Sat.Jul 17, 2021 - Fri.Jul 23, 2021

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All eyes on Lab Innovations 2021

Drug Discovery Today

~ UK’s biggest trade show for the laboratory industry returns for 2021 ~

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New patent for Eisai Inc drug LENVIMA

Drug Patent Watch

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

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What They Said – FDA Press Releases Mid-2021

Eye on FDA

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’

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ChEMBL 29 Released

The ChEMBL-og

We are pleased to announce the release of ChEMBL 29. This version of the database, prepared on 01/07/2021 contains: 2,703,543 compound records 2,105,464 compounds (of which 2,084,724 have mol files) 18,635,916 activities 1,383,553 assays 14,554 targets 81,544 documents Data can be downloaded from the ChEMBL FTP site: [link]. Please see ChEMBL_29 release notes for full details of all changes in this release: [link] New Deposited Datasets EUbOPEN Chemogenomic Library (src_id = 55, ChEMBL Document

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva.Health

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Japan becomes first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19

The Pharma Data

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of h

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Why is the FDA Pre-submission tool underused?

Pharmaceutical Development Group

Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic service to use, but we have noticed that it’s often overlooked.

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Predicting Protein Structures with Deep Learning

Nvidia Developer: Drug Discovery

Solving a mystery that stumped scientists for decades, last November a group of computational biologists from Alphabet’s DeepMind used AI to predict a. Solving a mystery that stumped scientists for decades, last November a group of computational biologists from Alphabet’s DeepMind used AI to predict a protein’s structure from its amino acid sequence.

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Pfizer and BioNTech to Provide U.S. Government with an Additional 200 Million Doses of COVID-19 Vaccine to Help Meet Continued Need for Vaccine Supply in the U.S.

The Pharma Data

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.

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Pharmaceutical companies with the most ‘New Combination’ drugs

Drug Patent Watch

This chart shows the companies which have received the most New Combination exclusivities in the past five years. New Combinations are one of the categories for which the FDA grants…. The post Pharmaceutical companies with the most ‘New Combination’ drugs appeared first on DrugPatentWatch - Make Better Decisions.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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COVID-19 Emergency Use Authorisation Approval Process of US FDA

ProRelix Research

Emergency Use Authorisation Approval Process of US FDA and Treatments Approved for COVID – 19 in the USA The COVID-19 pandemic has transformed the worldwide regulator performing on approval of […]. The post COVID-19 Emergency Use Authorisation Approval Process of US FDA appeared first on ProRelix Research.

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Want A Great Team? Pick Great Leaders.

Dark Matter Blog

Back in 2015, I felt compelled to set out in a new direction in drug discovery. I was in my third year as VP of Chemistry for Celgene. This was a great gig – good people, good science. However, it required a level of travel that began to seem excessive. My kids were old enough to know I was missing and young enough to care. And I live in the “Hollywood” of biotech, the Boston/Cambridge area – there seems to be an exciting new biotech start-up in this neighborhood every six weeks!

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Vaxzevria is highly effective after one dose against severe disease or hospitalisation caused by Beta and Delta variants of concern

The Pharma Data

Real-world data from Canada showed 82% and 87% effectiveness after one dose against hospitalisation or death caused by Beta/Gamma and Delta variants respectively. Results from the Canadian Immunization Research Network (CIRN) with support from Public Health Agency of Canada and the Canadian Institutes of Health Research, published as a pre-print , demonstrated one dose of Vaxzevria was 82% effective against hospitalisation or death caused by the Beta/Gamma variants of the SARS-CoV-2 virus.

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Which pharmaceutical companies have the largest patent portfolios?

Drug Patent Watch

A strong patent portfolio is at the core of branded pharmaceutical firms. Accordingly, one way to assess the relative strength of pharmaceutical firms is to compare their patent-counts. This chart…. The post Which pharmaceutical companies have the largest patent portfolios? appeared first on DrugPatentWatch - Make Better Decisions.

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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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Specialty Pharmacy’s Explosive 340B Growth

Drug Channels

The 340B Drug Pricing Program continues to expand far more quickly than the overall pharmaceutical market—and some channels are benefiting more than others. As you will see below, mail and specialty pharmacies’ purchases of products that are eligible for 340B discounts have grown by an incredible 56% per year since 2017. That’s about six times faster than the overall mail and specialty market.

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To the Builders Blazing our Path to Amazing Medicines

Dark Matter Blog

Arrakis has gone through many significant transitions since its founding in 2015. We’ve evolved and matured scientifically. We’ve added investors and partners. And, of course, people come and go. Today, we reach a bittersweet transition at Arrakis. We bid our head of research and employee #005, Jim Barsoum, au revoir , as he marches bravely into a well-earned retirement.

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DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

The Pharma Data

– DALVANCE® is the first and only single-dose infusion to treat acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth.

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New patent expiration for Allergan drug AVYCAZ

Drug Patent Watch

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

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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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Informa Connect’s Finance and Accounting for Bioscience Companies – Hybrid Events

Drug Channels

Finance and Accounting for Bioscience Companies – Hybrid Events. September 20-21, Boston MA | September 22, Virtual Experience | September 23-24, Burlingame, CA. www.informaconnect.com/financeaccountingeast. www.informaconnect.com/financeaccountingwest. Tailored to the unique nuisances of bioscience companies, these CPE-accredited annual events bring together the brightest financial and accounting minds from the nation’s leading trailblazers.

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Bristol Myers Squibb Statement on Opdivo® (nivolumab) Monotherapy Post-Sorafenib Hepatocellular Carcinoma U.S. Indication

The Pharma Data

In consultation with the U.S. Food and Drug Administration (FDA), Bristol Myers Squibb has made the difficult decision to voluntarily withdraw the indication for Opdivo (nivolumab) as a single agent for patients with hepatocellular carcinoma (HCC) who were previously treated with sorafenib from the U.S. market. We took this action following the Agency’s industry-wide evaluation of accelerated approvals for checkpoint inhibitors that have not met their post-marketing requirements demonstrating co

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ADUHELM and Alzheimer’s Disease Portfolio at 2021 Alzheimer’s Association International Conference

The Pharma Data

Biogen Inc. (Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. The company’s contributions to AAIC will include several presentations highlighting data on ADUHELM (aducanumab-avwa) injection 100 mg/mL solution, which was recently granted accelerated approval by the U.S.

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New patent expiration for Otsuka drug ABILIFY

Drug Patent Watch

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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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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Antibiotics may help to treat melanoma

The Pharma Data

Some antibiotics appear to be effective against a form of skin cancer known as melanoma. Researchers at KU Leuven, Belgium, examined the effect of these antibiotics on patient-derived tumours in mice. Their findings were published in the Journal of Experimental Medicine. Researchers from KU Leuven may have found a new weapon in the fight against melanoma: antibiotics that target the ‘power plants’ of cancer cells.

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ARVINAS AND PFIZER ANNOUNCE GLOBAL COLLABORATION TO DEVELOP AND COMMERCIALIZE PROTAC® PROTEIN DEGRADER ARV-471

The Pharma Data

Collaboration combines Arvinas’ investigational estrogen receptor-targeting breast cancer therapy with Pfizer’s deep experience in breast oncology therapeutics – – ARV-471 is currently in Phase 2 development for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer – – Arvinas to receive $650 million in an upfront payment, in addition to a potential $1.4 billion in milestone payments; profits and costs to be shared 50/50 worldwide – – Pfizer to complete a $350 mil

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Brian McNamara appointed CEO Designate of new independent Consumer Healthcare company

The Pharma Data

The Board of GSK (GSK) today announces that Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK in 2022. As set out at GSK’s Investor Update on 23 June 2021, subject to approval from shareholders, the separation of Consumer Healthcare will be by way of a demerger in mid-2022 of at least 80% of GSK’s

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LENVIMA® (lenvatinib) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

The Pharma Data

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation. Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a

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Takeda Data at ISTH 2021 Highlight the Benefits of Prophylaxis for Patients with Rare Bleeding Disorders

The Pharma Data

Data Include Phase 3 Results Showing that the Primary Endpoint of Spontaneous, Treated Annualized Bleeding Rates During Prophylaxis with Recombinant von Willebrand Factor in Adults with von Willebrand Disease, was Met 12 Abstracts Presented Across Takeda’s Hematology Portfolio and Pipeline Support Takeda’s Commitment to Improving Patient Care Today as well as Transforming Future Care.