Getting ready for EMA’s website relaunch on 5 December 2023

9 November 2023 - The EMA is relaunching its corporate website on 5 December 2023. ...

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UnitedHealth unit to add eight insulin products to its reimbursement list

9 November 2023 - UnitedHealth's pharmacy benefit manager unit said on Thursday it was adding eight insulin products to its ...

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FDA amends pembrolizumab’s gastric cancer indication

9 November 2023 - On 7 November 2023, the FDA revised the existing indication of pembrolizumab (Keytruda, Merck) with trastuzumab, fluoropyrimidine, ...

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MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight loss

8 November 2023 - For the first time in the UK, obese patients and people who are overweight with weight-related health ...

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Vanflyta approved in the EU as the first FLT3 inhibitor specifically for patients with newly diagnosed FLT3-ITD positive AML

9 November 2023 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival. ...

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Same drug, two prices: why the higher price prevails

8 November 2023 - Patients are paying hundreds of dollars more for a prescription than they would if their health plan ...

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HHS considers removing J&J’s Stelara from Medicare drug price negotiations

7 November 2023 - The Department of Health and Human Services in a supplemental court filing posted late last week ...

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FDA’s Califf wants to get the public as excited about life expectancy as cures

8 November 2023 - It’s easy to get people worked up about cures, but they don’t seem to be bothered ...

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Takeda receives US FDA approval of Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer

8 November 2023 - Fruzaqla is the first targeted therapy approved for metastatic colorectal cancer regardless of biomarker status or ...

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PHARMAC asked to reconsider funding RSV drug for at risk babies

9 November 2023 - Paediatricians and neonatal experts are pleading with PHARMAC to rethink its decision to stop funding a ...

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Updates to the HTA Policy and Methods Review Reference Committee (9 November 2023)

9 November 2023 - Two more documents are now available. ...

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First electronic product information published for selected human medicines

8 November 2023 - The Heads of Medicines Agencies (HMA), the European Commission and EMA have published for the first time ...

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Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira

7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...

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FDA approves new medication for chronic weight management

8 November 2023 - Today, the US FDA approved Zepbound (tirzepatide) injection for chronic weight management in adults with obesity (body ...

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Biogen-Sage Therapeutics post partum depression pill priced at $15,900

7 November 2023 - Sage Therapeutics has priced the oral post partum depression pill it developed with partner Biogen at ...

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