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 Regulations Drugs 264

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.

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Regulations Drugs 184

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.

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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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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.

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Regulations Drugs 283

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.

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Regulations Drugs 307

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

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.

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Regulations Drugs 284

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 82

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.

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Regulations Drugs 245

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 259

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.”

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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.

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Regulations Drugs 190

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.

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Regulations Treatment Drugs 176

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.

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Regulations Drugs 144

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 201

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.

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Small Molecule Regulations Drugs Research 222

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.

Production 299

Production FDA Regulations Drugs 299

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.

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Regulations Drugs 166

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.

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FDA Approval FDA Regulations Drugs 246

Drug Patent Watch

DECEMBER 10, 2024

This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers. In this article, we will delve into the benefits of working with integrated CDMO services and explore how they can streamline the drug development and manufacturing process.

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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.

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FDA Regulations Drugs 249

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.

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Production Government Regulations Disease 259

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

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 167

Regulations Drugs 167

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.

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Regulations Drugs 176

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 241

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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Drugs.com

APRIL 29, 2024

MONDAY, April 29, 2024 -- Laboratory tests used by millions of Americans are soon to be classified as medical devices, and as such be regulated by U.S. Food and Drug Administration, the agency announced Monday.The new rule does not apply to tests.

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Laboratories FDA Regulations Drugs 245

BioPharma Drive: Drug Pricing

JUNE 28, 2024

European drug regulators voted for a third time not to renew the approval of Translarna. Elsewhere, Sanofi invested in a brain disease biotech and Esperion sold royalties to help pay off a loan.

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Biosimilars Regulations Drugs Disease 167

Drugs.com

APRIL 2, 2025

Food and Drug Administration’s (FDA) top tobacco regulator, Brian King, has been placed on leave as part of a large wave of cuts across federal health agencies. WEDNESDAY, April 2, 2025 -- The U.S. King, who led the FDA's tobacco control.

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FDA Regulations Drugs 207

Drugs.com

JULY 28, 2023

FRIDAY, July 28, 2023 -- The diabetes drug metformin might also benefit older patients after an injury or illness, a small study suggests. Researchers found that metformin -- a drug that has been around for more than a half-century to regulate blood.

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Regulations Research Drugs 244

Science Daily: Pharmacology News

FEBRUARY 20, 2025

A new study identifies an inhibitor of gene regulation that specifically kills the malaria pathogen. Epigenetic inhibitors as a promising new antimalarial intervention strategy?

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Regulations Drugs 188

Drugs.com

AUGUST 23, 2023

23, 2023 -- Tainted eye drops are back in the news, with federal regulators warning consumers not to use certain eye drops because of contamination concerns. Food and Drug Administration on Tuesday advised people to avoid. WEDNESDAY, Aug.

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FDA Regulations Drugs 246

Drugs.com

AUGUST 6, 2023

Food and Drug Administration, which regulates. SUNDAY, Aug. 6, 2023 -- Whether you got a tattoo on a whim or after much thought, that ink on your body is fairly permanent. Tattoo removal is possible, but it comes with risks, according to the U.S.

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Regulations Drugs 246

BioPharma Drive: Drug Pricing

AUGUST 26, 2024

Regulators in Europe granted approval based on remission rates, while the FDA sought more progress in confirmatory trials when it rejected Ordspono.

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Regulations FDA Trials Drugs 184

Drug Target Review

DECEMBER 20, 2024

Artificial intelligence (AI) has revolutionised many industries, yet its adoption in pharmaceutical drug development has been notably slower. For years, AI and machine learning (ML) were often dismissed as little more than advanced statistics with little practical value in drug development.

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