Drug Discovery World

SEPTEMBER 16, 2022

Since the approval of Kymirah in 2017, the cell and gene therapy sector has emerged as an exciting and innovative market, representing some of the most promising drugs the pharmaceutical industry has ever seen. . Neelam Patel, CEO of London cluster organisation, MedCity. . Last year, Pfizer opened a $68.5

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Drug Discovery World

JULY 27, 2023

There are suggestions that pharmaceutical companies may judge it ‘not to be worth the effort to seek UK approval’, on account of the size of the national market (the UK makes up 2.4% As such, nearly 70% of new drugs authorised by UK authorities relied upon the EU’s approval process.

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The Pharma Data

NOVEMBER 15, 2020

Her healthcare experience spans diagnostics, medical devices, pharmaceuticals, and digital health. Wasman was with Schering-Plough Corporation, a global pharmaceutical company, for over eight years, holding various U.S. Before that, Ms. Kalin was a partner in the global healthcare practice of McKinsey & Company, from 1990-2002.

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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

JULY 31, 2023

2007 WL 2460776, at *6 (D. Medicis Pharmaceutical Corp. , 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.

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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 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 ? Sun Pharmaceuticals Industries, Ltd. The ruling in question was that the TwIqbal ( Bell Atlantic Corp. Twombly , 550 U.S. Iqbal , 556 U.S. though still operative ?

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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

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. . . . Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 692, 694 (5th 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

In that Fourth Circuit case we mentioned above , the court looked to Healy (which knocked out a Connecticut wholesale beer pricing law) and Pharmaceutical Research & Manufacturers of America v. You never need an authorization from a licensed professional to buy pork or fireworks. Walsh , 538 U.S. 644 (2003), but not to Pike.

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Drug & Device Law

FEBRUARY 2, 2023

Novartis Pharmaceuticals Corp. , 2007 WL 4042757, at *3 (N.D. 15, 2007); McNeil v. Luitpold Pharmaceuticals, Inc. , McNeil Consumer & Specialty Pharmaceuticals , 672 F.3d Bayer Healthcare Pharmaceuticals, Inc. , 2d 898, 909-10 (W.D. 2013); Massa v. Genentech Inc. 2012 WL 956192, at *5 (S.D. 3d 441 (E.D.

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