Thu.Jul 15, 2021

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Merck details an immunotherapy 'milestone' in early breast cancer

Bio Pharma Dive

Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives.

Drugs 321
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Biogen is in deep trouble and may not survive

World of DTC Marketing

SUMMARY: The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug. Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug. Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.

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Major health centers, insurers push back against Aduhelm

Bio Pharma Dive

The Cleveland Clinic and Mount Sinai won't yet administer the controversial Alzheimer's drug, while UnitedHealth's CEO said the insurer would need more time to iron out coverage.

Drugs 317
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Understanding the Link Between Alcohol and Depression

Pharma Mirror

Alcohol abuse is closely correlated with depression. This doesn’t necessarily mean one causes the other, but many people who suffer from depressive disorders turn to alcohol to escape. On the other side of that coin, those who abuse or overuse alcohol can develop symptoms of depression or exacerbate symptoms that are already present. So, how are these two issues related, and how can you help a loved one if you start to notice alcohol-induced depression or depression-induced alcohol abuse?

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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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Galapagos shares sink as first data from touted drug program disappoints

Bio Pharma Dive

The biotech will push forward with other candidates from its "Toledo" research, but investors did not appear encouraged by the mixed data Wednesday.

Drugs 161
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UK fines drugmakers record £260m for price gouging NHS

pharmaphorum

The UK’s competition authority has issued its largest ever fine of more than £260 million ($360 million) to several pharma companies accused of colluding to hike the price of medicines delivered to the NHS. The Competition and Markets Authority (CMA) took the action against Auden Mckenzie and Actavis UK – now known as Accord-UK – and other companies after an investigation into the price of hydrocortisone tablets, which rose by 10,000% over a 10-year period.

Marketing 119

More Trending

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Affinivax, Astellas’ pneumococcal vaccine wins breakthrough therapy status

Pharma Times

At the same time, Affinivax and Astellas revealed positive results from the Phase II trial of ASP3772

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Researchers Develop World’s First Saliva Test for Diabetes

XTalks

University of Newcastle researchers in Australia have developed a saliva test to evaluate glucose levels in diabetic patients. The test involves the use of testing strips that contain a glucose biosensor with electronic elements in the test’s transistor, like inks, that allow for mass printing of the test strips at low cost. Currently, diabetic patients who monitor their blood sugar levels daily have to draw a blood sample by pricking their finger with a lancet.

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Merck’s MET inhibitor tepotinib gains positive opinion from MHRA

Pharma Times

The positive opinion has been issued via the MHRA’s early access the medicine (EAMS) scheme

Medicine 129
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Do Vegan Wines Differ from Other Wines?

XTalks

PlantX, a vegan marketplace, added vegan wines to its online grocery selection. Brands in this selection include Rare Earth, Veuve Clicquot, Pino Cellars and Gravel Bar Winery. These options are available for purchase through a category on the web page titled “Plant-Based Wine.” Not many online grocery platforms have this category included on their e-commerce sites.

Protein 98
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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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Spaces still available in the 2021 Sales Awards

Pharma Times

There are still available spaces in the 2021 Sales Awards as we enter the last couple of months for entries.

Sales 123
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First US patient gets total heart replacement with CARMAT device

pharmaphorum

An experimental artificial heart developed by French medical device specialist CARMAT has been implanted into the first of 10 subjects due to be enrolled in a US trial. The Aeson bioprosthetic device has already been implanted in a number of European patients with end-stage biventricular heart failure – affecting both sides of the heart – and shown that it can keep them alive for months, even after they have been sent home for hospital.

Trials 98
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Regeneron Plans to Create 1,000 New Jobs with $1.8 Billion Expansion in New York

BioSpace

Regeneron continues to expand its presence in New York. Over the next six years, the company will invest approximately $1.8 billion to expand its Tarrytown facilities. The investment will support the addition of 1,000 new jobs.

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Elekta to work with academics on AI-directed radiotherapy

pharmaphorum

Radiotherapy specialist Elekta has joined forces with two academic groups in the Netherlands to explore the use of artificial intelligence (AI) to deliver more effective personalised therapy to patients. . The Swedish company will collaborate with scientists at the Netherlands Cancer Institute and University of Amsterdam (UvA) on a project that aims to use AI to improve the quality of imaging used to direct radiotherapy and guide the delivery of treatment.

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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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Lilly and Banner Alzheimer’s Institute in strategic research collaboration for donanemab trial

BioPharma Reporter

Eli Lilly and Company and Banner Alzheimerâs Institute have announced a strategic research collaboration as part of the planned Phase 3 study for donanemab in participants at risk from cognitive and functional decline related to Alzheimerâs disease.

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Arrival of land plants changed Earth’s climate control system

Scienmag

The arrival of plants on land about 400 million years ago may have changed the way the Earth naturally regulates its own climate, according to a new study led by researchers at UCL (University College London) and Yale. Credit: Katmai Preserve NPS Photo/Russ Taylor The arrival of plants on land about 400 million years ago […].

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Patient perspective key to any redesign of clinical trial protocols to suit decentralized approach

BioPharma Reporter

A holistic approach to decentralized clinical trials that combines intentional design, stakeholder collaborations, and user-friendly technology is whatâs needed to execute global clinical trials more efficiently, argues an expert.

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Accurate protein structure prediction now accessible to all

Scienmag

New artificial intelligence software can compute protein structures in 10 minutes Credit: Ian Haydon, UW Medicine Institute for Protein Design Scientists have waited months for access to highly accurate protein structure prediction since DeepMind presented remarkable progress in this area at the 2020 Critical Assessment of Structure Prediction, or CASP14, conference.

Protein 98
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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.

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Alexion’s Ultomiris Hits Mark in Phase III for Myasthenia Gravis

BioSpace

Boston-based Alexion Pharmaceuticals announced positive topline data from its Phase III trial of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis.

Trials 98
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Removing the lead hazard from perovskite solar cells

Scienmag

Credit: Endre Horváth (EPFL) “The solar energy-to-electricity conversion of perovskite solar cells is unbelievably high, around 25%, which is now approaching the performance of the best silicon solar cells,” says Professor László Forró at EPFL’s School of Basic Sciences. “But their central element is lead, which is a poison; if the solar panel fails, it […].

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Cancer Research UK reports ‘most successful financial year’ for its spinouts

Pharma Times

Investment raised by its spinouts more than doubled in the last year, the charity has reported

Research 129
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Bioengineering discovery paves way for improved production of bio-based goods

Scienmag

Credit: Courtesy of Klaudia Ciurkot Scientists have uncovered a way to control many genes in engineered yeast cells, opening the door to more efficient and sustainable production of bio-based products. The study, published in Nucleic Acids Research by researchers from DSM’s Rosalind Franklin Biotechnology Center in Delft, the Netherlands, and the University of Bristol, has […].

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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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Galapagos reports early clinical results for SIK inhibitor

Pharma Times

Novel drug candidate found to be generally safe and well-tolerated in inflammatory indications

Drugs 123
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New Book Defines Trend: Meet the Multispecies Family

Scienmag

SMU sociologist says treating pets like family impacts birth rates, budgets and job choice Credit: Hillsman S. Jackson In her new book, Just Like Family: How Companion Animals Joined the Household SMU sociologist Andrea Laurent-Simpson asserts what most pet-owners already know – the American family structure is changing to include nonhuman species, and the implications […].

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Pfizer Offers $345 Million to Settle Out of EpiPen Pricing Lawsuit

BioSpace

In 2016, Mylan’s EpiPen became the flashpoint of drug pricing outrage when it became widely reported the life-saving drug had increased more than 400% in price over a period of seven years.

Drugs 97
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Nearly 20 percent of intact forest landscapes overlap with extractive industries

Scienmag

Intact Forest Landscapes are critical for conserving biodiversity and fighting climate change Credit: Julie Larson Maher/WCS Byron Bay (16/7/2021) – A new study from WCS and WWF reveals that nearly 20 percent of tropical Intact Forest Landscapes (IFLs) overlap with concessions for extractive industries such as mining, oil and gas. The total area of overlap […].

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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Opdivo/Yervoy Combo Fails to Meet Endpoints in Head and Neck Cancer

BioSpace

The randomized, multi-center study called CheckMate -651 evaluates Opdivo 3 mg/kg every two weeks in combination with Yervoy 1mg/kg every six weeks.

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PPPL selected for new public-private fusion partnerships

Scienmag

Credit: Photos and collage by Elle Starkman/PPPL Office of Communications. Advanced capabilities ranging from the innovative use of artificial intelligence (AI) to state-of-the-art computer codes have won the U.S. Department of Energy’s (DOE) Princeton Plasma Physics Laboratory (PPPL) its third straight round of DOE-sponsored public-private partnerships to help accelerate the production on Earth of the […].

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Medtech HeartFlow Joins SPAC Movement, Plans to List on NYSE

BioSpace

Medtech company HeartFlow is heading to the New York Stock Exchange through a merger with special purpose acquisition company, Longview Acquisition Corp. II.

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Routine screening for BI-RADS lesions on automated whole-breast ultrasound

Scienmag

Return to routine screening for BI-RADS 3 lesions on supplemental automated whole-breast ultrasound substantially reduces the recall rate, while being unlikely to result in adverse outcome Credit: American Roentgen Ray Society (ARRS), American Journal of Roentgenology (AJR) Leesburg, VA, July 15, 2021–According to ARRS’ American Journal of Roentgenology (AJR), return to routine screening for BI-RADS […].

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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.