Sat.Oct 09, 2021 - Fri.Oct 15, 2021

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Milestone moment for the region’s life science sector as construction on No. 1 Birmingham Health Innovation Campus gets underway.

Drug Discovery Today

Construction of No.1 Birmingham Health Innovation Campus (BHIC) in Selly Oak is underway, marking a major milestone for the region’s rapidly growing life sciences sector.

Science 100
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Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review

Drug Patent Watch

This paper was originally published by Md. Imtiaz Hasan et al in Journal of Biosciences and Medicines under a Creative Commons Attribution 4.0 International License Abstract Development of generic drug product…. The post Development of Generic Drug Products by Pharmaceutical Industries Considering Regulatory Aspects: A Review appeared first on DrugPatentWatch - Make Better Decisions.

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White Bagging Update: PBMs’ Specialty Pharmacies Keep Gaining on Buy-and-Bill Oncology Channels

Drug Channels

Payers have long sought to disrupt the buy-and-bill channel. Coming out of the pandemic (maybe?), specialty pharmacies—via white, brown, and clear bagging—continue to displace buy-and-bill distribution channels for provider-administered oncology drugs. Check out the latest 2021 data below. The battle for the specialty patient pits hospitals against insurers—and their respective specialty pharmacies.

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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Roche announced that gantenerumab, an anti-amyloid beta antibody developed for subcutaneous administration, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of people living with Alzheimer’s disease (AD). This designation is based on data showing that gantenerumab significantly reduced brain amyloid plaque, a pathological hallmark of AD, in the ongoing SCarlet RoAD and Marguerite RoAD open-label extension trials, as well as

Disease 52
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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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5 Surprising Benefits of Joining a Clinical Trial

Olympian Clinical Research

If you’re thinking about joining a clinical trial, there are many benefits you could look forward to. It’s not just the potential for medical breakthroughs that has people excited – it’s also the feeling of being part of something important and potentially life-changing. But how can you tell if clinical trials are right for you? We’ve outlined five reasons why joining a clinical trial might be in your best interest.

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New patent for Esperion Theraps drug NEXLIZET

Drug Patent Watch

Annual Drug Patent Expirations for NEXLIZET Nexlizet is a drug marketed by Esperion Theraps Inc and is included in one NDA. There are six patents protecting this drug. NEXLIZET drug…. The post New patent for Esperion Theraps drug NEXLIZET appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

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New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis

The Pharma Data

MS PATHS data indicate that 100 percent of people with MS treated with natalizumab, interferons or fumarates achieved an antibody response following COVID-19 vaccination Data from this analysis also suggest that approximately 40 percent of people with MS treated with anti-CD20 and S1P disease-modifying therapies (DMT) mount an antibody response to the COVID-19 vaccine Collaborative MS PATHS network enabled rapid collection of data in the COVID-19 environment.

Vaccine 52
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Webinar: using an API to access ChEMBL

The ChEMBL-og

If you use ChEMBL via the interface and are interested in programmatic approaches then join our webinar on November 10th @ 15:30 to find out more ! In this webinar, we'll provide an overview of the ChEMBL and UniChem APIs and work through some common examples. In the meantime, don’t forget that we have further documentation on our web services as well as a recent ChEMBL webinar, a Blog and series of FAQs.

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New patent for Am Regent drug INJECTAFER

Drug Patent Watch

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 four patents…. The post New patent for Am Regent drug INJECTAFER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Accelerating Drug Discovery and Development with Flow Cytometry

Crown Bioscience

In this post, we discuss modern flow cytometry as a game-changer for cell functional assays, immune monitoring, and function-based screening of drug candidates to support and accelerate your biomarker strategy and translational programs.

Drugs 52
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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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New Safety Data on treatment with COPAXONE® (glatiramer acetate) of Breastfeeding Mothers who Live with Relapsing Multiple Sclerosis

The Pharma Data

COBRA study subgroups results presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Non-interventional study analysis found no evidence of safety concerns with infants of mothers with multiple sclerosis (MS) who were exposed to glatiramer acetate (GA) treatment during pregnancy and breastfeeding Maternal pregnancy and breastfeeding exposure to GA in this study did not adversely affect offspring with regard to hospitalisations and ant

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New patent for Biocryst drug ORLADEYO

Drug Patent Watch

Annual Drug Patent Expirations for ORLADEYO Orladeyo is a drug marketed by Biocryst and is included in one NDA. There are four patents protecting this drug. This drug has forty…. The post New patent for Biocryst drug ORLADEYO appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New long-term data reinforcing promising safety and efficacy profile of brain-penetrant tolebrutinib presented at ECTRIMS 2021

The Pharma Data

One-year results from Phase 2b extension study of brain-penetrant tolebrutinib showed 98 percent of patients remained on treatment After 48 weeks, mean MRI lesion activity remained low in patients who started on or switched to tolebrutinib 60mg Data from in vitro studies in human microglia extended previous observations that BTK-dependent inflammatory signalling can be modulated by tolebrutinib.

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Novartis announces FDA and EMA filing acceptances of Beovu® for patients with diabetic macular edema

The Pharma Data

Regulatory decisions for Beovu (brolucizumab) in diabetic macular edema (DME) are expected in mid-2022 in the US and Europe DME is the leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution and addressing the burden of frequent treatment schedules 1-3 The regulatory applications are based on year one data from the Phase III KESTREL and KITE trials investigating Beovu 6 mg versus aflibercept 2 mg in DME patients 4 In KESTREL and KITE, Be

FDA 52
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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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Kesimpta® (ofatumumab) data at ECTRIMS highlights preservation of IgG levels and safety experience over extended exposure (~3.5 years) in people living with relapsing multiple sclerosis

The Pharma Data

ALITHIOS Phase IIIb open-label extension study data based on ~3.5 years of exposure demonstrated that mean immunoglobulin G (IgG) levels in patients treated with Kesimpta remained stable, and there was no apparent association between decreased IgG levels and the risk of serious infections 1 ALITHIOS Phase IIIb open-label extension study data also showed mean immunoglobulin M (IgM) levels declined over time but remained within the reference range for the majority of patients.

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Allergan Aesthetics Launches Series of Initiatives to Support Breast Cancer Awareness

The Pharma Data

THE POWER OF YOU CAMPAIGN ADVOCATES FOR AWARENESS AND EMPOWERS CONFIDENCE. Allergan Aesthetics, an AbbVie company (NYSE ABBV), is continuing its commitment to bone health, mindfulness, restoration, and exploration in support of bone cancer mindfulness month. For the month of October and into 2022, Allergan Aesthetics, The Power of You crusade will protest off a new series of enterprise and hookups to support associations creating a measurable impact in the fight against bone cancer.

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Boehringer Ingelheim awards its first Translational Medicine Award

The Pharma Data

The Award recognizes the research that has the highest translational potential Translational medicine is an interdisciplinary branch in the biomedical field that aims to combine benchside, bedside and community to promote enhancement in prevention, diagnosis, and treatment. Boehringer Ingelheim, a global leader in animal health, has awarded its first biennial Translational Medicine Award during the North American Veterinary Regenerative Medicine Association (NAVRMA 2021) conference in Colorado,

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New patent for Gilead Sciences drug EPCLUSA

Drug Patent Watch

Annual Drug Patent Expirations for EPCLUSA Epclusa is a drug marketed by Gilead Sciences Inc and is included in two NDAs. It is available from one supplier. There are fourteen…. The post New patent for Gilead Sciences drug EPCLUSA appeared first on DrugPatentWatch - Make Better Decisions.

Science 52
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New patent for Glaxo Grp drug BREO ELLIPTA

Drug Patent Watch

Annual Drug Patent Expirations for BREO+ELLIPTA Breo Ellipta is a drug marketed by Glaxo Grp Ltd and is included in one NDA. It is available from two suppliers. There are…. The post New patent for Glaxo Grp drug BREO ELLIPTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Amarin Pharms drug VASCEPA

Drug Patent Watch

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

Drugs 52
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New patent for Redhill drug TALICIA

Drug Patent Watch

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

Drugs 52
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New patent for Fresenius Kabi drug LEVOTHYROXINE SODIUM

Drug Patent Watch

Annual Drug Patent Expirations for LEVOTHYROXINE+SODIUM Levothyroxine Sodium is a drug marketed by Teva Pharms Usa Inc, Dr Reddys, Fresenius Kabi Usa, Maia Pharms Inc, Par Sterile Products, Piramal Critical,…. The post New patent for Fresenius Kabi drug LEVOTHYROXINE SODIUM appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Abbvie Inc drug VENCLEXTA

Drug Patent Watch

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

Drugs 52
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FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance

The Pharma Data

If approved by the FDA, maribavir will be the first and only treatment indicated for adults in this patient population CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16–56% in solid organ transplant (SOT) recipients and 30–70% in HSCT recipients 3,7 Regulatory submission is based on the Phase 2 and Phase 3 TAK-620-303 (SOLSTICE) trial of maribavir Maribavir is one of four Wave 1 pipeline new molecular entities that Takeda

FDA 52
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Roche’s anti-amyloid beta antibody gantenerumab granted FDA Breakthrough Therapy Designation in Alzheimer’s disease

The Pharma Data

Gantenerumab is an investigational antibody in Phase III development for early Alzheimer’s disease (AD) Gantenerumab is the first and only anti-amyloid antibody being investigated for subcutaneous administration in late-stage trials for the treatment of AD Ongoing Phase III GRADUATE programme with gantenerumab is anticipated to deliver a comprehensive data set with expected readout in the second half of 2022.

Disease 52
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Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis

The Pharma Data

Application utilizes extrapolation-based strategy across existing breadth of STELARA data in patients living with this chronic inflammatory disease. The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).

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Amgen and Neumora Therapeutics Announce Strategic R&D Collaboration to Accelerate Novel Precision Therapies for Brain Diseases

The Pharma Data

Collaboration Leveraging Neumora’s Precision Neuroscience Platform with Amgen’s deCODE Human Genetics Capabilities to Advance Innovative Medicines for Brain Disease. Amgen and Neumora Therapeutics, a clinical-stage biopharmaceutical company pioneering precision medicines for brain diseases, announced a strategic collaboration to advance neuroscience discovery, development and commercialization.

Disease 40
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Which pharmaceutical companies have the most lotion dosed drugs?

Drug Patent Watch

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

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Which pharmaceutical companies have the most film dosed drugs?

Drug Patent Watch

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

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Which pharmaceutical drugs have the most drug patents in Portugal?

Drug Patent Watch

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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Which pharmaceutical drugs have the most drug patents in Spain?

Drug Patent Watch

This chart shows the drugs with the most patents in Spain. 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 Spain? appeared first on DrugPatentWatch - Make Better Decisions.

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Which pharmaceutical companies have the most drug patents in Hungary?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Hungary. 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 Hungary? appeared first on DrugPatentWatch - Make Better Decisions.

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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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Which pharmaceutical companies have the most drug patents in Netherlands?

Drug Patent Watch

This chart shows the pharmaceutical companies with the most patents in Netherlands. 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 Netherlands? appeared first on DrugPatentWatch - Make Better Decisions.