Sat.Jul 10, 2021 - Fri.Jul 16, 2021

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DrugPatentWatch and Abbvie discuss Pharmaceutical Portfolio Management

Drug Patent Watch

Come join me and Wendi Lau from Abbvie as we participate in an interactive roundtable discussion on pharmaceutical portfolio management. We’ll be sharing our expertise and best practices for strategic…. The post DrugPatentWatch and Abbvie discuss Pharmaceutical Portfolio Management appeared first on DrugPatentWatch - Make Better Decisions.

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A Look Back

Dark Matter Blog

49 years ago, when I was 16 years old, I wanted to do exactly what I am doing now. The only subject in school that held my interest was biology. As soon as I learned about DNA and RNA, I wanted to be a molecular biologist. I wanted to use molecular biology to create drugs. However, that was 1972, and the biotechnology industry did not exist. Growing up in Shrewsbury, Massachusetts, it was natural for me to attempt to get a summer job up the road at the Worcester Foundation for Biomedical Researc

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The Power of Partnerships: Why Pharma Needs to Redefine its Role With IDNs

Drug Channels

Today’s guest post comes from MMIT's Dinesh Kabaleeswaran, Director of Advisory Services, and John Griggs, Senior Solution Consultant. Dinesh and John discuss the expanding role and importance of integrated delivery networks (IDNs) in specialty medication administration and reimbursement. Dinesh and John also highlight MMIT’s Pulse Analytics solution , which allows pharma manufacturers the ability to monitor drug coverage at the brand and IDN level.

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Lilly and Banner Alzheimer’s Institute collaborate on planned Phase 3 prevention trial of donanemab

The Pharma Data

Trial will include participants at risk for cognitive and functional decline related to Alzheimer’s disease. Eli Lilly and Company (NYSE: LLY) and Banner Alzheimer’s Institute today announced a strategic research collaboration as part of the planned Phase 3, randomized, placebo-controlled study evaluating donanemab in participants at risk for cognitive and functional decline related to Alzheimer’s disease (TRAILBLAZER-ALZ 3).

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How Machine Learning Drives Clinical Trial Efficiency

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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New patent for Karyopharm Theraps drug XPOVIO

Drug Patent Watch

Annual Drug Patent Expirations for XPOVIO Xpovio is a drug marketed by Karyopharm Theraps and is included in one NDA. There are five patents protecting this drug. This drug has…. The post New patent for Karyopharm Theraps drug XPOVIO appeared first on DrugPatentWatch - Make Better Decisions.

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The first national clinical research priority setting study in the AoD sector in Australia

National Drug & Alcohol Research Centre Blog

Dr Krista Siefried, Clinical Research Lead and Deputy Director of the National Centre for Clinical Research on Emerging Drugs (NCCRED) The first national clinical research priority setting study in the AOD sector in Australia was conducted to determine the focus of clinical research, seed funding, and training programs for The National Centre for Clinical Research on Emerging Drugs (NCCRED).

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Conversion of Kiadis to a private limited liability company postponed until completion of statutory buy-out proceedings

The Pharma Data

Sanofi (Euronext: SAN and NYSE: SNY) and Kiadis today announce that the conversion of Kiadis from a public limited liability company ( naamloze vennootschap ) into a private limited liability company ( besloten vennootschap met beperkte aansprakelijkheid ) shall be postponed until the Offeror has completed the statutory buy-out proceedings. In Section 6.13 of the Offer Memorandum the Offeror stated that it has the intention to amend the articles of association of Kiadis following termination of

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New patent for Merck Sharp drug NOXAFIL

Drug Patent Watch

Annual Drug Patent Expirations for NOXAFIL Noxafil is a drug marketed by Merck Sharp Dohme, Schering, and Msd Merck Co and, and is included in four NDAs. It is available…. The post New patent for Merck Sharp drug NOXAFIL appeared first on DrugPatentWatch - Make Better Decisions.

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OPDP Sends Untitled Letter

Eye on FDA

Upfront Author’s Note: This is the first posting in a while as I have been working to migrate the subscription service to a new provider. As such, some subscribers were lost in the process. Anyone who signed up for a subscription prior to 2019, would need to sign up again. Apologies for the inconvenience and thanks for your patience. Years ago, a single regulatory action letter issued by FDA’s Office of Prescription Drug Promotion (OPDP) would not have merited a blog posting in and o

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PBMs and Drug Spending in 2020: Data from CVS Health (sort of), Express Scripts, Navitus, and WellDyne (Plus: The Demise of PBM Reporting)

Drug Channels

Since 2012, Drug Channels has examined commercial drug spending using the annual trend reports published by the largest PBMs. This year, we review 2020 data on commercial plan sponsor clients of CVS Health and Express Scripts along with two smaller PBMs—Navitus and WellDyne. As you will see below, plan sponsors experienced another year of single-digit growth in overall pharmacy benefit drug spending.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Extension Of Innovation Partnering Office at Monash University In Collaboration With Victorian State Government To Accelerate The Life-Sciences Hub

The Pharma Data

– Victorian State Government extends financing of JJIPO@Monash for an additional two years. – Extension will further boost Victorian hub for researchers and early-stage companies to connect with industry experts and deliver novel healthcare solutions. Johnson & Johnson Innovation announced today the extension of the Johnson & Johnson Innovation Partnering Office at Monash University’s Clayton Campus in Melbourne (JJIPO@Monash) in collaboration with the Victorian State

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New patent for Novartis Pharms drug ENTRESTO

Drug Patent Watch

Annual Drug Patent Expirations for ENTRESTO Entresto is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are eight…. The post New patent for Novartis Pharms drug ENTRESTO appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Blueprint Medicines drug AYVAKIT

Drug Patent Watch

Annual Drug Patent Expirations for AYVAKIT Ayvakit is a drug marketed by Blueprint Medicines and is included in one NDA. There are three patents protecting this drug. This drug has…. The post New patent for Blueprint Medicines drug AYVAKIT appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for LUPIN drug SOLOSEC

Drug Patent Watch

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

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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AstraZeneca receives final regulatory clearance for the proposed acquisition of Alexion from the UK’s Competition and Markets Authority

The Pharma Data

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OR REGULATIONS OF SUCH JURISDICTION. THIS IS AN ANNOUNCEMENT AND NOT A CIRCULAR OR PROSPECTUS OR EQUIVALENT DOCUMENT FOR THE PURPOSES OF THE UK PROSPECTUS REGULATION RULES OR THE UK AND EU PROSPECTUS REGULATIONS.

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Sanofi announces Paris 2024 Premium partnership for the Olympic and Paralympic Games in Paris

The Pharma Data

Tony Estanguet, Chairman of Paris 2024, Paul Hudson, Sanofi Chief Executive Officer, and Serge Weinberg, Chairman of Sanofi’s Board of Directors, today announced Sanofi will become a Premium Partner of Paris 2024 for the Olympic and Paralympic Games being held in Paris in 2024. Paris will become the second city to host the summer Olympic Games three times with the last Games held in Paris 100 years ago in 1924.

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Sanofi streamlines Consumer Healthcare portfolio in Latin America with divestiture of eight brands to Hypera Pharma

The Pharma Data

As part of Sanofi’s ongoing efforts to simplify its Consumer Healthcare portfolio and accelerate its growth trajectory, the company has signed an agreement with HYPERA S.A. (“Hypera Pharma”) for the divestiture of eight products commercialized in Latin America. The agreement also includes four prescription products from the General Medicine portfolio. “As discussed during our Capital Markets Day in Febru ary , simplifying the CHC product portfolio is an important part of our strategy to fo

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Acquisition agreement for Prothena’s ATTR amyloidosis programme

The Pharma Data

Prothena is eligible to receive development and sales milestone payments totalling up to 1.2 billion US dollars , including 100 million dollars in upfront and near-term clinical milestone payments Novo Nordisk will develop the phase 2 ready antibody PRX004 for the rare heart disease ATTR cardiomyopathy. Prothena Corporation plc and Novo Nordisk A/S today announced that the companies have entered into a definitive purchase agreement under which Novo Nordisk has acquired Prothe

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Lilly Announces Acquisition of Protomer Technologies

The Pharma Data

Eli Lilly and Company (NYSE: LLY) today announced the acquisition of Protomer Technologies (“Protomer”), a private biotech company. Protomer’s proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity. The potential value of the transaction is over $1 billion, with successful achievement of future development and commercial milestones.

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Amgen And The International Federation of Psoriasis Associations Launch UPLIFT Innovation Challenge

The Pharma Data

Challenge to Support an Innovative Solution That Addresses Disconnect in Perception of Psoriatic Disease Severity and Undertreatment Documented in Multinational UPLIFT Survey UPLIFT Data Presented at WPPAC 2021 Report Substantial Disease Burden for People Living With Psoriasis and Psoriatic Arthritis. Amgen (NASDAQ:AMGN), in partnership with the International Federation of Psoriasis Associations (IFPA), announced the launch of the Understanding Psoriatic Disease Leveraging Insights for Treatment

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New FreVAX™ smartphone application brings piglet vaccination to another level

The Pharma Data

FreVAX is an innovative intramuscular needle free vaccine injection device for pigs around weaning until the end of nursery. This recent development has resulted from a partnership with Henke-Sass Wolf 1 Boehringer Ingelheim has introduced the FreVAX app 2.0 that aims to enhance the interaction with the FreVAX device. Boehringer Ingelheim, a leader in animal health, announces that the FreVAX intramuscular needle free device can now be managed via an entirely new version of the FreVAX smartpho

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New patent for Therapeuticsmd Inc drug BIJUVA

Drug Patent Watch

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 fifteen patents…. The post New patent for Therapeuticsmd Inc drug BIJUVA appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Teva Branded drug AUSTEDO

Drug Patent Watch

Annual Drug Patent Expirations for AUSTEDO Austedo is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are six…. The post New patent for Teva Branded drug AUSTEDO appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Boehringer Ingelheim drug TRADJENTA

Drug Patent Watch

Annual Drug Patent Expirations for TRADJENTA Tradjenta is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from three suppliers. There are nine patents…. The post New patent for Boehringer Ingelheim drug TRADJENTA appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Chiesi drug FERRIPROX

Drug Patent Watch

Annual Drug Patent Expirations for FERRIPROX Ferriprox is a drug marketed by Chiesi and is included in three NDAs. It is available from two suppliers. There are five patents protecting…. The post New patent for Chiesi drug FERRIPROX appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Zurex Pharma drug ZURAGARD

Drug Patent Watch

Annual Drug Patent Expirations for ZURAGARD Zuragard is a drug marketed by Zurex Pharma and is included in one NDA. The generic ingredient in ZURAGARD is isopropyl alcohol. Additional details…. The post New patent for Zurex Pharma drug ZURAGARD appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Amicus Theraps drug GALAFOLD

Drug Patent Watch

Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Theraps Us and is included in one NDA. There are twenty-five patents protecting this drug. This drug…. The post New patent for Amicus Theraps drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Expirations for the Week of July 11, 2021

Drug Patent Watch

BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER (esmolol hydrochloride) Baxter hlthcare Patent: 6,310,094 Expiration: Jul 12, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical…. The post Drug Patent Expirations for the Week of July 11, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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Artificial intelligence could be new blueprint for precision drug discovery

The Pharma Data

online issue of Nature Communications, researchers at University of California San Diego School of Medicine describe a new approach that uses machine learning to hunt for disease targets and then predicts whether a drug is likely to receive FDA approval. The study findings could measurably change how researchers sift through big data to find meaningful information with significant benefit to patients, the pharmaceutical industry and the nation’s health care systems. “Academic labs an

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Phase 2/3 Studies of Molnupiravir, an Investigational Oral Antiviral Therapeutic for Mild to Moderate COVID-19.

The Pharma Data

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinical trials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic. The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).

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U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

The Pharma Data

Finerenone is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes / Despite guideline-directed therapies, many patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) still progress to loss of kidney function and are at high risk for cardiovascular events / By blocking MR overactivation, a key driver of CKD progressi

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Orelabrutinib, an Innovative CNS Penetrant BTK Inhibitor For the Potential Treatment of Multiple Sclerosis

The Pharma Data

Orelabrutinib is a Phase 2 oral small molecule Bruton’s tyrosine kinase inhibitor with high selectivity and the ability to cross the blood-brain barrier InnoCare to receive a $125 million upfront payment and is eligible to receive potential development and commercial milestone payments. Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) today announced that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine k

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New patent for Boehringer Ingelheim drug GLYXAMBI

Drug Patent Watch

Annual Drug Patent Expirations for GLYXAMBI Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent for Boehringer Ingelheim drug GLYXAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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TAKHZYRO® (lanadelumab) for Hereditary Angioedema Patients to be Presented at European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress

The Pharma Data

Analysis of Safety and Efficacy for up to 2.5 years with TAKHYZRO is Consistent with Initial Period of Treatment, Building on Growing Body of Evidence on the Long-term Safety and Efficacy Final Patient Subgroup Analysis Suggests Reductions of HAE Attacks Across Range of Patient Demographics and Disease Characteristics with TAKHZYRO. Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced results from two final analyses from the Phase 3 HELP (Hereditary Angioedema L