Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Over the last decade, many pharmaceutical companies have undertaken internal ‘harmonisation’ projects.

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Drug Discovery World

SEPTEMBER 14, 2023

In July 2023, AstraZeneca and Ionis Pharmaceuticals expanded their existing collaboration on eplontersen to also include Latin America. Moreover, in July 2023, AstraZeneca and Vaxess Technologies commenced a collaboration for the evaluation of a novel RNA-based pandemic influenza prototype vaccine in patch format.

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Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. in 2021, Switzerland became a third country from the E.U.

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The Pharma Data

DECEMBER 13, 2020

To access the live call, please dial 1 (833) 540-1168 (domestic) or 1 (929) 517-0359 (international) and refer to conference ID 8792127. SHP2 is a critical signaling node and regulator that promotes cancer cell survival and growth through the RAS pathway, playing a key role in the way cancer cells develop resistance to targeted therapies.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Drug Discovery World

JULY 16, 2024

That’s as agencies around the world continue to refine and update their requirements, with a bearing on development, marketing approval application and license maintenance processes. Another is in making prompter and more value-added use of regulatory intelligence. Again, these are likely to appear in local languages.

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Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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Drug Discovery World

APRIL 20, 2023

Regulators are therefore used to seeing cognitive data as primary or secondary outcomes in clinical trials, and are familiar with the instruments and methodological nuances of such data. Characterizing long COVID in an international cohort: 7 months of symptoms and their impact,” EClinicalMedicine, vol. depression). S Bliddal et al.,

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Agency IQ

MAY 28, 2024

regulator lays out proposal for international device and diagnostics recognition The British medical device regulator just issued its promised framework on international recognition. law as the Medical Devices Regulation 2002 (UK MDR 2002). law as the Medical Devices Regulation 2002 (UK MDR 2002).

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Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

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Drug Target Review

NOVEMBER 22, 2023

These proteins in turn regulate gene expression through the activation of several transcription factors, including NF-κB. We will present some of the data at the end of the study at an international conference next year. We are also developing our own TGF-β pathway inhibitor, IOA-359, which was licensed into iOnctura earlier this year.

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Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

NOVEMBER 29, 2020

MDM2 is a key regulator of the tumor suppressor p53 and one of the most potent inhibitors of apoptosis discovered thus far. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. SUZHOU, China and ROCKVILLE, Md. , Shaomeng Wang, Ph.D.,

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Policy Prescription

MAY 28, 2021

and licensed by your state board of pharmacy.” state-licensed board of pharmacy licensed pharmacy.”. Licensed Canadian retail pharmacies cannot dispense medications in person or through the mail that are not approved for sale in Canada. state-licensed board of pharmacy licensed pharmacy.”. Emphasis added).

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Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. Read AgencyIQ’s analysis of a lower court’s ruling.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

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New Drug Approvals

OCTOBER 24, 2023

1] [9] [10] Names Etrasimod is the international nonproprietary name. [11] “The Selective Sphingosine 1-Phosphate Receptor Modulator Etrasimod Regulates Lymphocyte Trafficking and Alleviates Experimental Colitis” J Pharmacol Exp Ther. 11] SYN ACS Med. “Velsipity (etrasimod) tablets, for oral use” (PDF). . ^

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Drug Discovery World

JULY 13, 2023

The rules and regulations Unlicensed drugs are drugs that have not yet been assessed by a regulator, while off-label use is when an approved medication is prescribed outside of the terms of its license, e.g., for a different disease or in a different patient group. What are the risks?

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Advarra

JUNE 14, 2024

Protocol and amendments Purpose: To document revisions of trial-related documents during the trial Documents: Log of protocol changes, IRB-approved protocol with principal investigator (PI) signature page, IRB-approved case report forms, IRB-approved advertisements and participant information sheets, protocol amendments Informed consent documents Purpose: (..)

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Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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The Pharma Data

JANUARY 10, 2021

They will use this opportunity to raise the profile of VALBIOTIS, a company specializing in the prevention of metabolic diseases, with over 10,000 international specialists from the healthcare industry who meet by invitation each year. Founded in 1983, this annual event has become the most important international conference in the sector.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Compass has studied psylocibin for PTSD in an open-label, Phase 2 setting.

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The Pharma Data

MARCH 1, 2022

Syndesi’s unique molecules act pre-synaptically to enhance synaptic efficiency by positively modulating the function of synaptic vesicle protein 2A (SV2A), which plays a central role in regulating neurotransmission. The lead molecule, SDI-118, was discovered by UCB before being out-licensed to Syndesi as of 2018.

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The Pharma Data

DECEMBER 12, 2020

Click here for available international numbers. Evercore Partners International LLP (“Evercore”), and Centerview Partners UK LLP (“Centerview Partners”) are acting as lead financial advisers. International plc (“Morgan Stanley”) and Morgan Stanley Bank International Limited and J.P. UK : +44 203 481 5237.

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The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. This disclosure contains information that Lipidor is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). Aurena Laboratories has already met the requirements of the U.S.

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PPD

MAY 7, 2024

The European Union (EU) is on the verge of a significant shift as it prepares to implement new health technology assessment (HTA) regulations in 2025. Challenges and opportunities of the new EU HTA regulation The implementation of centralized HTA presents both opportunities and challenges for pharmaceutical companies.

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The Pharma Data

MAY 13, 2021

In Focus: International. Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). Biogen licenses a stroke drug from Japanese drugmaker TMS ( BioPharmaDive ). Regulator seeks views on reclassification of pain medication ( MHRA 1 , 2 ). Medtech.

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Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to the FDA, delays arose due to issues with international inspections during the pandemic.

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Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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The Pharma Data

OCTOBER 15, 2020

Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. Researchers at MSK developed naxitamab and omburtamab, which are exclusively licensed by MSK to Y-mAbs. About Y-mAbs.

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The Pharma Data

DECEMBER 9, 2020

The company will operate in three international offices, Shanghai and Beijing in China and will also have a presence in Boston. . The creation of Overland isn’t the only exciting thing happening for international life sciences companies and organizations. Below is a roundup of some of this week’s interesting news.

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Drug Target Review

AUGUST 9, 2024

Global efforts to standardise regulations could streamline development processes and eventually improve the likelihood of drug development success. While current and future innovations in drug development hold immense promise, there are potential dangers that have not yet been accounted for in regulatory standards.

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The Pharma Data

NOVEMBER 27, 2020

This indication is approved under accelerated approval regulation based on overall response rate and duration of response. The FDA granted approval under the accelerated approval regulation. Researchers at Memorial Sloan Kettering Cancer Center (“MSK”) developed Danyelza, which is exclusively licensed by MSK to Y-mAbs.

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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

JANUARY 12, 2024

device regulation timelines To kick off 2024, the British device regulator offered its medical device and IVD plans for this year and next, promising public action on the post-market surveillance regulation by mid-2024 and on the core regulations in late 2024 or early 2025. New roadmap sets out U.K.

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