Drug Patent Watch

JULY 25, 2024

The generic drug market has been significantly impacted by the COVID-19 pandemic, with both challenges and opportunities arising from the crisis. As the world continues to recover…

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Drugs.com

APRIL 4, 2024

THURSDAY, April 4, 2024 (HealthDayNews) -- Following disappointing trial results, the maker of a controversial ALS drug said it is pulling the medication off the market. In a statement issued Thursday, Amylyx Pharmaceuticals said that Relyvrio.

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Drug Channels

NOVEMBER 13, 2024

As I predicted, the stand-alone Medicare Part D prescription drug plans (PDP) market is vanishing. The destruction of the Part D market marks yet another unintended consequence of the Inflation Reduction Act of 2022 (IRA). Read more » © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company.

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Cytel

MAY 7, 2024

Here we explore the evolution and impact of market exclusivity policies in the EU and US, highlighting their role in fostering innovation and accessibility in rare disease treatment. Market exclusivity for orphan drugs traces back to the early 1980s in the United States, with the landmark Orphan Drug Act of 1983.

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Drug Channels

NOVEMBER 15, 2024

The authors outline the challenges that manufacturers face when integrating internal and external datasets to build market access and commercialization strategies. TThey argue that unified datasets and the addition of AI-driven analytics tools can improve decision making throughout a drug’s life cycle. Read on for their insights.

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Fierce BioTech

OCTOBER 21, 2024

Chiefly, Sailer highlights the transformative impact of AI and machine learning in drug development, a trend which, he believes, can potentially double approval rates while reducing costs and time-to-market.

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Common Sense for Drug Policy Blog

NOVEMBER 15, 2024

Adulteration of MDMA in the Unregulated Market "Most of the concern with MDMA adulteration focuses on the plethora of other substances that have been detected in the MDMA supply. Piperazines first appeared in 2000 but saturated the market from 2008–2013, when these compounds were detected in about one-quarter (24 %) of drug items.

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Drugs.com

MARCH 11, 2024

MONDAY, March 11, 2024 -- Following disappointing trial results, the maker of a controversial ALS drug may pull the medication off the market. In a statement issued Friday, Amylyx Pharmaceuticals said that Relyvrio failed to help patients in a.

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Alta Sciences

NOVEMBER 5, 2024

Since poorly soluble drugs are difficult to formulate as tablets, formulation scientists are looking to two-piece, liquid-filled hard-shell capsules as a solution. And when it’s time to go to market, the scale-up of the manufacturing process for commercialization is straightforward. Why Liquid-Filled, Hard-Shell Capsules?

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The Premier Consulting Blog

NOVEMBER 12, 2024

For drug developers the 505(b)(2) pathway presents an expedited pathway to FDA approval. De-mystifying the payer evaluation process of 505(b)(2)s A drug developer’s 505(b)(2) product is approved by FDA. This often leads to a major disconnect at the time of launch. Non-preferred coverage. The process starts broad and then narrows.

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ProRelix Research

NOVEMBER 2, 2023

Although clinical trials provide useful information regarding the efficacy and safety of new drugs, biological products, and medical devices, the information captured through them is not all-encompassing. Limited patient populations, […] The post Post-Marketing Surveillance Strategies appeared first on ProRelix Research.

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BioPharma Drive: Drug Pricing

SEPTEMBER 26, 2024

The withdrawal comes as trial results indicate safety concerns with the drug, Oxbryta, which was first approved in the U.S.

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BioPharma Drive: Drug Pricing

AUGUST 8, 2023

The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.

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Common Sense for Drug Policy Blog

FEBRUARY 14, 2024

Nitazenes in the Global Drug Market "Highly potent synthetic opioids have not played such a prominent role in rising deaths among people who use drugs in the UK. Global drug markets are, however, rapidly evolving. Nitazenes-heralding a second wave for the UK drug-related death crisis? Lancet Public Health.

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Drug Patent Watch

OCTOBER 2, 2023

The FDA conducted a study to identify factors that may predict the likelihood of generic drug marketing applications.

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Collaborative Drug

APRIL 19, 2024

Tokyo, Japan, April 17, 2024 — In a significant move to bolster CDD Vault’s presence in the Japanese market, Collaborative Drug Discovery (CDD) is excited to announce the appointment of Mr. Yasushi Hamagashira as the new Head of Sales and Marketing for Japan.

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Drug Channels

NOVEMBER 19, 2024

In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). for his upcoming live video webinar, Drug Channels Outlook 2025 , on December 13, 2024, from 12:00 p.m. Fein, Ph.D., to 1:30 p.m.

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Fierce BioTech

AUGUST 21, 2024

Market-Moving Trends to Watch in H2 2024 In a market defined by unpredictability, volatility, and fast-paced evolution, it can be challenging to determine where it’s heading and what executives should concern themselves with in the second half of 2024 and beyond. Interest in obesity drugs has led to billions of new prescriptions.

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Drugs.com

JULY 19, 2024

Food and Drug Administration on Thursday authorized the sale of the country's best-selling e-cigarette.The agency's decision only applies to several tobacco-flavored versions of the reusable product, sold as Vuse. FRIDAY, July 19, 2024 -- The U.S.

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Common Sense for Drug Policy Blog

JUNE 6, 2024

Image and Performance Enhancing Drugs and Social Media Marketing "The final theme emanating from this exploration is the notable affordances and ‘malaffordances’ of both platforms that facilitate IPED supply. This has potentially negative consequences for the safety of users and the regulation of the market."

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Common Sense for Drug Policy Blog

JUNE 6, 2024

The Market for Image and Performance Enhancing Drugs (IPEDs) "The market for image and performance enhancing drugs has undergone seismic changes in the last two decades and, as has been alluded to above, its partial digitisation has created something of a dual space of commerce (Gibbs, Forthcoming ). Fincoeur et al.

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Common Sense for Drug Policy Blog

DECEMBER 14, 2023

Dark Web and the Street Drug Market "Highly anonymized, elusive, and unregulated, the Dark Web is an ideal landscape for vendors selling illicit substances. The substances, in addition to the markets themselves, that are available on the Dark Web at any given time are difficult to predict. Drug Science, Policy and Law.

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Fierce BioTech

SEPTEMBER 24, 2024

Unlocking European market access for rare disease therapies The European orphan drug market presents a significant opportunity for biotech firms. Learn more about early access programs (EAPs), and how they are emerging as a critical strategy for successfully launching rare disease therapies in this complex and diverse market.

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Nvidia Developer: Drug Discovery

OCTOBER 30, 2024

The integration of AI in drug discovery is revolutionizing the way researchers approach the development of new treatments for various diseases. The integration of AI in drug discovery is revolutionizing the way researchers approach the development of new treatments for various diseases. Traditional.

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Common Sense for Drug Policy Blog

FEBRUARY 14, 2024

The Future of North America's Unregulated Drug Market "The trend towards higher potency is likely most indicative of what to expect from future illicit substance market developments. According to Canadian drug seizure statistics heroin is no longer among the top ten recovered illegal substances [ 32 , 40 ].

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Reprocell

NOVEMBER 14, 2024

The journey of drug discovery is notoriously long; from initial discovery and development to clinical assessment and final approval, the process can take anywhere from 10 to 30 years and cost billions of dollars 1, 2.

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ProRelix Research

DECEMBER 27, 2022

Clinical trials form the crux of all regulatory decisions regarding any new health intervention such as drugs and medical devices and thus require to be performed with the utmost care […]. The post USA Clinical Trial Market Size and Opportunities appeared first on ProRelix Research.

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Common Sense for Drug Policy Blog

JUNE 24, 2024

Growth of New Psychoactive Substances on the Unregulated Market "The NPS phenomenon remains a considerable challenge due to its evolving nature. The range of compounds currently on the drug market is constantly changing, with new and previously unknown substances entering the market every year.

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Drug Patent Watch

OCTOBER 6, 2020

The post Finding and Evaluating Generic Drug Market Entry Opportunities appeared first on DrugPatentWatch - Make Better Decisions. Here is a copy of the talk I gave at the recent Marcusevans 13th Portfolio Management and Pipeline Optimization for Generics. I cover: How to find and evaluate generic entry….

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Fierce BioTech

JANUARY 9, 2024

This webinar provides a roadmap for organizations seeking to marry scientific excellence with market access acumen, driving transformative change for the benefit of patients. Listing Image QuartzListingLogo_250x190_clarivate.png Listing Introduction From R&D Promise to In-market Wins. Click here to login.

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Common Sense for Drug Policy Blog

JUNE 4, 2023

Drug Checking as a Market Intervention "This research sought the perspectives of people involved in the unregulated drug market on how drug checking could be implemented as a market intervention within the current context of a highly unpredictable drug supply and unprecedented rates of overdose.

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Common Sense for Drug Policy Blog

DECEMBER 14, 2023

Changes in Dark Web Drug Markets "Descriptive analysis of the data collected through both the literature review and data scraping on the Dark Web indicated varying periods of volatility in the availability and distribution of psychoactive substances. Decrypting the cryptomarkets: Trends over a decade of the Dark Web drug trade.

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Drug Channels

OCTOBER 2, 2024

The 340B contract pharmacy market shows little sign of slowing down. Drug Channels Institute’s exclusive analysis of the 2024 market reveals that: About 33,000 pharmacy locations—more than half of the entire U.S. For an updated look at what’s next for the 340B contract pharmacy market, join Adam J. Fein, Ph.D.,

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BioPharma Drive: Drug Pricing

NOVEMBER 14, 2024

A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing Leqembi up for authorization in a major market.

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Drug Patent Watch

JULY 24, 2024

As patents expire on blockbuster biologic drugs, manufacturers are increasingly employing a controversial tactic known as “product hopping” to maintain […] Source

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BioPharma Drive: Drug Pricing

JULY 22, 2024

Private biotech company acquisitions are on their fastest pace in years, a trend some in the industry say is driven by the abundance of mature, but not yet public, drug startups.

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Common Sense for Drug Policy Blog

DECEMBER 14, 2023

Estimated Size of Drug Markets on the Dark Web "An Internet survey conducted simultaneously in 10 European Union countries in the period 2017–2018 among some 20,000 Internet-using drug consumers,15 using various recruitment strategies,16 found that 8 per cent of survey respondents had bought drugs on the dark web.17

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