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 25, 2020

The platform harnesses electron-transfer chemistry to modulate key biological processes beyond the reach of current drug development approaches. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

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NIH Director's Blog: Drug Development

APRIL 7, 2015

This pioneering partnership between NIH and industry provides an avenue for pharmaceutical companies to allow compounds that have failed along the way to be made available to the scientific community for other applications. 2015 Feb 23. Nat Neurosci. 2012 Sep;15(9):1227-35. doi: 10.1038/nn.3178. Ann Neurol.

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The Pharma Data

JUNE 25, 2021

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. About Eisai Co.,

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Agency IQ

JUNE 29, 2023

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94 to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. .;

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The Pharma Data

JULY 29, 2021

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. About Eisai Co.,

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The Pharma Data

DECEMBER 15, 2020

Pancreatic cancer remains an area of unmet medical need, with no new approved therapies since the approval of nab-paclitaxel (Abraxane ® ) in combination with gemcitabine for first-line treatment in 2013 and Onivyde ® in combination with fluorouracil and leucovorin for second-line treatment in 2015. About BioLineRx BioLineRx Ltd.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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DrugBank

AUGUST 15, 2024

Drug development is challenging, including not only the complexities of biomolecular drug mechanisms but also the convolutions of regulatory pathways and commercialization strategies. This includes funding large-scale clinical trials and establishing robust manufacturing/distribution networks.

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Molecule Blog

JUNE 11, 2021

Imagine a world where patients directly fund researchers developing the next therapeutic breakthrough they need. One where drug development is collaborative, open, and decentralized — an open bazaar anyone with the right intentions can join. The majority of promising early-stage therapeutic research lacks funding and access.

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Codon

APRIL 9, 2024

The existing literature written in English on this story tends to attribute Tu Youyou’s achievements to a solo discovery, an understandable consequence of Tu receiving the Nobel Prize in Physiology or Medicine in 2015. Department of Defense administered mefloquine, the synthetic drug developed at Walter Reed in the U.S.,

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Advarra

AUGUST 10, 2023

The Orphan Drug Act creates incentives for developing orphan drugs to treat such diseases. FDA CBER began issuing approvals for gene therapies in 2015 and issued the first approval for a rare disease gene therapy in 2017, with the second rare disease approval issued in 2019. What is the FDA Proposing to do?

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Drug Target Review

JUNE 21, 2023

2,3 This is exemplified by drugs that target disease-specific genes or genetically distinct patient subsets which are more likely to succeed in demonstrating efficacy in clinical development. Leveraging genetic evidence to develop new therapeutics has been successful in the past. 2015 Sep 29;6:8382. Epub 2015 Nov 12.

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The Premier Consulting Blog

APRIL 25, 2023

Opinions regarding how the new act will impact the industry vary, with predictions ranging from everything remaining at the status quo to the end of animal testing for new drug development and approvals. 4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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The Pharma Data

MARCH 15, 2022

To further facilitate generic drug development, and to assist the generic pharmaceutical industry in this process, the FDA publishes product-specific guidances (PSGs) describing the agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to their brand name counterparts.

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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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Agency IQ

OCTOBER 6, 2023

According to the Substance Abuse and Mental Health Services Administration (SAMHSA), “between 2008 and 2015, amphetamine-related hospitalizations more than tripled, increasing from 55,447 instances to 206,180. Regulatory context FDA held a workshop in December 2019 to discuss development of substance use disorder therapies.

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Agency IQ

JULY 28, 2023

A big nitrosamine deadline approaches : Unless you’ve been hiding under a rock for the last few years, you’ve probably heard about major issues that the pharmaceutical industry has been having with nitrosamine contamination. But despite the law’s age, it is not yet fully operational.

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Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

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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. To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 [80 FR 55237] which revised 21 CFR 1.94

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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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Drug Target Review

JANUARY 20, 2025

The oncology drug development landscape is evolving rapidly, driven by the deployment of targeted therapies in precision medicine and regulatory initiatives like the FDAs Project Optimus. It also covers strategies for drug developers who have yet to identify a biomarker, helping them advance their programs effectively.

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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. It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies.

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Drug Target Review

FEBRUARY 25, 2025

As we look to the future, therapies like NKTR-255 could serve as vital components in a new generation of oncology treatments, transforming not only how we address complex cancers but also how we design drug development strategies in immuno-oncology, says Zalevsky.

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Drug Target Review

FEBRUARY 11, 2025

Drug development: addressing complexity and success rates Drug development is a complex and expensive process, requiring multidisciplinary expertise and high-risk financial investments. The major hurdles that pharmaceutical companies face are long lead times, high costs and a low probability of success (PoS).

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New Drug Approvals

APRIL 21, 2025

under reduced pressure to afford a solid residue of Formula IX.Example 7Preparation of a Pharmaceutically Acceptable Salt of Formula I The solid residue of Formula IX was dissolved in water (57 mL) and stirred for 10 min and cooled to 05 C. It is taken by mouth. [1] The aqueous solution was acidified with conc. 25 November 2024. PMC 7003869.

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