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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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.

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The Pharma Data

DECEMBER 15, 2020

Klisyri will be manufactured by Athenex, highlighting the vertically integrated capabilities of the company ranging from a preclinical lead to a developed product for market launch. Mr. Peter Guenter, CEO of Almirall, stated, “We are delighted to partner with Athenex to market Klisyri in the U.S. Founded in 2003, Athenex, Inc.

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The Premier Consulting Blog

AUGUST 21, 2024

The major markets follow ICH guidelines, which affords harmonization of a significant portion of the chemistry, manufacturing, and controls (CMC) content. The National Medical Products Administration (NMPA) and the Pharmaceuticals and Medical Devices Agency (PMDA) both follow the CTD format for submissions to China and to Japan, respectively.

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The Pharma Data

MARCH 17, 2021

Nally, chief marketing officer, Human Health, will leave the company at the end of March, and Frank Clyburn, chief commercial officer, Human Health, will become president, Human Health and lead all Human Health commercial and marketing for the company. Nally is leaving Merck for a leadership opportunity with another company. “As

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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.

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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. For increased flexibility in bringing PIPs to market, a developer can also submit both. This action will address Louisiana Environmental Action Network v.

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Agency IQ

SEPTEMBER 29, 2023

2040-AF92 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) EPA supports market-based mechanisms to accomplish its mission to protect human health and the environment especially regarding nutrient management.

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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).

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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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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.

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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

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 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. The terrorists themselves, and their middlemen who allegedly converted goods to cash on the black market, were of course never sued. See Atchley v.

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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 In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J.

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Drug & Device Law

MARCH 4, 2024

In the middle was In re Lipitor (Atorvastatin Calcium) Marketing, Sales Practices. & March 14, 2003), recognized that replacing an excluded expert “is not the way the Federal Rules of Civil Procedure work. However, that do-over took a year and cost the defendant who knows how much money, headaches and heartburn. 49, 55 (2005).

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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.” 2003), aff’d , 810 N.Y.S.2d For physicians to prescribe such a safer drug, it must reach the market. 2d 506 (N.Y.

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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

NOVEMBER 16, 2023

The plaintiffs allege that ranitidine, which had been sold under the brand name Zantac before it was removed from the market, caused them or their decedents to develop cancer. GlaxoSmithKline , 2023 IL App (1st) 221666 (2003). The court granted the motion and JAMA appealed. The appellate court reversed in Gibbons v.

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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., Knoll Pharmaceutical Co. 2003 WL 27423681, at *4 (N.D. Knoll Pharmaceutical Co. 2003 WL 27423679, at *3 (N.D.

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