The Pharma Data

MARCH 20, 2023

Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on January 6, 2023. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. In the U.S.,

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The Pharma Data

NOVEMBER 22, 2020

Alzprotect co-owns or has an exclusive worldwide license from the French National Institute of Health and Medical research (Inserm) and the University of Lille (France) on a total of 58 patents related to Ezeprogind in 39 countries. Alzprotect is financed by the XERYS fund (Paris). About Alzprotect.

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The Pharma Data

MAY 13, 2021

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 Watch this video to learn more.

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Progress in biology is arguably moving faster today than at any point in the course of human history. BMC Systems Biology (2007). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous. Nature Biotechnology (2020).

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The Pharma Data

NOVEMBER 5, 2020

Prior to that, Taveras was vice president of Small Molecule Drug Discovery and CMC Development at Biogen Idec, and Alantos Pharmaceuticals, which was acquired by Amgen in 2007. Most recently, Holland served as Global Head of licensing at Lonza AG. He also and served as president and CSO at ShangPharma ChemPartner.

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The Pharma Data

DECEMBER 1, 2020

2007) Am J. . National Institute of Mental Health. Major Depression. Retrieved from [link]. World Health Organization. Fact Sheets: Depression, accessed November 23, 2020, [link]. Rush AJ, et al. Psychiatry 163:11, pp. 1905-1917 (STAR*D Study). Forward Looking Statements.

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The Pharma Data

OCTOBER 22, 2020

months (Vermorken et al, JCO 2007). Innate Pharma’s commercial-stage product, Lumoxiti, in-licensed from AstraZeneca in the US, EU and Switzerland, was approved by the FDA in September 2018. The activity of cetuximab as a single agent in recurrent and/or metastatic SCCHN is limited, with a 12.6%

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Codon

AUGUST 10, 2023

Credit: Bruce Wetzel and Harry Schaefer, NCI, NIH | License Last edit: 13 September 2023 Progress in biology is arguably moving faster today than at any point in the course of human history. BMC Systems Biology (2007). Engineered biology has profound potential to change how we live, but the field has become broad, bloated, nebulous.

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DNA Cell Biology Engineering Molecular Biology 52

The Pharma Data

NOVEMBER 15, 2020

She has been a member of the board of directors and a member of the executive committee of the New York Biotechnology Association since 2007. Additionally, she is co-founder of the NY Hub of BioDirector, an organization supporting board effectiveness and diversity.

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The Pharma Data

JUNE 18, 2021

Bacterial Meningitis in the United States, 1998–2007. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 2015;61(5):767-775. 20 Thigpen MC, Whitney CG, Messonnier NE, et al. 2011;364(21):2016-2025. 21 Grant L, Slack M, Theilacker C, et.

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Agency IQ

JUNE 2, 2023

In 2007, the FDA held a public workshop to hear from the public about the Medication Guides system; per the agency , “the public testified that the Medication Guides distribution processes needed improvement” and that it should be “shorter and easier to read.”

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Agency IQ

JUNE 16, 2023

Final Rule Stage Clean Water Act Section 401: Water Quality Certification 2040-AG12 August 2023 Clean Water Act (CWA) section 401 provides States and Tribes with a powerful tool to protect the quality of their waters from adverse impacts resulting from federally licensed or permitted projects.

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Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . There’s a reason why prescribing physicians and implanting surgeons are called “learned” intermediaries.

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Drug & Device Law

JULY 31, 2023

2007 WL 2460776, at *6 (D. 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). 2007), held that “defective computer software may give rise to strict products liability in tort.” Buhimschi , 2007 WL 2902896, at *16 (E.D. 28, 2007), aff’d , 396 F. Henry , 2007 WL 2743097, at *2 (W.D.

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Drug & Device Law

MARCH 7, 2022

544 (2007), and Ashcroft v. It does not give him license to evade the less rigid ? It does not, however, give a plaintiff “license to evade the less rigid ? The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S. Iqbal , 556 U.S. though still operative ? strictures of Rule 8. . . . at 570)).

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Licensing Licensing Production FDA 59

Drug & Device Law

AUGUST 8, 2022

For qualified IMGs, it issues a certification, which IMGs can then use to apply to residency and other graduate medical education programs and to apply for state medical licenses. It verifies that IMGs received a degree from an appropriate institution and administers tests of medical knowledge and English proficiency. 471 (11th Cir.

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Drug & Device Law

FEBRUARY 20, 2023

Without an FDA license to produce another design, [defendant] was legally prohibited from distributing either [alternative design advocated by plaintiffs] at the time [plaintiff] received her vaccinations. As a result, appellee was prohibited by federal law from employing either of these [alternatives]. Wyeth Laboratories, Inc. ,

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Drug & Device Law

MAY 26, 2023

You never need an authorization from a licensed professional to buy pork or fireworks. One of those laws, FDAAA in 2007, established the REMS system, which reflects the importance of national uniformity in the delivery of healthcare. Prescription drugs are not. And no federal agency specifies an intended use for these products.

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Drug & Device Law

JUNE 2, 2022

This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v. 124 (2007), which would also be knocked out by Dobbs if it sticks. the state action would be preempted. Strickland , 531 F.3d 3d 406 (6th Cir. Both of these cases applied the U.S. Carhart , 550 U.S.

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Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.” Hence, the statute applied.

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Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use.

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Drug & Device Law

FEBRUARY 2, 2023

2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Texas, unlike most states, enforces a strong statutory presumption that prescription medical product warnings complying with FDA requirements imposed by “pre-market approval or licensing of the product” are adequate as a matter of law. Novartis Pharmaceuticals Corp. ,

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