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

FDA Law Blog: Biosimilars

JUNE 7, 2023

Kirschenbaum — The Inflation Reduction Act’s price negotiation program for drugs covered under Medicare Parts B and D (“Negotiation Program”) has been challenged in federal court. to transfer their patented pharmaceutical products to Medicare beneficiaries, for public use” at a government-dictated price that is a fraction of the drug’s value.

Government

FDA Law Blog: Biosimilars

MARCH 5, 2024

By Faraz Siddiqui — Last Friday, the Delaware District Court rejected AstraZeneca’s lawsuit against the Medicare Drug Price Negotiation Program enacted under the Inflation Reduction Act (IRA) and CMS’s guidance implementing it. Opinion at 17. contradicts the plain text of the statute and therefore must be set aside.” . ; see also 42 U.S.C.

Government

Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

Clinical Trials

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. These requirements are similar to what is already required for critical pharmaceutical products. In-house tests (in the U.S. Once the E.U.

Regulations

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. One of the core goals of the GDUFA program has been to increase the efficiency of the generic drug review program.

Science

Agency IQ

SEPTEMBER 6, 2023

FDA Warning Letters are often sent to manufacturers of generic drugs. Such products are often made in foreign facilities by staff less experienced with FDA regulatory requirements and at margins which may preclude significant investments in drug quality.

FDA

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

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. These include packaging for drugs (including prescription drugs) and medical devices, in addition to materials that are considered “reusable” or “refillable.”

Regulations

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

Drug Target Review

JUNE 5, 2023

Can you tell us more about ZW191 and its potential as an FRα-targeting antibody-drug conjugate? ZW191 is comprised of a novel fully humanised IgG1 antibody covalently conjugated to a novel topoisomerase 1 inhibitor ZD06519, a camptothecin derivative, via endogenous interchain cysteines with a drug-to-antibody ratio (DAR) of eight.

Treatment

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

Agency IQ

AUGUST 2, 2024

Positive August 2024 Eurneffy (epinephrine) Ars Pharmaceuticals Irl Limited Positive August 2024 MResvia (Respiratory Syncytial Virus mRNA vaccine) Moderna Biotech Spain S.L. Positive August 2024 Balversa (erdafitinib) Janssen-Cilag International N.V.

Regulations

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

The developer of that treatment, Sarepta Therapeutics, informed the Food and Drug Administration his case could be life-threatening. The distinction is clinically important as Elevidys is dosed by weight, so younger, lighter patients receive less of the drug. You can unsubscribe at anytime.

Therapies

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

Agency IQ

JUNE 16, 2023

The standards would begin with model year 2027 heavy-duty vehicles, with stringency levels through model year 2030 and beyond. The standards will begin with model year 2027 light-duty vehicles, with stringency levels set at least through model year 2030.

Regulations

Agency IQ

DECEMBER 15, 2023

March 2024 February 2024 Greenhouse Gas Emissions Standards for Heavy-Duty Vehicles—Phase 3 Final Rule Stage 2060-AV50 On April 12, 2023, EPA announced a proposal for more stringent standards to reduce greenhouse gas emissions from HD vehicles beginning in model year (MY) 2027. 7521(a), starting with model year 2027.

Regulations

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

JUNE 30, 2025

The COVID-19 vaccine pioneer said it will begin discussing an approval submission with the Food and Drug Adminstration, aiming to launch what would be the first messenger RNA-based influenza vaccine in the U.S. as early as the 2026-2027 flu season. By Jonathan Gardner • Sept. By Jonathan Gardner • Sept. Registered in England and Wales.

Vaccine

The Pharma Data

NOVEMBER 25, 2020

The interim final ruling on most-favored-nation status for drug prices is expected to be published on November 27 th in the Federal Register by the Centers for Medicare & Medicaid Services (CMS) at the Department of Health and Huma Services (HHS). Specifically, one study of 27 drugs found the U.S. CMS maintains otherwise.

Drugs

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