November, 2022

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Long-COVID personalized medicine enters Phase 2 trial

BioPharma Reporter

GeNeuro has recruited the first patients in a Phase 2 trial evaluating temelimab against long-COVID: assessing the efficacy of the treatment for improving cognitive impairment and fatigue.

Trials 145
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Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy

Fierce Pharma

Genentech starts phase 2 trial to optimize delivery of eye disease cell therapy. ntaylor. Mon, 11/28/2022 - 10:11.

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AI will continue to attract investment in near future in the healthcare industry

Pharmaceutical Technology

Artificial intelligence (AI) was seen as one of the top current investment priorities and was thought to continue to attract investment in the healthcare sector in the upcoming two years, according to GlobalData's latest report ‘Digital Transformation and Emerging Technology in the Healthcare Industry - 2022 Edition’. In this survey-based report tracker, digital media was prioritised as a top current investment target, with 53% of surveyed respondents confirming that their companies are currentl

Big Data 363
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What to make of Eisai and Biogen’s latest Alzheimer’s drug data

Bio Pharma Dive

At a medical conference, the companies detailed clinical trial results that could help support approval of their drug, lecanemab. However, some doctors aren’t yet convinced the medicine’s risks are worth its potential benefits.

Drugs 359
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Running Decentralized Trials at Scale: Planning for Success

There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

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Twitter will no longer enforce its COVID misinformation policy

NPR Health - Shots

Public health experts and social media researchers are concerned that the change could have serious consequences if it discourages vaccination and other efforts to combat the still-spreading virus.

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Bacteria that break down nicotine found in the guts of mice

Medical Xpress

A team of researchers affiliated with multiple institutions in China, working with a colleague in the U.S., has isolated a type of bacteria in the guts of mice that break down nicotine. In their paper published in the journal Nature, the group describes how they isolated the bacteria and why their finding could reduce incidences of fatty liver disease in humans.

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Brain cancer vaccine succeeds at prolonging survival in Phase 3 trial

BioPharma Reporter

A Phase 3 trial for Northwest Biotherapeuticsâs DCVax-L vaccine extended survival in patients with gliobastoma for many months, or in some cases, years: according to new data.

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In a field dominated by antibodies and small molecules, two cell-therapy based approaches have come under the spotlight for showing early signs of efficacy in treating lupus. In September, a group from Friedrich Alexander University Erlangen-Nuremberg reported that five patients with lupus achieved remission after an infusion of autologous chimeric antigen receptor (CAR)-T cells led to a deep depletion of B cells.

Antibody 362
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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.

Drugs 362
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NYC Mayor Adams faces backlash for move to involuntarily hospitalize homeless people

NPR Health - Shots

Mayor Eric Adams announced this week that officials will begin hospitalizing more homeless people by involuntarily providing care to those deemed to be in "psychiatric crisis." (Image credit: Michael M.

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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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Wireless smart bandage provides new insights on healing chronic wounds

Medical Xpress

Some wounds just won't heal. Infections, diseases like diabetes, and suppressed immune systems often stack up to slow healing. Chronic wounds can last months and lead to anxiety and depression. In the worst cases, they are life threatening. Cost of treatment has soared to $25 billion each year.

Research 143
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After three years in prison, ‘CRISPR babies’ scientist is attempting a comeback

STAT News

He Jiankui, the Chinese biophysicist who created the first gene-edited children , had been quiet since completing a three-year prison sentence in April, leaving many to wonder whether he had plans to return to scientific research. Earlier this month, we got his answer. On Nov. 9, He posted photos to Twitter of himself sitting at a computer in a white office.

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Could digital therapeutics provide a solution against opioid abuse?

pharmaphorum

Digital therapeutics are rapidly coming into the foreground to treat a variety of conditions. Ben Hargreaves discovers how chronic pain could be a key area for digital therapeutics, as they offer non-addictive and effective relief from the condition. The struggle to manage pain for individuals has been one that goes back a long way in history, with one of the earliest recorded medical prescriptions being for opium.

Drugs 135
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Cyagen and Neurophth partner to develop gene therapy vectors

Pharmaceutical Technology

Cyagen and Neurophth Therapeutics have entered a strategic partnership to jointly develop next-generation AAV gene therapy vectors for specific kinds of genetic ophthalmic ailments. According to the deal, Cyagen will leverage its artificial intelligence (AI)-driven high-throughput platform for discovering new AAV vectors with enhanced tissue targeting expertise, tissue specificity and productivity. .

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2022 Research: The Rapid Rise of Ocean Freight Visibility

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

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Centerview grows role as go-to adviser for biopharma dealmaking

Bio Pharma Dive

Over the past several years, the investment firm has served as a financial adviser on biopharma acquisitions worth more than $200 billion in total, with the latest announced Monday.

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Thousands of toddler sippy cups and bottles are recalled over lead poisoning risk

NPR Health - Shots

The bottom base of some Green Sprouts products can break off, exposing a solder dot that contains the toxic metal, a federal regulator said. No injuries have been reported from such incidents. (Image credit: U.S.

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New male contraceptive does not involve hormones

Medical Xpress

A team of researchers at a company called Contraline has developed a new kind of male contraceptive. Instead of using hormones to disrupt sperm production, the new technique involves placing a hydrogel called ADAM into the vas deferens to prevent sperm from making its way to the urethra. The new technique is not yet available for men seeking an alternative way to prevent pregnancy, however—it is currently undergoing a clinical trial in Australia.

Hormones 143
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‘A very worrying scenario’: Internal documents on India Covid-19 vaccine raise troubling questions about approval process

STAT News

As the Covid-19 pandemic spread across the world two years ago, one of India’s leading biotech companies was racing to develop a vaccine with crucial backing from the Indian government. The shot engineered by Bharat Biotech was, in part, an important effort to create a home-grown product that could   bolster the fortunes of the Indian pharmaceutical industry.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

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Advanced therapies and the high-profile pricing dilemma

pharmaphorum

The advancements made in drug development over the last decade have seen the arrival of a number of treatments that offer one-time cures and more effective therapies for conditions in smaller patient populations. However, alongside this progress, Ben Hargreaves finds that there is also a conundrum over how to price these therapies. It is no secret that the drug development process for the pharmaceutical industry has undergone a major transition in the last few decades.

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NHS expedites rollout of Bayer’s darolutamide for prostate cancer

Pharmaceutical Technology

The National Health Service (NHS) in England, UK, has expedited the rollout of Bayer ’s new life-extending drug, darolutamide, to treat the most advanced kinds of prostate cancer that have spread to other body parts. With the latest development, NHS will become the first healthcare system in Europe to offer this drug to prostate cancer patients. Nearly 9,000 men with prostate cancer will be eligible to receive this treatment.

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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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Hidden audits reveal millions in overcharges by Medicare Advantage plans

NPR Health - Shots

Taxpayers footed the bill for care that should have cost far less, according to records released under the Freedom of Information Act. The U.S. government may charge insurers $650 million as a result.

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Mandatory COVID Vaccination Policy Template

New vaccine mandates and testing policies will affect employers with more than 100 workers. Get Paycor’s free, customizable vaccination policy template to communicate critical details and new requirements to your employees. Get Paycor’s Template today!

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Political ideology and COVID-19 health outcomes

Medical Xpress

The higher the exposure to political conservatism, the higher the COVID-19 mortality rates and stress on hospital intensive care unit (ICU) capacity, according to a new study from Harvard T.H. Chan School of Public Health.

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Holmes gets more than 11 years in prison for Theranos scam

STAT News

A federal judge on Friday sentenced disgraced Theranos CEO Elizabeth Holmes to more than 11 years in prison for duping investors in the failed startup that promised to revolutionize blood testing but instead made her a symbol of Silicon Valley’s culture of audacious self-promotion. The sentence imposed by U.S. District Judge Edward Davila was shorter than the 15-year penalty requested by federal prosecutors but far tougher than the leniency her legal team sought for the mother of a year-o

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Data privacy concerns don’t hinder digital health app usage

pharmaphorum

A new survey conducted by juli, an AI-powered chronic condition platform, has revealed that the value placed on digital privacy differs widely among US users. With the HLTH 2022 event now well underway, digital health industry leaders all gathered together to attend in Las Vegas this week, the juli survey results reveal consumer responses to be more varied than one would have expected when it comes to data privacy.

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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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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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Experts are concerned Thanksgiving gatherings could accelerate a 'tripledemic'

NPR Health - Shots

As the holiday approaches, infectious disease specialists are bracing for the possibility that big family get-togethers and travel will propel the spread of RSV, flu and COVID-19.

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New study reveals that exposure to outdoor artificial light at night is associated with an increased risk of diabetes

Medical Xpress

A new study published in Diabetologia finds that outdoor artificial light at night (LAN) is associated with impaired blood glucose control and an increased risk of diabetes, with more than 9 million cases of the disease in Chinese adults being attributed to LAN exposure. The study is by Dr. Yu Xu and colleagues at the Shanghai Institute of Endocrine and Metabolic Diseases, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.

Medicine 136
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STAT+: Detailed data on Alzheimer’s therapy from Eisai, Biogen hold up to scientific scrutiny

STAT News

SAN FRANCISCO — A closely watched new treatment for Alzheimer’s disease held up to scrutiny in a detailed scientific presentation Tuesday, as its developers, partners Eisai and Biogen, begin the lengthy process of turning this medicine into what they hope could be a groundbreaking therapy. The drug, lecanemab, slowed the cognitive and functional decline of patients with early-stage Alzheimer’s by 27% relative to placebo in a roughly 2,000-volunteer clinical trial.

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First human trials of lab-grown red blood cells start in UK

pharmaphorum

Blood cells grown in a laboratory have been given to people for the first time in a clinical trial being carried out by researchers in the UK, in the hope that plentiful supplies of rare blood groups can be manufactured to order. A team from the universities of Bristol and Cambridge, NHS trusts and NHS Blood and Transplant (NHSBT) have started giving small quantities of the lab-grown red blood cells – a couple of teaspoons full – to two healthy volunteers to see if they are safe.

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AstraZeneca enters $320m deal to acquire Neogene

Pharmaceutical Technology

AstraZeneca has signed an agreement for the acquisition of all outstanding equity of clinical-stage biotechnology firm Neogene Therapeutics in a deal totalling up to $320m. Neogene focuses on discovering, developing and producing next-generation T-cell receptor therapies (TCR-Ts) that provide a new cell therapy approach for fighting cancer. TCR-Ts can detect intracellular targets such as cancer-specific mutations to unlock targets which were not accessible earlier using cell therapies.