Drug Discovery Today

MARCH 10, 2022

Heidelberg, 10 March 2022 Molecular Health and collaborators at the University of Florida College of Pharmacy, Takeda Oncology, and thinkQ² published a triad of articles that describe and prove the concept of a novel systems approach to elucidate molecular mechanisms of drug toxicities using real-world data (RWD).

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Drug Channels

MARCH 8, 2022

Next week, Drug Channels Institute will release our 2022 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. It’s the 13th edition of our popular and comprehensive examination of the entire drug pricing, reimbursement, and dispensing system. The exhibit below—one of 216 in our new report—provides a first look at the 15 largest organizations, ranked by total U.S. prescription dispensing revenues for calendar year 2021.

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Drug Patent Watch

MARCH 10, 2022

DrugPatentWatch developed this course to help users better understand the complexities and common strategies around brand erosion and generic entry. The positive responses received made it apparent that the course…. The post Free Online Course on Drug Patents, Generic and Branded Drugs appeared first on DrugPatentWatch - Make Better Decisions.

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Policy Prescription

MARCH 11, 2022

A recent opinion from an appeals court in Manitoba, Canada sheds new and more favorable light about the CanadaDrugs-related wholesale drug importation case that was first covered a decade ago in the Wall Street Journal. The case pertained to an indictment of CanadaDrugs, Ltd. for sales of mostly misbranded (but not counterfeit drugs) and two batches of counterfeit drugs.

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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.

Clinical Trials

Crown Bioscience

MARCH 10, 2022

Combination strategies of irradiation and immunotherapy have been shown to harness the immune system to improve responses in difficult-to-treat and/or unresponsive tumors. But, determining the administration sequence of radiotherapy and immunotherapy is not straightforward, so as a result, preclinical studies are being used to pinpoint the precise sequence.

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Drug Channels

MARCH 11, 2022

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey analyzes trends in patient support services and reimbursement hubs. Learn more about AssistRx’s specialty therapy initiation and patient support services at Asembia's Specialty Pharmacy Summit on May 2-5, 2022. Click here to schedule your meeting.

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The ChEMBL-og

MARCH 10, 2022

We are pleased to announce the release of ChEMBL 30. This version of the database, prepared on 22/02/2022 contains: 2,786,911 compound records 2,157,379 compounds (of which 2,136,187 have mol files) 19,286,751 activities 1,458,215 assays 14,855 targets 84,092 documents Data can be downloaded from the ChEMBL FTP site: [link] Please see ChEMBL_30 release notes for full details of all changes in this release: [link] New Deposited Datasets EUbOPEN Chemogenomic Library (src_id = 55, ChEMBL Document I

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The Pharma Data

MARCH 9, 2022

Novartis today announced a license option agreement with Voyager Therapeutics, a gene therapy company focused on next-generation adeno-associated virus (AAV) technologies, for three capsids to use in potential gene therapies for neurological diseases, with options to access capsids for two other targets. A leader in gene therapy with a strong commitment to developing treatments for diseases of the central nervous system, Novartis seeks to apply its expertise and recent learnings to neurological

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Atomwise Blog

MARCH 9, 2022

At the American Chemical Society Spring National Meeting & Expo, Atomwise members were selected to present their research and work. Learn what our Atoms have been working on below and visit Atomwise at ACS Spring 2022 National Meeting for other presentation sessions.

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Drug Patent Watch

MARCH 10, 2022

Annual Drug Patent Expirations for JORNAY+PM Jornay Pm is a drug marketed by Ironshore Pharms and is included in one NDA. There are thirteen patents protecting this drug. JORNAY PM…. The post New patent for Ironshore Pharms drug JORNAY PM appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Trials

Tecan

MARCH 9, 2022

By Nicholas Smith You are considering an Original Equipment Manufacturing (OEM) partner to support you in bringing your idea to market. The planned in vitro diagnostic device may require components, robotics and modules. You may need integration into an existing platform or the development of a completely new customized system. You may need to react quickly to unexpected circumstances requiring rapid changes in the throughput of your instruments.

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The Pharma Data

MARCH 9, 2022

Once-weekly efanesoctocog alfa met primary endpoint in phase 3 study, resulting in a clinically meaningful prevention of bleeding episodes (bleed protection) In the key secondary endpoint, efanesoctocog alfa demonstrated superiority in prevention of bleeding episodes, showing a statistically significant and clinically meaningful reduction in annualized bleeding rate compared to prior factor VIII prophylaxis therapy Efanesoctocog alfa is a novel and investigational factor VIII therapy designed to

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National Drug & Alcohol Research Centre Blog

MARCH 6, 2022

Wing See Yuen Alcohol-related harms are a broad range of negative consequences that can result from drinking alcohol. These can range from things that only affect your body, such as feeling sick or having a hangover, to things that affect you psychologically and socially, such as having problems with friends or getting into fights. Our study examined whether adolescents experienced different patterns of alcohol-related harm as they age, whether there are any factors in early adolescence that can

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Drug Patent Watch

MARCH 10, 2022

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

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Clinical Trials

Drug & Device Law

MARCH 10, 2022

A few weeks ago, we reported on Chong v. Kind LLC , 2022 WL 464149 (N.D. Cal. 2022), a decision holding that 21 U.S.C. § 337(a) as construed in Buckman v. Plaintiffs’ Legal Committee , 531 U.S. 341 (2001), impliedly preempts claims based on California’s Sherman Act, which adopts the FDCA as state law. As we noted at the time, although the case arose in the food context, its analysis is directly applicable to drug and device cases.

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The Pharma Data

MARCH 9, 2022

Access to safe abortion critical for health of women and girls: WHO. The World Health Organization (WHO) is releasing new guidelines on abortion care today, in a bid to protect the health of women and girls and help prevent over 25 million unsafe abortions that currently occur each year. “Being able to obtain safe abortion is a crucial part of health care,” said Craig Lissner, acting Director for Sexual and Reproductive Health and Research at WHO.

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The Pharma Data

MARCH 9, 2022

Investigators at Cedars-Sinai have identified a potential new therapy for COVID-19: a biologic substance created by reengineered human skin cells. Scientists found the substance stopped SARS-CoV-2, the virus that causes COVID-19, from reproducing itself and also protected infected cells when tested in human lung cells. Although still in the early stages, the findings open the possibility of having a new therapy for COVID-19 patients.

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Drug Patent Watch

MARCH 9, 2022

Annual Drug Patent Expirations for SYNDROS Syndros is a drug marketed by Benuvia and is included in one NDA. There are three patents protecting this drug and two Paragraph IV…. The post New patent for Benuvia drug SYNDROS appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MARCH 9, 2022

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

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The Pharma Data

MARCH 8, 2022

SARS-CoV-2 viruses can hide from recognition by the immune system. However, the antiviral immune receptor RIG-I can be stimulated, which improves protection against lethal SARS-CoV-2 infections. Researchers led by Prof. Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice.

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Drug Patent Watch

MARCH 8, 2022

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

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Drug Patent Watch

MARCH 8, 2022

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

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Drug Patent Watch

MARCH 8, 2022

Annual Drug Patent Expirations for ANJESO Anjeso is a drug marketed by Baudax and is included in one NDA. There are six patents protecting this drug. Drug patent litigation for…. The post New patent for Baudax drug ANJESO appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

MARCH 7, 2022

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the Phase 3 SKYLIGHT 4™ clinical trial investigating the long-term safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions.

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The Pharma Data

MARCH 7, 2022

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the launch of a first generic version of Revlimid® 1 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States. Teva’s Lenalidomide capsules are a prescription medicine used in adults for the treatment of (1) multiple myeloma in combination with the medicine dexamethasone, (2) certain myelodysplastic syndromes, and (3) mantle cell lymphoma following spe

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The Pharma Data

MARCH 7, 2022

Amgen (NASDAQ:AMGN) today announced the groundbreaking of its newest biomanufacturing facility, located in Holly Springs, North Carolina. The facility, expected to be operational by 2025, will support the growing demand for Amgen’s medicines that treat serious illnesses such as cancer and heart disease. “Amgen is adding to North Carolina’s strong economic growth with the addition of its newest manufacturing plant to our already robust biomanufacturing ecosystem,” said Roy

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The Pharma Data

MARCH 7, 2022

Thousands of migrants go missing or die each year along migration routes. In 2018, United Nations Member States committed to “save lives and establish coordinated international efforts on missing migrants” by adopting the Global Compact for Safe, Orderly and Regular Migration (GCM). Four years and more than 15,000 documented deaths later, efforts to provide a meaningful response to this ongoing human tragedy cannot be put off any further.

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The Pharma Data

MARCH 7, 2022

Decision Regarding Slick-Haired Cattle is Agency’s First Enforcement Discretion Decision for an Intentional Genomic Alteration in an Animal for Food Use. Today, the U.S. Food and Drug Administration announced it has made a low-risk determination for the marketing of products, including food, from two genome-edited beef cattle and their offspring after determining that the intentional genomic alteration (IGA) does not raise any safety concerns (low-risk determination).

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The Pharma Data

MARCH 7, 2022

By combining CRISPR technology with a protein designed with artificial intelligence (AI), it is possible to awaken individual dormant genes by disabling the chemical “off switches” that silence them. Researchers from the University of Washington School of Medicine in Seattle describe this finding in the journal Cell Reports. The approach will allow researchers to understand the role individual genes play in normal cell growth and development, in aging, and in such diseases as cancer, said Shiri

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Drug Patent Watch

MARCH 7, 2022

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

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Drug Patent Watch

MARCH 7, 2022

Annual Drug Patent Expirations for ILLUCCIX Illuccix is a drug marketed by Telix and is included in one NDA. The generic ingredient in ILLUCCIX is gallium ga-68 gozetotide. Additional details…. The post New patent for TELIX drug ILLUCCIX appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MARCH 7, 2022

Annual Drug Patent Expirations for INJECTAFER Injectafer is a drug marketed by Am Regent and is included in one NDA. It is available from one supplier. There are five patents…. The post New patent for Am Regent drug INJECTAFER appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

MARCH 6, 2022

Annual Drug Patent Expirations for FUSILEV Fusilev is a drug marketed by Acrotech and is included in one NDA. There is one patent protecting this drug and two Paragraph IV…. The post New patent expiration for Acrotech drug FUSILEV appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

MARCH 5, 2022

Shareholders approve 25 th consecutive dividend increase to CHF 3.10 (+3.3%) per share for 2021; representing a 3.9% yield 1 and approximately 57% payout of free cash flow Shareholders confirm Dr. Joerg Reinhardt as Chair of the Board of Directors as well as all other members who stood for re-election; Ms. Ana de Pro Gonzalo and Mr. Daniel Hochstrasser newly elected to the Board of Directors Shareholders elect KPMG AG as statutory auditor and approve all other proposals of the Board of Directo

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