2004, Packaging and Pharmaceuticals - Drug Discovery Digest

2004

Packaging

Pharmaceuticals

Takeda Manufacturing Facilities in Japan and Ireland Recognized With Category Awards for 2021 Facilities of the Year I Takeda

The Pharma Data

APRIL 28, 2021

OSAKA, Japan, April 28, 2021 – Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it was awarded by the International Society for Pharmaceutical Engineering (ISPE) for the 2021 Facility Of the Year Awards (FOYA) in two categories.

Packaging

Packaging Small Molecule Pharmaceutical Companies Engineering

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Agency IQ

APRIL 12, 2024

The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation This week, the European Parliament voted to adopt the compromise texts of both the revised pharmaceutical directive and regulation presented by Parliament’s health committee in March 2024. Directive 2001/83/EC and Regulation (EC) No 726/2004.

Pharmaceuticals

Pharmaceuticals Regulations Packaging Marketing

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Bridging Innovation & Patient Care: The Growing Role of AI

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AI in Drug Discovery - A Highly Opinionated Literature Review (Part II)

Practical Cheminformatics

JANUARY 8, 2024

While large pharmaceutical companies have data on thousands or even millions of compounds, this data is rarely shared due to intellectual property concerns. A 2004 paper by Vigers and Rizzi proposed a similar strategy for docking studies. The paper also provides links to several software packages for building MIL models.

Drugs

Drugs Small Molecule Bioinformatics Packaging

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Bridging Innovation & Patient Care: The Growing Role of AI

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Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

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

Packaging Licensing Licensing Regulations

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

By 2004, over a dozen companies were working on developing phage products and therapies, in locations ranging from Baltimore to Bangalore, where ten years previously, there had been none. And despite numerous high-profile, individual success stories in U.S. 4 But the same barriers still exist today.

Therapies

Therapies Virus DNA Clinical Trials

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

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

Regulations Marketing Production Vaccine

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

FDA

FDA Science Biosimilars Regulations

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

Agency IQ

DECEMBER 15, 2023

The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. 2004) and related cases. EPA, 358 F.3d 3d 936 (D.C.

Regulations

Regulations Compliance Production Government

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

Agency IQ

JUNE 16, 2023

The Lime Manufacturing NESHAP, codified in 40 CFR part 63, subpart AAAAA, was promulgated pursuant to section 112(d) of the Clean Air Act (CAA) on January 5, 2004. The MPP ELGs were last revised in 2004 and currently apply to only a subset of facilities nationwide. 2020) (LEAN).

Regulations

Regulations Compliance Production Science

Analysis Chemical Thank You What we expect the EPA to do in January 2024

Agency IQ

JANUARY 4, 2024

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. 2004) and related cases. The Lime Manufacturing NESHAP was promulgated pursuant to section 112(d) of the CAA on January 5, 2004. EPA, 358 F.3d 3d 936 (D.C.

Regulations

Regulations Government Compliance Science

Making a “Miracle” HIV Medicine

Codon

FEBRUARY 23, 2025

million by 2004. In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. Pharmaceutical companies generally charge high rates for patented drugs to recoup their huge investments into research, development, trials, and marketing.

Clinical Trials

Clinical Trials Virus Vaccine DNA

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

Drug & Device Law

JULY 31, 2023

2004) (“Movable or transferable property; personal property; esp[ecially], a physical object capable of manual delivery”). 2004) (statute only applies to “tangible products of trade”); Code Rebel, LLC v. Medicis Pharmaceutical Corp. , 2004 WL 7334819, at *18 (Mag. 2004), transfer denied (Mo. Graphic Process Co. ,

Production

Production Trials International Government

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 2004) (no causation where prescriber “continues to prescribe [similar] medication. . . Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. Teva Pharmaceuticals USA, Inc. , Novartis Pharmaceuticals Corp. , 3d 1223, 1233 (11th Cir.

Testimonials

Testimonials Production Pharmaceuticals Drugs

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d 1988) (no causation where prescriber “read the warning on the package insert and decided not to warn the [plaintiffs]”); Dunn v. 2004) (another case we discussed in 2008 ), because the plaintiff failed to “produce[] evidence that the risk. . .

Testimonials

Testimonials Doctors Production Laboratories

Takeda Manufacturing Facilities in Japan and Ireland Recognized With Category Awards for 2021 Facilities of the Year I Takeda

Article EMA Thank You The vote is in: The European Parliament has adopted the compromise pharmaceutical legislation

Webinars

Trending Sources

AI in Drug Discovery - A Highly Opinionated Literature Review (Part II)

Webinars

Article EMA Thank You New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., Great Britain, and the E.U.

Scaling Phage Therapy

Article EMA Thank You Commission proposes guidelines to flesh out the newly finalized Variations Regulation

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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 January 2024

Making a “Miracle” HIV Medicine

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

Confident Learned Intermediaries Defeat Warning Causation

Unimpressed Learned Intermediaries Defeat Warning Causation

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