Drugs.com

JANUARY 15, 2025

Food and Drug Administration has amended its color additive regulations to no longer allow the use of Federal Food, Drug, and Cosmetic Act (FD&C Act) Red No. WEDNESDAY, Jan. 15, 2025 -- The U.S 3 in food and ingested drugs.FD&C &C Red No.

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FDA Drugs Regulations 264

BioPharma Drive: Drug Pricing

MAY 19, 2025

Global regulators continue to raise the bar on sterile drug manufacturing—and West is responding.

Regulations 130

Regulations Drugs 130

BioPharma Drive: Drug Pricing

APRIL 21, 2025

regulators to clear an oral version of its weight loss drug Wegovy two years after reporting initial Phase 3 results. A spokesperson confirmed the Danish drugmaker has asked U.S.

FDA Approval 350

FDA Approval FDA Regulations Drugs 350

BioPharma Drive: Drug Pricing

APRIL 12, 2024

The decision clears a concern hanging over GLP-1 medicines like Ozempic since reports of suicidal ideation and self-harm among people taking the drugs surfaced in July.

Regulations 177

Regulations Drugs 177

BioPharma Drive: Drug Pricing

JUNE 9, 2023

The regulator will issue separate verdicts on the pioneering treatment’s use in sickle cell disease and beta thalassemia, with the first expected late this year.

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FDA Regulations Treatment Disease 321

BioPharma Drive: Drug Pricing

JULY 26, 2024

Eisai plans to appeal the EMA’s negative recommendation, hoping to break into a market analysts expect could eventually bring billions of dollars in sales for the Alzheimer’s drug.

Regulations 177

Regulations Marketing Drugs 177

Chemical Biology and Drug Design

NOVEMBER 13, 2024

ABSTRACT Nicotinamide adenine dinucleotide phosphate oxidase 4 (NOX4) has emerged as a promising target for developing drugs to tackle renal fibrosis. The drug affinity responsive target stability (DARTS) assay illuminated the robust binding stability of 14m with NOX4.

Regulations 100

Regulations Drugs Research 100

FDA Law Blog: Biosimilars

MARCH 24, 2025

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Marijuana would also remain subject to applicable provisions of the Food, Drug and Cosmetics Act.

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Regulations Testimonials Licensing Licensing 71

Covalent Modifiers

FEBRUARY 10, 2025

DOI Ansgar Oberheide, Maxime van den Oetelaar, Jakob Scheele, Jan Borggrfe, Semmy Engelen, Michael Sattler, Christian Ottmann, Peter Cossar and Luc Brunsveld RSC Med Chem 2025 [link] Protein-protein interactions (PPIs) are key regulators of various cellular processes.

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Biophysical Assays Small Molecule Engineering Regulations 173

ProRelix Research

MAY 14, 2025

In the ever-advancing field of pharmaceutical development, regulations surrounding drug clinical trials in the United States serve a critical purpose.

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Clinical Trials Regulations Trials Drugs 52

BioPharma Drive: Drug Pricing

SEPTEMBER 23, 2024

The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.

Regulations 300

Regulations Drugs 300

BioPharma Drive: Drug Pricing

FEBRUARY 3, 2025

regulators to convert Braftovi’s accelerated clearance in colorectal tumors into a full approval — boosting an oncology portfolio Pfizer is looking to for revenue growth. The results could sway U.S.

Regulations 277

Regulations Drugs 277

BioPharma Drive: Drug Pricing

JULY 12, 2023

The European drug regulator says it now has 150 reports of possible cases involving self-injury and suicidal thoughts among people taking GLP-1 medicines like Ozempic.

Regulations 245

Regulations Drugs 245

Drugs.com

JULY 13, 2023

TUESDAY, July 11, 2023 -- The European Medicines Agency is investigating concerns that popular weight-loss drugs like Ozempic and Saxenda may be linked to suicidal thoughts and thoughts of self-harm. Three case reports from Iceland spurred the.

Regulations 190

Regulations Drugs 190

BioPharma Drive: Drug Pricing

SEPTEMBER 6, 2024

regulators rejected GSK’s submission in 2018. New trial results could offer support for an expansion of Nucala’s label after U.S.

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Trials Regulations Drugs 253

BioPharma Drive: Drug Pricing

DECEMBER 12, 2023

Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.”

Drug Research 298

Drug Research Licensing Licensing Research 298

ProRelix Research

MAY 13, 2025

The landscape of Indian clinical trial regulations has undergone a profound transformation over the past two decades. Once perceived as a regulatory gray zone, the Indian clinical research ecosystem has […] The post A Closer Look at Compliance and Regulations for Drug Clinical Trials in India appeared first on ProRelix Research.

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Clinical Trials Compliance Regulations Trials 52

BioPharma Drive: Drug Pricing

MAY 1, 2024

The move broadens the antitrust regulator’s campaign against allegedly “improper or inaccurate” patent listings by drugmakers to include top-selling medicines for weight loss, diabetes, asthma and COPD.

Regulations 277

Regulations Drugs 277

Science Daily: Pharmacology News

AUGUST 24, 2023

The conversion is relevant e.g. for the preparation of drugs. A team of chemists have developed a novel concept in which a mixture of molecules that behave like mirror images is converted to a single form. To this end, they use light as external energy source.

Regulations 181

Regulations Drugs 181

BioPharma Drive: Drug Pricing

DECEMBER 15, 2023

While a positive recommendation for the gene editing treatment Casgevy was expected, a clearance for Biogen’s Skyclaris, acquired through a recent acquisition, was no sure bet.

Regulations 169

Regulations Treatment Drugs 169

Science Daily: Pharmacology News

NOVEMBER 13, 2023

A compound -- one of 27 million screened in a library of potential new drugs -- reversed four types of chronic pain in animal studies, according to new research.

Small Molecule 226

Small Molecule Drugs Regulations Research 226

BioPharma Drive: Drug Pricing

JUNE 23, 2023

An EMA committee expressed concern with the main study meant to show Amylyx’s drug is safe and effective. The company now plans to ask for a re-examination of its approval application.

Regulations 141

Regulations Drugs 141

Drug Patent Watch

FEBRUARY 10, 2025

Streamlining the Generic Drug Supply Chain: Best Practices to Improve Efficiency and Patient Access As the generic drug industry continues to grow, it's becoming increasingly clear that the traditional supply chain model is no longer sustainable. At the heart of a streamlined generic drug supply chain are several key best practices.

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Drugs Regulations Production 71

BioPharma Drive: Drug Pricing

JULY 10, 2024

Having recently withdrawn its only product from the market, Amylyx hopes to rebound with a drug that regulates GLP-1 activity and is poised to enter pivotal testing early next year.

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Regulations Drugs Production Marketing 195

Drugs.com

OCTOBER 27, 2023

27, 2023 -- Federal regulators have sent warning letters to two companies for illegally selling probiotic products for use in preterm infants. Food and Drug Administration also sent a letter to health care providers warning of. FRIDAY, Oct.

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Production FDA Regulations Drugs 299

Science Daily: Pharmacology News

JANUARY 8, 2025

Governments need to test and regulate chemicals and chemical products as closely as they safeguard prescription drugs, the researchers write. Nations must better safeguard health and reduce childhood diseases linked to exposures to toxic chemicals, according to researchers.

Production 270

Production Government Regulations Disease 270

BioPharma Drive: Drug Pricing

AUGUST 25, 2023

market against Biogen’s inflammation-regulating medicine Tysabri. According to one analyst, the approval was the last hurdle keeping Sandoz’s Tyruko from directly competing in the U.S.

FDA Approval 246

FDA Approval FDA Regulations Drugs 246

BioPharma Drive: Drug Pricing

JANUARY 6, 2025

By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.

FDA 244

FDA Regulations Drugs 244

Drug Target Review

APRIL 30, 2025

In the rapidly evolving field of cell and gene therapy (CGT), the ability to manage complex biological data, optimise manufacturing processes, and accelerate drug discovery is crucial. The future of AI in CGT AI holds tremendous potential to reshape drug discovery and development in CGT.

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Drugs Therapies Clinical Trials Trials 90

FDA Law Blog: Drug Discovery

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. who intend to evaluate a drug, biologic, medical device, or food for medical purposes that targets a rare disease in a clinical trial. By Sarah Wicks & James E.

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Clinical Development Production Clinical Trials Treatment 69

BioPharma Drive: Drug Pricing

MAY 22, 2025

regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup. An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.

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FDA Regulations Drugs 189

The Premier Consulting Blog

OCTOBER 30, 2024

In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. Continuous manufacturing, by contrast, integrates all steps of drug production into a seamless, ongoing process.

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FDA Regulations Pharmaceuticals Production 52

Drug Patent Watch

JUNE 9, 2025

"Navigating the Maze of Regulations: How Pharmaceutical Companies Can Safeguard Their Drug Portfolios As the pharmaceutical industry continues to evolve, regulatory environments are becoming increasingly complex.

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Pharmaceutical Companies Drugs Pharmaceuticals Regulations 75

Drugs.com

JULY 3, 2024

WEDNESDAY, July 3, 2024 -- A regulation allowing the use of brominated vegetable oil in food was revoked Tuesday by the U.S. Food and Drug Administration after the agency concluded the additive was unsafe for human consumption.Brominated vegetable.

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FDA Regulations Drugs 246

BioPharma Drive: Drug Pricing

JANUARY 11, 2024

As a result of the planned consultation, Eisai now expects an approval decision on Leqembi in Europe by the end of June, rather than March.

Regulations 161

Regulations Drugs 161

BioPharma Drive: Drug Pricing

FEBRUARY 28, 2025

European regulators “reaffirmed” a positive view of Eisai and Biogen’s Alzheimer’s drug after conducting a new safety review.

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Regulations Drugs 236

BioPharma Drive: Drug Pricing

JULY 10, 2024

Antitrust regulators are set to file suit against CVS Caremark, Express Scripts and Optum Rx over how they negotiate discounts for drugs, including insulin, per the report.

Regulations 169

Regulations Drugs 169