Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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DrugBank

OCTOBER 4, 2024

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. IQVIA has a vast collection of healthcare information, including over 1.2 increase on a reported basis and an 4.8%

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Drug Target Review

JULY 6, 2023

History behind animal testing In December 2022, the US Government approved the ground-breaking US Food and Drug Association (FDA) Modernization Act 2.0, 3 The first act was approved in 1938 in response to a drug — elixir sulphanilamide — that caused 105 deaths after researchers failed to test the antibiotic before release.

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PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drug development industry is undoubtedly in a season of change.

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FDA Law Blog: Biosimilars

AUGUST 28, 2023

Lenz, Principal Medical Device Regulation Expert — Following up on our first post discussing Digital Health Technologies (DHTs) ( here ), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

More recently, use of wearable sensors and applications running on mobile devices (Apps) by study participants has introduced new questions on how to incorporate DHTs into the study, and what information is needed to verify and validate that they are fit for purpose in the study.

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Agency IQ

AUGUST 2, 2024

FDA Regulations and guidance under OIRA review as of August The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

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Agency IQ

JUNE 29, 2023

Specifically, this ANPRM seeks comments, research, information, data, and responses from certain categories of stakeholders that can inform the Agency’s modernization of FDA’s recall regulation. This proposed revision to 21 CFR 807 is for consistency with FDA’s current regulations under 21 CFR part 1271, subpart A.

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The Pharma Data

JANUARY 24, 2021

About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. For more information, please visit: [link]. Contact Information.

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The Pharma Data

SEPTEMBER 17, 2020

A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen. .

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Agency IQ

JUNE 2, 2023

We’re expecting that there are a lot of companies that aren’t aware of this requirement, but we’re also expecting that this information will be hugely helpful to the FDA and its ability to even know what it regulates. government’s way of informing stakeholders of the regulations that are under active development.

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Conversations in Drug Development Trends

JULY 9, 2024

However, once the trial concludes, the drug is no longer given to the patients, leading to concerns about the continuity of care and managing expectations post-study, particularly in regard to the detrimental effects of weight gain and muscle wasting once the participant stops taking the medication.

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The Pharma Data

DECEMBER 9, 2020

We routinely post information that may be important to investors on our website at www.biogen.com. For more information about Eisai Co., 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.

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The Pharma Data

NOVEMBER 6, 2020

We routinely post information that may be important to investors on our website at www.biogen.com. For more information about Eisai Co., 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.

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Agency IQ

SEPTEMBER 29, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED SEP 25, 2023 10:39 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. the drug and device) of the combination product.

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FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.

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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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The Pharma Data

OCTOBER 27, 2020

The collaboration aims to leverage Molecular Partners’ proprietary DARPin® technologies and Novartis’ broad expertise in global drug development, regulatory affairs, manufacturing and commercialization to rapidly advance the program in keeping with the unprecedented global urgency created by the pandemic. About Novartis.

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Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. 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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Pharmaceutical Development Group

JANUARY 7, 2022

Start Up and Generic Pharmaceutical Drug and Biologic Companies have high quality, affordable products and biosimilars that improve the quality of life for their patients. Author Information William E. However, this often is associated with austere conditions wherein time and funds are both in short supply. Spanogle, Ph.D.

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Agency IQ

FEBRUARY 12, 2024

to analyze data, generate summaries of certain information, or other tasks of interest to companies in the interest of efficiencies. A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice.

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The Pharma Data

OCTOBER 29, 2020

We routinely post information that may be important to investors on our website at www.biogen.com. For more information about Eisai Co., 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.

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The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. In the US, new small molecule drugs are developed under the requirements of Sections 505(b)(1) and 505(b)(2) of the FFDCA.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

[(Emphasis in original)] This brings us to a spate of recent letters from the PTO to PTE applicants we’ve seen titled “REQUIREMENT FOR INFORMATION PURSUANT TO 37 C.F.R. They all as for the same type of information: U.S. Of course, PTE applicants respond to the PTO’s information requests, but it takes time and money to do so.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. is the largest dedicated food and drug law firm in the country. life sciences industry.

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Agency IQ

JULY 8, 2024

The information below includes the event type and whether the meeting can be attended by the public (Open) or not (Closed). Upcoming meetings The following list encapsulates meetings expected for the month of July for various European bodies, including relevant committees.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

JULY 28, 2023

That’s because significant guidance documents typically require review and approval by the White House’s Office of Information and Regulatory Affairs (OIRA) prior to publication. 264) and the regulations in 21 CFR part 1271(361 HCT/Ps) are not regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

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