The Pharma Data

NOVEMBER 5, 2020

X4 Pharmaceuticals – Art Taveras was named CSO of Cambridge, Mass.-based 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.

Pharmaceuticals

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.

Drugs

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.

Clinical Trials

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.

Regulations

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.

Regulations

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.

Testimonials

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.

Production

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. ,

FDA

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.

Production

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.

Production

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.

FDA Approval

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 ?

Licensing

New Drug Approvals

APRIL 27, 2025

6] It was first approved in the US in 2004, and an extended release version was brought to market in 2007. 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] 5] It works by causing the smooth muscle in the bladder to relax. [3]

FDA Approval

New Drug Approvals

MAY 20, 2025

For this reason, it was subsequently licensed to Evotec , which is now developing it for the treatment of insomnia. [3] 3] By 2007, dimdazenil completed phase II clinical trials for this indication, with positive findings reported. [5] 5] In China, the drug was developed by Zhejiang Jingxin Pharmaceutical. Syed YY (March 2024).

Production

Codon

MAY 29, 2025

The way we typically prepare white beans completely deactivates the mild toxin that could otherwise cause food poisoning, the highly venomous cone snail that produced that shell was long gone by the time you picked it up, and Botox has been safe to inject by licensed healthcare professionals since FDA approval in 1991.

Drugs

Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. If a permanent freeze goes into effect, researchers estimate there could be 8.7

Clinical Trials