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.

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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.

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Disease Pharmaceutical Companies Treatment Licensing 40

Perficient: Drug Development

JANUARY 25, 2024

This is a disappointing reversal for payers, as the 2010 results showed a nine-point gain compared to the 2003 figure. And 32% rated their interactions as “Poor” (the third-highest in that category, trailing only pharmaceutical companies and nursing homes). Quite frankly … not much. So there’s not much to celebrate in these results.

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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.

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Analytical Chemistry Pharmaceuticals Small Molecule Therapies 40

Drug Target Review

OCTOBER 24, 2024

In 2003, he was selected by EE Times as one of the top 13 most influential people in the semiconductor industry. He was also Vice President and Head of the Microbiome Division at Eagle Genomics Ltd, in Cambridge. Raminderpal earned his PhD in semiconductor modelling in 1997.

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Cell Based Assays Science Disease Doctors 52

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.

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Government Compliance Drugs Production 45

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.

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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)

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FDA Approval FDA Treatment Therapies 52

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.

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Metabolic Stability Pharmacokinetics Drugs Science 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

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The Premier Consulting Blog

AUGUST 21, 2024

Phase-appropriate information and data to support CMC content, such as specifications, analytical methods, analytical method validation, pharmaceutical development, and stability, should be developed as clinical development progresses. QOS – optional Module 3.2.S QOS – optional Module 3.2.S

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Clinical Development Pharmaceuticals Clinical Trials Trials 52

The Pharma Data

MARCH 17, 2021

Clyburn joined Merck in 2008 and has had responsibility for numerous global pharmaceutical franchises, including diabetes, cardiovascular and women’s health, as well as leadership of marketing and sales teams. Ireland and Sweden markets as well a variety of roles in commercial operations, business development and investor relations.

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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

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

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

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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

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.

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Regulations Compliance Science Marketing 40

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.

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Clinical Trials Treatment FDA Trials 40

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.

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Drugs Regulations FDA Pharmaceuticals 52

Common Sense for Drug Policy Blog

JUNE 4, 2023

2003 ) and strong results from RIOTT indicating improved outcomes for ‘treatment refractory’ people (i.e. intervention expense (costs of pharmaceutical product, staff and facilities for supervised consumption); 3. Despite a robust international evidence base for the social and health benefits of HAT ( Haasen et al.,

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Treatment International Trials Government 40

Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Refstad, 2003 ) but were rarely detected in our sample ( n= 3), the last time in 2012. Pharmaceuticals (5 %) and supplements (4 %) appeared consistently as adulterants, but their prevalence has generally declined over time. Psychedelic and dissociative drugs showed sizable fluctuations as adulterants over time. 2024.112467.

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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

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.

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FDA Approval FDA Drugs Compliance 59

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

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.

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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).

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Drug & Device Law

DECEMBER 11, 2023

Merrell Dow Pharmaceuticals, Inc., In other cases with similar facts, courts have found that healthcare defendants are not necessary or indispensable parties in a products liability claim against a medical device or pharmaceutical manufacturer. Knoll Pharmaceutical Co. 2003 WL 27423681, at *4 (N.D. See also Todd v.

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Drug & Device Law

NOVEMBER 16, 2023

GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). And alleged governmental misfeasance, said the court, was “a ‘collateral matter’ that is not directly relevant to [the plaintiff’s] claims that the pharmaceutical company defendants intentionally or negligently marketed a drug that caused cancer.” 2023 IL App (1st) 221666 ¶ 42.

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Government FDA Pharmaceutical Companies Regulations 64

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.

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Production Drugs Laboratories Doctors 59

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. ,

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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.

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Testimonials Science Trials International 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

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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

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

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.

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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.

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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.

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