Drug Discovery World

FEBRUARY 22, 2023

Craig Caceci, Managing Director at Terebellum, offers guidance to pharmaceutical companies that are in the position to take their drugs to market. With over 25 years’ experience in the pharmaceuticals sector, Craig drives the growth and operations of global specialty pharmacy and healthcare services provider, Terebellum.

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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. By doing so, LLMs can uncover valuable insights that inform decision-making processes, enhance the accuracy of clinical research outcomes, and streamline the development of therapeutic interventions.

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Drug Discovery World

FEBRUARY 10, 2023

DDW Editor Reece Armstrong explores the Scandinavian drug discovery sector and speaks to key players about Sweden’s place in the market. Scandinavia represents one of the most exciting but perhaps underrepresented markets for the discovery and development of pharmaceuticals. A good part of half of those are within pharma.

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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. Pharmacokinetics: How the body handles drugs.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here. Read or listen now.

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The Pharma Data

JUNE 29, 2021

Global Head Regulatory Affairs and US Head of Drug Development as Chief People & Organization Officer. Dr. Kowalski is a senior drug development and regulatory executive with over 25 years of industry experience. Novartis announced today the appointment of Rob Kowalski, Pharm.D., He will report to Vas Narasimhan, M.D.,

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Broad Institute

JUNE 11, 2024

When Moe Haines first moved from Beirut, Lebanon to the United States for college, his goal was to earn a degree in pharmacy. After graduating from college, Haines moved closer to his passion for proteomics, working as an analytical development research scientist for a pharmaceutical company in Albany, NY before relocating to Massachusetts.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Drug Discovery World

MARCH 29, 2023

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. What are the rNPV effects of forcing pharma companies to pursue new indications requested by third parties, and of opening up the authorisation process to third parties?

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The Pharma Data

JANUARY 13, 2021

. Psychedelic Pharmaceutical Scientist and Clinical Pharmacologist Robert Barrow Appointed as Chief Development Officer. Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA.

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Drug Discovery World

DECEMBER 18, 2023

About the author Deepika Khedekar is a Clinical Trial Lead at IQVIA, where she spearheads clinical trial monitoring programmes for major pharmaceutical companies. She holds a Master’s degree in Pharmacy from the University of Mumbai. Why 90% of clinical drug development fails and how to improve it?

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Elrig

APRIL 29, 2024

Harini joined Serna Bio in early 2021 and has been an integral part of the multidisciplinary teamworking on target ID platform development to drug discovery. I pursued a degree in Pharmacy from the University of Murcia to become a qualified Pharmacist, followed by an MSc in Cancer Pharmacology at London Metropolitan University.

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The Pharma Data

JANUARY 12, 2021

Akin to the NASA Deep Space Network, SYNERGY-AI OCTCC is a real time data and communication network between patients, sites, and pharmaceutical companies, with the Massive Bio AI-enabled engine orchestrating these stakeholders for successful operations. NEW YORK–( BUSINESS WIRE )– Massive Bio, Inc. , 75N91020C00016.

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The Pharma Data

OCTOBER 30, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. TARRYTOWN, N.Y. , 30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. Contacts: Media Relations Alexandra Bowie Tel: +1 (914) 847-3407 alexandra.bowie@regeneron.com. View original content: [link].

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Codon

FEBRUARY 13, 2024

The weakened dose of phages helped bacteria develop resistance, and the trial became yet another study that provided evidence phages are safe, but little more. Phage therapies are sold at a pharmacy in Georgia. 4 But the same barriers still exist today. (Its

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The Pharma Data

OCTOBER 14, 2020

14, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA) approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for the treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

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The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. 6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis. Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients.

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Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Agency IQ

OCTOBER 27, 2023

Date What’s Happening Explanation Source October 31 FDA deadline on Florida drug importation plan The FDA has said in court filings that it plans to make a ruling on Florida’s prescription drug importation plan by October 31. The following PDUFA dates were obtained from publicly available sources.

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The Pharma Data

OCTOBER 28, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. FDA, which is reviewing an Emergency Use Authorization submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes. Investor Relations Mark Hudson Tel: +1 (914) 847-3482 mark.hudson@regeneron.com . .

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The Pharma Data

DECEMBER 17, 2020

17, 2020 /PRNewswire/ — Regeneron Pharmaceuticals, Inc. Senior Vice President and Head of Global Clinical Development at Regeneron and lead author of the publication. patients under an Emergency Use Authorization, and we also continue a robust clinical development program.” SOURCE Regeneron Pharmaceuticals, Inc.

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Agency IQ

DECEMBER 1, 2023

The guidance will include FDORA, Section recommendations FDORA, Section on the inclusion of the “the longest feasible expiration date supported by such data” in a drug’s label. ” The report will also cover Federal agency roles in addressing vulnerabilities and statutory limitations.

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The Pharma Data

JANUARY 12, 2021

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. Doses are being supplied for use pursuant to the FDA Emergency Use Authorization for high-risk patients with mild to moderate COVID-19 in order to reduce the risk of progression to severe COVID-19 and/or hospitalization. NASDAQ: REGN ) today announced that the U.S.

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The Pharma Data

NOVEMBER 20, 2020

November 21, 2020 – Regeneron Pharmaceuticals, Inc. Food and Drug Administration (FDA). TARRYTOWN, N.Y., Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases and rare diseases.

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The Pharma Data

DECEMBER 29, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes. First antibody therapy to demonstrate anti-viral effect in patients hospitalized with COVID-19. View original content: [link].

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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The Pharma Data

NOVEMBER 21, 2020

Regeneron Pharmaceuticals, Inc. SOURCE Regeneron Pharmaceuticals, Inc. Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation program. Contacts: Media Relations Alexandra Bowie Tel: +1 (914) 847-3407 alexandra.bowie@regeneron.com.

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The Pharma Data

NOVEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. About Regeneron Pharmaceuticals, Inc. FDA accepted for priority review Libtayo ® (cemiplimab-rwlc) for both advanced non-small cell lung cancer and basal cell carcinoma. FDA approved Inmazeb for Ebola ( Zaire ebolavirus). Forward-Looking Statements and Use of Digital Media.

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