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. Her healthcare experience spans diagnostics, medical devices, pharmaceuticals, and digital health. Before that, Ms. Before joining Acorda, Ms.

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Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Under DSHEA, manufacturers are responsible for ensuring their products are safe prior to release to the market. An NDI is defined as a dietary ingredient not marketed before October 15, 1994.

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Agency IQ

NOVEMBER 10, 2023

Services incurring fees include marketing authorization applications, variations, scientific advice, and inspections. Fees supplemental to the basic fees can be collected for authorization of additional strengths and pharmaceutical forms. literature monitoring), since national regulators charge their own fees.

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Agency IQ

NOVEMBER 27, 2023

The requirement related to the presentation of side effects and contraindications was amended in 2007, with the passage of the Food and Drug Administration Amendments Act (FDAAA). In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations.

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Agency IQ

JULY 22, 2024

EPA’s regulatory agenda for Spring 2024 Agenda Stage of Rulemaking Title Estimated Publication Former Estimated Date First on Agenda Proposed Rule Stage Removal of Affirmative Defense Provisions from Specified CAA Section 111 and 112 Regulations July 2024 Spring 2024 Final Rule Stage Standards of Performance for New, Reconstructed, and Modified Sources (..)

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Drug Patent Watch

JANUARY 26, 2025

The Battle for Sleep: A Patent Dispute that Could Shake the CNS Market As we navigate the complexities of the pharmaceutical industry, it's not uncommon to come across disputes over patents and intellectual property. But the recent case of Avadel CNS Pharmaceuticals LLC v. Jazz Pharmaceuticals Inc.

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Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Adulteration of MDMA in the Unregulated Market "Most of the concern with MDMA adulteration focuses on the plethora of other substances that have been detected in the MDMA supply. Piperazines first appeared in 2000 but saturated the market from 2008–2013, when these compounds were detected in about one-quarter (24 %) of drug items.

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Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. The Primary Copper Smelting area source NESHAP, subpart EEEEEE, was promulgated pursuant to section 112(d) of the CAA on January 23, 2007. This rule is the second of two rulemakings (Phase II) that EPA is undertaking to update its FOIA regulations.

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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. 21] [22] The approval earned Indevus a milestone payment of $120M from Pliva, which had already paid Indevus $30 million at signing; the market for overactive bladder therapies was estimated to be worth $1.1

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The Pharma Data

MAY 7, 2021

World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. It cannot be justified to keep confidential efficacy and safety data of a medicine available on the market, or which has been refused access to the market.”. .

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Perficient: Drug Development

DECEMBER 19, 2024

Ground Floor of TMC-3 at the Helix Center (Houston, Texas) Ground Floor of TMC-3 at the Helix Center (Houston, Texas) Pumps & Pipes: A Convergence of Expertise Founded in 2007, Pumps & Pipes exemplifies Houstons unique position as a global hub for medicine, energy, and aerospace. 3 billion in annual research expenditures.

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Agency IQ

DECEMBER 15, 2023

The EPA received a petition for reconsideration of the 2006 rulemaking and, in 2007, EPA announced its reconsideration of several aspects of the rule. These subparts were originally promulgated pursuant to section 111(b) of the CAA on June 29,1990 (subparts III and NNN), August 31, 1993 (subpart RRR), and November 16, 2007 (subpart VVa).

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The Pharma Data

NOVEMBER 25, 2020

A study of 600 brand-name drugs, conducted at the University of Pittsburgh Center for Pharmaceutical Policy and Prescribing (CP3) earlier this year, found that list prices increased 159% between 2007 and 2018. But, prices have increased dramatically.

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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. Pharmaceutical developers often avoid fluorine because the element can alter pharmacokinetics, making it hard to predict how a drug will be absorbed, metabolized, and excreted.

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Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & However, that do-over took a year and cost the defendant who knows how much money, headaches and heartburn. A plaintiff seeking to replace an excluded expert likewise drew back a nub in Winters v. Fru-Con Inc. , 3d 734 (7th Cir. Secretary of HHS , 66 Fed.

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Drug & Device Law

FEBRUARY 22, 2024

This “keep selling” theory found some traction in two 2007 decisions, Abigail Alliance for Better Access to Developmental Drugs v. 2007) (en banc), and CareToLive v. Ohio 2007), but has generally failed to expand that foothold since. von Eschenbach , 495 F.3d 3d 695 (D.C. von Eschenbach , 525 F. 2d 952 (S.D.

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Drug & Device Law

JANUARY 8, 2024

Forest Pharmaceuticals, Inc. 2007 WL 1164832, at *7 (S.D. April 19, 2007). E.g., In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices & Products Liability Litigation , 174 F. 3d , 2023 WL 8711617 (S.D.N.Y. 18, 2023), #5 Onglyza Products Cases , 307 Cal. 3d 480 (Cal. 2023), and #16 Daniels-Feasel v.

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Drug & Device Law

DECEMBER 21, 2023

We’ve been diligently preparing bottom ten annual lists since 2007, even though it’s distasteful, because if we don’t do it nobody else is likely to, and these abominable decisions deserve to be called out for what they are. Takeda Pharmaceutical Co. , Luitpold Pharmaceuticals, Inc. Geri-Care Pharmaceuticals Corp. ,

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Drug & Device Law

DECEMBER 11, 2023

May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation , 2011 WL 2746086 (S.D. Merrell Dow Pharmaceuticals, Inc., Implantable Defibrillators Products Liability Litigation , 2007 WL 2572048, at *2 (D. 30, 2007) (“joinder of the malpractice claim. . .

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Drug & Device Law

NOVEMBER 10, 2023

That’s not limited to just pharmaceuticals, that’s every kind of product that’s made. These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. Valsartan , 2023 WL 1818922, at *24.

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Drug & Device Law

OCTOBER 23, 2023

312 (2008), that essentially all product liability claims against manufacturers of FDA pre-market approved (“PMA”) medical devices were preempted. That’s a toxic mix, indeed, when combined with the plaintiffs’ bar’s latest concerted attempt to drive a form of birth control off the market through product liability litigation.

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Drug & Device Law

JULY 31, 2023

no[r] a marketing product” under Lanham Act). 2007 WL 2460776, at *6 (D. Medicis Pharmaceutical Corp. , 2007 WL 218242, at *4 (N.D. 26, 2007) (bespoke software not a UCC good). Leading Market Technologies, Inc. , Gray Loon Outdoor Marketing. Paragon 28, Inc. 2019 WL 4751807, at *8 (D. 2001); Isham v.

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Drug & Device Law

MAY 26, 2023

The word “generic” in that sentence was not limiting, as the logic applied more broadly: “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.” Id. Walsh , 538 U.S.

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Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth Laboratories, Inc. , 2d 839, 851 (N.Y.

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Drug & Device Law

FEBRUARY 2, 2023

1974) (applying Texas law), the Fifth Circuit had held: [T]o conclude that the maker of an unavoidably unsafe product did not act unreasonably in placing it on the market is not to relieve him of the responsibility to market it in such a way as to prevent unreasonable danger. Novartis Pharmaceuticals Corp. , 2d 1264 (5th Cir.

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Drug & Device Law

AUGUST 8, 2022

They contribute to the specific industry by way of sponsoring educational activities, and assisting in marketing, maintaining governmental relations, researching, establishing public relations, standardization and specification within the industry, gathering statistical data and responding to consumer needs and interests. 471 (11th Cir.

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Drug & Device Law

JUNE 6, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. Teva Pharmaceuticals USA, Inc. , Novartis Pharmaceuticals Corp. , Salinero also followed the recent Hubbard v. 3d 1223, 1233 (11th Cir. as opposed to temporary hair loss ?

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Drug & Device Law

JUNE 2, 2022

If the draft Dobbs decision becomes the final decision, then preemption may take on an increasingly prominent role in combatting state laws designed to limit reproductive rights by, at least in part, limiting the use of medical products on the market pursuant to FDA decisions. 124 (2007), which would also be knocked out by Dobbs if it sticks.

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Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J. Janssen Pharmaceuticals, Inc. Wyeth Pharmaceuticals, Inc. Ortho-McNeil Pharmaceutical, Inc. 692, 694 (5th Cir.

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