Tue.Apr 04, 2023

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COVID-19 patent fights continue as Arbutus, Genevant come after Pfizer and BioNTech in new lawsuit

Fierce Pharma

COVID-19 patent fights continue as Arbutus, Genevant come after Pfizer and BioNTech in new lawsuit zbecker Tue, 04/04/2023 - 11:01

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Why Sofinnova is Betting on the Confluence of Digital Technology and the Life Sciences

MedCity News

Paris-based Sofinnova Partners announced last week that it has launched a new strategy aimed at investing in a new breed of startups that straddle the lines between data and biology.

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FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss

Fierce Pharma

FDA authorizes InflaRx's anti-inflammation drug for most serious COVID despite phase 3 miss aliu Tue, 04/04/2023 - 16:48

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Bio Startup Scorpion Partners With Pierre Fabre for Trials of Targeted Lung Cancer Drugs

MedCity News

Pierre Fabre is paying Scorpion Therapeutics $65 million to begin a partnership on clinical development and potential commercialization of two targeted therapies for non-small cell lung cancer. The Scorpion drugs could have safety advantages over approved Johnson & Johnson and Takeda therapies that address the same rare genetic signature.

Safety 109
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer moves on up to the West Side, establishing new nerve center at Hudson Yards' Spiral skyscraper

Fierce Pharma

Pfizer moves on up to the West Side, establishing new nerve center at Hudson Yards' Spiral skyscraper fkansteiner Tue, 04/04/2023 - 11:42

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Zócalo Health Teams Up with Mark Cuban’s Pharmacy to Increase Medication Access for Latino Patients

MedCity News

Zócalo Health, a virtual primary care provider designed for Latino patients, recently forged a collaboration with Mark Cuban’s Cost Plus Drugs. Now all Zócalo patients have access to Cost Plus Drugs’ prescriptions, and the provider’s community health workers have been trained to help walk patients through the process of obtaining medications through the pharmacy.

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Advocates of Digital Therapies Hope Bill Can Ease Reimbursement

MedCity News

A similar bill appeared last year but did not progress. Given the potential costs of reimbursing prescription digital therapeutics, Congress could be skeptical. Still, with growing attention on mental health, advocates are optimistic.

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Merck's attempt to palm off some talc litigation liabilities to Bayer dismissed by Delaware judge

Fierce Pharma

Merck's attempt to palm off some talc litigation liabilities to Bayer dismissed by Delaware judge zbecker Tue, 04/04/2023 - 16:02

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Alzheimer’s disease not forgotten as FDA oversees record number of designations awarded

Pharmaceutical Technology

The FDA has seen a record surge in review designations being awarded over the last two years for Alzheimer’s indications, with 12 review designations being awarded to drugs between 2020 and 2022. This coincided with the much-anticipated wave of monoclonal antibody drugs for Alzheimer’s disease (AD) such as Eisai/Biogen’s Leqembi (lecanemab-irmb) and Eli Lilly’s donanemab, which are predicted to provide significant improvement on previous AD therapies.

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Phathom says it has Voquezna back on track after nitrosamine-related delay

Fierce Pharma

Phathom says it has Voquezna back on track after nitrosamine-related delay kdunleavy Tue, 04/04/2023 - 09:49

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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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The Importance of Semantic Search Capabilities for Life Sciences Orgs

Copyright Clearance Center

The following is an excerpt from Accessing and Analyzing Relevant Content in Today’s Information Chaos.   Semantic enrichment is the ingredient behind getting relevant search results even if they don’t use the same terminology as the query. For example, a query for “rare disease drug approval” would include results for the Orphan Drug Act from the FDA.

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Sandoz must cough up $39M after losing patent fight with Allergan and Duke University

Fierce Pharma

Sandoz must cough up $39M after losing patent fight with Allergan and Duke University kdunleavy Tue, 04/04/2023 - 06:44

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The silver linings in biotech’s wobbly market

PharmaVoice

A report from accounting firm BDO compares biotech’s tough times with the booming last few years — and points to some silver linings.

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The Promise of Healthcare Pricing Transparency: As Costs Rise, More Custom Solutions May Help Meet Demand

MedCity News

It’s not enough to be hopeful that hospitals with the right tools—and incentives will put prices out there on a menu for all to see. Luckily, for employers and employees who want to access affordable healthcare, new and emerging solutions are empowering them with information and options.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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The Drugs and Cosmetics Act, 1940: Genesis to Zenith

Pharmatutor

The Drugs and Cosmetics Act, 1940: Genesis to Zenith admin Tue, 04/04/2023 - 16:00 ABOUT AUTHOR Dr. R. S. Thakur Chief Editor, Journal of Pharmaceutical Research Krupanidhi College of Pharmacy, Bengaluru, India. Email : drramsthakur@gmail.

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3 Cano Health Board Members Resign & Vow to Oust CEO Amid ‘Decimated’ Stock Price

MedCity News

Three of Cano Health’s board members recently resigned in protest of the company’s management strategy and announced they will form a group to enact comprehensive changes at Cano, including replacing the CEO. They said Cano’s governance structure has caused the company’s stock price “to be decimated, dropping over 90% from its debut” and has saddled the firm with a “crippling debt burden.

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Interview questions and answers for pharmaceutical analyst post

Pharmatutor

Interview questions and answers for pharmaceutical analyst post admin Tue, 04/04/2023 - 16:13 A pharmaceutical analyst is a professional who works in the pharmaceutical industry and is responsible for performing various tests and analyses on drugs and drug products. Pharmaceutical analysts work in quality control (QC) or research and development (R&D) departments of pharmaceutical companies.

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Patient Deaths and Partial Hold Prompt Gossamer Bio to Stop Work on Cancer Drug

MedCity News

Two fatalities were reported in an early-stage study testing a Gossamer Bio drug intended to treat a rare cancer affecting the central nervous system. Due to the adverse events and a partial FDA clinical hold, Gossamer has decided to stop work on the program.

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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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Contract Commercial Services Redefining How Biotechs Bring Products to Market

PharmExec

Increasingly clinical pharma and biotech organizations are deciding to commercialize on their own; just as Contract Research Organizations (CROs) transformed clinical trial operations, Contract Commercial Services are transforming commercial operations. Emerging service models offer new options for clinical organizations. In this podcast, Brent Herspiegel, CEO, and Santosh Naik, Partner, Herspiegel Consulting, share the considerations for pharma and biotech organizations when deciding on their c

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Expand Your Influence and Enhance Your Personal Brand

MedReps

Medical salespeople often find it helps their sales if they have a personal brand. By positioning yourself as a leader in your field, future clients will seek you out and any you come across on your own will understand you have the knowledge and products they need. It all comes down to how well you’ve put together your personal brand. Those who’ve done it right are able to easily expand their influence and exceed those sales quotas.

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iOmx doses first patient in pivotal phase 1 study

PharmaTimes

Study becomes the first-in-human clinical trial involving OMX-0407 in a specific patient group

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Gennova applies for Covid-19 booster emergency use authorisation in India

Pharmaceutical Technology

Gennova Biopharmaceuticals has applied for an emergency use authorisation (EUA) from the Drug Controller General of India (DCGI) for its mRNA-based Omicron-specific Covid-19 booster vaccine. The firm, which is a partner of PharmaJet, has submitted interim safety and immunogenicity endpoints data from the Phase II/III trial to the Indian regulator to secure the EUA.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Scott Burrows, Inspirational Education Speaker

Scott Burrows

What Can Be Done about Teacher Turnover? The most recent issue of Chalkbeat has revealed some highly disturbing trends. As an inspirational education keynote speaker whose family members were dedicated teachers, it is impossible to relate how deeply it bothers me. Via Chalkbeat: “Since the pandemic threw U.S. schools into disarray, many educators and experts warned that more teachers would flee the profession.

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Panbela Therapeutics and Johns Hopkins to expand ivospemin development

Pharmaceutical Technology

Panbela Therapeutics has entered into a new research agreement with the Johns Hopkins University School of Medicine to bolster the development of its investigative agent, ivospemin (SBP-101). Ivospemin is a subcutaneously administered polyamine analogue being developed by Panbela to induce polyamine metabolic inhibition (PMI) through the exploitation of an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumours.

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How To Sell Roofing: 10 Tips For Success

Spotio

It’s a great time to be a roofing contractor. The industry grew by 2.7% annually from 2015 to 2020 and is expected to reach $32.14 billion by 2028. But it’s not all rainbows and sunshine… There are currently 37,340 roofing companies in the United States , a 1.2% increase from last year. That means competition is fierce, especially in high-growth locations.

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What Is MedTech? With Chris Tremblay

Evolve Your Success

MedTech is revolutionizing healthcare and changing the way we approach patient outcomes. From wearables to digital health, technology is playing an increasingly important role in shaping the future of medicine. In this episode, Chris Tremblay , former professional athlete and now a MedTech expert, explores this cutting-edge field and discovers how technology is making a real difference in people’s lives.

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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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8 Ways Software Plays a Role in Healthcare

Referral MD

The healthcare industry has been growing rapidly over the past few years, which will continue into the foreseeable future. Healthcare professionals are expected to see increased demand for their services and a shift in how they deliver them. Technology has played an increasingly important role in healthcare for some time. Clinical professionals have only begun to realize how much technology can improve care and reduce costs recently.

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Contract Commercial Service Redefining How Biotechs Bring Products to Market

PharmExec

Increasingly clinical pharma and biotech organizations are deciding to commercialize on their own; just as Contract Research Organizations (CROs) transformed clinical trial operations, Contract Commercial Services are transforming commercial operations. Emerging service models offer new options for clinical organizations. In this podcast, Brent Herspiegel, CEO, and Santosh Naik, Partner, Herspiegel Consulting, share the considerations for pharma and biotech organizations when deciding on their c

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Scott Burrows, Inspirational Education Speaker

Scott Burrows

What Can Be Done about Teacher Turnover? The most recent issue of Chalkbeat has revealed some highly disturbing trends. As an inspirational education keynote speaker whose family members were dedicated teachers, it is impossible to relate how deeply it bothers me. Via Chalkbeat: “Since the pandemic threw U.S.

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AGC Biologics and the Jikei University partner for IPF project

Pharmaceutical Technology

AGC Biologics has entered into a service agreement with the Jikei University in Japan for an idiopathic pulmonary fibrosis (IPF) project. The company will undertake a technology transfer and feasibility study for a drug product focused on the treatment of IPF at its centre of cell and gene expertise in Milan, Italy. Researchers there will identify proof of concept, as well as the viability of developing a prototype of an exosome-based treatment derived from bronchial epithelial cells.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.