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FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. To Boehringer’s first and most significant argument, that Congress intended the terms “strength” to match FDA’s interpretation in 2009—prior to the codification of the definition in 21 C.F.R.

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Coronavirus: Health workers' army to be trained to deliver Covid vaccine

The Pharma Data

The UK remains under the jurisdiction of the European Medicines Agency and its licensing scheme until the end of the Brexit transition period on 31 December 2020. A rapidly-developed vaccine for H1N1 swine flu in 2009, Pandemrix, was linked to a small number of people developing chronic sleep disorder narcolepsy. Source link.

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Saphnelo (anifrolumab) approved in the US for moderate to severe systemic lupus erythematosus

The Pharma Data

Financial considerations AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. The option for Medarex to co-promote the product expired on its acquisition by Bristol-Myers Squibb (BMS) in 2009.

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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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ATUZAGINSTAT

New Drug Approvals

At CTAD, the company announced plans for a confirmatory trial, pending discussions with regulators. In August 2022, Cortexyme discontinued the gingipain inhibitor program, and offered it for external licensing ( press release ). 2009 Mar;77(3):1246-61. All were deemed unrelated to drug. Infect Immun. Epub 2008 Dec 29 PubMed.

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Article FDA Thank You Vaccines advisory panel endorses move to trivalent formulation for U.S. flu vaccines

Agency IQ

Influenza strains are named according to the HA and NA subtypes (at least 18 HA and 11 NA subtypes have been identified), as with the H1N1 influenza strain that famously wreaked havoc in 2009. That influenza A virus strain is now termed A(H1N1)pdm09, to signify the pandemic of 2009.

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Treatment Plans That Worked

The Pharma Data

The Executive Director of the Institute for Behavior Change (IBC), licensed psychologist and certified school psychologist Steve Kossor, has been involved in the planning and delivery of what became known as Intensive Behavioral Health Services (IBHS) in Pennsylvania since 1981. push(arguments)},i[r].l=1*new PA Senate honors IBC Founder.