March, 2023

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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside.

Drugs 363
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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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Mexican pharmacies are selling pills to U.S.travelers laced with deadly fentanyl

NPR Health - Shots

Researchers say Mexican pharmacies that cater to U.S. tourists and medical travelers are selling medications that look safe but are laced with deadly fentanyl and methamphetamines.

Pharmacy 145
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Opinion: To deal with the next pandemic, the FDA needs an Office of Preparedness and Response

STAT News

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Low-dose radiation linked to increased lifetime risk of heart disease

Medical Xpress

Exposure to low doses of ionizing radiation is associated with a modestly increased excess risk of heart disease, finds an analysis of the latest evidence published by The BMJ today.

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Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit

Fierce Pharma

Pfizer, Viatris and more must face 'overarching conspiracy' claims in generic price-fixing suit aliu Wed, 03/01/2023 - 10:03

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More Trending

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GPCR-targeting drugs: A renewed focus on a ubiquitous group of proteins

Bio Pharma Dive

As many as a third of FDA-approved drugs target GPCRs in some fashion, with uses ranging from treating cancer to pain. But biotech startups say there is still room to develop more.

Protein 360
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Idaho lawmakers pass a bill to prevent minors from leaving the state for abortion

NPR Health - Shots

The first of its kind in the country, the Idaho legislature has passed a bill allowing criminal charges for those who help a minor get an abortion out of state. The bill now goes to Gov. Brad Little.

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Cases of Marburg going unreported in Equatorial Guinea, WHO says

STAT News

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

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Getting around muscle aging by modulating the function of immune cells

Medical Xpress

Muscle is able to regenerate through a process that involves multiple steps and players, including the immune system. As our organism ages, the muscles lose the capacity to regenerate.

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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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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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Brazil’s ANVISA approves Takeda’s dengue vaccine candidate Qdenga

Pharmaceutical Technology

The National Health Surveillance Agency (ANVISA) in Brazil has granted approval for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003). The vaccine has received approval for preventing dengue disease in people aged four years to 60 years. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes and is designed to provide protection against any of these.

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J&J-backed startup launches with $100M to build better brain drugs

Bio Pharma Dive

Rapport Therapeutics aims to find new so-called receptor-associated proteins that could serve as targets for neurological disease medicines. Its most advanced drug is already in early-stage human testing.

Drugs 362
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'Live free and die'? The sad state of U.S. life expectancy

NPR Health - Shots

A decade after a landmark report on Americans' shorter lives, the problem has only gotten worse. Unlike other wealthy nations, U.S. life expectancy has not bounced back from the pandemic.

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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: I finally got used to practicing telepsychiatry. Now the DEA wants to change everything

STAT News

I am by no means telepsychiatry’s biggest fan. But since March 2020, when my practice of outpatient psychiatry changed overnight, I have adapted to it. I have learned to get up between appointments so I don’t sit in front of a computer all day and how to fit in patient visits while on a work trip. I still prefer being in the actual room with a patient, but I accept this is the way my job looks now.

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Those who support Black Lives Matter tend to be less hesitant about vaccines, study finds

Medical Xpress

Efforts to encourage vaccination might do well to take advantage of the positive feelings and actions between different social groups, according to a study of attitudes toward vaccines among supporters of the Black Lives Matter movement.

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Moderna opts for Oxfordshire in quest for innovation

Pharma Times

Vaccines developed at the facility will cover a wide range of respiratory diseases

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Hipra’s Covid-19 booster gets EMA nod and enters an uncertain landscape

Pharmaceutical Technology

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

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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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Mathai Mammen, former J&J executive, to become FogPharma CEO

Bio Pharma Dive

The veteran pharmaceutical executive was J&J’s head of R&D until his departure last August. He’s agreed to run FogPharma, a richly funded startup, and take over for founder Greg Verdine.

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At a Nashville hospital, the agony of not being able to help school shooting victims

NPR Health - Shots

A pediatric surgeon and his colleagues at Vanderbilt University Medical Center had prepared for a mass casualty event, but the victims of Monday's shooting had already died by the time they arrived.

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Opinion: There is no epidemic of autism. It’s an epidemic of need

STAT News

On Thursday, the Centers for Disease Control and Prevention announced another increase in the prevalence of autism among children. In a pair of new reports — one focused on 8-year-olds and one on 4-year-olds — the CDC found that 1 out of every 36 children has autism. This is a significant increase from the 2021 estimate of 1 in 44 , which was a big jump from 1 in 110 in 2006.

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Unraveling long COVID's causes and impacts

Medical Xpress

Most of the time, viruses leave our bodies as quickly as they arrived. After we suffer a week or two of fever, muscle aches, and other indignities, a surge of antibodies sends the miniature invader on its way. Case closed.

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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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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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Covant Therapeutics Debuts with Boehringer Partnership Targeting ADAR1

BioSpace

Covant Therapeutics Debuts with Boehringer Partnership Targeting ADAR1 3/29/2023

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ALS drugmakers, encouraged by recent FDA feedback, set their sights on a key protein

Bio Pharma Dive

A closely watched meeting showed the FDA’s own external advisers think that effects on this protein, known as neurofilament, could be enough to warrant conditional approval of certain drugs.

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NYC Mayor Eric Adams is telling stores to have customers remove their face masks

NPR Health - Shots

"We are putting out a clear call to all of our shops: Do not allow people to enter the store without taking off their face mask," the mayor said. A flurry of questions ensued.

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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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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT News

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

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Comprehensive tool measuring chronic condition burden shows reliable results compared to surveys

Medical Xpress

Researchers have evaluated the Assessment of Burden of Chronic Conditions (ABCC) scale, which was developed to improve care by facilitating shared decision making and self-management. The scale assesses and visualizes the patient's experience of one or multiple chronic conditions, and integrates it in daily care. The researchers determined it is valid and reliable in people with Chronic Obstructive Pulmonary Disease (COPD), asthma or type 2 Diabetes Mellitus (T2DM).

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GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial

Fierce Pharma

GSK plays defense after California judge approves plaintiff's expert testimony in high-stakes Zantac trial fkansteiner Fri, 03/24/2023 - 10:05

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AbbVie Clinches Back-to-Back Clinical Wins in Ulcerative Colitis, Lupus

BioSpace

AbbVie Clinches Back-to-Back Clinical Wins in Ulcerative Colitis, Lupus 3/24/2023

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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