Sat.Jul 23, 2022 - Fri.Jul 29, 2022

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'Flat is the new up': After biotech correction, venture investors turn to safer bets

Bio Pharma Dive

New companies are being built more carefully and platform technologies are less in vouge as the downturn's effects ripple through the private sector.

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Entrance of novel therapies will drive Niemann-Pick type C disease market growth

Pharmaceutical Technology

According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. The three major markets (3MM: the US, Germany and the UK) will increase in market size from $128.35m last year to $188.35m in 2031, at a compound annual growth rate (CAGR) of 3.9%.

Marketing 306
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Amazon’s big gamble

World of DTC Marketing

Quick Read: Amazon will dramatically expand its healthcare reach with its planned $3.9 billion acquisition of One Medical, a primary care provider with 188 offices in 25 markets nationwide but are they making a strategic move or a mistake? Telehealth has a future, but one could argue that physicians need to see patients firsthand to diagnose and evaluate patients.

Doctors 283
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Nursing homes are suing friends and family to collect on patients' bills

NPR Health - Shots

Debt lawsuits — a byproduct of America's medical debt crisis — can ensnare not only patients but also those who help sick and older people be admitted to nursing homes, a KHN-NPR investigation finds.

Nurses 145
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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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Versant partners with AbCellera to arm startups with better antibodies

Bio Pharma Dive

The companies pitch their collaboration as a way to give young drugmakers backed by Versant a head start. “Our business is advanced by great ideas coming into the funnel,” said AbCellera’s CEO.

Antibody 331
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Embracing digitalization in the pharmaceutical supply chain

Pharmaceutical Technology

The COVID-19 pandemic triggered significant changes to the way healthcare operates. Digitalization is now in full swing as medical care integrates with ICT to take the patient experience to the next level. According to Tom Lenaerts, Head of Global Process Engineering at Datwyler, this transformation will reshape the entire healthcare ecosystem. “There are already opportunities for patients to track their health through smart medical devices sending reports directly to their healthcare provider.

Engineer 286

More Trending

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A doctor in Nigeria warned the world about monkeypox years ago. Did anyone listen?

NPR Health - Shots

Dr. Dimie Ogoina detected monkeypox in an 11-year-old patient in 2017 and saw many other cases since. He's tried to warn health officials that the virus has changed the way it spreads — to no avail. (Image credit: Dr.

Doctors 145
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FDA, in another test of its flexibility, agrees to review Biogen's closely watched ALS drug

Bio Pharma Dive

Known as tofersen, the drug failed in the main study being used to support its approval. But an apparent effect on a protein of interest in ALS research has Biogen convinced the treatment will pass muster with regulators.

Drugs 321
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Pfizer reports 53% operational growth in Q2 2022 revenues

Pharmaceutical Technology

Pfizer has reported a 53% operational growth in revenues to $27.7bn in the second quarter (Q2) of 2022 compared to $18.9bn in the same quarter last year. The rise in revenues was chiefly driven by robust contributions from Covid-19 therapies Paxlovid and Comirnaty. On an operational basis, the revenues rose by $128m or 1%, excluding Paxlovid and Comirnaty’s contributions.

Sales 264
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White House to launch effort to develop next generation of Covid vaccines

STAT News

The Biden administration is preparing a sweeping initiative to develop a next generation of Covid-19 immunizations that would thwart future coronavirus variants and dramatically reduce rates of coronavirus infection or transmission, building on current shots whose impact has been mainly to prevent serious illness and death, the White House told STAT.

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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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Because of Texas abortion law, her wanted pregnancy became a medical nightmare

NPR Health - Shots

New, untested abortion bans have made doctors unsure about treating some pregnancy complications. That's led to life-threatening delays, and trapped families in a limbo of grief and helplessness.

Doctors 145
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AstraZeneca, Daiichi breast cancer drug set for speedy FDA review

Bio Pharma Dive

The agency agreed to quickly assess the companies’ drug Enhertu for “HER2 low” metastatic breast cancer, an indication for which it could become the first targeted treatment option.

Drugs 320
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FDA accepts to review ImmunityBio’s BLA for bladder cancer treatment

Pharmaceutical Technology

The Food and Drug Administration (FDA) has acc epted to review ImmunityBio’s Biologics License Application (BLA) for N-803 to treat Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) carcinoma in situ (CIS) patients with or without Ta or T1 disease. A decision from the regulatory agency on approval for the treatment is anticipated on 23 May next year.

Trials 264
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Encouraged by right-wing doctor groups, desperate patients turn to ivermectin for long Covid

STAT News

Almost two years have passed since Dean Fritzemeier fell ill with Covid in October 2020. As the rest of the world moves on, shrugging off new variants and traveling with a vengeance, he remains trapped in a life weighed down by the virus. Fritzemeier is always tired, but can’t sleep. The 52-year-old once walked 7 miles a day, but now can only get outside if he’s pushed in a wheelchair.

Doctors 140
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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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Monkeypox is a public health emergency. Here's what you need to know about the virus

NPR Health - Shots

The World Health Organization has declared monkeypox a public health emergency of global concern. From how it spreads to preventive measures, here's what you need to know about the disease.

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Epigenetic editing: a tunable CRISPR alternative

Bio Pharma Dive

Three startups have recently emerged with plans to edit the epigenome rather than DNA directly. Here’s why that matters and what they aim to do.

DNA 325
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Can a nasal spray tackle agitation in autism?

Pharmaceutical Technology

The rate at which children are being identified with autism spectrum disorder (ASD) has tripled in the past two decades. While the prevalence was 1 in 150 children in 2000, it reached the rate of 1 in 44 in 2018, in the US, according to the Centers for Disease Control and Prevention. Some people with ASD can experience acute agitation and crisis behaviours.

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Macmillan alliance will provide digital health apps to cancer patients

pharmaphorum

Newly diagnosed cancer patients across the UK will get free access to digital mental health therapies, thanks to a new partnership between Macmillan Cancer Support and Big Health. The alliance, billed as the first of its kind in the UK, means that cancer patients will be able to use Big Health apps like Sleepio and Daylight, which aim to treat insomnia and anxiety using cognitive behavioural therapy (CBT) techniques.

Trials 134
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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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Officials boost access to a drug that can protect the immunocompromised from COVID-19

NPR Health - Shots

Evusheld, a course of injected antibodies, helps protect people with weak immune systems for up to six months. The government is making it available through pharmacies and individual providers.

Pharmacy 143
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Seagen, Astellas claim positive results in study key to cancer drug's success

Bio Pharma Dive

The mid-stage trial tested the companies’ drug Padcev with Merck’s Keytruda in first-line bladder cancer. The data are reportedly a factor in Merck’s talks with Seagen over a potential buyout.

Drugs 293
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EMA task force begins review of Veru’s sabizabulin for Covid-19

Pharmaceutical Technology

The Emergency Task Force (ETF) of the European Medicines Agency (EMA) has commenced the review of Veru’s sabizabulin to treat hospitalised Covid-19 patients at increased acute respiratory distress syndrome (ARDS) risk. The review will facilitate the use of the therapy for emergency usage in countries in the European Union (EU). Under this process, the ETF will analyse all available data, including findings from a trial in moderate-to-severe Covid-19 patients admitted to hospital who are at incre

Medicine 262
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Opinion: Value-based payment has produced little value. It needs a time-out

STAT News

The value-based payment crusade is now two decades old. But despite the tens of billions of dollars — perhaps hundreds of billions — spent on these programs, they have done little to improve Americans’ health or lower health care costs. It is time for proponents of value-based care to call a halt to these programs until they have an answer to this question: “Why have the vast majority of value-based payment experiments failed to improve value?

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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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A Texas teen raises over $700,000 for abortions after Rep. Matt Gaetz mocked her

NPR Health - Shots

Florida Rep. Matt Gaetz told a crowd in Tampa that "nobody wants to impregnate you if you look like a thumb," launching him into an online battle with a teenage activist.

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Pfizer sales of COVID-19 vaccine, pill beat forecasts as company prepares for future waves

Bio Pharma Dive

The company plans to ready a booster shot by the fall that targets the BA.4 and BA.5 strains that are currently most prevalent in the U.S. and other countries.

Sales 306
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Late-stage ulcerative colitis pipeline continues to innovate

Pharmaceutical Technology

Ulcerative colitis (UC), an inflammatory bowel disease, is characterised by inflammation and ulcers in the large intestine, often causing symptoms that impact a patient’s quality of life, including diarrhoea, abdominal pain and cramping, fatigue, weight loss and pain. While the exact cause of UC remains unknown, it is often associated with immune system malfunction.

Trials 246
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Personalizing the Cancer Patient Journey

Pharma Marketing Network

In the first two weeks after a cancer diagnosis, there are likely dozens of doctor’s visits, tests, consultations, and decision points. The patient care team supplies an abundance of information, although sifting through brochures and online resources can be daunting for the patient and their caregiver. Adhering to regulatory guidelines is an important step pharma takes to ensure that promotional medical materials contain balanced information that is accurate and relevant. 1 The marketer’s goal

Marketing 130
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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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Reformulated COVID vaccine boosters may be available earlier than expected

NPR Health - Shots

The Biden administration may scrap plans to expand eligibility for second boosters to younger adults. Instead, it's trying to speed up the next generation of boosters targeting the omicron variant.

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Bristol Myers CAR-T sales rise, despite production problems

Bio Pharma Dive

Demand has increased faster than Bristol Myers can make Abecma, although the company said supply is improving. A manufacturing issue for Breyanzi, meanwhile, impacted sales.

Sales 286
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BMS reports 2% rise in total revenue in Q2 2022

Pharmaceutical Technology

Bristol Myers Squibb (BMS) has reported a 2% rise in revenues to $11.9bn in the second quarter (Q2) of 2022 compared to $11.7bn in Q2 last year. The revenue growth was driven by in-line products, mainly Eliquis and Opdivo, as well as the company’s latest product portfolio comprising Abecma, Opdualag and Reblozyl. New LOE products, especially Revlimid and foreign exchange, impacts partially offset the increase in revenues.

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Philips on designing innovation and cultivating partnerships – part one

pharmaphorum

Sachin Grover, lead of solutions vertical at Philips India, tells me about the company’s innovations during India’s COVID outbreak and how they’ve led to increased healthcare access in the region. There is a vast difference in India’s healthcare system between rural and urban areas, but Philips’ team in the region is working hard to close that gap and improve access to healthcare. “It’s been 75 years since India’s independence.

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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.