2003, Marketing, Pharmaceuticals and Regulations

RE-TRANSMISSION: XPhyto Appoints European Healthcare Executive to Board of Directors

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

Pharmaceutical Companies International Pharmaceuticals Production

CMC Content for Global Clinical Development of Pharmaceuticals

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.

Clinical Development

Clinical Development Pharmaceuticals Clinical Trials Trials

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

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.

FDA Approval

FDA Approval FDA Treatment Small Molecule

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations

Regulations Compliance Production Government

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

Regulations

Regulations Compliance Production Science

Analysis Chemical Thank You What we expect the EPA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

What we expect the EPA to do in October 2023 In this returning feature, AgencyIQ looks at public data to determine what the Environmental Protection Agency (EPA) is planning to do in the month ahead, including deadlines, meetings, events, planned regulations, comment periods, and more.

Regulations

Regulations Compliance Science Marketing

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science

Science Regulations International FDA

Return of the MEDS Act? Colorado Seeks Drug Imports Beyond Canada

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

Drugs Regulations FDA Pharmaceuticals

How the Fifty States View Electronic Data as a “Product”

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

Production International Trials Government

The FDA and Feasible Alternative Designs

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.

FDA

FDA FDA Approval Testimonials Vaccine

Logical Contradiction Doctrine: Buckman for Textualists

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

FDA Regulations Production Government

Reporter’s Privilege Protects JAMA Peer-Review Documents from Discovery

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.

Government

Government FDA Pharmaceutical Companies Regulations

NPP, DCC, And FDA-Regulated Medical Products

Drug & Device Law

MAY 26, 2023

We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram.

Regulations

Regulations Production FDA FDA Approval

Drug Discovery Digest

RE-TRANSMISSION: XPhyto Appoints European Healthcare Executive to Board of Directors

CMC Content for Global Clinical Development of Pharmaceuticals

Trending Sources

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp

Analysis Chemical Thank You The 174 regulations the EPA is currently working on

Analysis Chemical Thank You Highlights of the EPA’s Unified Agenda for Spring 2023

Analysis Chemical Thank You What we expect the EPA to do in October 2023

Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Return of the MEDS Act? Colorado Seeks Drug Imports Beyond Canada

How the Fifty States View Electronic Data as a “Product”

The FDA and Feasible Alternative Designs

Logical Contradiction Doctrine: Buckman for Textualists

Reporter’s Privilege Protects JAMA Peer-Review Documents from Discovery

NPP, DCC, And FDA-Regulated Medical Products

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