Sat.Jan 01, 2022 - Fri.Jan 07, 2022

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10 clinical trials to watch in the first half of 2022

Bio Pharma Dive

Biotech stocks ended 2021 in a slump. But positive results from eagerly anticipated studies in breast cancer, schizophrenia and Alzheimer's disease could help turn the sector's fortunes around.

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The financial toxicity of treating cancer

World of DTC Marketing

(Stat News) Today, a study followed 380 patients being treated at community oncology groups across the U.S. after they were diagnosed with metastatic colon cancer. They told the researchers that insurance didn’t protect them from serious money problems. While 98% of them had insurance, 71% fell deeper into debt, took out a new loan, sold or refinanced a home, or experienced at least a 20% decline in income — or a combination of these over the year they answered quarterly surveys.

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B-cell lymphoma clinical trials now open on the TrialWire Platform

Pharma Mirror

ADELAIDE, AUS – TrialWire(TM) is pleased to announce new B-cell lymphoma clinical studies are now available on the TrialWire Platform. More than 6 million people have used TrialWire over the past few years to find clinical trials that are right for them at clinics and specialist centers near them. The studies on TrialWire are available in Australia, New Zealand, and the U.S.

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New blood test can identify presence of cancer

Pharma Times

The test is a technological first in determining the metastatic status of a cancer without using prior insight of the primary cancer presented.

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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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As three biotechs head to Wall Street, a battered sector braces for a pullback

Bio Pharma Dive

Amylyx, CinCor and Vigil raised about $480 million combined, a sign of continued investor interest in biotech IPOs. But industry analysts expect fewer and smaller offerings in 2022 due to investor fatigue from high valuations.

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A realistic view of healthcare in 2022

World of DTC Marketing

Yes, there will be changes in healthcare in the coming years but put away the thoughts that telehealth and wearable devices will revolutionize healthcare. More and more patients demand a level of service they want with the increased costs of health insurance premiums. Here are things I believe are more realistic. 1ne: The value proposition of prescription drugs still outweighs potential side effects – Wegovy’s demand quickly exceeded supply after the FDA approved once-weekly semaglut

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More Trending

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MHRA grants approval for Pfizer’s oral COVID-19 antiviral pill

Pharma Times

Pfizer’s Paxlovid has a success rate of nearly 90% as a prophylaxis treatment against severe COVID-19 when administered shortly after the patient has been infected with the virus.

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Pfizer, BioNTech bet mRNA can make a better shingles vaccine

Bio Pharma Dive

The pharma company, already partnered with BioNTech on vaccines for COVID-19 and influenza, will pay $225 million upfront to further expand its work with the German biotech.

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The most significant threat to American healthcare

World of DTC Marketing

The estimated numbe r of annual deaths attributable to obesity among U.S. adults is approximately 280,000 based on H.R.s from all subjects and 325,000 based on H.R.s from only nonsmokers and never-smokers. As the N.Y. Times recently reported, estimates of the medical cost of adult obesity in the United States (U.S.) range from $147 billion to nearly $210 billion per year.

Genetics 234
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Gritstone bio trumpets first data for ‘multivariant’ COVID jab

pharmaphorum

A COVID-19 vaccine that could work against multiple variants of the coronavirus – developed by US biotech Gritstone bio – has generated encouraging immune response data in its first clinical trial. The new vaccine differs from the currently approved shots because it delivers antigens for both the spike protein and other proteins found in SARS-CoV-2.

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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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Finally: A comprehensive diagnostic guide to a well-established boxwood disease

Scienmag

For more than 150 years, Volutella blight has been one of the most common diseases of the loved and iconic boxwood plant as well as other plants in the family, including pachysandra and sarcococca. Despite its presence on every continent except Antarctica, the disease can be hard to identify. To help with diagnosis, a group […].

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5 FDA approval decisions to watch in the first quarter

Bio Pharma Dive

The first three months of 2022 could bring clearances for a new type of immunotherapy and a first-of-its kind HIV drug as well as mark the start of a price battle in oncology.

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Good Rx? Actually not

World of DTC Marketing

GoodRx promotes itself as a company that allows you to compare drug prices and find coupons at over 60,000 pharmacies across the country, but actually, most pharmacists hate it. When they say compare prescription drug prices, they mean the cost of a prescription if you aren’t using insurance. And advertising? Uh, no. GoodRx makes money in two main ways: Advertisements on their site and a percentage fee every time a GoodRx coupon is used at the pharmacy.

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AstraZeneca goes bigger in amyloidosis with Neurimmune deal

pharmaphorum

AstraZeneca has clearly made the rare disease transthyretin amyloidosis (ATTR) a key component of its rare disease pipeline, licensing a second drug candidate in the space of a couple of months. In the latest deal, the pharma group is paying $30 million upfront with another $730 million in milestone’s for global rights to Neurimmune’s NI006, a drug in early-stage clinical for cardiomyopathy, a progressive and fatal complication affecting some patients with ATTR.

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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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Biogen and Eisai move forward with investigational Alzheimer's therapy

BioPharma Reporter

Lecanemab, an investigational anti-amyloid beta (AÎ) protofibril antibody for the treatment of early Alzheimer's disease, has been granted Fast Track designation by the US Food and Drug Administration (FDA).

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After years of decline, drugmakers' price hikes may have bottomed out

Bio Pharma Dive

Inflation in 2021 may have offered drugmakers a catalyst for taking slightly bigger increases on a list price basis. But rebates to insurers are still keeping net price rises lower.

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Sosei Heptares and Verily to collaborate on immune-mediated disease treatments

Pharma Times

The companies share the goal of furthering knowledge around GPCR biology in immune cells in order to better understand a range of immune system disorders.

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Digital health innovation in 2022: Anticipating healthcare trends ahead of the J.P. Morgan week

pharmaphorum

We spoke with Tanja Dowe, ahead of the annual J.P. Morgan Health Care Conference 2022, about radical innovation in healthcare, including the potential of digital solutions to diagnose disease earlier, using digital therapeutics or preventive digital solutions more efficiently, and making use of technologies that result in accelerated drug discovery and development.

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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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Shingles is new focus for Pfizer and BioNTech in mRNA vaccine development partnership

BioPharma Reporter

Pfizer and BioNTech, in what will be the third mRNA vaccine collaboration between the two companies, are teaming up on the development of a potential first mRNA-based vaccine for the prevention of shingles.

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Lilly pours more money into genetic treatments for neurological diseases

Bio Pharma Dive

For $50 million, Lilly has secured rights to a technology that's meant to transport nucleic acid therapies in a way that's more targeted and better tolerated than other methods.

Genetics 300
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3 Reasons Why a Talent Community is Valuable for Life Science Recruitment

XTalks

Have you ever been asked to join a company’s talent community during a job search? If so, then you must know that these talent communities are becoming a vital recruitment strategy for employers. . A talent community is a digital network of potential employees that have previously expressed interest in certain roles from your organization. Many companies have built highly successful talent communities and benefited from their advantages for recruitment. .

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FDA gives AbbVie’s c-Met lung cancer ADC a breakthrough tag

pharmaphorum

The FDA thinks an antibody-drug conjugate (ADC) developed by AbbVie could set new standards in treatment for certain patients with lung cancer, awarding the drug breakthrough status. Teliso-V (telisotuzumab vedotin) is pitching to become the first targeted cancer treatment for people with non-small cell lung cancer (NSCLC) whose tumours overexpress c-Met.

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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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PCR not needed following lateral flow test under new guidelines

Pharma Times

Testing rules for COVID-19 are set to be eased for those who test positive on a lateral flow test but are asymptomatic.

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AstraZeneca adds to rare disease drug pipeline with Neurimmune deal

Bio Pharma Dive

Neurimmune, which will license to AstraZeneca an early-stage treatment for a rare form of cardiomyopathy, is probably best known for its invention of the antibody that became Biogen's Alzheimer's drug Aduhelm.

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Danone Partners with Cold Stone Creamery for Plant-Based Dessert

XTalks

Danone North America is partnering with Cold Stone Creamery to offer a new plant-based dessert: The Silk Chocolate Almondmilk Frozen Dessert. Along with the flavor launch, Cold Stone Creamery is introducing a new menu item called Don’t Cry Over Spilled Silk Creation, which features this latest flavor as well as banana, peanut butter and roasted almonds.

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Putting patient perspectives at the heart of kidney cancer research

pharmaphorum

Kidney cancer is the 14 th most common cancer, with approximately 400,000 new cases worldwide every year. Renal cell carcinoma (RCC) is by far the most prevalent type of cancer originating from the kidney, making up nine out of ten kidney cancer diagnoses. As chief medical officer, head of global medical affairs, patient safety and patient affairs – putting patient interests first is central to my role and values.

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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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FDA approves Immix Biopharma Rare Pediatric Disease Designation for cancer treatment

BioPharma Reporter

Biopharmaceutical company ImmixBio has been granted Rare Pediatric Disease (RPD) designation from the US Food and Drug Administration (FDA) for IMX-110 for the treatment of a life-threatening form of pediatric cancer in children, rhabdomyosarcoma.

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Avrobio stops work on rare disease gene therapy after unexpected study results

Bio Pharma Dive

The biotech's treatment was one of the furthest along in testing for Fabry, a rare inherited disease that's become a target for gene therapy developers.

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Revised PhRMA Code Took Effect on January 1, 2022, and Certain State Obligations Follow

FDA Law Blog

By Faraz Siddiqui — Happy New Year! On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance.

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Another big AI deal as Sanofi taps Exscientia for 15 new drugs

pharmaphorum

If the last couple of days is an indication, 2022 is already shaping up to be the year of big-ticket alliances between big pharma companies and specialists in artificial intelligence-driven discovery. Shortly after Amgen unveiled its $1.9 billion alliance with Generate Biomedicines aimed initially at five drug molecules, Sanofi has announced a big expansion of its longstanding partnership with Exscientia that covers no fewer than 15 programmes.

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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.