Drug Target Review

JANUARY 31, 2024

Since joining Allergan Aesthetics in 2001, my role in medical affairs has always focused, in one way or another, on supporting the journey of a drug/device from bench to bedside. One of the biggest obstacles I faced early in my career was the perception that women often quit their career to achieve a work-life balance.

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Conversations in Drug Development Trends

MAY 23, 2024

Regulatory Harmonization of Clinical Trials in the EU The EU-CTR repealed the Clinical Trial Directive 2001/20/EC (CTD) and national implementing legislation in the EU Member States on 31 January 2022. This blog delves into the key aspects of the EU regulatory space and provides insights into navigating these changes effectively.

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The Pharma Data

DECEMBER 20, 2020

They are one of the top pharmaceutical firms in China and are considered a market leader in the antibiotics space. There is an urgent need in China, and indeed, globally, to bring new antibiotics to the market that can address critical resistance issues. Shanghai Haini) was founded in 2001. and EU based on these results.

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The Pharma Data

OCTOBER 18, 2020

develops, manufactures and markets wearable robotic exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke. ReWalk’s mission is to fundamentally change the quality of life for individuals with lower limb disability through the creation and development of market leading robotic technologies.

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Agency IQ

APRIL 12, 2024

Directive 2001/83/EC and Regulation (EC) No 726/2004. For the regulation , this centered on market exclusivity for orphan drugs and whether there should be a separate category for medicinal products addressing unmet need. Orphan drug market exclusivity: Orphan drugs would receive 9 years’ market exclusivity (currently 10 years).

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The Pharma Data

DECEMBER 15, 2020

We will make full use of our advantages, such as nationwide marketing, promotion, networking, to formulate market strategies, complete academic promotion, brand management and other integrated services together with CHIPCREEN BIOSCIENCES. ” About CHIPSCREEN BIOSCIENCES. ” About CHIPSCREEN BIOSCIENCES.

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Agency IQ

AUGUST 9, 2024

BY Scott Stephens, MPA | Aug 6, 2024 8:17 PM CDT The Stockholm Convention and its implementation in the EU Adopted in 2001, the Stockholm Convention is an international treaty aimed at limiting the production, release, and damaging effects of persistent organic pollutants (POPs).

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FDA Law Blog: Drug Discovery

APRIL 23, 2023

The Draft Guidance also states that sponsors must include in their marketing applications relevant patient-level data for both arms. Additionally, the Draft Guidance states: “Sponsors must include in their marketing applications relevant patient-level data (i.e., or a non-inferiority study.”).

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Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

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Agency IQ

JUNE 7, 2024

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. Key Documents and Dates Single Market Compliance Space (NANDO) database Notified Body applications for designation

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Agency IQ

MARCH 7, 2024

To keep critical devices and in vitro diagnostics (IVDs) available for patients in Great Britain (England, Scotland, and Wales), a much smaller market than the remaining 27 Member States of the E.U., post-market regulation here.] In the wake of Brexit, the E.U. no longer recognized products certified in the U.K., but the U.K.

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Agency IQ

AUGUST 23, 2024

applications) on biopharmaceutical products to regulators for review and marketing authorization throughout the region via three routes. First, sponsors can opt to pursue marketing authorization in an EU member state by submitting their dossier to that state’s health authority (i.e., the “national competent authority,” or NCA).

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Agency IQ

AUGUST 16, 2024

Lykos Therapeutics’ New Drug Application (NDA) for MDMA capsules to treat post-traumatic stress disorder (PTSD) A lengthy regulatory history: The initial investigational new drug application for midomafetamine was filed in 2001. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

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New Drug Approvals

JANUARY 13, 2023

Jump up to: a b Kushiku K, Yamada H, Shibata K, Tokunaga R, Katsuragi T, Furukawa T (January 2001). . “Population pharmacokinetic-pharmacodynamic modelling of angiotensin receptor blockade in healthy volunteers” Clinical Pharmacokinetics. 41 (2): 137–52. doi : 10.2165/00003088-200241020-00005. PMID 11888333. S2CID 13185772.

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Agency IQ

SEPTEMBER 29, 2023

The intent is to create a single market for data, establish common European data spaces, and allow the companies that generate the data to keep control and maintain trade secrets. market regardless of the location of the business. The Act would apply to manufacturers of connected products and related services on the E.U.

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LifeSciVC

NOVEMBER 30, 2023

Several years into the post-bubble bear market, the public biotech sector has only contracted by 4.5% Here are the data from BMO Capital Markets, looking at the changes to the overall public market company counts: Shutdowns were only 2% of the sector: declaring failure and closing up shop just hasn’t happened often.

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Agency IQ

JULY 12, 2024

Next, the European Commission collected data from marketing authorization holders, suppliers and national competent authorities for the selected medicines. Marketing authorization holders also were asked to provide a supply chain risk assessment evaluating potential vulnerabilities and the expected economic viability of the medicine.

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Agency IQ

NOVEMBER 3, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. The provision aims to ensure patient access to medicines where they have been marketed. healthcare systems for years. Several legislative efforts are under way to ensure supply of medicines in the E.U.

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PLOS: DNA Science

MARCH 21, 2024

Gene therapy had progressed faster in Europe over the previous decade than in the US, due to delays in clinical trials in the wake of the death of 18-year-old Jesse Gelsinger in a trial to treat a urea cycle disorder, and then after five boys developed leukemia, with one death, in a trial for a form of severe combined immune deficiency in 2001.

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The Pharma Data

OCTOBER 21, 2020

Those drugs belong to a class called tyrosine kinase inhibitors (TKIs), and include Gleevec — the first TKI approved, back in 2001 — as well as newer ones like Sprycel and Bosulif. When it came to market in 2014, the price tag for one treatment cycle was $89,000. The chemo-free approach could shorten that.

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The Pharma Data

OCTOBER 21, 2020

Those drugs belong to a class called tyrosine kinase inhibitors (TKIs), and include Gleevec — the first TKI approved, back in 2001 — as well as newer ones like Sprycel and Bosulif. When it came to market in 2014, the price tag for one treatment cycle was $89,000. The chemo-free approach could shorten that.

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Agency IQ

JANUARY 26, 2024

Samples retained for testing should be kept under similar storage conditions and within the same container-closure system in which the drug is marketed. In 2001, the American Medical Association (AMA) conducted a survey of relevant stakeholders – including PhRMA, the U.S.

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Agency IQ

JUNE 21, 2024

For products that seek approval through the “centralized marketing authorization application,” the EMA’s Committee for Medicinal Products for Human Use (CHMP) conducts a scientific evaluation and issues a positive or negative opinion on whether an authorization should be granted. Conversely, authorization in specific E.U.

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The Pharma Data

MAY 13, 2021

Nel 2001 la mia salute stava andando. Dal momento che la. maggior parte delle medicine sono molecole sintetiche, sono tossiche per. il corpo umano e causano frequentemente effetti indesiderati, ulteriori. malattie ed addirittura la morte. Per nascondere. questo schema infame, l’industria farmaceutica spende miliardi di dollari in.

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Agency IQ

JULY 8, 2024

In 2001, the FDA issued a guidance to “alert hospitals, nursing homes, and other health care facilities to the hazards of medical gas mix-ups.” While the use of medical gases raises few safety concerns when they are used as intended, there have been instances where mix-ups involving medical gases have resulted in serious patient injuries.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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Agency IQ

DECEMBER 15, 2023

Currently, only Article 23a and Article 81 of Directive 2001/83/EC address medicines supply across the E.U. Of note, marketing authorization holder obligations are also being updated through the revision of the pharmaceutical legislation. healthcare systems for years. The Union list may include medicines not found on a national list.

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Codon

JANUARY 2, 2024

The D’Autry-Gilson micropipettes were sold across Europe, but rights to the United States market were bought by Kenneth Rainin , a young California businessman. As Gilson and Rainin competed for large chunks of the micropipette market, other businesses popped up to profit from their disposable tips. Micropipette innovators.

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FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

Not surprisingly, then-presidential candidate Asa Hutchinson, DEA Administrator from 2001 to 2003, did not sign the letter. The illicit marijuana market remains strong despite state laws legalizing marijuana. The letter is signed by six former DEA administrators and five former Directors of National Drug Policy.

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Common Sense for Drug Policy Blog

JUNE 4, 2023

Data between 2001-2018 evidences a substantial increase in drug poisonings over time for people who use opioids, with risk increasing particularly between the years of 2010-2018, an effect which was not entirely explained by the ageing of this cohort ( Lewer et al., dwf_admin Sun, 06/04/2023 - 19:58 Source Poulter, H.

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LifeSciVC

OCTOBER 28, 2024

Today’s market likes products. Investors, especially in the public markets, only want late stage de-risked assets. Or so the conventional wisdom goes in the equity capital markets these days. The tone of today’s market reveals it’s close to suffering those latter conditions. Platforms aren’t in vogue anymore.

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Codon

DECEMBER 12, 2024

7 During the few years that thalidomide was available on the market — and before Australian doctor William McBride warned of its consequences in a letter published in The Lancet in 1961 — it affected more than 10,000 babies, killing about half of them within months after birth.

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Agency IQ

JUNE 16, 2023

For increased flexibility in bringing PIPs to market, a developer can also submit both. Market-based mechanisms include water quality trading under the Clean Water Act (CWA), an approach that may cost less than more traditional regulatory approaches. EPA is reviewing the comments received and is planning to issue a final rule.

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Perficient: Drug Development

JANUARY 3, 2025

It helps web editors and marketers handle everything from social media and blog posts to advanced personalization. Since its launch in 2001, it has become popular for managing digital content, optimizing user experiences, and analyzing customer data from both online and offline interactions.

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Agency IQ

MARCH 29, 2024

April 2024 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program (Proposed Rule Stage) 2040-AG02 EPA supports market-based mechanisms, including water quality trading under the Clean Water Act (CWA). EPA plans to continue its outreach efforts with affected parties.

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Agency IQ

DECEMBER 15, 2023

April 2024 Market-Based Approaches Under the National Pollutant Discharge Elimination System (NPDES) Program Proposed Rule Stage 2040-AG02 EPA supports market-based mechanisms, including water quality trading under the Clean Water Act (CWA). These standards were vacated on 7/24/2001 and on 2/13/2002.

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Drug Target Review

FEBRUARY 15, 2024

This support is essential if there is likely no established commercial market for that drug. There is now widespread consensus that the commercial anti-infective market is broken and unable to address the growing threat of antimicrobial resistance. Available from: [link] The Antibiotic Market Is Broken—and Won’t Fix Itself [Internet].

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