Codon

NOVEMBER 3, 2024

In 2018, GlaxoSmithKline (GSK) piloted a new vaccine that may outmatch the BCG vaccine in treating pulmonary TB in adults. Researchers in 2018 tested out another TB vaccine, called H4:IC31 , against two control groups — a placebo arm and an arm receiving a BCG booster. coli bacteria from growing.

Vaccine

The Pharma Data

JUNE 23, 2025

Food and Drug Administration (FDA) , with a regulatory decision anticipated in Q4 2025. Additionally, the company is working to enhance the positioning of its oral semaglutide formulation, Rybelsus® , with label expansion filings submitted to both the EMA and FDA.

Trials

FDA Law Blog: Biosimilars

APRIL 7, 2025

Koblitz & Dara Katcher Levy Promotional claims do not receive the most attention with respect to FDA enforcement these days, and veterinary promotion is no exception. And, going into detail about the primary effectiveness endpoint, FDA raised concerns about claims allegedly exaggerating the speed of action for Zenrelia (i.e.

Vaccine

New Drug Approvals

APRIL 19, 2025

Landiolol 133242-30-5 ONO-1101 Ono 1101 WHO 7516 FDA APPROVED 11/22/2024, Rapiblyk , To treat supraventricular tachycardia C25H39N3O8 509.6 FDA Approves AOP Health’s Rapiblyk (landiolol) for Atrial Fibrillation and Atrial Flutter in the Critical Care Setting” (Press release). Food and Drug Administration (FDA).

FDA

BioPharma Drive: Drug Pricing

JULY 16, 2025

Sarepta is working on a new regimen of immune-suppressing drugs to manage the safety risks, and plans to soon share its findings with the FDA. The company’s share price is lower by more than 80% this year amid concerns about Elevidys’ future and the chance new FDA leadership might restrict its use. You can unsubscribe at anytime.

Therapies

New Drug Approvals

JULY 8, 2025

US FDA granted fast track designation for pritelivir in 2017 and breakthrough therapy designation 2020. 7] If the virus also acquires resistance to foscarnet, then there is currently no FDA approved treatment. 2018 Oct 23;9:2483. 2018 Jan;149:1-6. This is particularly important in immune compromised patients. PMC 286876.

Virus

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. Come Monday March 3rd, if Congress does not pass a budget or continuing resolution, the FDA will enter a shutdown and shutter many offices and programs while Congress works out their inter-party squabbles on national priorities.

Government

New Drug Approvals

JULY 7, 2025

Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of NMPA granted pimicotinib breakthrough therapy designation (BTD) for the treatment of tenosynovial giant cell tumor patients that are not amenable to surgery in January 2023 and July 2022, respectively. [7] 2018-11-29. [2]. 6] The U.S. clinicaltrials.gov.

Small Molecule

PPD

APRIL 14, 2025

It is worth noting that trial ran from 2018 to 2021, before the U.S. Food and Drug Administrations (FDA) diversity and inclusion in clinical trials mandate. For example, the SELECT trial enrollment comprised just 28% of women participants and 12% Black participants.

Clinical Trials

BioPharma Drive: Drug Pricing

JUNE 26, 2025

However, it flamed out in testing in 2018 and Incyte was forced to pivot research toward other candidates. questions vaccine evidence By Delilah Alvarado FDA investigating Elevidys safety; Nektar shares spike on eczema data By BioPharma Dive staff Cassidy challenges RFK Jr. You can unsubscribe at anytime. TechTarget, Inc.s

Therapies

Drug Patent Watch

DECEMBER 11, 2024

Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japans Pharmaceuticals and Medical Devices Agency (PMDA). 2018, March 29). Quality by Design (QbD) Principles : Embrace QbD principles to create robust and scalable manufacturing processes that prioritize product quality and performance attributes.

Compliance

FDA Law Blog: Biosimilars

JUNE 1, 2025

Snow & Dara Katcher Levy In a recent letter to FDA Commissioner Dr. Martin Makary, U.S. Durbins letter addresses FDAs capacity to oversee the increasing volume of DTC advertisements, particularly on platforms like social media. By Charles D. Kennedy Jr., In 2021, the U.S.

Pharmaceutical Companies

FDA Law Blog: Biosimilars

FEBRUARY 12, 2025

Given these features, the TCA authorized FDA to ban or modify the use of menthol in cigarettes based on scientific evidence, and required FDA to study and report on the impact of the use of menthol cigarettes on the public health through a newly created Tobacco Product Scientific Advisory Committee (TPSAC). 111-58, at 38-39 (2009).

FDA

BioPharma Drive: Drug Pricing

JANUARY 2, 2025

The agency’s main drug review office cleared 50 novel medicines last year, short of 2018’s record total but on the higher end of recent annual tallies.

FDA Approval

Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

FDA Approval

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling. Digital technologies as drug labeling: An intro to PDURS What is PDURS?

FDA

FDA Law Blog: Drug Discovery

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J.

FDA

BioPharma Drive: Drug Pricing

JULY 22, 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 Dive Brief // Vaccines Sanofi to acquire vaccine biotech in billion-dollar deal The French pharma will pay $1.15 You can unsubscribe at anytime. Track how they’re performing.

Vaccine

Eye on FDA

AUGUST 10, 2023

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. And there is more to tell.

FDA

Eye on FDA

AUGUST 27, 2023

But in fact, as can be seen in previous years such as 2019, 2018 and 2015, the mid-year tally (in red) is not always predictive of what we may see by year’s end (in blue). AdComms and Approval Votes Are Up – In addition to NME approvals, there have been an increased number of FDA Advisory committees held to discuss new treatments.

FDA

Agency IQ

SEPTEMBER 22, 2023

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance A long-awaited draft guidance on Prescription Drug Use-Related Software (PDURS) outlines when information from digital health tools could be represented on prescription drug labeling.

FDA

FDA Law Blog: Biosimilars

JULY 8, 2025

Snow — Recently, FDA announced a deadline shift, although the Agency did so quietly. Confirmatory testing remains due by August 1, 2025, but FDA has now acknowledged that full implementation of mitigation strategies—such as reformulation or the addition of new specifications—may take longer. By Charles D. What does this mean?

FDA

Advarra

JULY 26, 2022

The 2018 Farm Bill. The 2018 Farm Bill removed hemp from the Controlled Substance Act. Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

Regulations

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). Under the Administrative Procedure Act, FDA is obligated to address major substantive issues when – and not so much if – it publishes a final rule.

FDA

FDA Law Blog: Biosimilars

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

FDA

FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

FDA

FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). Youth behavioral data was not specifically required but FDA encouraged such information.

FDA

Eye on FDA

JULY 14, 2021

Years ago, a single regulatory action letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) would not have merited a blog posting in and of itself. In the last several years, however, FDA’s enforcement arm has issued only a few letters each year. Apologies for the inconvenience and thanks for your patience.

FDA

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations

The Pharma Data

MAY 5, 2021

FDA officials said that the number of a product specific guidances (PSGs) issued by the Office of Generic Drugs (OGD) has increased steadily since FY 2013. Lei Zhang, the deputy director for the office of research and standards in OGD, said that in FY 2020, FDA issued a record high number of new and revised PSGs totaling 258.

Drug Development

FDA Law Blog: Biosimilars

JULY 25, 2023

Recent industry comments submitted to FDA and new, international efforts against these nefarious, potentially carcinogenic organic compounds have the shifting state of regulation here back in the news. What is FDA doing about NDRSIs? Seek, and ye shall find, so FDA hopes. By John W.M. Claud & Sara W. What are nitrosamines?

FDA

Eye on FDA

JANUARY 16, 2023

Through its Human Drugs Advisory Committee process FDA has a vast array of outside experts to consult on matters related to product approval as well as questions about policy or safety issues concerning approved products. FDA Advisory Committees (AdComms) ain’t what they used to be. In-person FDA AdComms were not really fun.

FDA

FDA Law Blog: Drug Discovery

DECEMBER 13, 2023

Sasinowski — On December 12, 2023, FDA announced the creation of a new advisory committee specifically for treatments for genetic metabolic diseases, the Genetic Metabolic Diseases Advisory Committee, or “GeMDAC.” Note that FDA is currently soliciting applications to staff this committee. Tobolowsky & James E. Raver & Frank J.

Disease

The Pharma Data

JANUARY 18, 2021

FDA advisory committees recommended just 50 percent of the 18 new therapies and indications they reviewed in 2020, the lowest rate since 2007, and the agency seems to be reserving the panels for more problematic applications, according to Prevision Policy, a Washington, D.C.-based based research firm.

FDA

The Pharma Data

JANUARY 14, 2021

Food and Drug Administration (FDA) approved Pfizer ’s Xalkori (crizotinib) for pediatric patients one year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. Manuel Esteban/Shutterstock.

FDA Approval

Eye on FDA

DECEMBER 6, 2023

For those working closely with the development of new medicines for FDA approval, it can be informative respecting the future to look back at recent activity and take note of any potential changes from years past. At the outset of the COVID-19 pandemic, FDA began conducting advisory committee meetings virtually. Virtual Meetings.

FDA

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. 16 This concludes our exploration of metabolism of last year’s FDA approved small molecule drugs.

Small Molecule