Drug Target Review

NOVEMBER 1, 2023

Capivasertib originated from a collaboration between my former company Astex Pharmaceuticals and the ICR and was further developed by AstraZeneca. In 2001, he joined Astex Pharmaceuticals in Cambridge where he became an expert in fragment-based drug discovery working on diabetes, thrombotic and oncology drug targets.

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The Pharma Data

DECEMBER 10, 2020

Dr. Pirozzi began his career as a Medical Advisor for Servier in Italy in 2001. Pirozzi now serves as Senior Vice President, Head of Clinical Development and Translational Sciences at Alexion Pharmaceuticals, Inc., positions he assumed in 2020.

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Drug Target Review

JANUARY 31, 2024

As a female undergraduate student studying pharmaceutical sciences, one of the biggest challenges was not having enough female leaders as mentors. Since joining Allergan Aesthetics in 2001, my role in medical affairs has always focused, in one way or another, on supporting the journey of a drug/device from bench to bedside.

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Policy Prescription

MARCH 11, 2022

The focus of this post is to simply show that the accused parties did not disregard patient safety in the manner that the pharmaceutical industry sought to portray. . Kris Thorkelson never pled guilty to selling counterfeit drugs.

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FDA Law Blog: Biosimilars

OCTOBER 4, 2023

Engler , a 2001 decision by the Sixth Circuit Court of Appeals. See Order at 23 (the Medicare Negotiations cannot be considered confiscatory “because pharmaceutical manufacturers who do not wish to participate in the Program have the ability—practical or not—to opt out of Medicare entirely.”). See Order at 15, 21.

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The Pharma Data

DECEMBER 15, 2020

(hereinafter referred to as: CHIPSCREEN BIOSCIENCES) and ZHEJIANG HISUN PHARMACEUTICAL CO., hereinafter referred to as: HISUN PHARMACEUTICAL) announced that they have reached a strategic cooperation. SH) was founded in Shenzhen on 2001, specializing in the research and development of novel small molecule drugs.

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New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Development of a highly cardioselective ultra short-acting beta-blocker, ONO-1101” Chemical & Pharmaceutical Bulletin. June 1992). 40 (6): 14629.

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Drug Target Review

SEPTEMBER 26, 2023

2001 Sep;24(9):517–26. Gaps and challenges in nonclinical assessments of pharmaceuticals: An FDA/CDER perspective on considerations for development of new approach methodologies. The electrophysiological development of cardiomyocytes. Adv Drug Deliv Rev. 2016 Jan 15;96:253–73. Rudy B, McBain CJ. Trends Neurosci. 2023 Mar;139:105345.

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Conversations in Drug Development Trends

MAY 23, 2024

Regulatory Harmonization of Clinical Trials in the EU The EU-CTR repealed the Clinical Trial Directive 2001/20/EC (CTD) and national implementing legislation in the EU Member States on 31 January 2022. This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

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Alta Sciences

SEPTEMBER 13, 2023

ELECTRICAL STIMULATION MODELS Using controlled electrical currents, or impulses, scientists can investigate the effects of pharmaceutical compounds on neural muscular or physiological systems. billion people that suffer from chronic pain, globally , (51.6 million of which are located in the U.S.).

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Agency IQ

NOVEMBER 20, 2023

See also Article 11 of Directive 2001/83/EC.) The Package Leaflet (PL, also sometimes called Package Information Leaflet or PIL) is included in medicine packaging and contains information for end-users, usually patients (see also Article 59 of Directive 2001/83/EC).

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Agency IQ

AUGUST 4, 2023

pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation. Pharmaceutical Directive. s official exit from the E.U. as of January 1, 2021.

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Agency IQ

MARCH 7, 2024

An example: For GSPR 12 on devices that incorporate medicinal products, rather than citing the European pharmaceutical regulations (Directive 2001/83/EC), the U.K. Keating did observe that the GSPRs will be tailored to U.K. requirements, although this primarily means citing U.K. rather than European regulations.

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Agency IQ

NOVEMBER 3, 2023

The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. The Pharmaceutical Strategy document notes that Covid-19 just compounded medicines shortages that had already impacted patient health and the E.U. wide level.

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Agency IQ

JULY 12, 2024

The Commission’s communication was accompanied by a Q&A document defining key terms and ideas, including how the effort was related to ongoing efforts to overhaul the pharmaceuticals legislation. active pharmaceutical ingredient, fill/finish, packaging/labeling). reducing the frequency of a dose) or pharmaceutical form (e.g.,

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Agency IQ

JANUARY 26, 2024

In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S. Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.”

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The Pharma Data

JANUARY 13, 2021

14, 2021 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals, Inc. Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. CHATHAM, N.J., Holding Corp. 175:1091-1101 (1992) 2 Karpusas, M et al.,

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Agency IQ

DECEMBER 15, 2023

In 2020, the European Commission adopted the Pharmaceutical Strategy for Europe , noting that medicines shortages “have been a serious concern in the EU for several years.” The Pharmaceutical Strategy document notes that the Covid-19 pandemic compounded medicines shortages that had already impacted patient health and the E.U.

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Agency IQ

JUNE 21, 2024

It applies to products with marketing authorizations according to Regulation (EC) No 726/2004 and Directive 2001/83/EC, but does not apply to the transfer of the marketing authorization from one holder to another. In April 2023, the Commission issued proposals to revise the current pharmaceutical Directive and Regulation.

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Codon

DECEMBER 12, 2024

A drug called thalidomide, initially made by a West German pharmaceutical company called Chemie Grünenthal, was manufactured and given to patients as a mixture containing both enantiomers. In 2001, in an outbreak that had nothing to do with a lab leak, foot-and-mouth disease in the U.K.

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Agency IQ

JUNE 16, 2023

Proposed Rule Stage Restoration of Inadvertently Removed Exemption From the Requirements of FIFRA 2070-AK25 August 2023 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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Agency IQ

DECEMBER 15, 2023

April 2024 September 2023 Restoration of Inadvertently-Removed Exemption from the Requirements of FIFRA Proposed Rule Stage 2070-AK25 In 2001, EPA inadvertently removed an exemption from the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). These standards were vacated on 7/24/2001 and on 2/13/2002.

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Drug & Device Law

MARCH 4, 2024

2001), recognized that “fairness does not require that a plaintiff, whose expert witness testimony has been found inadmissible. . ., The district court was not required to give [plaintiff] a “do over” and therefore we find that the district court did not abuse its discretion. On analogous facts, Nelson v. Tennessee Gas Pipeline Co. ,

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Drug & Device Law

FEBRUARY 15, 2024

Additionally, if applied retroactively, the revisions would impose a new duty on pharmaceutical drug manufacturers and sellers at the time the injury occurred, where none had existed before. Lynch & Co. Flex Techs., 2d 180, 182 (Mich. Nothing about retroactivity. This defies logic, fairness, and – unsurprisingly – due process.

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Drug & Device Law

FEBRUARY 11, 2024

Another of our posts quoted similar concerns raised by our clients in the pharmaceutical industry as the matter was being successfully appealed to the United States Supreme Court: The Fifth Circuit’s ruling threatens to stifle pharmaceutical innovation by disrupting industry’s reasonable investment-backed expectations. Buckman Co.

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Drug & Device Law

JANUARY 8, 2024

Forest Pharmaceuticals, Inc. 2001), aff’d , 303 F.3d In our recent post describing the best prescription medical product liability litigation decisions of 2023, no fewer than three of the opinions we discussed: #4 In re Acetaminophen-ASD-ADHD Products Liability Litigation , F. 3d , 2023 WL 8711617 (S.D.N.Y. 3d 480 (Cal. Amorgianos v.

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Drug & Device Law

DECEMBER 4, 2023

2001). “[A] federal court in a diversity case should be reluctant to expand state common law.” Senju Pharmaceutical Co. , 341 (2001). 2001), aff’d , 358 F.3d Wyeth Pharmaceuticals , 471 F. Boehringer Ingelheim Pharmaceuticals, Inc. Camden County Board of Chosen Freeholders v. Beretta, U.S.A. 3d 78, 92 n.7

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Drug & Device Law

OCTOBER 23, 2023

Ortho Pharmaceutical Corp. , 341 (2001), which put an end to any doubt about this proposition. Again citing Bausch , the decision indicates that “a violation of a statute, designed to protect human life, is prima facie evidence of negligence in Illinois.” 2023 WL 6216933, at *7. That single-sentence discussion overlooked Martin v.

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Drug & Device Law

OCTOBER 20, 2023

LLC litigation, in which an anti-abortion group is seeking to invalidate regulatory actions taken by the FDA with regard to mifepristone , a pharmaceutical FDA-approved for use in the termination of pregnancy to ten weeks, in combination with misoprostol. 341 (2001), is so important. FDA/Alliance for Hippocratic Medicine v.

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Drug & Device Law

OCTOBER 10, 2023

341 (2001). Similarly, the court in Nexus Pharmaceuticals, Inc. A provision that has been enforced and reinforced in the courts for at least the last 22 years when the Supreme Court decided Buckman Co. Plaintiffs’ Legal Comm. , See Telebrands , at *8-11. In doing so, found that that precedent required dismissal here.

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Drug & Device Law

OCTOBER 6, 2023

341 (2001), (2) impossibility preemption barring “stop selling” claims under Mutual Pharmaceutical Co. Bexis concluded that three forms of preemption, (1) obstacle preemption under Buckman Co. Plaintiffs Legal Committee , 531 U.S. Bartlett , 570 U.S. 472 (2013), and (3) express OTC drug preemption under 21 U.S.C.

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Drug & Device Law

SEPTEMBER 22, 2023

in part to aid the cause of medical device and pharmaceutical manufacturers , targets in our lawsuit-obsessed country. 341 (2001), recognized that any state-law claim that depends on the existence of the FDCA is impliedly preempted by 21 U.S.C. § 604 (2011), and Mutual Pharmaceutical Co. 379r(a)(1). Mensing , 564 U.S.

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Drug & Device Law

SEPTEMBER 11, 2023

341 (2001), is so important. In our line of work, much of what we do depends on the continuing validity of how the FDA regulates prescription medical products. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. In fact, somebody actually tried. See Enriquez v. Johnson & Johnson , 2021 WL 5272370, at *3 (N.J.

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Drug & Device Law

SEPTEMBER 1, 2023

The FDA approved the defendant’s first TDF drug in 2001, and the company started its first clinical trial on a different compound—tenofovir alafenamide (“TAF”)— about a year later. So the plaintiffs pivoted. Superior Court , which plaintiffs have to find a way around.

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Drug & Device Law

AUGUST 28, 2023

341 (2001), is so important. In our line of work, much of what we do depends on the continuing validity of what the FDA does with respect to prescription medical products. That’s why Buckman Co. Plaintiffs Legal Committee , 531 U.S. In fact, somebody actually tried and drew back a nub. See Enriquez v.

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Drug & Device Law

JULY 31, 2023

2001); Isham v. Medicis Pharmaceutical Corp. , 2001), relied on these other statutes to hold that a road could not be a “product”). 2001) (applying Illinois law); Serpico v. vs. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 2917651 (Pa. Ortho-McNeil-Janssen Pharmaceuticals , 2013 WL 3480286, at *7-11 (Pa.

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Drug & Device Law

JULY 24, 2023

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , 341 (2001). Takeda Pharmaceutical Co. , 3d 1243 (9th Cir. Plaintiffs Legal Committee , 531 U.S.

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