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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Don’t blame mental health for mass murder

World of DTC Marketing

According to the National Institutes of Health, people with a mental health diagnosis committed less than 5 percent of gun-related homicides between 2001 and 2010. Mental health experts, including representatives from the American Psychological Association, have called it “unfounded” to blame mass shootings on mental illness in place of considering other possible factors, such as hate, bigotry, and access to assault weapons.

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What does good cybersecurity look like in 2022?

pharmaphorum

The pharma industry is becoming an increasingly hot commodity for cybercriminals. In recent years, digital adoption has accelerated at a rapid pace, with companies racing to integrate cloud-based platforms and telehealth services to expand the delivery of modern healthcare. Combined with the sudden arrival of COVID-19, this perfect storm of events handed cybercriminals an opportunity to exploit weaknesses in fledging systems and processes.

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AstraZeneca kidney inflammation treatment trial reaches dosing stage

Pharma Times

Initial group of patients have received Saphnelo in a phase 3 trial evaluating lupus nephritis

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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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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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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Alternative to open heart surgery emerges following NIHR research

Pharma Times

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

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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 324
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Gun violence is a national health issue

World of DTC Marketing

Gun violence isn’t just a criminal justice issue; it’s a public health issue. There was nearly a 30 percent increase in homicides between 2019 and 2020, making it the most significant one-year increase in six decades. The number of gun deaths in 2021 climbed even higher and is approaching the previous peaks in gun death rates in the early 1970s and early 1990s. .

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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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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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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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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 322
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Find your inner data and take precision marketing to the next level

pharmaphorum

Data is the powerhouse of the pharmaceutical sector. It powers drug discovery, clinical trials, and operational performance. But sizeable reservoirs of data remain unseen and untapped to commercial operations, allowing insights, opportunities, and efficiencies to leak away. Organisations are missing out on the ability to harness their data to energise precision marketing and transform commercial performance.

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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.

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

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EC approves Janssen T-cell therapy for multiple myeloma treatment

Pharma Times

Approval provides another step forward in transforming multiple myeloma outcomes and eliminating the disease

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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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Angle claims FDA okay for Parsortix liquid biopsy system

pharmaphorum

After more than six years of development, Angle has scored an FDA approval for Parsortix as a diagnostic for metastatic breast cancer – the first ever in the US for a device used to detect cancer by harvesting cells from a patient blood sample. In a statement , the UK medical device firm said its “liquid biopsy” approach “offers the prospect of a new era of personalised cancer care” and moves it closer to positioning Parsortix as a go-to technology for assessing cancer st

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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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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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Thousands to potentially benefit from Roche treatment for sight loss

Pharma Times

Faricimab is administered as an eye injection with an interval of up to 16 weeks

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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.

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USAID on expanding digital health globally – part two

pharmaphorum

This article follows part one of our two-part series, in which we discussed how USAID invests in digital infrastructure as part of its development and humanitarian assistance programmes. . Adele Waugaman, senior digital health coordinator of the COVID-19 response at the United States Agency for International Development (USAID), discusses the value of establishing donor partnerships and how those collaborations can improve digital health options globally. .

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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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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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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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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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Top 5 takeaways from international hybrid and virtual meeting guidance for pharma

pharmaphorum

The move to online international meetings has left pharma companies with uncertainty around contact compliance. But new joint guidance, from the IFPMA, EFPIA, and PhRMA, provides clarity. To say the world of work has changed is something of an understatement in the pharma and biopharma industry. Since COVID-19 reared its head more than two years ago, the traditional hustle and bustle of in-person annual congresses have largely been consigned to the history books.

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Capsule dosed drug patent expirations by year

Drug Patent Watch

This chart shows the patent expirations for capsule dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Capsule dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.

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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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NICE recommendation for Sanofi and Regeneron’s CSCC treatment

Pharma Times

Libtayo has been approved for adults when curative surgery or radiation is not appropriate

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Common barriers to patient engagement: What's your strategy?

Bio Pharma Dive

As with treatment, and even adherence, there is no 'one size fits all' when it comes to patient engagement.

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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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Bone Void Filler Cerament G: The Combination Product by BONESUPPORT Gets Market Authorization from the FDA

XTalks

Ceramanet G, a bone void filler with the antibiotic gentamicin, fills bone voids and immediately begins bone healing with protection. Cerament G is a complete kit that allows for a single-stage surgery. Photo courtesy of BONESUPPORT. Osteomyelitis (“osteo” meaning bone and “myelitis” meaning inflammation) is one of the most common acute and chronic bone infections that affects the bone and bone marrow at any age.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time