Sat.Mar 05, 2022 - Fri.Mar 11, 2022

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Sanofi, with positive data in hand, to ask for approval of longer-lasting hemophilia therapy

Bio Pharma Dive

Patients with severe hemophilia A who were given the drug had, on average, less than one bleeding event over a year, results that Sanofi and partner Sobi believe will pass muster with regulators.

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The biggest challenge for healthcare

World of DTC Marketing

American healthcare is the most expensive globally, but it’s not close to being the best. Our healthcare system has become like a mass-market retailer, in the door to treat the problem and out the door with an Rx or other treatment recommendation. What’s missing is the basic premise of any good care: the focus on the person, not just the condition.

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Top Reasons to See a Chiropractor in Solana Beach CA

Pharma Mirror

As we get older, it becomes more challenging to take care of our bodies. Injuries, aches, and pains are more likely to occur. To combat aging, it’s smart to invest in your physical health. One of the primary ways that people stay healthy in California is by receiving chiropractic care. A chiropractor in Solana Beach CA can help you maintain your health while avoiding future injuries.

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Boehringer backs AI-powered anti-infective startup ArrePath

pharmaphorum

A new company set up to use machine learning to find new anti-infective drugs – ArrePath – has launched onto the scene with $20 million in seed financing from a group of investors including the Boehringer Ingelheim Venture Fund. The Princeton, New Jersey-based startup will use the funding to develop its artificial intelligence and imaging based drug discovery platform, used to identify compounds with new and under-exploited mechanisms of action.

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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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After slower-than-expected review, Pfizer and Arena to close buyout deal

Bio Pharma Dive

Arena Pharmaceuticals expects its $7 billion sale to Pfizer to close Friday, ending a slightly protracted regulatory review that raised questions about whether the deal would be cleared as anticipated.

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We need evidence-based digital health

World of DTC Marketing

Digital health companies aim to address the numerous health care challenges, including poor patient engagement, communication gaps between patients and providers, lack of longitudinal data, inconvenience of care delivery, and insufficient clinical decision support for providers and patients. Maybe, however, they should check with patients first. A 2016 study reported that 259,000 digital health apps were available for consumers.

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Alliance aims to drive inclusivity in trials backed by digital devices

pharmaphorum

A consortium led by the Digital Medicine Society (DiMe) has been set up to try to end inequities in access to clinical trials, focusing on the increasing number of studies that use digital devices to allow participation. The organisation has teamed up with drugmakers GlaxoSmithKline and Amgen as well as partners in the clinical research, patient engagement and data analytics sector on a project to develop the principles that can be used to make sure trials are designed from the ground up to allo

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AbbVie keeps up dealmaking pace in neuroscience

Bio Pharma Dive

On the heels of its Syndesi acquisition, the company has announced an agreement with Gedeon Richter focused on researching and developing new dopamine-regulating drugs for neuropsychiatric diseases.

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Edelman Trust Barometer raises questions

World of DTC Marketing

After two years of pandemic fatigue, healthcare trust is at an all-time low, according to Edelman’s Trust Barometer Special Report on Trust in Healthcare. Still, the report may be too generalized for every healthcare player. Trust is a vital determinant of health behaviors and outcomes, but COVID-19 has dramatically influenced how the public makes healthcare decisions, according to the February online survey of more than 10,000 people in 10 countries worldwide.

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Emmes Acquires Casimir, Its Fourth Major Acquisition

Pharma Mirror

Casimir Further Differentiates Emmes’ Industry-Leading Rare Disease Research Capabilities Rockville, MD, March 10, 2022 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Casimir, a U.S.-based CRO. Casimir has experience in more than 20 rare diseases and has worked with regulators, sponsors and patients to develop outcome measures that capture the nuan

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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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Vibalogics adds capacity for virotherapy manufacturing in Germany

BioPharma Reporter

Vibalogics, which was recently acquired by Swedish company, Recipharm, says the completion of its expansion project at its facility in Germany boosts capacity and further enhances its flexibility, minimizing time to clinic for customers.

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AbbVie holds off another Humira challenger with Alvotech deal

Bio Pharma Dive

A settlement will allow the Iceland-based drugmaker to launch its Humira copycat, currently under FDA review, in the U.S. beginning next July.

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AbbVie sucks

World of DTC Marketing

AbbVie’s wall of patents protecting its top-selling drug Humira will keep another would-be competitor from entering the U.S. market until next year, with the pharmaceutical company announcing Tuesday a settlement with the Iceland-based Alvotech. Sales of Humira earned AbbVie $20.7 billion last year, the highest total for any pharmaceutical product and they will do anything to keep that money.

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Common Risks of Working as a Healthcare Professional

Pharma Mirror

The healthcare professions are rewarding, stimulating, prestigious, and lucrative. Few other professionals can say that their daily task is to save lives. The post Common Risks of Working as a Healthcare Professional appeared first on Pharma Mirror Magazine.

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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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Looking at Women’s Leadership in Life Science Industries on International Women’s Day

XTalks

On International Women’s Day, Xtalks is celebrating women’s leadership in the life sciences by highlighting some of the female leaders at the forefront of scientific discovery, as well as the continuing challenges of attaining more equitable representation. From leading COVID-19 vaccine developments to being at the helm of the latest gene therapies and inventing ground-breaking DNA technologies like CRISPR, women have been at the forefront of some of the most leading-edge scientific discov

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Bluebird's CFO resigns as cash woes raise doubts about its future

Bio Pharma Dive

The gene therapy developer's top financial executive, Gina Consylman, is stepping down amid concerns the company needs to raise additional cash to survive for more than a year.

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Small biotech start-ups should look to web analytics

World of DTC Marketing

Biotech start-ups face challenges in raising money and cutting through the “noise” of other prominent pharma marketers, but their website can provide a wealth of insights into what visitors want to know. One of our most frequent requests is to analyze small biotech websites. Some are in the start-up mode and don’t have the money to hire full-time digital marketers; others may have just received limited approval of one of their drugs and are still in clinical trials.

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Mallinckrodt pays $260m to settle kickback, rebate fraud charges

pharmaphorum

Mallinckrodt’s liability problems in the US have been lightened slightly, after it agreed a $260 million deal to resolve allegations of Medicare rebate fraud and payment of illegal kickbacks. The Ireland-domiciled company was accused of illegally paying smaller drug rebates to Medicaid than were due, as well as using a charitable foundation to cover co-pays for its Acthar Gel (corticotropin) epilepsy treatment – which is not allowed under US law.

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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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Waiting times for cancer referrals highest on record

Pharma Times

93% of people suspected by GPs to have cancer should be seen by a specialist within two weeks but this has fallen to just 75%

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Novartis turns to Voyager for nervous system gene therapies

Bio Pharma Dive

The deal, which carries a $54 million upfront payment, could give Novartis access to as many as five of Voyager's capsids, which would be used to develop gene therapies for the central nervous system.

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One-stop-shop CDMO to support manufacturing of AAV-based product targeting Alzheimer’s disease

BioPharma Reporter

Finnish company, Biovian Oy, has been engaged by a South Korea biotechnology company to carry out process development and manufacturing of an AAV-based innovative drug candidate.

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bluebird says future uncertain as delays to gene therapies bite

pharmaphorum

As bluebird bio struggles to get its gene therapies over the finishing line, the company says its financial position raises “substantial doubt” about its ability to continue as a going concern. The biotech is sitting on around $442 million in liquid assets, but is expecting its cash burn in 2022 to be around $400 million, having recorded a net operating loss of $563 million last year.

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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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Johnson & Johnson Remorseful Over Funding Human Asbestos Experiments, But Says They Were Common in the Past

XTalks

Johnson & Johnson’s baby powder woes do not look like they will be ending any time soon as newly unsealed court documents, first reported by Bloomberg , reveal that the company funded human experiments in 1971 that involved injecting almost a dozen prisoners in a Pennsylvania jail with asbestos. In one study, the investigators wanted to evaluate the possible cancer-causing effects of asbestos versus talc, one of the main ingredients in the baby powder, on the skin of the prisoners.

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Moderna extends patent waiver for COVID vaccine, but only for lower-income countries

Bio Pharma Dive

Health advocates say Moderna is narrowing its pledge not to enforce patents worldwide for the duration of the pandemic, while the company argues that, in higher-income countries, vaccine supply isn't a barrier to access anymore.

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Giant impact crater in Greenland occurred a few million years after dinosaurs went extinct

Scienmag

Danish and Swedish researchers have dated the enormous Hiawatha impact crater, a 31 km-wide meteorite crater buried under a kilometer of Greenlandic ice. The dating ends speculation that the meteorite impacted after the appearance of humans and opens up a new understanding of Earth’s evolution in the post-dinosaur era. Credit: University of Copenhagen Danish and […].

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Scenic Bio raises $31m for genetic modifier platform

pharmaphorum

18 months after signing its first partnering deal with Genentech, Scenic Biotech has raised $31 million in first-round financing that it will use to take its own genetic modifier-targeted medicines into clinical trials. The Netherlands-based biotech, which is putting together a pipeline of genetic modifier drugs for cancer and rare diseases, said the new funding would also allow it to double its headcount to add clinical capabilities and move to a larger facility.

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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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The Advantages and Challenges of Next Generation Sequencing in Food Safety Testing

XTalks

In the last decade, next generation sequencing (NGS) has gone from being solely a research tool to becoming routinely applied in many fields, including food safety testing. While legacy food safety testing methods — such binary pathogen detection tests — can be useful, companies can no longer rely on them alone. Xtalks spoke to Sasan Amini, founder and CEO of Clear Labs, to find out more about the evolving food safety standards. .

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Novartis turns cell therapy skill into contract manufacturing deal

Bio Pharma Dive

In an unusual arrangement, the Swiss pharma will make Carisma Therapeutics' experimental cell therapy at its Morris Plains factory, part of its plans to build up a CMO business.

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How do blind cavefish survive their low-oxygen environment?

Scienmag

Cavefish have obvious adaptations such as missing eyes and pale colors that demonstrate how they evolved over millennia in a dark, subterranean world. Credit: ANDREW HIGLEY/UC CREATIVE Cavefish have obvious adaptations such as missing eyes and pale colors that demonstrate how they evolved over millennia in a dark, subterranean world. Now researchers at the University […].

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WHO announces international hub for mRNA vaccine training

pharmaphorum

The World Health Organization (WHO) announced the opening of a global biomanufacturing hub located in South Korea to provide training to low- and middle-income countries seeking to produce vaccines and other biologics, such as insulin and monoclonal antibodies. . Vaccines are a powerful tool and crucial part of fighting diseases, such as tetanus, measles, meningitis, and, recently, COVID-19.

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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.