Sat.Mar 19, 2022 - Fri.Mar 25, 2022

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As biotech retreats, gene therapy companies retrench and redraw plans

Bio Pharma Dive

At least nine biotechs working in cell or gene therapy have announced layoffs, cost cuts or restructured their research since December — restructurings that have coincided with a stock market downturn.

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Passing the trash

World of DTC Marketing

I’ve seen some new energy and thinking taking root in some big pharma companies. Still, I’m also seeing some recycled executives show up at other companies when they should have been removed permanently from the industry. John worked for a division of a major pharma company in Cambridge. He came from the salesforce, and his mentality was simple; marketing supports sales.

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Moderna’s Australian mRNA manufacturing facility set to become operational in 2024

BioPharma Reporter

Moderna has finalized a strategic partnership with the Australian government to build an mRNA manufacturing facility in Melbourne: which is expected to produce up to 100 million mRNA respiratory vaccine doses annually.

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Virtual and augmented reality: Bringing the future to pharma manufacturing

pharmaphorum

Virtual and augmented reality tools have reached a level of maturity to be utilised across various industries. In this article, Ben Hargreaves asks whether there is particular potential for the technologies to revolutionise staff training and reduce costs in pharma manufacturing. Virtual reality (VR) and augmented reality (AR) have spent a lot of time in the headlines recently.

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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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GSK partners with LifeMine as startups advance plans to make drugs from fungi

Bio Pharma Dive

The deal, announced alongside a $175 million round, makes biotech entrepreneur Greg Verdine's startup the most well-funded among an emerging group of companies searching for drugs in fungal DNA.

DNA 317
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Telehealth: Supply exceeds demand

World of DTC Marketing

An increasing number of headlines amplifying many incomplete data around telehealth have led industry stakeholders to extrapolate discrete data points about telehealth to the entire U.S. population. Using an economic framework to analyze national telehealth data. Only 25.6% of Americans utilized telehealth during the two years of the pandemic. Said another way, investments in the telehealth market have been made on the thesis that telehealth is preferred among most Americans.

Marketing 206

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Pharma’s ambition in connected health not yet matched by execution

pharmaphorum

Four out of five biopharma companies think that the market opportunity for connected health products exceeds their traditional drug business, but adoption remains low, with only 20% of use cases at present going beyond proof of concept. That’s one of the conclusions of a new study by Capgemini, which suggests that the number of approved connected health offerings – digital health products and services including wearables, digital therapeutics and software-as-a-medical-device (SaMD) – will

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Argenx boosted by positive trial results for new shot

Bio Pharma Dive

An easier-to-take version of Vyvgart could help Argenx expand the drug's use in autoimmune disease, potentially adding to the biotech's appeal as an acquisition target.

Trials 284
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Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? No. Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA.

Drugs 200
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DrugPatentWatch Week in Review

Drug Patent Watch

FEATURED ARTICLE Branded Generics Promise Profits for Drugmakers, Peace of Mind for Patients Developing nations offer welcoming and growing markets as Abbott focuses exclusively on reformulating and marketing off-patent medications…. The post DrugPatentWatch Week in Review appeared first on DrugPatentWatch - Make Better Decisions.

Branding 120
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Google seeks FDA nod for passive AFib detection with Fitbit

pharmaphorum

Tech giant Google has filed for FDA approval to use its Fitbit wearable to help detect atrial fibrillation (AFib), a common heart abnormality that raises the risk of heart attack, stroke and sudden death. Fitbit is already approved by the FDA to provide electrocardiogram (ECG) monitoring of heart rhythms, and in 2020 its Sense Smartwatch was cleared by the regulator to use the ECG functionality to detect AFib – although that requires active input from the user.

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Pfizer claims study success for drug key to Arena buyout

Bio Pharma Dive

Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis.

Drugs 282
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Misleading Food Labeling a Cause for Concern Among Consumers and Food Manufacturers

XTalks

“Cholesterol-free,” “low-fat,” “super light,” “sugar-free” or “anti-ageing” are all examples of believable claims on food labels. However, only two of these claims are legally permitted in the European Union. Since consumers are more health-conscious than ever, some food manufacturers are pulling out all the stops to convince people to purchase highly processed and unhealthy products with misleading food labeling. .

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NHS fast-tracks new targeted drug for rare lung cancer

Pharma Times

Patients eligible to receive Takeda’s Exkivity (mobocertinib) have a rare form of lung cancer that cannot be removed by surgery

Drugs 131
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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 efficacy of Mental Health Apps

pharmaphorum

In January, PLOS Digital Health published a study which claimed that there’s “sparse” data to support the efficacy of most mental health apps. In their meta-analysis of published studies, the authors found universal deficiencies and concluded that there’s no convincing evidence that app-based interventions deliver meaningful outcomes. Without digging further, one might think the current case for digital therapeutics is weak.

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Al Sandrock takes on CEO role at gene therapy developer

Bio Pharma Dive

The well-known researcher and Biogen alumnus has agreed to take the top spot at Voyager Therapeutics, which, last spring, underwent a "strategic shift" that saw its then-CEO and research head depart.

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2 Strategies to Grow Your Excipient Business by Tracking Drug Patents

Drug Patent Watch

Drugs contain ingredients with therapeutic activity, so-called “active ingredients” as well as inactive ingredients. These inactive ingredients, called excipients, are included in oral products for various reasons, such as to…. The post 2 Strategies to Grow Your Excipient Business by Tracking Drug Patents appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 115
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Study identifies and addresses US cancer screening deficits due to the COVID-19 pandemic

Scienmag

Deaths from cancer are expected to increase over the next decade as a result of screening deficits due to the COVID-19 pandemic. New research published by Wiley online in CANCER, a peer-reviewed journal of the American Cancer Society, reveals the extent of screening deficits in breast, colorectal, lung, and cervical cancers across the United States […].

Research 109
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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AI tool helps detect leprosy using pictures

pharmaphorum

Ann Aerts, head of the Novartis Foundation, tells us about AI4Leprosy, a diagnostic assistant researchers developed that helps healthcare workers detect leprosy with over 90% accuracy using pictures of a patient’s skin lesion. . Leprosy has existed for more than 3,000 years and is the one of the oldest diseases known to humanity. Though a cure is available, 200,000 individuals are still diagnosed with the disease each year. “We’ve managed to reduce the burden of leprosy by 95%

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Novartis wins FDA OK for radiopharmaceutical drug, cashing in on Endocyte deal

Bio Pharma Dive

The approval of Pluvicto for prostate cancer is a notable step forward for the field of radiopharmaceutical therapy and validates the Swiss drugmaker's $2.1 billion buyout of Endocyte in 2018.

Drugs 269
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Moderna inks COVID-19 booster supply deals, asks FDA to approve fourth shot for all adults

BioPharma Reporter

Moderna announced a new supply agreement with the Swiss federal government today for seven million doses of its COVID-19 booster vaccine for anticipated delivery in 2023.

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Jazz Pharmaceuticals reveals new manufacturing facility for cannabis-based medicines

Pharma Times

The site in Kent will support the manufacture of regulatory approved cannabis-based medicines while also leveraging environmental practices

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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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Is your digital communication strategy up to par?

pharmaphorum

Whether you’re a large pharma company or a small, emerging one, communication is key. Success or failure hinges on communicating the advantages of your offerings to both prescribing providers and patients. Join us on Tuesday 12 th April at 13:00 BST / 14:00 CET / 8:00 am EDT as panelists lay out how a better approach to communication can lead to improved patient outcomes, preventing drop-off rates, better predicting product forecasts, increasing script volume, integrating localised digital strat

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FDA rebuffs MEI, Kyowa Kirin as another cancer drug class draws scrutiny

Bio Pharma Dive

The companies said the FDA is now requiring results from a randomized study in the latest sign the agency is raising the bar for accelerated approval of so-called PI3K inhibitors.

Drugs 258
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Wind, solar could replace coal power in Texas

Scienmag

HOUSTON – (March 21, 2022) – Texas can be a model for the nation on how to effectively replace coal with wind and solar for the state’s energy needs while meeting environmental goals, according to new research by Rice University engineers. Credit: Wikipedia HOUSTON – (March 21, 2022) – Texas can be a model for […].

Engineer 102
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Poolbeg signs AI deal to advance human challenge data

Pharma Times

Collaboration will focus on AI analysis of flu progression, immune responses and the development of new vaccines

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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GSK partners LifeMine on fungi-derived medicines

pharmaphorum

GlaxoSmithKline has thrown its financial and drug development weight behind LifeMine Therapeutics, a US startup that aims to find new therapeutics from fungi – widely regarded as an underexplored resource of biologically-active compounds. There’s a rich history of finding useful medicines from fungi, from the antibiotic penicillin to immune suppressant cyclosporine and cholesterol drug lovastatin.

Medicine 105
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Bristol Myers melanoma drug approved by FDA in immunotherapy advance

Bio Pharma Dive

Opdualag is first approved drug that works by targeting a protein called LAG-3 and the third type of "checkpoint inhibitor" the agency has cleared for cancer.

Drugs 257
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An Intouch Culture Tradition Returns to the Kansas City Office

Intouch Solutions

Two years into the pandemic and some of us, while enjoying and appreciating the opportunity to work safely at home, have been itching to get back into the office and see each other … to do the things we used to do. There were cake days and happy hours and meeting up in the office kitchens to just take a minute — to be friends and catch up on each others’ lives — agency life is fast and furious, so breaks and fun are a must sometimes.

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Plant-Based Ice Cream Brand Coconut Bliss Adds Dairy to Product Lineup

XTalks

After 17 years as a plant-based brand, Coconut Bliss has added a dairy-based ice cream to its product lineup. Founded in 2005, Coconut Bliss was once ahead of its time with recognizing the power and soon-to-be popularity of plant-based dairy options. Now, rebranded as Cosmic Bliss, the brand is attempting to boost sustainable dairy with its organic, grass-fed, clean-label dairy ice cream line. .

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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.