2011, Packaging and Pharmaceuticals - Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Agency IQ

APRIL 12, 2024

Draft guidance on potency assays for CGT products garners extensive stakeholder input Late last year, the FDA published a draft update to its 2011 guidance on potency assays for cell and gene therapy products, unveiling a major shift in approach to the issue. As a result, the 2011 guidance was generally seen as basic and outdated.

Production

Production FDA Therapies Biochemical Assays

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. Data from pharmaceutical legislation is not included by default, though some specifically named pharma data relating to chemicals will be encompassed.

Packaging

Packaging Regulations Laboratories Animal Testing

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Data on these novel approvals is published throughout the year by both CDER and CBER.

FDA

FDA Biosimilars Science Production

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

Amgen Reports Second Quarter 2021 Financial Results

The Pharma Data

AUGUST 3, 2021

SOLIRIS is a registered trademark of Alexion Pharmaceuticals, Inc. In anticipation of future demand for our medicines, we will invest approximately $1 billion to build two new manufacturing facilities – a packaging plant in Ohio and a drug substance plant in North Carolina. XmAb is a registered trademark of Xencor, Inc. Tax Petition.

Biosimilars

Biosimilars Production Treatment FDA

Discovering an Antimalarial Drug in Mao’s China

Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. Miller and Su published an article on Tu’s story in Cell in 2011. Extensive research into previously confidential documents led Miller and his colleague Xinzhuan Su to Tu Youyou.

Drugs

Drugs Science Research Doctors

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

Agency IQ

JULY 22, 2024

CDER is the FDA office in charge of reviewing pharmaceuticals and therapeutic biologics. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). Data on these novel approvals is published throughout the year by both CDER and CBER.

Clinical Trials

Clinical Trials Trials Science FDA

The Book of Nimbus

LifeSciVC

APRIL 27, 2023

Our small team was able to support multiple major pharmaceutical companies plowing through diligence, not just withstanding the onslaught but in fact delivering a data package of Phase 3-ready quality. For further reading about Nimbus’ first chapter, many an excellent blog has been written about those formative days.

Small Molecule

Small Molecule Computational Chemistry Engineering Clinical Development

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

Agency IQ

DECEMBER 15, 2023

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. Similarly, the Group I and II Polymers and Resins NESHAP were most recently updated when the agency conducted its RTR on December 16, 2008, and April 21, 2011.

Regulations

Regulations Compliance Production Government

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

Agency IQ

JUNE 16, 2023

Manufacturers (including importers) who have manufactured these chemical substances in any year since January 1, 2011, would be subject to the reporting and recordkeeping requirements. This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration.

Regulations

Regulations Compliance Production Science

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

I pulled them from a 2011 blog post ( oH mY goD tHat’S nOt pEEr-ReVieWeD!!! ) For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A typical enzyme collides with its substrate 500,000 times per second. A molecule of glucose travels at 250 miles per hour. Let’s be real.

DNA

DNA Therapies Engineering Clinical Trials

Codon Digest: Hackathon Prize Winners

Codon

JUNE 26, 2023

I pulled them from a 2011 blog post ( oH mY goD tHat’S nOt pEEr-ReVieWeD!!! ) For context, the AAV9 that is often used in gene therapies has a packaging limit of 4,700 DNA bases.) A typical enzyme collides with its substrate 500,000 times per second. A molecule of glucose travels at 250 miles per hour. Let’s be real.

DNA

DNA Therapies Engineering Clinical Trials

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

Drug & Device Law

JULY 31, 2023

Medicis Pharmaceutical Corp. , 2011 WL 13186258, at *2 (C.D. May 17, 2011) (flight simulator and associated training materials were not products subject to strict liability); Heindl v. Wells Fargo Bank , 2011 WL 1833020 (D. Iowa 2011). Paddock Pool Construction Co. , 2d 968, 972 (Ariz. 3d 944, 949 (Ariz.

Production

Production International Trials Government

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

Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). Thus, CEH turned on implied impossibility preemption, specifically an application of Mensing ( 2011+1 ) independence principle. Forest Pharmaceuticals, Inc. Pacira Pharmaceuticals, Inc.

Testimonials

Testimonials FDA Drugs Vaccine

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. Johnson & Johnson , 2011 WL 3876997 at *11 (S.D. 31, 2011), aff’d , 483 Fed. Janssen Pharmaceuticals, Inc.

Testimonials

Testimonials Doctors Production Laboratories

Confident Learned Intermediaries Defeat Warning Causation

Drug & Device Law

JUNE 6, 2022

Bayer HealthCare Pharmaceuticals, Inc. , Wyeth Pharmaceuticals , 526 F.3d Janssen Pharmaceuticals , 2018 WL 1977258, at *12 (Mag. Teva Pharmaceuticals USA, Inc. , 2011) (no causation where “at the time of her deposition ? May 23, 2011) (no causation where prescriber “testified. . . 3d 1223, 1233 (11th Cir.

Testimonials

Testimonials Production Pharmaceuticals Treatment

Preemption as a Backup for the Learned Intermediary Rule

Drug & Device Law

FEBRUARY 19, 2024

Ortho Pharmaceutical Corp., All three of those states have federal district court precedent, and Rhode Island has unpublished federal appellate authority in addition. Then there’s Oregon. That state was an early adopter of the learned intermediary rule, see McEwen v. 2d 522, 528 (Or. 201.100(a-b). Such special controls are preemptive.

Licensing

Licensing Licensing Regulations FDA

Drug Discovery Digest

Article FDA Thank You Draft guidance on potency assays for CGT products garners extensive stakeholder input

Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Trending Sources

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

Amgen Reports Second Quarter 2021 Financial Results

Discovering an Antimalarial Drug in Mao’s China

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

The Book of Nimbus

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

Codon Digest: Hackathon Prize Winners

Codon Digest: Hackathon Prize Winners

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

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

Unimpressed Learned Intermediaries Defeat Warning Causation

Confident Learned Intermediaries Defeat Warning Causation

Preemption as a Backup for the Learned Intermediary Rule

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