Drug Discovery Today

JANUARY 26, 2022

Saffron Walden, 26th January 2022 / Domainex Ltd., a leading provider of integrated drug discovery services to life science organisations globally, is delighted that Professors Daniel Longley, Tim Harrison and colleagues at Queen’s University Belfast have entered into a collaboration and licensing agreement with Ipsen. The agreement provides an exclusive licence to research, develop, manufacture and commercialise FLIP inhibitors.

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Eye on FDA

JANUARY 26, 2022

FDA’s Office of Prescription Drug Promotion (OPDP) issued the first regulatory action letter for 2022. This one has some notable characteristics. As has been frequently noted, enforcement actions by OPDP have diminished considerably over the years. Another characteristic of recent enforcement actions over the past several years is that smaller, less well-known companies have mostly been the recipients of letters from OPDP.

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Drug Patent Watch

JANUARY 24, 2022

Annual Drug Patent Expirations for ESBRIET Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are twenty-one patents…. The post New patent expiration for Genentech Inc drug ESBRIET appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Channels

JANUARY 28, 2022

Today’s guest post comes from Fiza Bari, Senior Solutions Consultant and GTM Liaison at MMIT. Fiza discusses the impending influx of biosimilars and its effect on manufacturers, specifically in the immunology space. To learn more, sign up for MMIT’s Immunology Biosimilars webcast. It's a moderated discussion with payers on how the changing market might impact their management strategies in immunology.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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Molecule Blog

JANUARY 28, 2022

A blossoming Decentralized Science (DeSci) movement is changing the biopharma landscape by enabling the formation of patient- and researcher-centric communities building with an open-source ethos. Breaking Eroom’s Law We are all familiar with Moore’s Law - the observation that the number of transistors in a dense integrated circuit doubles about every two years, which broadly describes the exponential growth we see in computational power over time.

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Drug & Device Law

JANUARY 25, 2022

Using its increasingly notorious “ shadow docket ,” the United States Supreme Court recently stayed operation of the COVID-19 vaccine mandate that the Occupational Safety and Health Administration (“OSHA”) had imposed on large (more than 100 employees) employers nationwide. See National Federation of Independent Businesses v. OSHA , S. Ct. , 2022 WL 120952 (U.S.

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Drug Channels

JANUARY 25, 2022

Super Bowl LVI is on the horizon. Time for some blow-out beer commercials, occasionally interrupted by a football game. But who needs a Super Bowl party when you can tackle this month’s selection of notable news stories, intercepted for you from the Drug Channels gridiron: Offsides : A shocking update about the gross-to-net bubble for insulin Trick Play : OptumRx trolls us Fumble : High-deductible health plans foul out with patients Offensive Lines : The 340B program’s unstoppable growth Plus, t

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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for XARELTO Xarelto is a drug marketed by Janssen Pharms and is included in one NDA. It is available from three suppliers. There are four patents…. The post New patent for Janssen Pharms drug XARELTO appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for VALTOCO Valtoco is a drug marketed by Neurelis Inc and is included in one NDA. There are five patents protecting this drug. VALTOCO drug price…. The post New patent for Neurelis Inc drug VALTOCO appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for NUBEQA Nubeqa is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Bayer Healthcare drug NUBEQA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for BIJUVA Bijuva is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are nineteen patents…. The post New patent for Therapeuticsmd Inc drug BIJUVA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 28, 2022

Annual Drug Patent Expirations for TYRVAYA Tyrvaya is a drug marketed by Oyster Point Pharma and is included in one NDA. There are five patents protecting this drug. This drug…. The post New patent for Oyster Point drug TYRVAYA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 27, 2022

Annual Drug Patent Expirations for ABILIFY+MAINTENA+KIT Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. It is available from one supplier.…. The post New patent expiration for Otsuka Pharm drug ABILIFY MAINTENA KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 27, 2022

Annual Drug Patent Expirations for ABILIFY+MYCITE+KIT Abilify Mycite Kit is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are thirty-one…. The post New patent expiration for Otsuka drug ABILIFY MYCITE KIT appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Trials

Drug Patent Watch

JANUARY 27, 2022

Annual Drug Patent Expirations for NYMALIZE Nymalize is a drug marketed by Arbor Pharms Llc and is included in one NDA. It is available from one supplier. There are four…. The post New patent for Arbor Pharms drug NYMALIZE appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 27, 2022

Annual Drug Patent Expirations for ALPHAGAN+P Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent expiration for Allergan drug ALPHAGAN P appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 27, 2022

Annual Drug Patent Expirations for ABILIFY Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from two suppliers.…. The post New patent expiration for Otsuka drug ABILIFY appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 26, 2022

Annual Drug Patent Expirations for BIJUVA Bijuva is a drug marketed by Therapeuticsmd Inc and is included in one NDA. It is available from one supplier. There are nineteen patents…. The post New patent for Therapeuticsmd Inc drug BIJUVA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 26, 2022

ABILIFY MAINTENA KIT (aripiprazole) Otsuka pharm co ltd Patent: 9,089,567 Expiration: Jan 28, 2022 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence…. The post Drug Patent Expirations for the Week of January 23, 2022 appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 26, 2022

Annual Drug Patent Expirations for CYTALUX Cytalux is a drug marketed by On Target Labs and is included in one NDA. The generic ingredient in CYTALUX is pafolacianine sodium. Additional…. The post New patent for On Target drug CYTALUX appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 25, 2022

Annual Drug Patent Expirations for ALPHAGAN+P Alphagan P is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. There are eight patents…. The post New patent expiration for Allergan drug ALPHAGAN P appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 25, 2022

Annual Drug Patent Expirations for REXULTI Rexulti is a drug marketed by Otsuka and is included in one NDA. It is available from one supplier. There are six patents protecting…. The post New patent for Otsuka drug REXULTI appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 24, 2022

Annual Drug Patent Expirations for GIAPREZA Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for La Jolla drug GIAPREZA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 24, 2022

Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Sun Pharm drug WINLEVI appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 22, 2022

Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Abbvie Inc drug RINVOQ appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 28, 2022

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, Zydus Pharms, and Pfizer and, and is included…. The post New tentative approval for Amneal Pharms drug fesoterodine fumarate appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 27, 2022

This chart shows the drugs with the most supplementary protection certificates (SPCs). SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating for the long…. The post Which drugs have the most supplementary protection certificates? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 23, 2022

This chart shows the pharmaceutical drugs with the greatest number of patents still in force. The number of patents covering a drug can be indicative of the value of a…. The post Which pharmaceutical drugs have the most patents? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 25, 2022

This chart shows the pharmaceutical companies with the most patents in Australia. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Australia? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 28, 2022

This chart shows the pharmaceutical companies with the most concentrate dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most concentrate dosed drugs…. The post Which pharmaceutical companies have the most concentrate dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 24, 2022

This chart shows the drugs with the most patents in Portugal. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.…. The post Which pharmaceutical drugs have the most drug patents in Portugal? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

JANUARY 22, 2022

This chart shows the pharmaceutical companies with patents in the most countries. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the greatest global patent coverage? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug & Device Law

JANUARY 24, 2022

As a follow-on to our post last year about remote (Zoom) depositions), we received a suggestion that we examine MDL orders to see how they have been handling remote deposition procedure during the COVID-19 pandemic. That made sense to us because in MDLs every procedural jot and tittle is gone over with a fine-toothed comb. We asked our crack legal assistants to review our internal library of MDL procedural orders (yes, we have such a thing) to see what recent MDL transferee judges – advised by

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Drug & Device Law

JANUARY 26, 2022

If the pelvic mesh litigation ever ends, the tongue of history will tell a tale of specious plaintiff theories that hoodwinked judges and juries into condemning good products. Plaintiffs extracted millions of dollars and erased product lines by cobbling together irrelevant workplace material handling sheets, counterfactual stories in which the FDA does not exist, and expert theories grounded in junk science.

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