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Form 10-K Jaguar Health, Inc. For: Dec 31

Form 10-K Jaguar Health, Inc. For: Dec 31
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EMA Relaunches Policy 0070 On Publication Of Clinical Data For Medicinal Products For Human Use - Healthcare

In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human.

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EMA | Benzinga

U.S. stocks finished the week slightly lower as investors gave today s poor housing data a slack, and blame it on the weather. “Investors are willing to cut the market some slack because of the weather; I m keeping my fingers crossed that the economy heats up as the weather warms up,” Jack. Read More. Don t Miss Any Updates! News Directly in Your Inbox Subscribe to:

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Biocon's unit Biocon Biologics receives approval for Kixelle

Biocon Biologics, a subsidiary of Biocon has announced that Kixelle, a biosimilar Insulin Aspart co-developed with Viatris Inc, has received marketing authorization approval from the European Commission. Biocon said that approval was received following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Kixelle, a fast-acting insulin analog indicated for the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above, has been approved as a 100 units/ml solution for injection in vial and pre-filled pen presentations. The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway.

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CHMP | Benzinga

In a report published Wednesday, Leerink analyst Paul Matteis commented on Orexigen Therapeutics, Inc. (NASDAQ: OREX) and wrote that following a positive opinion from the CHMP, the company expects a final opinion from the EMA on the Mysimba (Contrave) marketing authorization application. Matteis. Read More. Don t Miss Any Updates! News Directly in Your Inbox Subscribe to:

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