FDA Law Blog: Biosimilars

APRIL 7, 2025

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).

Science 59

Science Government FDA Pharmaceuticals 59

Drug Target Review

JULY 3, 2025

New approach methodologies data In April, the US Food and Drug Administration (FDA) announced a plan to replace animal testing in the development of monoclonal antibodies and other therapies with validated “human-relevant” methods, including AI-based computational models evaluating toxicity, cellular lines and organoid toxicity.

Drug Development 64

Drug Development Drugs Animal Testing Engineering 64

FDA Law Blog: Biosimilars

MARCH 18, 2025

Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. FDA has already been there , of course, with respect to 180-day exclusivity.)

Pharmaceutical Companies 59

Pharmaceutical Companies FDA Production Regulations 59

FDA Law Blog: Biosimilars

NOVEMBER 7, 2023

” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. As FTC explains in a Press Release , the Agency “challenged more than 100 patents” that it believes are improperly or inaccurately listed in the Orange Book.

FDA 59

FDA Drugs Production 59

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. However, as your high-school literature teacher warned youto ace the test, you need to read the book, ahem, source regulations, guidance, or other policy documents.

Therapies 59

Therapies FDA Production Disease 59

Drug Patent Watch

JULY 24, 2020

The FDA Orange Book, or Approved Drug Products with Therapeutic Equivalence Evaluations, is the definitive source to link drugs with the patents that protect them. The post Free Orange Book PDF Library from DrugPatentWatch appeared first on DrugPatentWatch - Make Better Decisions. Over the years we’ve had….

FDA 40

FDA Production Drugs 40

FDA Law Blog: Biosimilars

SEPTEMBER 25, 2024

Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “ Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness? ” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released (..)

Drugs 59

Drugs Pharmaceuticals 59

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

FDA 59

FDA Biosimilars Production Regulations 59

FDA Law Blog: Biosimilars

SEPTEMBER 23, 2024

Hatch Foundation’s For cheap generic drug prices, you can thank 40 years of Hatch-Waxman We Work For Health’s Hatch-Waxman Act: Celebrating 40 Years of a Balanced and Innovative Drug Ecosystem Tradeoffs’ Race to the Bottom Series FDA CDER Conversations – 40th Anniversary of the Generic Drug Approval Pathway The U.S. Waxman (sadly, Sen.

FDA 59

FDA Drugs International Pharmaceuticals 59

Drug Channels

MARCH 14, 2022

This year, Dr. Scott Gottlieb, former FDA commissioner and author of Controlled Spread , will deliver the keynote address. Click here to read my review of Dr. Gottlieb’s excellent book. Click here to view the agenda. Fein of Drug Channels Institute.

Specialty Pharmacies 74

Specialty Pharmacies Pharmacy FDA Science 74

Agency IQ

JULY 26, 2024

FDA finalizes guidance on electronic submissions for OTC products FDA has fulfilled its commitment under the Over-the-Counter Monograph Drug User Fee (OMUFA) program to issue final guidance on how sponsors can electronically submit monographs and other documents. Read AgencyIQ’s explainer on the CARES Act here.

FDA 40

FDA Production Regulations Packaging 40

FDA Law Blog: Biosimilars

JULY 24, 2024

Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act. FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ).

Small Molecule 52

Small Molecule Clinical Trials FDA Pharmaceuticals 52

FDA Law Blog: Biosimilars

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. Rather, the FTC questioned whether these patents meet the statutory and regulatory criteria for listing in the Orange Book.

Drugs 45

Drugs FDA Regulations FDA Approval 45

PLOS: DNA Science

JUNE 1, 2023

The newest FDA-approved gene therapy treats the severe, skin-peeling condition dystrophic epidermolysis bullosa (DEB). My now decade-old book The Forever Fix: Gene Therapy and the Boy who Saved It , told the stories of children who had received one-time deliveries of working copies of genes, to compensate for their mutations.

FDA Approval 52

FDA Approval Therapies FDA Disease 52

FDA Law Blog: Biosimilars

JUNE 12, 2024

The ideal candidate will have a book of business. Our firm culture is collaborative, and the subject matter is intellectually stimulating. Strong verbal and writing skills are required. Strong verbal and writing skills are required. Compensation is competitive and commensurate with experience. HP&M is an equal opportunity employer.

Government 59

Government FDA Pharmaceuticals Drugs 59

LifeSciVC

OCTOBER 5, 2023

In the days before Airbnb and on-line travel websites, he had all the books and had thoroughly researched each destination, every transport option, all the food venues. We’ve established a GMP manufacturing facility, weathered an FDA inspection unscathed, and introduced and revised processes along the way.

Clinical Trials 130

Clinical Trials Drug Development International FDA 130

Agency IQ

SEPTEMBER 15, 2023

For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Without sufficient resources, the FDA is unable to do so.

FDA 40

FDA Government Drugs Production 40

Agency IQ

MARCH 1, 2024

Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. The appropriations bills that expire March 1 include the Agriculture-FDA appropriations bill.

Government 40

Government FDA Biosimilars Regulations 40

Agency IQ

MAY 10, 2024

FDA holds the line on remanufacturing definitions in newly finalized guidance Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications.

FDA 40

FDA Regulations Compliance Production 40

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We will see if FDA is willing to accept those changes later this month.

FDA 40

FDA Science Regulations Production 40

LifeSciVC

JULY 8, 2025

Introduction At this year’s Guggenheim biotech investor conference in Boston, the keynote wasn’t about drug pipelines, IPO windows, or FDA guidance. As the landscape becomes more layered, infrastructural, and globally entangled, the kinds of organizations we build and the leadership they require may need to evolve in response.

Hospitals 56

Hospitals Small Molecule Science Nurses 56

Alta Sciences

AUGUST 24, 2023

The open forum dialogue includes scientific support and participation by the FDA and will cover the evolving methodological considerations for the preclinical and clinical evaluation of abuse potential and dependence of CNS-active drugs. Want to meet with Dr. Setnik?

FDA 40

FDA Drugs 40

LifeSciVC

AUGUST 21, 2024

Regulatory Submissions, Meetings and Feedback How is the Briefing Book coming? Will you be able to take a breath when you have pressed the button to submit the Pre-IND or IND meeting request to FDA or a CTA to another regulatory agency? There is no ‘cruise control’ when the clock starts ticking upon submission.

Clinical Trials 81

Clinical Trials Trials Disease Treatment 81

KIF1A

APRIL 25, 2024

However, we needed to wait for Susannah to finish her trial before we could submit to the FDA for Sloane’s ASO use. February 2024 – n-Lorem submitted an IND (investigational new drug) to the FDA for Sloane. March 2024 – The FDA approved the IND, and the administering doctor (Dr.

Therapies 52

Therapies FDA Approval FDA Treatment 52

Drug Target Review

MAY 15, 2024

3 The value required is more than just a greater number of FDA approvals, it is also about completing milestones with limited capital – ie, biotech survival. The latter group (ie, most of us) are waiting for wet lab validation, market demonstration (FDA approvals), and a few other things (which we often cannot define).

FDA Approval 59

FDA Approval FDA Science Marketing 59

Alta Sciences

DECEMBER 14, 2023

Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. BOOK A VISIT You may also be interested in the following webpages:​​​ Clinical Research Services Pharmaceutical CDMO and Contract Manufacturing Services DID YOU KNOW? Fully equipped to support all types of IP administration forms.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

The Pharma Data

DECEMBER 2, 2020

LLC are acting as joint lead book-running managers for the offering. The Tablo Hemodialysis System, FDA cleared for use from the hospital to the home, represents a significant technological advancement that transforms the dialysis experience for patients and operationally simplifies it for providers. About Outset Medical, Inc.

Hospitals 52

Hospitals FDA Production 52

The Pharma Data

AUGUST 7, 2020

For more pivotal trends from regulatory bodies, download MasterControl’s white paper to find out how the FDA is modernizing its plans to change the regulatory landscape to improve public health. Download the e-book here. Source link.

Clinical Trials 52

Clinical Trials Trials Packaging Therapies 52

The ChEMBL-og

JUNE 13, 2023

ChEMBL database version ChEMBL 33 release notes _ # This version of the database, prepared on 31/05/2023 contains: 2,399,743 compounds (of which 2,372,674 have mol files) 3,051,613 compound records (non-unique compounds) 20,334,684 activities 1,610,596 assays 15,398 targets 88,630 documents BioAssay Data Sources: Number Assays: Number Compound Records: (..)

FDA Approval 97

FDA Approval Pharmacokinetics International Production 97

Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. Hence, they are similar, but not identical to, the reference product.

Biosimilars 40

Biosimilars Science FDA Licensing 40

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The Pharma Data

JANUARY 7, 2021

Jefferies is acting as the sole book-running manager for the offering and Oppenheimer & Co. CERC-006, 801, 802 and 803 have all received Orphan Drug Designation and Rare Pediatric Disease Designation, which makes all four eligible for a priority review voucher upon FDA approval. is acting as lead manager for the offering.

Clinical Development 52

Clinical Development Disease Treatment FDA Approval 52

The Pharma Data

JANUARY 13, 2021

is acting as sole book-running manager for the offering. Prior to FDA approval to commercially market GIMOTI, metoclopramide was only available in oral and injectable formulations and remains the only drug currently approved in the United States to treat gastroparesis. Laidlaw & Company (UK) Ltd.

Pharmaceutical Companies 40

Pharmaceutical Companies FDA Approval Clinical Trials Pharmaceuticals 40

Vial

FEBRUARY 19, 2024

I don’t know if you’ve read that book, but it’s a very important book, where you always do your best. Ahmed Hamdy: The FDA, and all the regulatory bodies around the world, have been doing a great job in partnering with pharma and designing ways to be able to have better treatments for patients.

Small Molecule 52

Small Molecule Therapies Treatment Science 52

The Pharma Data

DECEMBER 15, 2020

are acting as joint book-running managers for the offering. Ocular Therapeutix’s first commercial drug product, DEXTENZA®, is FDA-approved for the treatment of ocular inflammation and pain following ophthalmic surgery. Jefferies LLC and Piper Sandler & Co. Raymond James & Associates, Inc. Ocular Therapeutix, Inc.

FDA Approval 40

FDA Approval Disease Therapies Clinical Development 40

The Pharma Data

OCTOBER 14, 2020

He has published over 320 peer reviewed articles and book chapters in the field of heart failure and has served on the executive and steering committees for multiple national and international clinical trials in heart failure. the company’s key growth market, the alfa pump has been granted breakthrough device designation by the FDA.

Clinical Trials 40

Clinical Trials Therapies Clinical Research Trials 40

KIF1A

APRIL 24, 2023

If you are attending in person please fill out our conference registration form and hotel room booking form. – FDA: The United States Food and Drug Administration has announced its approval of the use of biomarkers in the assessment of gene therapies. It’s time to sign up for the conference and reserve your hotel rooms!

Packaging 52

Packaging Drug Development Research Therapies 52