FDA Law Blog

SEPTEMBER 19, 2023

Karst — Listing patent information in the Orange Book is a matter of judgment, but that judgment call is about to get a bit more scrutiny. Last week, the FTC held a Listening Session about the listing of patents in the Orange Book, which concluded with a unanimous vote to issue a Policy Statement. Koblitz & Kurt R.

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Drug Discovery World

SEPTEMBER 1, 2023

News round-up for 28 August – 1 September by DDW Digital Content Editor Diana Spencer. Axcella granted US patent for long Covid fatigue treatment The US Patent and Trademark Office (USPTO) has granted a patent for Axcella Therapeutics’ long Covid treatment candidate AXA1125.

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FDA Law Blog

NOVEMBER 7, 2023

Mass hysteria! ” At least that’s this blogger’s reaction to the recent news that FTC sent out Notice letters to 10 different drug companies about the patent information they list in the Orange Book. f)(1), FTC notified FDA that it disputes “the accuracy or relevance of patent information submitted to. and published by FDA.”

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Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Court of Appeals for the Federal Circuit reversed a district court patent dispute decision in GlaxoSmithKline Beecham Ltd. In October, the U.S.

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pharmaphorum

MAY 6, 2021

Shares in COVID-19 vaccine manufacturers have taken a hit after the US signalled its support for waiving patents on them, a moved aimed to boost global supplies of the life-saving shots. Stocks hit by the news included companies such as Pfizer and Moderna, who are making profits from their COVID-19 vaccines.

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Pharma in Brief

FEBRUARY 8, 2023

Digby as the new Chairperson of the Patented Medicine Prices Review Board ( PMPRB ). According to the Government’s news release , “Mr. Under the Patent Act , the Chairperson and other Board Members can serve a maximum of two five-year terms.

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pharmaphorum

NOVEMBER 3, 2022

Specifically, they claim the chapter includes proposals that would impose changes to the patent system in India and make it easier for drugmakers to secure “evergreening” patents that would delay the entry of lower-cost generics.

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XTalks

MAY 25, 2021

AbbVie (NYSE:ABBV) continues to face heat over complaints of patent exploitation and price hikes of its world’s best-selling drug Humira (adalimumab) to build a market monopoly and block out Humira biosimilar competition. As of 2020, AbbVie filed 247 patents of which over 130 were granted. Humira Biosimilars: Alvotech Lawsuit.

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Pharmaceutical Technology

MAY 12, 2023

Matinas announced the news in a May 10 statement. The news means the collaboration between the two companies lasted just over a year. The company has submitted provisional patent applications for the formulations. Whilst the formulation had been successful in vitro , the oral administration in mice did not elicit activity.

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BioTech 365

JANUARY 11, 2022

DGAP-News: BRAIN Biotech AG / Key word(s): Patent 11.01.2022 / 18:50 The issuer is solely responsible for the content of this announcement. Zwingenberg, Germany, January 11th, 2022 BRAIN-Engineered-Cas (BEC) Considered a Patentable Technology BRAIN Biotech AG received an international search … Continue reading →

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Drug Discovery World

SEPTEMBER 16, 2022

News round-up for 12-16 September by DDW Digital Content Editor Diana Spencer. A slightly quieter week for news in light of national events in the UK, but the vital work of the international drug discovery community goes on and new discoveries are being made all the time. . Potential Alzheimer’s drug receives US patent .

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Pharma in Brief

OCTOBER 26, 2023

The Patented Medicine Prices Review Board ( PMPRB ) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023.

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BioTech 365

AUGUST 31, 2021

DGAP-News: Defence Therapeutics Inc. / Key word(s): Patent 31.08.2021 / 08:30 The issuer is solely responsible for the content of this announcement. CSE: DTC FSE: DTC USOTC: DTCFF PRESS RELEASE DEFENCE THERAPEUTICS FILES ACID-BASED HYDROGELS USA PROVISIONAL PATENT APPLICATION Vancouver, … Continue reading →

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BioTech 365

JULY 20, 2021

DGAP-News: BRAIN Biotech AG / Key word(s): Patent 21.07.2021 / 07:30 The issuer is solely responsible for the content of this announcement. Zwingenberg (Germany), July 21st, 2021 Novel Genome Editing Tool: Filing of International Patent Application Positive data evaluation Management … Continue reading →

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STAT News

MARCH 20, 2023

… Either due to cost or ongoing shortages, people are seeking alternatives to the brand name medications Ozempic and Wegovy, both of which contain the active ingredient semaglutide, NBC News tells us. And some people are turning to compounding pharmacies for the hard-to-get weight-loss drugs.

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BioTech 365

NOVEMBER 24, 2021

Biotechnology, Pharma and Biopharma News – Research – Science – Lifescience ://Biotech-Biopharma-Pharma: Enhancing the workhorse: Artificial intelligence, hardware innovations boost confocal microscope’s performance.Since artificial intelligence pioneer Marvin Minsky patented the principle of confocal microscopy in 1957, it (..)

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BioTech 365

DECEMBER 8, 2021

DGAP-News: BRAIN Biotech AG / Key word(s): Miscellaneous/Patent 08.12.2021 / 15:00 The issuer is solely responsible for the content of this announcement.

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BioTech 365

MARCH 2, 2021

DGAP-News: Virpax(R) Pharmaceuticals Inc. / Virpax Pharmaceuticals Announces Newly Issued Patent for Probudur(TM) WEST CHESTER, PA, March 2, 2021 – Virpax(R) Pharmaceuticals Inc. Key word(s): Miscellaneous 02.03.2021 / 14:00 The issuer is solely responsible for the content of this announcement. … Continue reading →

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Drug Discovery World

SEPTEMBER 8, 2023

News round-up for 4-8 September by DDW Digital Content Editor Diana Spencer. The post This week in drug discovery (4-8 September) appeared first on Drug Discovery World (DDW).

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Drug Discovery World

SEPTEMBER 26, 2022

DDW Editor Reece Armstrong takes a look at the recent Covid-19 patent battles involving key players in the pharmaceutical sector. . Moderna states that Pfizer and BioNTech’s Covid-19 vaccine Comirnaty infringes Moderna’s patents for its mRNA technology filed between 2010 and 2016.

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XTalks

OCTOBER 12, 2021

Related: AbbVie in Hot Water Over Patent Abuses and Price Hikes to Block Humira Biosimilar Competition. The new investigational arthritis vaccine against inflammatory arthritis is based on the 14-3-3? (14-3-3 And on World Arthritis Day, this is very hopeful news for the millions of sufferers of the disease.

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Pharma in Brief

JANUARY 11, 2023

Biosimilar drugs are subsequent-entry biologics which often enter the market after the patent or data protection rights for the originator biologic have expired. December 20, 2022 News Release , “Ontario Expanding Safe Use of Biosimilars”. An originator biologic is the first version of a biologic drug.

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The Pharma Data

NOVEMBER 19, 2020

” Several authors disclosed financial ties to the biopharmaceutical industry; several authors disclosed holding patents related to this work. More News Resources. Professional. AI Model May Predict Immunotherapy Response in Melanoma. THURSDAY, Nov. 19 in Clinical Cancer Research. .” © 2020 HealthDay. All rights reserved.

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XTalks

NOVEMBER 29, 2023

As per Masimo, Masimo SET® is the primary pulse oximetry technology used at nine of the top ten hospitals as ranked in the 2022 to 2023 US News & World Report Best Hospitals Honor Roll. In October, the US International Trade Commission (ITC) ruled that the Apple Watch violates patents owned by Masimo.

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XTalks

JUNE 20, 2022

Related: Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology. Alnylam has also been in the news recently over claims that it holds the patent for the lipid nanoparticle technology Pfizer and Moderna used in their COVID-19 vaccines. points in an external placebo group.

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Pharma in Brief

SEPTEMBER 1, 2022

In this post, we summarize the current status of reforms to the Patented Medicine Prices Review Board ( PMPRB ). These reforms commenced with August 2019 amendments to the Patented Medicines Regulations (the Amendments ) and accompanying changes to the Board’s Guidelines. Background of the proposed reforms. Soliris Settlement.

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pharmaphorum

APRIL 21, 2021

It propped up sales at GSK for years after patents expired because of delays developing cheaper copycats in the US, where the FDA has tough rules for drug/device combination products such as asthma inhalers.

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The Pharma Data

DECEMBER 3, 2020

Several authors disclosed financial ties to the biopharmaceutical industry, and several authors reported holding patents. More News Resources. Professional. Dexamethasone May Hinder Immunotherapy for Glioblastoma. THURSDAY, Dec. 25 in Clinical Cancer Research. Bryan Iorgulescu, M.D., © 2020 HealthDay. All rights reserved.

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Pharma in Brief

JUNE 20, 2023

The Patented Medicine Prices Review Board ( PMPRB ) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 ( Interim Guidance ). 1] The Board has also provided an update on a forthcoming consultation regarding new Guidelines.

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The Pharma Data

MARCH 3, 2021

This news release of Merck & Co., The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn.

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The Pharma Data

FEBRUARY 25, 2021

This news release of Merck & Co., The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn.

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The Pharma Data

MAY 7, 2021

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. . US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). Pharma Has Limited Legal Options If Vaccine Patents Waived ( Bloomberg ). It Needs More Than a Patent Waiver. (

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The Pharma Data

DECEMBER 20, 2020

Transcend is a research driven biotechnology company committed to addressing unmet mental health needs through the development of patented next generation psychedelic therapeutics including the Lysergic Acid Diethylamide (“LSD”) derivative BOL-148. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS. Source link.

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pharmaphorum

SEPTEMBER 18, 2020

“Picking the next merger candidate is hard enough, doing so before everyone else jumps on board, then picking the right time to sell makes for a dangerous investment game,” said one BBC News article from December 1998. Blockbusters go off patent. The EU patents expired in 2010 and 2011, causing further profit loss.

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XTalks

JANUARY 17, 2023

In light of this, he said the approval “is good news” for this segment of adult asthmatics who make up more than 80 percent of asthma patients in the US. Generics maker Viatris was able to win over a remaining patent on the drug, but AstraZeneca was able to counter it with a legal win of its own in December last year.

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Drug Discovery World

JANUARY 8, 2024

2 The discovery follows the news that MIT researchers have identified a new class of antibiotic candidates that can kill another deadly bacteria, methicillin-resistant Staphylococcus aureus (MRSA). Government incentives provide one solution.

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The Pharma Data

MARCH 16, 2021

This news release of Merck & Co., The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-Looking Statement of Merck & Co., Kenilworth, N.J., Kenilworth, N.J., Private Securities Litigation Reform Act of 1995.

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