Sat.Mar 12, 2022 - Fri.Mar 18, 2022

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FDA sets out advice to developers of gene editing medicines

Bio Pharma Dive

Draft recommendations from the agency were generally straightforward, analysts said, although the document emphasized the potential safety risks of gene editing.

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Are small biotechs in trouble?

World of DTC Marketing

It’s not only getting harder for small biotechs to find funding; too many have scaled up operations by adding employees too quickly, forcing them to lay off people as the path to new drug approvals gets more complicated. With two of its prized gene therapies on clinical hold, Bluebird, a small biotech company in Cambridge, is going through some hard times.

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Omicron BA.2 variant triggers COVID-19 surge in England

Pharma Times

The sub-variant combines mutations from both Omicron and Delta

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Will people be left behind by the digital health revolution?

pharmaphorum

The uptake of digital health tools during the pandemic has been enormous due to improved access they provide to healthcare. In this article, Ben Hargreaves asks whether there are gaps in those utilising these solutions and what action is being taken to address this. Digital health has a tremendous capacity to transform the healthcare industry, with the ability to provide easy access to a multitude of services and new types of therapies.

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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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Passage Bio to cut jobs in latest biotech restructuring

Bio Pharma Dive

Stung by a stock market downturn, a number of biotechs are trimming spending and reprioritizing research to save cash. Passage's layoffs will reduce its workforce by 13%.

Marketing 325
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Moderna takes HIV trimer mRNA vaccine into clinical trials

BioPharma Reporter

The first participant has been dosed in a Phase 1 clinical trial of HIV trimer mRNA vaccine candidate mRNA-1574.

More Trending

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AZ, Merck get FDA okay for Lynparza as adjuvant breast cancer therapy

pharmaphorum

The FDA has cleared AstraZeneca and Merck & Co’s Lynparza as an adjuvant or neoadjuvant treatment for breast cancer, extending its lead over pretenders to its PARP inhibitor crown. The new approval is for use in patients with BRCA-mutated, HER2-negative early-stage breast cancer who have already been treated with chemotherapy – either before or after surgery – and are at high risk of the disease coming back.

Sales 140
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FDA clears AstraZeneca, Merck drug to treat some genetic breast cancers early

Bio Pharma Dive

Lynparza is the first drug targeting BRCA mutations to be approved for use in early breast cancer, a decision that could lead to more genetic testing.

Genetics 321
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Artificial intelligence paves the way to discovering new rare-earth compounds

Scienmag

Artificial intelligence advances how scientists explore materials. Researchers from Ames Laboratory and Texas A&M University trained a machine-learning (ML) model to assess the stability of rare-earth compounds. This work was supported by Laboratory Directed Research and Development Program (LDRD) program at Ames Laboratory. The framework they developed builds on current state-of-the-art methods for experimenting with […].

Scientist 132
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Scientists identify two more hybrid variants alongside Deltacron

Pharma Times

The hybrid of Delta and Omicron, known as ‘Deltacron’, has been identified in France, Denmark and the Netherlands

Scientist 133
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Sisram Medical Ltd Announces 2021 Record Annual Results

Pharma Mirror

HONG KONG, Sisram Medical Ltd (the “Company” or “Sisram”, stock code: 1696.HK; together with its subsidiaries referred as the “Group”), a global consumer wellness group, featuring a never-before-seen synergistic ecosystem of business building blocks and consumer-focused branding, ranging from medical aesthetics capital equipment, via injectables therapy, aesthetic dentistry, personal care and more, today announced its audited consolidated annual results for th

Branding 130
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Two decades and $200 billion: AbbVie's Humira monopoly nears its end

Bio Pharma Dive

Biosimilar copies of Humira will arrive in the U.S. beginning early next year, testing both AbbVie and the market potential for knockoff biologic drugs.

Marketing 312
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Enveric taps University of Calgary to study psychedelic therapy in cancer-related distress

Outsourcing Pharma

The pharma company and academic institution will explore the viability of a psychedelic treatment to help patients suffering from cancer-related distress.

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COVID-19 infections seeing spike across UK

Pharma Times

In the coming months, an additional vaccine booster will be offered to those over 75, care home residents and to those over 12 who are most vulnerable

Vaccine 124
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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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Eisai hands off responsibility for Aduhelm to Biogen

pharmaphorum

Japanese pharma Eisai has backed away from its 50:50 profit-sharing arrangement with Biogen for troubled Alzheimer’s therapy Aduhelm, handing over full responsibility to its US counterpart. The changes to the terms of their longstanding collaboration on Aduhelm (aducanumab) means that Eisai’s profit-share converts to a simple royalty rate on revenues from 1 January next year.

Sales 118
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Alnylam sues Pfizer, Moderna over technology used in COVID vaccines

Bio Pharma Dive

The biotech claims the lipid nanoparticles used by Pfizer and Moderna for delivery of their coronavirus shots infringe on a key patent it holds.

Vaccine 312
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Sanofi announces €300m collaboration with Blackstone Life Sciences for multiple myeloma treatment

BioPharma Reporter

Sanofi and Blackstone today announced a strategic, risk-sharing collaboration under which funds managed by Blackstone Life Sciences will contribute up to â300m ($329m) to accelerate development for subcutaneous formulation and delivery of anti-CD38 antibody Sarclisa to treat patients with multiple myeloma (MM).

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NICE to improve diagnosis for foetal alcohol spectrum disorder

Pharma Times

Better treatment for conditions experienced by individuals who were exposed to alcohol before birth

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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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FDA says no to AZ’s Fasenra for nasal polyp indication

pharmaphorum

AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic rhinosinusitis in people with nasal polyps, after the FDA rejected its marketing application. The US regulator has asked for additional clinical data, according to AZ, which said it remains committed to brining the drug to patients with the inflammatory condition, which results in the growth of nasal polyps in the nose that can sometimes require surgical intervention.

Sales 116
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How Merck's 'puzzling' results could impact immunotherapy's role in early lung cancer

Bio Pharma Dive

New study data add to evidence that checkpoint inhibitors can slow the return of lung tumors. But the results also leave some doubt over the best way to use the drugs.

Drugs 295
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The Butterfly Cup: Fully Compostable Coffee Cups Coming to A&W Canada

XTalks

Canadian fast-food chain A&W is piloting the Zero Cup, a fully recyclable and compostable coffee cup designed by UK-based company Butterfly Cup. The environmentally-friendly cup is made entirely of paper and requires no lid, straw or plastic liner. A&W claims to be the first quick service restaurant (QSR) in North America to pilot the Butterfly Cup.

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Finalists announced for the 2022 International Clinical Researcher of the Year

Pharma Times

With the significant increase in entries this year, the competition to name the finalists proved incredibly tough. The International Clinical Researcher judging panel, however, have made their decisions and the finalists have now been announced.

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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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Does COVID-19 infection raise the risk of diabetes?

pharmaphorum

Researchers in Germany are have found a possible link between mild COVID-19 infection and an increased risk of type 2 diabetes, although they caution the signal needs further investigation. The team from Heinrich Heine University in Dusseldorf and healthcare data science company IQVIA identified the possible correlation after analysing health records from 8.8 million patients registered at 1,171 health practices across Germany, including almost 36,000 who had been diagnosed with mild COVID-19.

Insulin 114
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Sanofi lures Blackstone backing in unusual deal for multiple myeloma drug

Bio Pharma Dive

Rather than fund development of a more convenient version of its blood cancer drug Sarclisa on its own, Sanofi has instead turned to Blackstone, which has fast become one of the sector's more active investors.

Drugs 295
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Pharma leaders should step up on artificial intelligence: ConcertAI

Outsourcing Pharma

An executive from the AI specialist discusses how recent advances have provided opportunities for industry professionals to champion new ways of thinking.

Research 103
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Severe COVID-19 linked to risk of mental health effects

Pharma Times

Patients who were bedridden for seven days or longer were at increased risk of depression and anxiety over the study period

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pharma group seeks digital measure standards for Alzheimer’s

pharmaphorum

A group of pharma companies and academic groups have joined forces with the Digital Medicine Society (DiMe) to develop standardised, digital clinical measures that can be used in the development of therapies for Alzheimer’s disease and related dementias. According to the consortium – which includes drugmakers Biogen, Eisai, Eli Lilly and Merck & Co – there is a lack of measures that can be used to determine whether new therapies for Alzheimer’s are actually working.

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Nektar, Bristol Myers drug combination fails in late-stage melanoma trial

Bio Pharma Dive

The trial results were the most significant setback for the companies' four-year-old partnership and will likely force Nektar to cut costs.

Trials 290
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Novel theory of entropy may solve materials design issues

Scienmag

A challenge in materials design is that in both natural and manmade materials, volume sometimes decreases, or increases, with increasing temperature. While there are mechanical explanations for this phenomenon for some specific materials, a general understanding of why this sometimes happens remains lacking. Credit: Elizabeth Flores-Gomez Murray/Jennifer M.

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Bill & Melinda Gates Foundation launch initiative for future pandemics

Pharma Times

The initiative will catalyse discovery and early development of antiviral medicines for future pandemics

Medicine 103
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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.