Sat.Oct 29, 2022 - Fri.Nov 04, 2022

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Building a biotech in a downturn: 3 lessons from VCs and startup CEOs

Bio Pharma Dive

In a panel discussion hosted by BioPharma Dive, venture capitalists and CEOs discussed how startups can navigate a challenging market as well as possible ripple effects from the new U.S. drug pricing law.

Marketing 362
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GSK speeds up the race to bring first RSV vaccine for older adults to market

Pharmaceutical Technology

After decades of setbacks, the respiratory syncytial virus (RSV) vaccine field has bounced back with positive Phase III trial results in older adults. There are currently five players in the race, with vaccines in Phase III of development from GlaxoSmithKline (GSK) , Pfizer , Johnson & Johnson , Moderna and Bavarian Nordic. However, recent data from GSK’s sub-unit vaccine, GSK-3844766A, have pushed the candidate to the top, with the highest efficacy demonstrated in a pivotal trial to date.

Vaccine 338
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Newly Discovered Gut Microbe Could Be a Trigger For Rheumatoid Arthritis

AuroBlog - Aurous Healthcare Clinical Trials blog

Rheumatoid arthritis affects 1 in 100 people worldwide. It causes inflamed, painful and swollen joints, often in the hands and wrists, and can lead to loss of joint function as well as chronic pain and joint deformities and damage. What causes this condition has been unknown. [link] In our recently published study, my colleagues and […].

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CDC issues new opioid prescribing guidance, giving doctors more leeway to treat pain

NPR Health - Shots

The updated recommendations seek to course correct after guidelines from 2016 were criticized for harshly limiting access to needed pain medication. (Image credit: Jose M.

Doctor 145
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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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String of gene therapy deals spurs cautious optimism on Wall Street

Bio Pharma Dive

To some analysts, the recent acquisitions of Akouos and AGTC, as well as Astellas’ equity investment in Taysha, are a positive signal for an area of drug research that’s been “in investors' penalty box for much of 2022.

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Pfizer records 6% decline in revenue in Q3 2022

Pharmaceutical Technology

Pfizer has reported a 6% decline in revenue to $22.6bn in the third quarter (Q3) of 2022 as against $24bn in the same quarter last year. In the quarter, revenues rose 2% operationally on omitting contributions from Covid-19 therapies, Paxlovid and Comirnaty. Reduction in revenues from Comirnaty outside the US and reduced revenues for some Comirnaty-linked manufacturing works carried out on behalf of BioNTech, Xeljanz and Sutent worldwide were the key drivers that contributed to the revenue dec

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Digital cognitive behaviour therapies recommended by NICE across the NHS

Pharma Times

Treatment will assist young people and children with symptoms of mild-to-moderate anxiety

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Bispecific cancer drugs and gene therapy advances: What to watch at next month’s ASH meeting

Bio Pharma Dive

Competition is increasing behind newly approved drugs from Roche and J&J, while the long-term benefit of gene therapies for chronic blood disorders is being put to the test.

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Inside the European mass shift to data-driven health solutions

Pharmaceutical Technology

In a few weeks, the EU-funded research project Darwin EU will announce its first batch of data partners for the ambitious real-world data -driven Horizon 2020 project. This project centres around the use of electronic health records (EHRs) from different European countries to drive research and improve responses to expected and unexpected crises. A major objective of this project hinges on exploiting national EHR data to complete observational studies quicker than industry standards.

Big Data 278
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These DNA-Damaging Molecules May Be The Link Between Colon Cancer And IBD

AuroBlog - Aurous Healthcare Clinical Trials blog

Scientists have discovered DNA-damaging molecules made by gut bacteria that may help explain why people with inflammatory bowel disease (IBD) have higher rates of colorectal cancer than those without the condition. [link] In a new study, published Thursday (27 October) in the journal Science, researchers identified a previously unknown class of DNA-damaging molecules, or genotoxins, […].

DNA 240
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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CVS and Walgreens announce opioid settlements totaling $10 billion

NPR Health - Shots

It could amount to the last round of huge settlements after years of litigation over the industry's role in an overdose crisis linked to more than 500,000 deaths in the U.S. over the past two decades.

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Artiva cancels IPO plans and cuts a deal with Affimed

Bio Pharma Dive

With public offerings difficult to pull off, Artiva is focusing its energy on a cancer drug deal with the German biotech.

Drugs 347
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Recurrent drug shortages signal onerous outlook for cardiovascular care

Pharmaceutical Technology

Drug shortages continue affecting cardiovascular clinical practice across the world, reflecting rising demand and cost-effective manufacturing challenges. While the stock of currently affected drugs is expected to improve as production is increased in the near future, experts say it is likely that the cardiovascular sector will be particularly affected by such shortages in the long run as demand continues to grow from an aging population.

Drugs 277
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Purified Sand Particles Have Anti-Obesity Effects, Scientists Confirm

AuroBlog - Aurous Healthcare Clinical Trials blog

Porous particles of silica made from purified sand could one day play a role in attempts to lose weight. Past clinical trials have already produced promising results, but the actual weight-lowering mechanism behind the potential treatment has been poorly understood. [link] To sift out the key variables, researchers have now tested a range of silica […].

Scientist 232
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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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Pfizer, BioNTech report bivalent Covid-19 booster more protective than original vaccine

STAT News

New data from Pfizer and BioNTech on their bivalent Covid-19 vaccine suggests the updated product may be more protective against more recent Omicron subvariants than the original version of the vaccine, the companies said in a statement released Friday. The companies said the levels of neutralizing antibodies that target the BA.4 and BA.5 subvariants of the SARS-CoV-2 virus were four-fold higher in people aged 55 and older who received the bivalent booster than in similarly aged people who recei

Vaccine 141
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What the FDA’s guidance on diversity means for rare disease sponsors

Bio Pharma Dive

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

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Roche’s Actemra gets Health Canada approval for Covid-19 treatment

Pharmaceutical Technology

Hoffmann-La Roche (Roche Canada) has received approval from Health Canada for Actemra IV (tocilizumab for injection) vials to treat Covid-19 patients. The treatment is indicated for adult Covid-19 patients who are on systemic corticosteroids and need additional oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation.

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Experts call for using pharmacogenetics to develop treatments for rare diseases

AuroBlog - Aurous Healthcare Clinical Trials blog

As drug companies have embarked on an initiative to launch affordable medicines for rare diseases in India, experts have called for using pharmacogenetics to develop treatments and whole genome sequencing to identify etiologies. “Although rare diseases have a huge impact when taken together, there is a significant gap between clinical interventions and basic research.

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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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Opinion: How the world can end Covid-19 as a public health threat

STAT News

The journal Nature published today global consensus recommendations to end Covid-19 as a public health threat. It took a panel of almost 400 independent-thinking scientists, doctors, and representatives of community groups from more than 100 countries (we were among the co-chairs) some 14 months to develop and agree on these recommendations. There have been times when we wondered if it was worth the effort.

Doctor 141
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FDA again delays review of Amicus rare disease drug

Bio Pharma Dive

For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

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MIT and Toyota Improve Robotic Grasping Techniques

Pharmaceutical Technology

Concept: Massachusetts Institute of Technology (MIT)’s Computer Science and Artificial Intelligence Laboratory (CSAIL) researchers have developed a system called ‘series elastic end effectors’ (SEED) that enable robots to use grabbed tools correctly and successfully. It was developed in partnership with the American Toyota Research Institute (a technology research unit of Toyota).

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IPC introduces draft amendment to microbial contamination in non-sterile products in IP 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

In a bid to control the microbial quality of pharmaceutical products, the Indian Pharmacopoeia Commission (IPC) has come out with a draft amendment to microbial contamination in non-sterile products in Indian Pharmacopoeia (IP) 2022. The new draft amendment released by IPC on October 26, 2022 introduced changes to enumeration of aerobic microorganisms present in the […].

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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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RSV is surging. Here's what to watch for and answers about treatment options

NPR Health - Shots

Doctors say they are seeing an unprecedented number of cases. How concerned should parents be? Why are young children so vulnerable? What's causing this year's outbreak? We offer some answers.

Doctor 140
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Moderna cuts sales forecasts for its COVID-19 vaccine

Bio Pharma Dive

The biotech dialed back its financial projections after reporting lower-than-expected sales for the shot, which currently remains the company’s only marketed product.

Sales 306
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What can Rishi Sunak do for the UK’s pharma industry

Pharmaceutical Technology

Last week, after a tumultuous 45 days under Liz Truss’s control , the role of the UK’s Prime Minister (PM) was passed on to Rishi Sunak , in a bid to restore balance to the British economy. During her short reign, Truss’s cabinet had promised a £45 billion ($51.59 billion) mini-budget that included unfunded tax cuts for the rich, enacted a U-turn on an energy price freeze, and oversaw the largest drop in value for the British pound against the US dollar.

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QR code to curb spurious drugs circulation & its traceability through supply chain in Indian pharma

AuroBlog - Aurous Healthcare Clinical Trials blog

High optimism prevails on the implementation of QR code which would aid faster traceability through the supply chain among Indian pharma. Nakul Pasricha, president, Authentication Solution Providers’ Association (ASPA), noted that a sharp spike was observed in the number of counterfeiting incidents related to pharma and medical products estimated as high as at 47 percent. […].

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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What causes Alzheimer's? Study puts leading theory to 'ultimate test'

NPR Health - Shots

Researchers are launching a make-or-break study to test the conventional wisdom about what causes Alzheimer's disease.

Research 140
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Novo obesity drug sales lag as manufacturing problems persist

Bio Pharma Dive

Manufacturing problems continue to weigh on Novo’s Wegovy launch as competition looms from Eli Lilly’s fast-selling diabetes medicine Mounjaro.

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Rankings: Research and Development

Pharmaceutical Technology

FEATURED COMPANIES COMMENDED : • Innovation • Product Launch • Safety VIEW PROFILE COMMENDED : • Business Expansion • Innovation • Investments VIEW PROFILE COMMENDED: • Social VIEW PROFILE. The Excellence Rankings celebrate the greatest achievements and innovations in the industry. The programme provides a platform to recognise the people and companies that are driving change.

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Despite Their Scary Name, Some ‘Zombie’ Cells May Not Be All Bad

AuroBlog - Aurous Healthcare Clinical Trials blog

“Zombie cells” that contribute to age-related diseases also help heal damaged tissues, so wiping them out could come with major downsides, a new study suggests. The zombies, scientifically known as “senescent” cells, are cells that stop multiplying due to damage or stress but don’t die, according to the National Institute on Aging.

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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.