Sat.May 21, 2022 - Fri.May 27, 2022

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Responding to outbreak, Moderna starts early work on monkeypox vaccine

Bio Pharma Dive

One day after the U.S. began releasing supplies of an approved Bavarian Nordic shot, Moderna said it's beginning development of its own vaccine against the virus.

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Mental health apps and services may be doing more harm than good

World of DTC Marketing

Cerebral will stop writing prescriptions for Adderall, Ritalin, and other controlled substances to new ADHD patients as concerns grow about telehealth companies’ prescribing practices. To make matters worse, a former executive at Cerebral, a well-funded online mental health startup, claims in a labor lawsuit that the company fired him after he complained that the company was too quick to prescribe powerful stimulant drugs.

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Pfizer makes non-profit pledge for low-income nations

pharmaphorum

US pharma giant Pfizer has said it will sell some of its patented medicines at non-profit prices to 45 of the world’s poorest countries – including new launches. The initiative will focus on infectious diseases, cancer, inflammation, rare diseases and women’s health, and will include its BioNTech-partnered COVID-19 vaccine Comirnaty as well as oral antiviral therapy Paxlovid (nirmatrelvir/ritonavir).

Medicine 111
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PTC Therapeutic’s Upstaza has been recommended by both the EMA and CHMP

Pharma Times

It is the first gene therapy to be directly administered into the brain to treat aromatic L-amino acid decarboxylase (AADC) deficiency

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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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Mirati matches Amgen with updated data for KRAS-blocking cancer drug

Bio Pharma Dive

Fresh study results showed similar rates of response and progression-free survival with Mirati's experimental adragasib as with Amgen's approved Lumakras. The new data might raise safety questions, however.

Drugs 319
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NeuroMetrix’s Quell Device Gets FDA Approval as First Non-Drug Treatment for Fibromyalgia

XTalks

Fibromyalgia is a chronic condition that causes widespread pain, difficulty concentrating, sleep problems, fatigue, mood disorders and other symptoms. People with fibromyalgia have abnormal pain perception processing, so they may be more sensitive to pain compared to people without the condition. Fibromyalgia affects approximately 4 million adults in the US, which is about 2 percent of the US adult population.

More Trending

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Cumulus Neuroscience begins studies of digital biomarker

Pharma Times

Technology is already being used in clinical trials of new treatments for Alzheimer’s and new studies will provide additional validation

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3 cancer drug studies to watch at next month's ASCO meeting

Bio Pharma Dive

Detailed results from important studies of AstraZeneca’s breast cancer drug Enhertu, Gilead’s Trodelvy and Roche’s TIGIT blocker are among the most anticipated late-breaking data set to be presented next month.

Drugs 317
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World Hunger Day 2022: History, Theme and Ways to Support the Movement

XTalks

World Hunger Day is observed each year on May 28 to raise awareness about the dramatic rise in hunger in recent years. While the day was created prior to the COVID-19 pandemic, the unprecedented global crisis has forced hundreds of millions of people into chronic hunger, escalating the need for change. Here’s everything you need to know about World Hunger Day 2022.

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Biotech founder arrested in US amid murder-for-hire investigation

pharmaphorum

The co-founder of Los Angeles biotech Enochian Biosciences has been arrested in connection with a federal investigation into the murder of a Vermont man in 2018. Serhat Gümrükcü (39) has been charged with conspiring to use interstate commerce facilities in the commission of murder-for-hire, along with alleged co-conspirator Berk Eratay (35) of Las Vegas.

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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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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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Concert drug helps regrow hair in study, boosting shares

Bio Pharma Dive

There are no treatments specifically approved for alopecia areata. Concert follows Pfizer and Eli Lilly in reporting positive late-stage results for drugs they're developing for the autoimmune disorder.

Drugs 286
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Dupixent (dupilumab) Becomes the First FDA-Approved Treatment for Eosinophilic Esophagitis

XTalks

The US FDA approved Dupixent (dupilumab) developed by Regeneron as the first treatment for eosinophilic esophagitis, a chronic immune disorder that damages the esophagus. Eosinophilic Esophagitis (EoE) is a chronic inflammatory disease caused by type 2 (allergic) inflammation. An overreaction of the immune system recruits eosinophils, a type of white blood cell, to the esophagus, resulting in inflammation as they respond to the “threat”.

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Why Go With A PCD Pharma Franchise Company?

Fossil Remedies

Are you going to launch a new business by partnering with a new PCD Pharma Company ? Or do you want to expand your business by adding one more company? In both situations, you should be careful and selective while choosing a company. There are several companies around when you search for it. But it is always good to associate with the best one. Why should you prefer the best company?

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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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Inceptor Bio generates $37m in funding round as it advances CAR-T platform into the clinic

BioPharma Reporter

Inceptor Bio, a biotechnology company advancing cell therapies for difficult-to-treat cancers, recently closed a US$37m Series A financing round led by Kineticos Ventures.

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FDA starts clock on review of CSL, UniQure gene therapy

Bio Pharma Dive

The regulator agreed to assess the companies' data under priority review, setting up a decision on approval of the hemophilia B treatment in six months.

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Kidfresh: The Better-For-You Kid’s Brand with Hidden Veggies

XTalks

Kidfresh, a New York-based brand of frozen children’s food featuring hidden veggies, recently added two new products to its robust lineup of frozen meals. The new Cheeseburger Mac & Cheese and Cheese Pizza Wagon Wheels feature high-quality ingredients and hidden carrots and beets. Both entrees contain 13 grams of protein, are good sources of calcium and are free from preservatives and artificial ingredients.

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Pay deal averts strike action at GSK’s UK sites

pharmaphorum

Industrial action at several GlaxoSmithKline manufacturing plants in the UK has been called off, after an improved pay deal was accepted by the Unite union. Unite said last month it was calling for strike by GSK workers for the first time in the company’s history, saying a “derisory” 2.75% pay increase was in fact a pay cut in real terms given the rising rate of inflation in the UK, currently at around 9%.

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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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Spinning is key for line-dancing electrons in iron selenide

Scienmag

HOUSTON – (May 23, 2022) – Rice University quantum physicists are part of an international team that has answered a puzzling question at the forefront of research into iron-based superconductors: Why do electrons in iron selenide dance to a different tune when they move right and left rather than forward and back? Credit: Photo by […].

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Pfizer pledges not-for-profit sale of medicines in low-income countries

Bio Pharma Dive

The pharma has been criticized for not doing enough to make its COVID-19 vaccine and pill available globally. The new initiative commits Pfizer to supplying current and future branded medicines at lower cost to 45 countries.

Medicine 244
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Lenacapavir, Gilead’s Investigational HIV Drug, Gets Its Clinical Hold Lifted By the FDA

XTalks

Acquired immune deficiency syndrome (AIDS) is an ongoing public health issue across the world. About 36.9 million people — which corresponds to 0.5 percent of the planet’s population — have contracted the human immunodeficiency virus (HIV). It is predicted that there are 5000 new cases of HIV infection every day, and 500 of these happen in children.

Drugs 98
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Akili partners with gaming giant Roblox on ADHD therapy delivery

pharmaphorum

Digital health company Akili Interactive has agreed a deal that could see its gamified therapy for attention-deficit hyperactivity disorder (ADHD) hosted on the creative gaming platform Roblox, used by around 55 million users worldwide. First launched in 2006, Roblox is an online space where users can play games – more than 20 million of them at a recent count – created by developers and individuals.

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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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Polymersomes efficiently deliver siRNA to treat breast cancers in preclinical model

Scienmag

BIRMINGHAM, Ala. – Small interfering RNAs, or siRNAs, hold promise to treat tumors, through their ability to specifically knock down oncogenes that promote tumor growth, without the toxicity that accompanies chemotherapy. However, the siRNAs need a delivery vehicle to protect them from degradation and clearance on their journey through the bloodstream to the cancer tumor. […].

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Former Editas CEO Bosley joins UK venture capital firm

Bio Pharma Dive

Bosley, who once led the CRISPR gene editing biotech, will become a venture partner at Advent Life Sciences, which backs a range of early-stage drug companies.

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Driscoll’s Rose Berries Are Back Just in Time for Summer

XTalks

Driscoll’s, a global producer of fresh berries, is bringing back its popular Rose Berries, along with a new high-flavor strawberry innovation, Tropical Bliss. The new flavor will join Rose Berries and Sweetest Batch, making Driscoll’s the first fresh berry company to offer three different high-flavor strawberries mapped to a proprietary sensory wheel. .

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Takeda, Daiichi-backed wearable study planned in Japan

pharmaphorum

A study that will look at the feasibility of tracking people’s lifestyle habits for an extended period using a wearable device has got underway in Japan, backed by drugmakers Takeda and Daiichi Sankyo. The device will be worn by 2,000 people for a year, harvesting data on sleep status, heart rate, and activity levels, according to the study partners, which also include digital health and telemedicine firm MICIN and Tohoku University.

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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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Gene linked to severe learning disabilities governs cell stress response

Scienmag

DURHAM, N.C. – A gene that has been associated with severe learning disabilities in humans has been found to also play a vital role in cells’ response to environmental stress, according to a Duke University study appearing May 24 in the journal Cell Reports. Credit: DINACHI OKONKWO, Duke University DURHAM, N.C. – A gene that […].

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Merck study results signal blood cancer potential for new type of immunotherapy

Bio Pharma Dive

Bristol Myers beat Merck to the first approval of a so-called LAG-3 inhibitor.

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How do you expand cell therapy manufacturing to reach more patients per year?

BioPharma Reporter

The potential of cell therapy is proven, but its impact is limited by manufacturing bottlenecks.

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Alternative to open heart surgery emerges following NIHR research

Pharma Times

Less invasive procedure offers an equally effective alternative for heart condition patients

Research 111
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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.