2016, Licensing and Packaging - Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

What is likely to be the cumulative effect on innovation of the different losses in exclusivity, also given the forthcoming Patent Package which could link the review’s rules on product shortages to EU-wide compulsory licensing?

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Deliberate Dysentery

Codon

JANUARY 21, 2024

We wouldn't do a challenge trial for Ebola, because the disease is extremely severe, and there are currently no licensed treatments or vaccines. With hepatitis C, what changed within the last 10 years was the development of direct-acting antivirals , or DAAs, which are packaged into pills that you can take once a day for a few months.

Vaccine

Vaccine Trials Disease Virus

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

These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. wide license: The requirements of the E.U.

Packaging

Packaging Licensing Licensing Regulations

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

Regulations

Regulations FDA Science Production

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. There is also a growing body of successful treatments in the U.S., Phage therapies are sold at a pharmacy in Georgia.

Therapies

Therapies Virus DNA Clinical Trials

Codon Digest: Seeing Colors After Gene Therapy

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Two of these proteins are about 30% the size of Cas9 , and thus much easier to package into viruses for gene therapy. No longer.

Therapies

Therapies RNA DNA Engineering

Codon Digest: Seeing Colors After Gene Therapy

Codon

JULY 27, 2023

A company, Agragene , has now started greenhouse tests with this technology (it’s licensed from Synvect, a spin-out from Omar Akbari’s lab at the University of California, San Diego). Two of these proteins are about 30% the size of Cas9 , and thus much easier to package into viruses for gene therapy. No longer.

Therapies

Therapies RNA DNA Engineering

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

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

Agency IQ

JUNE 16, 2023

This action also proposed the second supplemental standard addressing the remand of the 2016 standard-setting rulemaking. EPA’s risk evaluation for PCE, describing the conditions of use is in docket EPA-HQ-OPPT-2019-0502, with the 2022 unreasonable risk determination and additional materials in docket EPA-HQ-OPPT-2016-0732.

Regulations

Regulations Compliance Production Science

Unblock My Hormones And Start Burning Fat TODAY With HB5

The Pharma Data

MAY 13, 2021

For example, a 2016 study in the Journal of Environmental Health found that supplementing with these minerals led to higher levels of T3 and T4 in the bloodstream…iv. So go ahead and choose your discounted package of HB5 right now…. And the answer is to simply click on one of the packages you see below right now….

Production

Production Packaging Doctors Research

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

Drug & Device Law

JULY 31, 2023

2016) (citations omitted). 2016) (citation and quotation marks omitted). ADT, LLC , 2016 WL 3208483, at *3 (N.D. June 10, 2016); GCube Insurance Services., 2016 WL 6836950, at *4 (C.D. 28, 2016) ( Winter citation omitted). [C]ourts However, licensed software can be a UCC sale of “goods.”

Production

Production International Trials Government

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

While these five FDA findings (the last in response to the MDL court’s invitation for the FDA to participate directly in this litigation) were nails in these experts’ Rule 702 coffins, they would also support reversing this MDL’s prior adverse preemption decision ( 2016-10 ). The G/N MDL was created in 2013 and mostly settled in 2016.

Testimonials

Testimonials FDA Drugs Vaccine

A Texas Mess

Drug & Device Law

JANUARY 4, 2024

115, 125 (2016). For “covered persons” and “covered countermeasures” the Act provides extensive preemption: (8) Preemption of State law During the effective period of a declaration. . ., 247d-6d(b)(8). [B]ecause Puerto Rico v. Franklin-California Tax-Free Trust , 579 U.S.

Vaccine

Vaccine FDA FDA Approval Pharmacy

Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

MAY 30, 2022

The law presumes that licensed doctors know what they are doing. W]e believe that a drug manufacturer cannot be required legally to foresee that a licensed physician will disregard express warnings regarding a drug’s use. . . . See In re Accutane Litigation , 2016 WL 5958375, at *19, *27, 33, *47-48 (N.J. Fortenberry , 530 So.2d

Testimonials

Testimonials Doctors Production Laboratories

Drug Discovery Digest

European Commission vs Big Pharma, or profit vs access?

Deliberate Dysentery

Trending Sources

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

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Scaling Phage Therapy

Codon Digest: Seeing Colors After Gene Therapy

Codon Digest: Seeing Colors After Gene Therapy

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

Unblock My Hormones And Start Burning Fat TODAY With HB5

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

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

A Texas Mess

Unimpressed Learned Intermediaries Defeat Warning Causation

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