FDA Law Blog: Biosimilars

JUNE 7, 2023

to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value. First, Merck characterizes the program as a “ per se taking” without just compensation under the Fifth Amendment, because manufacturers are “force[d]. Complaint at 2.

Government 45

Government Compliance Drugs Production 45

The Pharma Data

JANUARY 26, 2021

The company was founded in 2003 based on innovative research from Uppsala University , Sweden. The project portfolio is a combination of fully funded projects run in partnership with global pharmaceutical companies and innovative in-house projects with significant market and out-licensing potential.

Disease 40

Disease Pharmaceutical Companies Licensing Licensing 40

The Pharma Data

NOVEMBER 4, 2020

Thoresen is an experienced leader with an impressive track record in a wide range of executive management roles in the pharmaceutical industry. Thoresen was the managing director of Nycomed Pharma AS acquired by Takeda Pharmaceutical Company Limited in 2011 as part of an acquisition transaction with a total value of approximately USD $14B.

Pharmaceutical Companies 40

Pharmaceutical Companies International Pharmaceuticals Production 40

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. Venugopal most recently served as executive director at Intercept Pharmaceuticals.

Analytical Chemistry 40

Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

The Pharma Data

DECEMBER 23, 2020

In addition, many survivors of the first SARS-CoV-1 epidemic in 2003 continued to report classic chronic fatigue-like symptoms after recovering from the acute illness. Studies show that patients who recover from COVID-19 can report the persistence of symptoms (See: JAMA Network ). See: PLOS ONE ). AIM CEO Thomas K.

Clinical Trials 52

Clinical Trials Trials Virus International 52

The Pharma Data

DECEMBER 15, 2020

TWO) for actinic keratosis in Taiwan and has partnered with Xiangxue Pharmaceuticals (SHE:300147) for actinic keratosis in China, Hong Kong, and Macau. Founded in 2003, Athenex, Inc. Athenex has partnered with Almirall (Almirall, S.A., In addition to the partnership with Almirall, Athenex has partnered with PharmaEssentia (6446.TWO)

FDA Approval 52

FDA Approval FDA Treatment Small Molecule 52

Drug Target Review

NOVEMBER 30, 2023

Then I was approached to co-found AC Immune in 2003. People from different backgrounds bring different experiences and points of view, and it is this diversity of knowledge and opinion that can often make the difference in pharmaceutical development. My family and friends said I was crazy to take this step.

Disease 95

Disease Laboratories Therapies Treatment 95

The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). In 2003, the original eCTD was adopted by health authorities and sponsors both in the U.S. and around the world, and eCTD v3.2.2,

Packaging 52

Packaging FDA International Pharmaceuticals 52

The Pharma Data

AUGUST 19, 2021

Gorsky’s leadership has been oncology, with the Company’s sales in this area growing from approximately $2 billion in 2011 to over $12 billion in 2020, while acquisitions have included Actelion, the largest in the Company’s history, which significantly expanded Johnson & Johnson’s Pharmaceutical segment portfolio of rare-disease treatments.

Pharmaceuticals 52

Pharmaceuticals Vaccine International Government 52

Agency IQ

JULY 5, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. The Agency is now reconsidering that action. This action will address Louisiana Environmental Action Network v.

Regulations 40

Regulations Compliance International Engineering 40

Drug Discovery World

AUGUST 15, 2023

Current Pharmaceutical Design, 12(4): 397- 406 Rassmussen et al. About the authors: Dr Mark Treherne has been involved in the pharmaceutical industry for over 30 years and led a drug discovery research group at Pfizer’s research facility in the UK, including using electrophysiological techniques for screening compounds. Tisdale et al.

Drugs 130

Drugs Clinical Pharmacology Disease Engineering 130

Drug Discovery World

FEBRUARY 20, 2024

Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018. BMJ 2003; 327: 484-487. DDW Volume 25 – Issue 1, Winter 2023/2024 References Rogers CA, Ahearn JD and Bartlett MG. Ther Innov Regul Sci. 2020; 54: 1123-1133.

Clinical Trials 130

Clinical Trials Pharma Companies Trials Compliance 130

Drug Discovery World

FEBRUARY 20, 2024

Data Integrity in the Pharmaceutical Industry: Analysis of Inspections and Warning Letters Issued by the Bioresearch Monitoring Program Between Fiscal Years 2007–2018. BMJ 2003; 327: 484-487. DDW Volume 25 – Issue 1, Winter 2023/2024 References Rogers CA, Ahearn JD and Bartlett MG. Ther Innov Regul Sci. 2020; 54: 1123-1133.

Clinical Trials 130

Clinical Trials Pharma Companies Trials Compliance 130

Metabolite Tales Blog

MARCH 1, 2023

2018, 26, 965-972 [link] 4a Pharmaceutics, 2022, 14, 1001 [link] 5 Phys. 2003, 31, 1240-1250 [link] 16 Drug Metab. 2017, 30, 1, 13–37 [link] 2a Drug Metab. 2006 , 34, 145-51 [link] 3 Drug Metab. 1980, 8, 34-38 [link] 4 J. Food Drug Anal. 2000, 2, 195-201 [link] 6 Biochem. 1966 98, 266-277 [link] 7 Metabolites.

Metabolic Stability 52

Metabolic Stability Pharmacokinetics Drugs Science 52

Drug Target Review

OCTOBER 4, 2023

10 Proteasome inhibitors Since the approval of Bortezomib in 2003, 11 new proteasome inhibitors have emerged with reduced side effects. 9 Others, like psymberin, have been used as ADC payloads, with a β-glucuronide linker to target CD-30-positive and CD-70-positive malignancies.

Small Molecule 125

Small Molecule Drugs Immune Response Targeted Protein Degradation 125

New Drug Approvals

JULY 10, 2023

Possible CGRP involvement in migraine has been the basis for the development and clinical testing of a number of compounds, including for example, advanced clinical candidates rimegepant (BHV-3000) and zavegepant (BHV-3500), which are developed by Biohaven Pharmaceutical Holding Company Ltd., New Haven, CT.

Clinical Trials 40

Clinical Trials Treatment FDA Trials 40

Agency IQ

JUNE 16, 2023

The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on May 20, 2003, and subsequently amended on July 13, 2006. The Coke Ovens: Pushing, Quenching, and Battery Stacks NESHAP, subpart CCCCC, was promulgated pursuant to section 112(d) of the CAA on April 14, 2003.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

DECEMBER 15, 2023

The Taconite Iron Ore Processing NESHAP was promulgated pursuant to section 112(d) of the CAA on October 30, 2003. The Iron and Steel Manufacturing Facilities NESHAP was promulgated pursuant to section 112(d) of the Clean Air Act on May 20, 2003, and subsequently amended on July 13, 2006. section 7412(d)(6). section 7412(d)(6).

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA. Today, the FDA and other global regulators are working to understand the interplay of IDMP with other databases and data standards.

Science 40

Science Regulations International FDA 40

Agency IQ

SEPTEMBER 29, 2023

The Volatile Organic Liquid Storage Vessels NSPS, Subpart Kb, was promulgated pursuant to section 111(1)(B) of the Clean Air Act (CAA) on April 8, 1987, with updates promulgated on August 11, 1989; October 8, 1997; October 17, 2000; December 14, 2000; October 15, 2003; and January 19, 2021.

Regulations 40

Regulations Compliance Science Marketing 40

FDA Law Blog: Biosimilars

JANUARY 9, 2024

After its enactment in 2003, successive administrations thwarted its implementation by declining to certify to Congress that importation will pose no additional risk to public health and safety and will result in a significant reduction in cost to American consumers, as the statute requires.

FDA Approval 59

FDA Approval FDA Drugs Compliance 59

Policy Prescription

MARCH 12, 2021

Existing law, as found in the Medicare Prescription Drug Modernization and Improvement Act of 2003 (MMA), only allows wholesale drug importation from Canada (if safety and savings are certified by the HHS Secretary). State of Reform does a nice job covering this bill, but this post gives some underlying and important history.

Drugs 52

Drugs Regulations FDA Pharmaceuticals 52

Agency IQ

JANUARY 4, 2024

The Taconite Iron Ore Processing NESHAP was promulgated pursuant to section 112(d) of the CAA on October 30, 2003. The AWIA, Section 2009(a), also revises the scope of a consolidation plan under the Safe Drinking Water Act (SDWA), subsection 1414(h)(1), to include a contract for significant managerial or administrative functions of a PWS.

Regulations 40

Regulations Compliance Government Science 40

Policy Prescription

MARCH 19, 2021

Becerra (D-CA) voted for the “Canadian drug importation law” in 2003. And that gets us back to former Congressman Becerra’s vote in 2003. He voted for the Pharmaceutical Market Access Act of 2003, H.R. The post Becerra’s Vote for Drug Importation in 2003 appeared first on Policy Prescription. Congratulations!

Drugs 52

Drugs Pharmaceuticals Marketing 52

Drug & Device Law

JULY 31, 2023

2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. 23, 37 (2003) (“the phrase refers to the producer of the tangible goods that are offered for sale, and not to the author of any idea, concept, or communication embodied in those goods”). Medicis Pharmaceutical Corp. ,

Production 52

Production International Trials Government 52

Drug & Device Law

FEBRUARY 14, 2022

So instead of suing anyone that is deliberately acting in cahoots with international terrorists, the other side has hijacked JASTA and used it to sue – the pharmaceutical industry. So the plaintiffs perverted JASTA to target American and other western pharmaceutical companies, rather than terrorists and their shadowy sponsors.

Government 59

Government International Pharmaceutical Companies Pharmaceuticals 59

Drug & Device Law

JUNE 1, 2023

Merrell Dow Pharmaceuticals, Inc. , 2003) (a court that “permits [an expert] to testify as an expert without first determining whether he or she has a sufficient basis” is “abdicating its evidentiary gatekeeping responsibilities”) (footnote omitted). Astrazeneca Pharmaceuticals, LP , 2010 WL 1267219, at *9 (Del. Cooper , 496 P.3d

Testimonials 59

Testimonials Trials Science Government 59

Drug & Device Law

DECEMBER 18, 2023

I’m a partner with Butler Snow LLP’s Pharmaceutical, Medical Device and Healthcare practice, and I’ve focused my practice on mass torts for almost my entire career. 2003) supported their positions. I remember talking with Jim Beck and Mark Herrmann many years ago when the blog was just getting started (pretty sure it was 2006).

Clinical Trials 59

Clinical Trials Production Trials Pharmaceuticals 59

Drug & Device Law

FEBRUARY 20, 2023

2003), aff’d , 810 N.Y.S.2d 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. Lederle Laboratories recognized that courts, generally, are “reluctan[t]. . . 2d 839, 851 (N.Y. 2d 506 (N.Y. 2006), app.

FDA 59

FDA FDA Approval Testimonials Vaccine 59

Drug & Device Law

JANUARY 30, 2023

2019), or Mutual Pharmaceutical Co. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S. 440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. Albrecht , 139 S. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v. Levine , 555 U.S. 555 (2009), and rated only a “ cf.

FDA 72

FDA Regulations Production Government 72

Drug & Device Law

APRIL 10, 2023

135, 156-57 (2003); Metro-North Commuter Railroad Co. AstraZeneca Pharmaceuticals, LP , 223 F.R.D. As best we know, the following decisions in the following states have rejected no-injury medical monitoring. Federal law : Norfolk & Western Railway Co. Ayers , 538 U.S. Buckley , 521 U.S. 424, 439-40 (1997); June v. 2007); Syms v.

Laboratories 59

Laboratories Production Disease Engineering 59

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 2003) (risk differences between two types of vaccines held insufficient to justify a warning that one was “preferred”); Thomas , 949 F.2d Janssen Pharmaceuticals, Inc. Wyeth Pharmaceuticals, Inc. Ortho-McNeil Pharmaceutical, Inc.

Testimonials 59

Testimonials Doctors Production Laboratories 59

Drug & Device Law

MARCH 4, 2024

March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work. Secretary of HHS , 66 Fed. 49, 55 (2005). In Rimbert v. Eli Lilly & Co. 2009 WL 10672150 (D.N.M. Bairnco Corp. , 2d 357, 386 (S.D.N.Y.

Testimonials 52

Testimonials Production Vaccine Pharmaceuticals 52

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. 644 (2003), but not to Pike. Walsh , 538 U.S.

Regulations 59

Regulations Production FDA FDA Approval 59

Drug & Device Law

JUNE 13, 2023

2003) (citation and quotation marks omitted); see also State v. Merrell Dow Pharmaceuticals, Inc., State ex rel. Weirton Medical Center v. Mazzone , 584 S.E.2d 2d 606, 611 (W. Lockhart , 542 S.E.2d 2d 443, 450 (W. Mangum , 466 S.E.2d 2d 171, 174 (W. 1995) (internal citations omitted): The question of admissibility under Daubert v.

Testimonials 59

Testimonials Science International Trials 59

Drug & Device Law

JANUARY 17, 2022

Thus, we’re pleased to bring to your attention Pharmaceutical Care Management Association v. PCMA involved something altogether outside our sandbox – express preemption under ERISA and/or the 2003 statute that created “Medicare Part D.” 702 in a non-prescription medical product case. Wehbi , 18 F.4th 4th 956 (8th Cir. Wehbi , 18 F.4th

Production 45

Production Regulations Pharmaceuticals 45

Drug & Device Law

NOVEMBER 14, 2023

Caraco Pharmaceutical, Inc. , June 30, 2023), certif. denied , 2023 WL 6961977 (D. 20, 2023); Alston v. 2d 279, 287 (S.D.N.Y. 2009); Sorrentino v. Barr Laboratories, Inc. , 2d 418, 422-23 (W.D.N.Y. 2005), aff’d , 218 Fed. 2007); Foister v. Purdue Pharma, L.P., 2d 693, 705 (E.D. Riccelli v. Rector , 2023 WL 6267079 (Ohio C.P.

Production 59

Production Doctors Laboratories Drugs 59