The Pharma Data

NOVEMBER 15, 2020

Prior to Celgene, she held leadership roles in marketing, sales and new business development from 2002 to 2011 at Johnson & Johnson. Kalin was a partner in the global healthcare practice of McKinsey & Company, from 1990-2002. Before that, Ms.

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Agency IQ

MARCH 25, 2024

As explained in a 2013 Government Accountability Office report, the intent of the CPG was to “identify those circumstances under which the agency believed establishments with retail pharmacy licenses were engaged in ‘manufacturing, distributing, and promoting unapproved new drugs’ in a manner outside the traditional pharmacy practice of compounding.”

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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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DrugBank

DECEMBER 4, 2024

Still, it also provides flexibilities, such as compulsory licensing and parallel importation, that LMIC can utilize to improve access to medicines. The MPP's model of voluntary licensing has been hailed as a successful example of how intellectual property rights can be leveraged to promote public health goals.  

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Agency IQ

JULY 28, 2023

That law built upon several other previous laws, including the Public Health Threats and Emergencies Act of 2000, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and the Project BioShield Act of 2004. Some of the affected former NDAs were approved using drug master files (DMFs).

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FDA Science Biosimilars Regulations 40

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. EPA, 955 F.3d 3d 1088 (D.C. 2020) (LEAN).

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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. Cell (2002). Nature Genetics (2002). 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 Molecular Biology Engineering 98

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. Cell (2002). Nature Genetics (2002). & Reinberg D. Nature Methods (2013). & Shamir R.

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DNA Cell Biology Engineering Molecular Biology 52

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. . . . 2002), aff’d , 356 F.3d American Cyanamid Co. , 3d 496, 514 (6th Cir. Synthes Spine Co. ,

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Drug & Device Law

JANUARY 4, 2024

2002); Tracker Marine, L.P. 2002 WL 32830975, at *4 (Tex. May 15, 2002); Bass v. See Henry Schein, Inc. Stromboe , 102 S.W.3d 3d 675, 698 (Tex. Ogle , 108 S.W.3d 3d 349, 358 (Tex. 2003); Birdsong v. Toyota Motor Credit Corp. Hendrix , 931 F. 523, 529 (S.D. 1996) (all refusing to apply DTPA extraterritorially). 247d-6d(b)(8).

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Drug & Device Law

JULY 31, 2023

2002), held that a videogame could not be a “product” for strict liability purposes. “[I]n considering whether to recognize a new tort recovery theory, the Colorado courts give great weight to the theory’s impact on free expression.” Connecticut Connecticut’s products liability statute does not define the term “product.” See Conn.

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Drug & Device Law

FEBRUARY 2, 2023

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. March 4, 2005), rev’d on other grounds , 462 F.3d 3d 364 (5th Cir. American Home Products Corp. ,

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Drug & Device Law

NOVEMBER 9, 2023

357 (2002); United States v. The FDA, of course, has long thought otherwise, but as we have discussed in the above prior posts, it has been piling up losses on this issue over the last couple of decades. E.g. , Sorrell v. IMS Health Inc. , 552 (2011); Thompson v. Western States Medical Center , 535 U.S. Caronia , 703 F.3d 3d 149 (2d Cir.

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Drug & Device Law

FEBRUARY 19, 2024

That regulation provides that a prescription-only drug – one that can only be obtained through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’” – is “exempt” from requirements to provide adequate directions for use to patients. Ortho Pharmaceutical Corp., 2d 522, 528 (Or. Griffith v.

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Drug & Device Law

JUNE 13, 2022

That requirement comes with an exception: Provided, however , That such information may be omitted from the dispensing package if, but only if, the article is a device for which directions, hazards, warnings, and other information are commonly known to practitioners licensed by law to use the device. Bard, Inc. , 3d 1272 (11th Cir.

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LifeSciVC

OCTOBER 28, 2024

In-licensing molecules from other players, due to a partner’s strategic shifts, budget challenges, or geographic access, can be a great way to jumpstart early stage companies around more advanced assets. In its aftermath, the nuclear winter of 2002-2005 occurred in the capital markets, and it had a profoundly “anti-platform” bias.

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New Drug Approvals

APRIL 27, 2025

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] 26] Indevus had developed intellectual property around the extended release formulation which it licensed to Madaus for most of the world. [25] Miller J (23 September 2002).

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