FDA Law Blog: Biosimilars

AUGUST 23, 2023

DHTs have been used in clinical trials for decades in the context of measurements made when participants visit clinical trial sites. FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website.

Production

Vial

DECEMBER 7, 2023

In the ever-evolving field of medical science, artificial intelligence (AI) has emerged as a revolutionary tool, particularly in drug discovery. As a newer alternative to the time-consuming nature of traditional candidate screening and drug discovery, AI-designed drugs have started to make their mark, promising quick and efficient results.

Drugs

The Pharma Data

JANUARY 26, 2021

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. NEW YORK , Jan. Q BioMed Inc.

Treatment

Agency IQ

JULY 22, 2024

Ultimately, this module will interact with CTIS , the drug clinical trial information system. The independent auditing schedule showed publication of full functionality in mid-2027. Another notable challenge has been development of the clinical investigation and performance study module (CI/PS).

Regulations

FDA Law Blog: Biosimilars

JULY 24, 2023

Koblitz — Neither Jazz Pharmaceuticals nor Avadel CNS Pharmaceuticals has taken the battle of sodium oxybate—a drug approved to treat narcolepsy—lying down. Like in the multitude of Orphan Drug Act cases preceding this one, Jazz alleges that FDA’s authority under the Orphan Drug Act was limited by the statutory language.

FDA

Agency IQ

JANUARY 26, 2024

Class A devices needed to be IVDR-ready on the original date (May 26, 2022), but class D had until May 2025, class C until May 2026, and class B and sterile class A until May 2027. In-house tests (in the U.S. called laboratory-developed tests manufactured and used in a single lab) had until May 26, 2024.

Regulations

The Pharma Data

JANUARY 25, 2021

This activity could increase (or reduce the size of any decrease in) the market price of the Company’s common stock, the notes or the Company’s 2.50% Convertible Senior Notes due 2027 at that time. About BridgeBio.

Marketing

The Premier Consulting Blog

NOVEMBER 20, 2023

Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Clinical development experts would need to navigate the potential complexities arising from this regulatory shift, particularly in terms of trial design and evidence generation.

Laboratories

Agency IQ

FEBRUARY 2, 2024

There are also continued questions about regulatory capacity and what the field will look like going forward, with implications for drug developers who rely on diagnostic products. A sea change for lab tests, the implications for drug developers and outstanding questions about endpoints In the U.S.,

FDA

Agency IQ

AUGUST 18, 2023

In 2022, the MDCG offered a guidance document on the borderline between drugs and devices, and the manual itself containing decisions on products came out in September 2022. It also planned to update MDCG 2022-9 (IVD summary of safety and performance template) and MDCG 2022-10 (the interface between IVDR and the Clinical Trials Regulation).

Science

Agency IQ

FEBRUARY 21, 2024

In 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the “strongly recommended format” for submission of applications to the FDA. The format and organization of the CTD is outlined in the ICH M4 Guideline.

Science

Agency IQ

NOVEMBER 3, 2023

October 1, 2027) in order to align with the next iteration of the device user fee program, the QS compliance requirement for LDTs could theoretically be in place by FY2027. A trial run: The Covid-19 EUA transition. If the agency intends for the LDT policy’s final phase to begin “not before” FY2028 (i.e.,

FDA

BioPharma Drive: Drug Pricing

JULY 21, 2025

After the fierce competition between Humira (adalimumab) biosimilars, manufacturers are keeping a close eye on adoption dynamics for biosimilars of Johnson & Johnson’s autoimmune drug, Stelara (ustekinumab). You can unsubscribe at anytime. So how will these low-cost biosimilars distinguish themselves from one another?

Biosimilars

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA

FDA Law Blog: Biosimilars

JUNE 14, 2023

This is about reducing the time and cost and increasing the predictability of going from concept to commercialization.” – Dr. Jeff Shuren During a presentation at the May 17, 2023 Food and Drug Law Institute (FDLI) Annual Conference, CDRH Director, Dr. Jeff Shuren discussed TAP with enthusiasm.

Production

Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

Regulations

Agency IQ

OCTOBER 20, 2023

A January 2022 Seminars in Arthritis and Rheumatism publication noted that a “generic [drug] may only cost $1 million to $4 million and take two years to develop vs $100 million to $250 million and seven to eight years for a biosimilar.”

Science

Advarra

JUNE 13, 2023

Research in gene therapies and genetically engineered drugs and vaccines are growing exponentially, and will only continue to become more popular. between 2020-2027. Additionally, in some cases, gene therapy treatments make permanent changes to a human’s genetic profile, which is different than typical drug treatments.

Therapies

Agency IQ

JULY 28, 2023

DSCSA implementation – Down to the wire as a deadline draws near: The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 as part of the Drug Quality and Security Act (DQSA), following several drug counterfeiting scandals in which falsified medical products entered the supply chain.

FDA

BioPharma Drive: Drug Pricing

JULY 21, 2025

Published July 21, 2025 Ben Fidler Senior Editor Ned Pagliarulo Lead Editor post share post print email license Courtesy of Sarepta One month ago, a 51-year-old man treated in a clinical trial with an experimental gene therapy became dangerously sick. You can unsubscribe at anytime. The distinction also has regulatory implications.

Therapies

The Pharma Data

FEBRUARY 8, 2021

RE47,739 (‘739) by more than four years until March 5, 2027. The PTE certificate was granted under the patent restoration provisions of the Drug Price Competition and Patent Term Restoration Act of 1984. Food and Drug Administration (FDA). Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0%

Clinical Trials

The Pharma Data

DECEMBER 30, 2020

Multiple drugmakers agreed to cut prices of some of their newest drugs by as much as 50% in order to receive coverage from China’s national insurance program. The companies agreed to the steep price cuts in order to have their drugs made available to the world’s second-largest pharmaceutical market. billion by 2027.

Immune Response

Codon

OCTOBER 6, 2024

Results such as these have been so encouraging that in September of last year, the FDA began to review the idea of moving to human trials. Indeed, the stakes in the first real-world use of artificial wombs may be higher than in almost any clinical trial imaginable. Another major issue in human babies is blood clotting.

FDA

BioPharma Drive: Drug Pricing

JUNE 30, 2025

Published June 30, 2025 Jonathan Gardner Senior Reporter post share post print email license Moderna announced results from an influenza vaccine clinical trial on June 30, 2025. as early as the 2026-2027 flu season. An mRNA cancer vaccine it developed has generated promising data , but remains in late-stage testing.

Vaccine

The Pharma Data

MAY 4, 2021

RE47,739 for Ibrance by more than four years until March 2027. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Lorbrena, expanding the indication to include first-line treatment of people with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

Vaccine

BioPharma Drive: Drug Pricing

AUGUST 13, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from AbbVie to build API plant in Illinois as it steps up US production The expansion is part of AbbVie’s larger $10 billion commitment to U.S. You can unsubscribe at anytime.

Production

Drug Target Review

MARCH 20, 2025

This development is not just a significant milestone in drug discovery, but also a potential breakthrough for clinical practice, as it may address a critical gap in current treatments by offering effective stroke prevention with a reduced risk of bleeding.

Therapies