Wed.Mar 22, 2023

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At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

Bio Pharma Dive

Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

Protein 357
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Digital health tech: a solution to substance use disorders?

Pharmaceutical Technology

Healthcare providers are under pressure to address the growing issue of substance use disorders. Spurred on by factors such as the Covid-19 pandemic, geopolitical tensions, and a fluctuating macroeconomic environment, GlobalData forecasts that by 2028, total prevalent cases in the 16 major pharmaceutical markets (16MM*) for opioid addiction will surpass eight million; cases of alcohol addiction will reach 770 million; and cases of smoking cessation will surpass 360 million.

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Novo partners with Dewpoint to mine an emerging field for new drugs

Bio Pharma Dive

The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.

Insulin 294
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March 22, 2023: A Decade of PCORnet Research in This Week’s PCT Grand Rounds

Rethinking Clinical Trials

In this Friday’s PCT Grand Rounds, Erin Holve, Russell Rothman, Schuyler Jones, and Neha Pagidipati will present “From Observational Studies to Pragmatic Clinical Trials: (Almost) A Decade of Research in PCORnet®.” The Grand Rounds session will be held on Friday, March 24, 2023, at 1:00 pm eastern. Holve is the chief research infrastructure officer for PCORI.

Research 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Moderna CEO defends price of COVID shot at Senate hearing

Bio Pharma Dive

Stéphane Bancel said his company's planned price hike covers the higher costs of commercial sales. Sen. Bernie Sanders called it part of industry’s “unprecedented level of corporate greed.

Sales 277
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Experts advocate decriminalizing existing drugs act without compromising on drug quality and patient safety

AuroBlog - Aurous Healthcare Clinical Trials blog

Drug regulatory experts have advocated for decriminalizing the existing drugs act without compromising on the drug quality and patient safety.

Drugs 143

More Trending

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Marburg fever outbreak in Equatorial Guinea widens, WHO reports

STAT News

The ongoing Marburg fever outbreak in Equatorial Guinea is significantly larger than has previously been acknowledged, according to new information released Wednesday by the World Health Organization, which warned there may be undetected chains of transmission of the deadly virus in the West African country. The update, the first in nearly a month, shows that the number of confirmed and probable cases has grown from nine to 29, with cases having been reported in three different provinces over a

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Biohaven strikes a deal to take TYK2 drugs in a new direction

Bio Pharma Dive

The rebooted biotech plans to test whether blocking TYK2 in the brain could help treat neurological diseases, licensing a compound from China-based Hangzhou Highlightll Pharmaceutical.

Licensing 161
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The CDC is investigating recalled eyedrops after infections cause death and blindness

NPR Health - Shots

Infections from drug-resistant bacteria have caused death and illness in 68 patients across the U.S., the CDC says. The strain has been linked to recalled eyedrops like EzriCare Artificial Tears.

Bacteria 139
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FTC wades into dispute between Supernus, generic competitor

Bio Pharma Dive

The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.

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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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Uh-oh. A new tropical mosquito has come to Florida. The buzz it's creating isn't good

NPR Health - Shots

Little is known about the mosquito species known as Culex lactator. But it belongs to a group of mosquitoes known to carry diseases and researchers are worried about what will happen.

Research 129
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Hidden 'super spreaders' spur dengue fever transmission, finds study

Medical Xpress

For mosquito-borne diseases such as dengue fever, the abundance of the insects in places where people gather has long served as the main barometer for infection risk. A new study, however, suggests that the number of "hidden" infections tied to a place, or cases of infected people who show no symptoms, is the key indicator for dengue risk.

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Meet the 'glass-half-full girl' whose brain rewired after losing a hemisphere

NPR Health - Shots

Mora Leeb was 9 months old when surgeons removed half her brain. Now 15, she plays soccer and tells jokes. Scientists say Mora is an extreme example of a process known as brain plasticity.

Scientist 128
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Opinion: Living kidney donors rely on a promise to protect our future health. We’re scared it will go away

STAT News

Five years ago, I donated my “spare” kidney at the Mayo Clinic to a woman I read about in the newspaper. Though living with only one kidney has risks, I was not particularly concerned about my own health. The clinic’s medical evaluation was extremely thorough, and I knew their highly conscientious selection committee would not approve me to be a living donor if they were even the slightest bit concerned the procedure would cause me long-term health problems.

Nurses 111
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump

Fierce Pharma

AbbVie's blockbuster-to-be Parkinson's combo hits a wall as FDA questions delivery pump aliu Wed, 03/22/2023 - 11:17

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STAT+: FDA advisory panel recommends conditional approval of Biogen’s drug for rare form of ALS

STAT News

An independent panel of advisors to the Food and Drug Administration on Wednesday concluded that a treatment developed by Biogen for a rare, genetic form of ALS should be approved, despite unanswered questions about its benefit to patients. By a 9-0 vote, the FDA advisory panel said the “totality of the evidence” was sufficient to support conditional approval of the Biogen drug, called tofersen.

Drugs 111
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Study finds 'considerable uncertainty' around effectiveness and safety of analgesics for low back pain

Medical Xpress

Despite nearly 60 years of research, there is still a lack of high-certainty evidence on the effectiveness and safety of commonly used painkillers (analgesics) for short bouts of low back pain, finds an analysis of the evidence published by The BMJ.

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Stéphane Bancel, Bernie Sanders spar over what Moderna owes the federal government

STAT News

WASHINGTON — Moderna CEO Stéphane Bancel and Senate health committee Chair Bernie Sanders shook hands amicably before Wednesday’s hearing examining the company’s vaccine pricing strategy began. That’s about where the goodwill ended between the two.

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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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Phase 1 study: New medicine extends terminally-ill cancer patients' lives

Medical Xpress

A promising cancer drug that targets only cancer cells has been developed by researchers from the Norwegian University of Science and Technology (NTNU) and a university spin-off company, APIM Therapeutics.

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Carrying the torch of his slain brother, a Chicago ER doctor struggles against the violence around him

STAT News

CHICAGO — Abdullah Hassan Pratt is giving a tour of a sheep heart that sits, heavy and sodden, in his hand. Dressed all in black, with his Jordans and easy manner, Pratt doesn’t look all that different from his audience: dozens of teenagers from this city’s roughest and poorest neighborhoods. One student raises a tentative hand, utterly confused by how blood travels through the heart.

Doctors 105
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Researchers develop first-of-its-kind prediction model for newborn seizures

Medical Xpress

Researchers from the Neuroscience Center at Children's Hospital of Philadelphia (CHOP) have developed a prediction model that determines which newborn babies are likely to experience seizures in the Neonatal Intensive Care Unit (NICU). This model could be incorporated into routine care to help the clinical team decide which babies will need electroencephalograms (EEGs) and which babies can be safely managed in the Neonatal Care Unit without monitoring through EEGs.

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STAT+: 89bio treatment reduces liver scarring in patients with NASH, meeting study goals

STAT News

Biotech company 89bio said Wednesday that its experimental treatment improved liver scarring at more than three times the rate of placebo without worsening other symptoms of patients with the fatty liver disease known as NASH. The results met the main goal of a mid-stage clinical trial, with the potential for less frequent injections than a similar experimental treatment being developed by a competing drugmaker.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Study shows frequent COVID testing of nursing home staff protected residents, saved lives

Medical Xpress

A new study, appearing today in the New England Journal of Medicine, shows that nursing homes that conducted staff surveillance testing more regularly during the COVID-19 pandemic experienced significantly lower rates of COVID infections and deaths among residents.

Nurses 98
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Biden administration plans revamp of organ transplant system

STAT News

WASHINGTON — The Biden administration said Wednesday it will attempt to break up the network that runs the nation’s organ transplant system as part of a broader modernization effort. More people than ever are getting new organs, with a record 42,888 transplants last year — but that’s not nearly enough to meet the demand. More than 100,000 patients are on the national transplant list, thousands die waiting, and critics have long urged an overhaul  to save more liv

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Research links low education and income to severe epilepsy

Medical Xpress

Statistically, people with low educational attainment and income who have epilepsy suffer more than others from the condition. Not only are they hospitalized with epilepsy more often than others, but they also have less access to specialized neurological care, a University of Gothenburg thesis shows.

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Opinion: The much-maligned ‘quality-adjusted life year’ is a vital tool for health care policy

STAT News

Health policy circles have erupted in debate over a wonky administrative tool: the quality-adjusted life year ( QALY ) and similar metrics to value and price drugs and other health interventions. Rep. Cathy McMorris Rodgers (R-Wash.) has warned of the potential for these approaches to discriminate, arguing that “All lives are worth living. It’s unconscionable that a health care bureaucracy would so callously determine that someone’s life is worth less,” suggesting tha

Drugs 105
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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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Ending GP performance pay in Scotland linked to decline in quality of some care

Medical Xpress

Ending performance-related payments for NHS GPs in Scotland was associated with a decline in the quality of some aspects of care, compared with England where financial incentives have continued, finds a study published by The BMJ today.

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STAT+: Cerebral and other telehealth startups face new legal and regulatory challenges over ad models

STAT News

A potential class-action lawsuit against troubled digital prescribing startup Cerebral raises crucial questions about whether online marketing methods violate legal and ethical standards — an issue with important implications for dozens of other telehealth companies doing largely the same thing , experts tell STAT. For years, Cerebral and other telehealth companies have used free tracking technologies  known as “pixels” — provided by big technology companies like

Marketing 105
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Pharma By The Numbers: A Retrospective Look at the Industry and 20 Years of Xtalks History

XTalks

In October 2022, Xtalks celebrated two decades of bringing diverse stakeholders in the life science industry together through first holding physical events, then soon after, hosting exclusively online events. In that time, we’ve gone from running 25 webinars each year to over 400, working with more than 800 expert speakers each year. To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, b

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STAT+: Researchers devise new strategies to overcome a key CRISPR flaw

STAT News

DALLAS — It took just three years, after the tool’s invention, for researchers to devise ways of using CRISPR-Cas9 gene editing to treat mice with Duchenne muscular dystrophy. Since those first 2015 papers, dozens more have been published and multiple startups have launched, spurred by the hope that CRISPR could outperform the gene therapy approaches now nearing approval.

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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.