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.

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RFID: The future of smart labelling?

Pharmaceutical Technology

The pharmaceutical industry began using radio frequency identification (RFID) tags in the early 2000s. Pfizer was the first to use the tech, adding RFID tags to track a Viagra (sildenafil) shipment circa 2006. Various uses soon became apparent including those for supply chain management, anti-counterfeiting, and to improve patient safety. As computing has developed in the past decade, so has the potential to store and use information in the cloud.

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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.

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‘Right shoring’ API production in Europe

Pharmaceutical Technology

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. It was a money-saving strategy that was paying off until Covid-19 hit. During the pandemic, the shortage of basic drugs such as paracetamol in key EU countries led to growing calls to push local drug manufacturing to ensure a smooth supply and to minimise shortages.

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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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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.

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Risk of venous thromboembolism in Covid-19 outpatients found to be low

Pharmaceutical Technology

A recent study exploring the risk of venous thromboembolism (VTE) in non-hospitalised Covid-19 patients has found that their absolute risk of VTE is low. Fang and colleagues conducted a cohort study of 398,530 adult outpatients with Covid-19, assessing the rates of VTE in the first 30 days of Covid-19 diagnosis and in follow-up. They found that non-hospitalised Covid-19 patients had a low risk of developing VTE, although this risk was slightly higher in the first 30 days after diagnosis.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

The demand for injectable drugs is rising. According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This was higher than the number of approvals in 2019 and 2020. In addition, in 2022, non-new molecular entity (NME) injectables approvals were the highest they have been for the last decade.

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FDA advisers support conditional clearance of Biogen’s ALS drug

Bio Pharma Dive

Though the drug, called tofersen, missed the main goal of a key clinical trial, it showed an effect on a protein tied to ALS. Experts see that as a good sign, but some worry Biogen has not yet gathered enough supportive evidence.

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Optimising biopharma production through process intensification

Pharmaceutical Technology

Process intensification can loosely be described as making more product with the same or fewer resources. There are a few ways to achieve this such as optimisation of existing unit operations, for example, changing cell culture feeding strategies. Existing technologies could also be run in a different way. For example, running a bioreactor in perfusion mode instead of batch, or using continuous instead of batch chromatography.

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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.

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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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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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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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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.

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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 148
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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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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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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 138
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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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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.

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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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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.

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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.

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Opinion: The lesson biotech absolutely should not take from Silicon Valley Bank’s failure

STAT News

As a five-time biotech CEO, I’ve guided my companies through recessions, supply chain disruptions, Wall Street volatility, even a global pandemic. Yet nothing quite prepared me for the news on Thursday, March 9, that my cell therapy company’s ability to make payroll could be jeopardized by the mother of all bank runs unfolding at Silicon Valley Bank.

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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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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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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.

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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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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.

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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+: Senators interrogate health secretary Becerra on Alzheimer’s drug coverage

STAT News

WASHINGTON — The future of Alzheimer’s treatments and coverage hung heavily over lawmakers’ Wednesday hearing with Health and Human Services Secretary Xavier Becerra. Dotted throughout the hearing room for Becerra’s testimony on the president’s proposed health care budget for 2024 were purple-clad advocates for Alzheimer’s disease treatments, who Democrats and Republicans alike acknowledged repeatedly throughout the hearing.

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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.

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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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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.