Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Starting with the drug. Pharmacokinetics: How the body handles drugs.

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Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. What can you expect?

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Policy Prescription

MAY 28, 2021

For the past decade, I’ve written extensively about my view that pharma-funded organizations and initiatives are responsible for misleading Americans about the safety of buying more affordable prescription drugs over the Internet for import from Canada and other countries. Here’s one example and you can be the judge.

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Drug Target Review

DECEMBER 22, 2023

The regulatory science project I pursued for my first master’s degree titled, “21st Century Pharmaceutical Excipients: Consequences of a Global Supply Chain and Lack of Excipient Regulations” aimed to draw attention to the risks created by the lack of sufficient oversight of the pharmaceutical excipient supply chain.

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The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). International regulators and WHO call for wider public access to clinical data ( EMA ). Generic Drug Cos.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act.

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Drug Target Review

MARCH 6, 2024

Driven by our 3D generative algorithms, in combination with our expert drug hunters, and guided by our pipeline of models and 2D generative approaches, we designed ‘539 through iterative design and learning cycles.

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The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range.

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Drug Discovery World

MARCH 29, 2023

Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.

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The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. . DMT (N,N-dimethyltryptamine). Prof. ” Prof. XPhyto Therapeutics Corp.

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Drug Channels

SEPTEMBER 29, 2020

Exclusive Offer for Drug Channels Readers – View the complete agenda and register today – Be sure to use your exclusive promo code USAVE3 to save $300 *. As managing copay programs continues to be significantly more complex, it is imperative to stay on top of current trends, emerging regulations and future legislation.

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Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. The integration of technology in healthcare not only promises advancements but also raises concerns about security, regulation and potential disparities in access.

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Agency IQ

NOVEMBER 27, 2023

The changes, which should take effect in mid-2024, should result in drug ads with fewer distracting elements and more emphasis on the major risks of the drug. These requirements are further established under 21 CFR 202.1 , which outline FDA’s expectations for prescription drug advertising.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

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The Pharma Data

JANUARY 24, 2021

Management of the Company believe that the proposed acquisition will strengthen PharmaDrug’s product pipeline, intellectual property portfolio and pharmaceutical development expertise. Food and Drug Administration (“FDA”) approval. Food and Drug Administration (“FDA”) approval.

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Agency IQ

JANUARY 4, 2024

Pharmacopeia (USP) defines impurities as “any component of the drug substance that is not the chemical entity that is defined as the drug substance” or, “any component of a drug product that is not the drug substance or an excipient in the drug product.” Read AgencyIQ’s analysis of the ICH guideline here ].

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Drug Discovery World

APRIL 14, 2023

He is being recognised for his celebrated contributions to the understanding and targeting of pancreas cancer metastasis, including work that has assisted with the development of minnelide, a pro-drug of triptolide for the treatment of pancreas and gastrointestinal cancers that is currently in Phase II clinical trials.

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The Pharma Data

NOVEMBER 16, 2020

“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We

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The Pharma Data

SEPTEMBER 29, 2021

Heerspink, Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University center Groningen, Netherlands, and Co-Chair of the study’s Executive Committee. “If In July, finerenone was approved under the name Kerendia® by the us (U.S.)

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Drug Discovery World

JULY 27, 2023

Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). This agreement is called the Windsor Framework.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. What is drug compounding?

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Drug Discovery World

JUNE 20, 2024

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. The fusion of LLMs with clinical research processes marks a significant evolution and can help us reshape our approach to drug development and patient care. So, what are the roles of LLMs in clinical trials?

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Agency IQ

JULY 12, 2024

In response to even more acute drug shortages during the Covid-19 pandemic, the European Commission issued proposals to set up a “European Health Union” meant to address drug shortages in several ways. Following this regulation, the EMA now coordinates shortage prevention, management and communication efforts among Member States.

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Agency IQ

JANUARY 26, 2024

The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste As drug shortages have made headlines over the past few years, the FDA has announced the extension of expiration dates on a variety of drug products.

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Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. December also typically brings end-of-year perspectives on the agency’s accomplishments.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. There are as many PDUFA dates in November and December as we’ve seen all year.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

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The Pharma Data

MAY 13, 2021

I’ll also show you why their top scientists are now saying that this breakthrough treatment could replace traditional medical approaches for a wide range of painful conditions… What this means is that you can now say goodbye to your daily aches and pains without harmful drugs or having to resort to painful surgery. he continued.

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Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients. Fake DSCSA Pedigrees.

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Agency IQ

FEBRUARY 15, 2024

Priority A List.

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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.

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Drug & Device Law

FEBRUARY 20, 2023

Drug manufacturers often could trade a little less efficacy for a little more safety, but the safest design is not always the best one. to determine whether a proposed alternative drug would have received FDA approval.” For physicians to prescribe such a safer drug, it must reach the market. Wyeth LLC , 562 U.S. 2d 506 (N.Y.

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Drug & Device Law

DECEMBER 29, 2023

2023) (HHS cannot force pharmaceutical manufacturers to sell unlimited amounts of prescription drugs at a discount) ( here ). This year’s Drug & Device Law Blog top ten decisions of the year reinforced preemption – the most powerful defense we can assert. 332 (2023) ( here ); Sanofi Aventis U.S. 4th 696 (3d.

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