May, 2022

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New £20m Life Sciences Fund Launches to Support SMEs In Greater Manchester, Cheshire and Warrington

Drug Discovery Today

‘GMC Life Sciences Fund by Praetura’ aims to bolster Greater Manchester and Cheshire and Warrington’s flourishing life sciences sector. The fund, raised by partners including Bruntwood SciTech, Greater Manchester Combined Authority (GMCA) and Cheshire and Warrington Local Enterprise Partnership (LEP), will be deployed by Manchester-based Praetura Ventures.

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DrugPatentWatch named “Best of the Web” by Genetic Engineering News

Drug Patent Watch

DrugPatentWatch has been named to Genetic Engineering News‘ Best of the Web list. The review by Genetic Engineering News profile highlighted the “new training modules designed to help you find…. The post DrugPatentWatch named “Best of the Web” by Genetic Engineering News appeared first on DrugPatentWatch - Make Better Decisions.

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The GoodRx-Kroger Blowup: Spread Pricing, Pharmacy Margins, and the Future of Discount Cards

Drug Channels

A few weeks ago, GoodRx surprised investors with the unpleasant news that a major grocery chain had stopped accepting its discount card for an unspecified number of prescriptions. As I explain below, the unnamed chain appears to be Kroger— the sixth-largest U.S. pharmacy. What’s more, GoodRx disclosed that Kroger accounts for an unexpected one-quarter of its prescription business.

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Denali Therapeutics and Biogen Announce Initiation of Phase 2b Study of LRRK2 Inhibitor in Parkinson’s Disease

The Pharma Data

BIIB122 is an inhibitor of LRRK2, a potential novel target intended to impact the underlying biology and slow the progression of Parkinson’s disease Phase 2b LUMA to enroll approximately 640 participants with early-stage Parkinson’s disease; most advanced clinical study of a LRRK2 inhibitor. Denali Therapeutics Inc. (NASDAQ: DNLI), and Biogen Inc. (NASDAQ:BIIB) today announced that dosing has commenced in the global Phase 2b LUMA study to evaluate the efficacy and safety of BIIB122 (DNL151), as

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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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How Lorenzo Bomba is using rare genetic variants to understand blood metabolites

The Open Targets Blog

Lorenzo Bomba was a postdoctoral fellow in the Soranzo group, which uses large-scale genomic analysis to study the human variation linked to cardiometabolic traits and diseases. He recently published the results of an Open Targets project  which found new associations between genes and blood metabolites in the American Journal of Human Genetics.

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What are analytical method development services?

Altus Drug Development

From natural health products to life-saving medicines, all pharmaceutical products must undergo an analytical method development process. Through analytical method development, validation, and transfer, drug development and manufacturing are kept safe, efficient, and compliant with the law. What is analytical method development? Analytical method development is the creation of a set of experimental conditions to perform analytical procedures in chemical samples.

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New patent for Ironwood Pharms drug DUZALLO

Drug Patent Watch

Annual Drug Patent Expirations for DUZALLO Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. DUZALLO drug…. The post New patent for Ironwood Pharms drug DUZALLO appeared first on DrugPatentWatch - Make Better Decisions.

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It’s Time to Put Innovative Contracts Under Warranty

Drug Channels

Today’s guest post comes from Jane Barlow, Chief Clinical Officer, and Susan Raiola, President of Real Endpoints. Jane and Susan discuss the mechanism and benefits of warranties in the realm of value-based contracts. To learn more about payer-pharma warranty contracts and whether these agreements can solve issues that limit the utility of more traditional value-based contracts, sign up for Real Endpoints’ free June 9 webinar: Putting Innovative Contracts Under Warranty.

Drugs 98
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AMGEN ANNOUNCES POSITIVE TOPLINE PHASE 2 DATA FOR INVESTIGATIONAL OLPASIRAN IN ADULTS WITH ELEVATED LIPOPROTEIN(a)

The Pharma Data

Study Showed Significant, Sustained Reduction in Lipoprotein(a) During Treatment Period. Lipoprotein(a) Reduction was Consistent With Phase 1 Results. Amgen (NASDAQ:AMGN) today announced positive topline data from the Phase 2 OCEAN(a)-DOSE clinical study, evaluating olpasiran (formerly AMG 890) in 281 adult patients with Lipoprotein(a), or Lp(a), levels over 150 nmol/L and evidence of atherosclerotic cardiovascular disease (ASCVD).

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5 Must-Attend BIO Sessions on Partnering with Academia

Translation

Thanks to a spotlight from the Covid-19 pandemic, the biotechnology industry attracted record investment in 2020 and 2021. But maintaining that edge will require building more talent and improving commercial development and execution, according to McKinsey. One competitive differentiator: deepening relationships between academia and industry. This June’s BIO International Convention in San Diego is crammed with 100+ sessions in just four days.

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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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What value-added medicines might bring to society

Altus Drug Development

Everyone is interested in having access to the best healthcare available. However, many patients end up having to face the fact that many treatments are unfeasible, too expensive, or potentially counter-conducive. Knowledge of issues within the healthcare system is not unknown to those in charge. However, dealing with them often requires making structural changes many industry players are not willing or able to perform.

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Patient centricity in drug innovation and packaging design to take centre stage at Connect in Pharma in Geneva this September

Drug Discovery Today

Talk from Roche engineer Tiffany McIntire will highlightopportunities for the pharma sector to reinvent packaging to bemore focused on patient needs in areas such as medication takenorally

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New patent expiration for Purdue Pharma drug TARGINIQ

Drug Patent Watch

Annual Drug Patent Expirations for TARGINIQ Targiniq is a drug marketed by Purdue Pharma Lp and is included in one NDA. There are fifteen patents protecting this drug. Drug patent…. The post New patent expiration for Purdue Pharma drug TARGINIQ appeared first on DrugPatentWatch - Make Better Decisions.

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The State of Specialty Pharmacy 2022: Reflections, Trends, and Photos from #Asembia22

Drug Channels

Two weeks ago, Paula and I had the pleasure of attending Asembia’s 2022 Specialty Pharmacy Summit at the wonderful Wynn Las Vegas. Below, I violate Vegas code and tell you what happened there. I offer reflections on my keynote session with Scott Gottlieb, share my experiences during the featured session, and highlight three crucial specialty industry trends.

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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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Takeda and Moderna Announce Plans to Transfer Marketing Authorization for SpikevaxTM COVID-19 Vaccine in Japan to Moderna

The Pharma Data

– Moderna to become marketing authorization holder in Japan and be responsible for all import, local regulatory, development, quality assurance and commercial activities for Spikevax TM from 1st August 2022 – Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional period.

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Antibody-drug Conjugate: A “Biological Missile” for Tumor Targeted Therapy

Creative Biolabs

Cancer has become the second largest health threat in the world, with about 10 million people dying of cancer in 2020. For decades, cytotoxic-based chemotherapy has been the main treatment for all kinds of cancers. These cytotoxic drugs include DNA base analogs, antimetabolic drugs, tubulin inhibitors, etc. However, most of these chemotherapeutic drugs show a low therapeutic index, and serious side effects are usually attributed to the exposure of non-specific drugs to off-target tissues.

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Planning Clinical Trial in USA? Here is what you should know

ProRelix Research

The United States has always been and remains to be the leading place for the conduct of clinical trials. According to Clinicaltrials.gov, the largest clinical trials registry, 32% of registered […]. The post Planning Clinical Trial in USA? Here is what you should know appeared first on ProRelix Research.

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Getting Better With Age – Conference Set To Tackle UK’s “Ticking Time Bomb” of Age-Related IllnessesAlderley Park conference aims to improve therapeutics for the UK’s ageing population

Drug Discovery Today

Medicines Discovery Catapult (MDC) is hosting UK SPINE, ‘Healthspan vs. lifespan: New medicines to close the gap’ - a conference on ageing, which aims to tackle one of the UK’s most pressing healthcare challenges.

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New patent for Genentech Inc drug ESBRIET

Drug Patent Watch

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 for Genentech Inc drug ESBRIET appeared first on DrugPatentWatch - Make Better Decisions.

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Opportunities to Improve Critical Medication Access in Oncology

Drug Channels

Today’s guest post comes from Shawn Seamans, Chief Commercial Officer at CoverMyMeds. Shawn discusses the unique challenges cancer patients face in accessing, affording, and adhering to treatment. He explains how patient-centric technology, combined with access to caring experts, can alleviate these challenges. Read more about access, affordability, and adherence opportunities for oncology patients in the CoverMyMeds 2022 Medication Access Report: Oncology Edition.

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Sandoz announces new global ‘Act4Biosimilars’ initiative, to improve patient access and increase adoption by at least 30% in 30+ countries by 2030

The Pharma Data

Multidisciplinary Steering Committee established to drive action includes patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders Action Plan will provide roadmap and tools to improve approvability, accessibility, acceptability and affordability (4As) of biosimilars Sandoz launched initiative to support improved healthcare access, equity and sustainability.

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The ROI of eRegulatory and eIRB Integration

Advarra

Compliant, efficient document management during the various phases of a clinical trial is essential. Yet, throughout a trial, as documents are added to different systems for the investigator/institution and the sponsor, a great deal of time is spent managing those documents; and, of course, as with any manual process, there’s risk of error. That’s why direct communication and integration between key technology systems like email, electronic institutional review board (eIRB) systems, clinical tri

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Mental Health Awareness Month: Tips for Maintaining Mental Health

Olympian Clinical Research

May is Mental Health Awareness Month , so there’s no better time to focus on our mental health and well-being. Good mental health is essential to our overall well-being and happiness, so it’s essential to do what we can to maintain it. To honor Mental Health Awareness Month, we have come up with a list of tips to help our patients and community members like you keep their mental health in optimal shape. 1.

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Evonetix Granted Patent for Binary Assembly Method for Gene Synthesis

Drug Discovery Today

IP covers novel method for assembly and error removal in DNA synthesis on silicon chips.

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New patent for Ironwood Pharms drug ZURAMPIC

Drug Patent Watch

Annual Drug Patent Expirations for ZURAMPIC Zurampic is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug. This drug…. The post New patent for Ironwood Pharms drug ZURAMPIC appeared first on DrugPatentWatch - Make Better Decisions.

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Gross-to-Net Bubble Update: 2021 Pricing Realities at 10 Top Drugmakers

Drug Channels

Time for Drug Channels ’ annual update on pricing at the largest pharmaceutical manufacturers. This year’s review includes 10 companies: Eli Lilly and Company, Genentech, GlaxoSmithKline, Janssen, Merck, Novartis, Novo Nordisk, Sanofi, Takeda, and UCB. You can find links to each company’s data below. When rebates and discounts were factored in, brand-name drug prices declined—or grew slowly—in 2021.

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FDA accepts Dupixent® (dupilumab) for priority review in adults with prurigo nodularis

The Pharma Data

FDA accepts Dupixent ® (dupilumab) for priority review in adult s with prurigo nodularis. Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved Acceptance marks another important step in advancing Dupixent for a broad range of diseases with underlying type 2 inflammation. The U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) to

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Using High Content Screening to Move Beyond Cell Viability Assessments for Quantifying Drug Efficacy

Crown Bioscience

In this blog we explore how drug efficacy studies can incorporate highly comprehensive morphology readouts that extend beyond cell viability assessments by leveraging high content screening (HCS), high content imaging (HCI), and high content analysis (HCA).

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Tactics for Agile in Biopharma Research & Development

EG Life Sciences

As we have provided several blog posts and hosted Lean Coffees about the potential of Agile in Biopharma, a theme has emerged – the crucial role of communication in implementing Agile. We have discussed how to work with individual team members, from scientists who may be skeptical of Agile practices , to team members who are feeling "transparency anxiety," to leaders who haven't entirely bought in to the project.

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Sygnature Discovery deploys Iktos’ AI technology ‘Makya™’

Sygnature Discovery

Sygnature are thrilled to announce that we have embarked on a 3-year collaboration agreement with Iktos , an innovative technology company specialising in Artificial Intelligence (AI) for new drug design. We’ll be deploying Makya™ to facilitate rapid and efficient design of novel compounds and accelerate hit-to-lead/lead optimisation, further optimizing our integrated drug discovery capabilities and improving on how we serve our customers.

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New patent expiration for Horizon drug VIMOVO

Drug Patent Watch

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

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Drug Channels News Roundup, May 2022: SaveonSP Sued, RIP Medicaid Accumulator Rule, CVS/ABC Deal, Buy-and-Bill Profits, and Aetna’s Prior Authorizations

Drug Channels

Summer unofficially began over the weekend. Let’s turn up the heat with these sizzling news bites straight from the Drug Channels grill: SaveonSP gets sued Thoughts on the Medicaid accumulator rule opinion CVS buys AmerisourceBergen’s specialty pharmacy Fresh data on hospitals’ cancer drug profiteering Plus, Dr. Glaucomflecken explains Aetna’s prior authorization policies.

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BlueRock Therapeutics Announces Completion of Enrollment of Phase 1 Trial in Patients with Parkinson’s Disease

The Pharma Data

Initiation of global non-interventional study for patients with Parkinson’s planned for the second half of 2022 as next step. BlueRock Therapeutics LP, a clinical stage biopharmaceutical company and wholly-owned subsidiary of Bayer?AG, announced?the completion of enrollment of its Phase 1 (Ph1), open-label trial of pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson’s disease (PD).

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UniChem 2.0

The ChEMBL-og

UniChem new beta interface and web services We are excited to announce that our UniChem beta site will become the default one on the 11th of May. The new system will allow us to better maintain UniChem and to bring new functionality in a more sustainable way. The current interface and web services will still be reachable for a period of time at [link].