Drug Discovery World

OCTOBER 16, 2023

Next, Saleko highligts how Northumberland and the North East of the UK are recognised for pharmaceutical manufacturing prowess. It’s also where my Co-founder Ed and I met in 2001, at a company called Camitro, from which the foundational technologies of Optibrium emerged. billion in funding.

Drugs 189

Drugs Science Therapies Targeted Protein Degradation 189

Drug Target Review

JULY 6, 2023

Dr Yoshitsugu Shitaka is the Chief Scientific Officer (CScO) at Japan-based pharmaceutical company, Astellas Pharma Inc. Masahiko graduated from Nagoya University’s Faculty of Science, holds a doctorate from Tokyo University of Science and touts more than 25 years of pharmaceutical industry experience. Nature News. 2021;17(1):55–69.

Targeted Protein Degradation 98

Targeted Protein Degradation Small Molecule Clinical Trials Science 98

The Pharma Data

NOVEMBER 30, 2020

A total of 2,350,330 singleton pregnancies were identified from 2001 to 2012, including 4,058 singleton pregnancies among psoriasis patients. ” One author disclosed financial ties to the pharmaceutical industry. Yu-Heui Huang, M.D., to 1.89), 1.5 to 1.75), and 1.57 (1.36 © 2020 HealthDay. All rights reserved. Source link.

Pharmaceuticals 52

Pharmaceuticals Research 52

The Pharma Data

APRIL 10, 2021

Maria and William have diverse backgrounds spanning medical research, pharmaceuticals, business, not-for profit boards and public health. From 2001 through 2018 Mr. Jones was the President, Chief Executive Officer and a director of City Scene Management Company, a real estate management company.

Government 52

Government Science International Disease 52

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.,

Pharmaceuticals 52

Pharmaceuticals Small Molecule Vaccine Protein Expression 52

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.

Pharmaceuticals 59

Pharmaceuticals Government Regulations Drugs 59

Drug Discovery World

NOVEMBER 29, 2022

After that, the students go out into industry placements with companies like AstraZeneca, GSK, Takeda, Niche Pharmaceuticals, Richmond Pharmacology, and Lapcorp, to find out what working life is like. He worked in the Montréal Heart Institute for four months in 1998 and spent all of 2001 at the University of Nevada in Reno, USA.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

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.

Trials 52

Trials Clinical Trials Therapies Regulations 52

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.

Disease 52

Disease Research Doctors Clinical Development 52

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.

Online Pharmacies 52

Online Pharmacies Pharmacy FDA International 52

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.

Fragment Screening 96

Fragment Screening Biochemical Assays Small Molecule Biophysical Assays 96

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.

Clinical Trials 97

Clinical Trials Production Science Research 97

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.

Pharmaceuticals 40

Pharmaceuticals Small Molecule Clinical Trials Production 40

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.

Regulations 40

Regulations Production Marketing Vaccine 40

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.

Regulations 40

Regulations International Pharmaceuticals Production 40

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.).

Clinical Trials 52

Clinical Trials Treatment Trials Pharmacokinetics 52

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).

Production 40

Production Packaging Regulations Hospitals 40

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.

Regulations 40

Regulations Pharmaceuticals Vaccine Treatment 40

Drug Discovery World

NOVEMBER 9, 2023

Dimitris Skokos, PhD, Senior Director, Cancer Immunology, Regeneron Pharmaceuticals, on: ‘Tumour-targeted costimulation via CD28 bispecific antibodies: Turning immunotherapy “cold” tumours “hot”’.

Engineering 130

Engineering Protein Production Therapies Science 130

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.

Packaging 40

Packaging Licensing Licensing Regulations 40

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.

Drugs 110

Drugs FDA Disease Animal Testing 110

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.”

Science 40

Science FDA Packaging Production 40

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.

Regulations 40

Regulations International Government Production 40

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.

Regulations 40

Regulations Compliance Production Government 40

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).

Regulations 40

Regulations Compliance Production Science 40

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.

Production 52

Production International Trials Government 52

Drug & Device Law

DECEMBER 27, 2022

Novartis Pharmaceuticals Corp. , at *167 (quoting Glastetter v. 3d 986, 991 (8th Cir. A Not-at-All Bitter End – How Sweet It Is. Having excluded all of the Zantac plaintiffs’ experts as inadmissible under Rule 702, summary judgment for the defendants followed as a matter of course.

Laboratories 59

Laboratories FDA Production International 59

Drug & Device Law

FEBRUARY 20, 2023

151, 163-68 (2001)) (lengthy discussion of FDA regulatory process omitted). The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 9, 2023

Bayer Healthcare Pharmaceuticals Inc. 341, 352 (2001) (“neither an express pre-emption provision nor a saving clause bars the ordinary working of conflict pre-emption principles”). ASH-ADHD is illustrative of the big difference that the “product liability” exception to express preemption for OTC drugs makes. 2022 WL 16951538 (S.D.N.Y.

Regulations 59

Regulations Nurses FDA FDA Approval 59

Drug & Device Law

JUNE 1, 2023

2001)); Turbyfill v. Merrell Dow Pharmaceuticals, Inc. , Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. 2001), pointing out that Idaho’s Rule 702 does not have the same language (it still does not). Union Pacific Railroad Co. , 3d 77, 83 (Ark. State , 53 S.W.3d 3d 56, 61 (Ark. State , 211 S.W.3d

Testimonials 59

Testimonials Trials Science Government 59

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.

Testimonials 52

Testimonials Pharmacy FDA Doctors 52

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.

Government 59

Government Regulations FDA Nurses 59

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. ,

Testimonials 52

Testimonials Production Vaccine Pharmaceuticals 52

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.

Production 64

Production Marketing Pharma Companies FDA Approval 64

Drug & Device Law

JANUARY 30, 2023

341 (2001), with the rejection of the so-called “purposes and objectives” prong of implied preemption by the most conservative justices (at least in terms of federalism) on the Court. 2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S. Plaintiffs Legal Committee , 531 U.S.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

MARCH 6, 2023

2001), and Simmons v. Defendants have provided a large amount of pharmaceutical litigation case law where joinder was found not to be appropriate, and the Plaintiffs have elected not to reply or distinguish that case law.” July 5, 2002) (Bexis, again), In re Rezulin Products Liability Litigation , 168 F. 2d 136 (S.D.N.Y.

Production 75

Production Laboratories Hospitals Pharmaceuticals 75

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 2001) (no warning causation notwithstanding heeding presumption where prescriber testified that “the risk of him having a problem due to his [condition] was much greater than him taking the [drug]”) (applying Oklahoma law); Porterfield v. 3d 203 (5th Cir.

Testimonials 59

Testimonials Doctors Production Laboratories 59