product is determined by the manufacturer. March 29, 2023: “The U.S.

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AI-Powered Category Management: Practical Use Cases To Boost Savings and Value

Pharma and Life Sciences Blog

Get up to speed with the latest developments in intelligent category management tools. Understand use cases where you can best leverage AI and other emerging technologies. ET / 3 p.m. BST [gep:registration_form] Thank you page Thank You Template Without Top Banner

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