Sat.Feb 04, 2023 - Fri.Feb 10, 2023

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Tracking the bird flu, experts see a familiar threat — and a virus whose course is hard to predict

STAT

Veteran influenza epidemiologist Keiji Fukuda remembers vividly when he first became fearful that a virulent bird flu virus, H5N1, might be on the verge of triggering a devastating pandemic. The virus, seemingly out of nowhere, did something bird flu viruses were thought not to be able to do. It infected 18 people, killing six of them. That happened in 1997, in Hong Kong.

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Woman of the Week: KaliVir Immunotherapeutics’ Helena Chaye

PharmaVoice

The triple threat CEO — scientist, lawyer and biotech pro — thinks she’s discovered a key to curing a wide range of cancers.

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Trick of the Trade: Antibiotic ointment for removal of artificial nail glue from eyelids

ALiEM - Pharm Pearls

A bottle of nail glue and timolol eye drops (reproduced with permission from BMJ Publishing Group Ltd [1]) You are working a busy shift in your department’s fast track area and sign up for a patient with a complaint of “eye pain.” The patient is a fan of glue-on nails and mistook her nail glue bottle for her eyedrops. Now she is unable to open her eyelid for the exam and you struggle to open it yourself.

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Black History Month: Pharmacy Trailblazers

Pharmacy Is Right For Me

February marks Black History Month in the United States. We want to take this opportunity to recognize some Black pharmacists who have made significant contributions to the pharmacy field. James McCune Smith James McCune Smith was born into slavery in 1813. He earned his medical degree from Glasgow University. He is recognized as the first African American to earn a medical degree, the first to be published in American medical journals, as well as the first African American to own and operate a

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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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Opinion: Mindstrong’s demise and the future of mental health care

STAT

One of the shinier entrants to have emerged in the world of mental health startups abruptly announced last week it would wind down, right in the middle of an ongoing crisis in mental health care. Mindstrong, which had raised a total of $160 million from a who’s-who of blue-chip investors, and was led for a while by a former National Institute of Mental Health director, simply couldn’t find a way to make money delivering the low-cost, high-quality care it had promised.

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United by inequity: The healthcare disparities plaguing rare disease patients and Black Americans

PharmaVoice

Guided by her personal experiences, Tamar Thompson is aiming to improve rare disease care through her advocacy work at Alexion, AstraZeneca Rare Disease.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. Changes have been spurred by the COVID-19 pandemic, which emphasised the need to urgently modernise outdated EU pharmaceutical law and revise regulatory ambitions in the MedTech sector.

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Opinion: The fungal crisis is here and desperately needs addressing

STAT

Fungus-caused infections — real ones, not the ones sparking the zombie apocalypse on the popular show “The Last of Us” — pose a growing threat in the United States and around the world. Mississippi has become the latest state to report residents infected with Candida auris, a highly contagious fungus that thrives in hospitals and nursing homes.

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3 ways the FDA’s restructuring plan could impact pharma

PharmaVoice

FDA’s food program is in for a major overhaul — here’s why pharma should pay attention.

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4D Molecular’s Fabry gene therapy program on FDA clinical hold

Pharmaceutical Technology

4D Molecular Therapeutics (4DMT), the California-based biotechnology company focused on developing gene therapies for rare and large market diseases, has had the FDA place a clinical hold onto its Fabry disease (FD) gene therapy program (4D-310). 4DMT had paused enrollment of patients to two of its trials for 4D-310 last month following a significant adverse event where three patients experienced kidney issues; however, these were treated and resolved in a four-week period. 4DMT has stated that

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Astellas and Bayer announce management changes

European Pharmaceutical Review

Changes to management for Big Pharma companies Astellas and Bayer AG have been announced for 2023. Astellas Astellas Pharma Inc. has approved changes of its Representative Director, President and CEO and its management structure. Effective April 1, 2023, Naoki Okamura and Kenji Yasukawa will hold the following positions: Naoki Okamura is currently Representative Director, Executive Vice President of Astellas.

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STAT+: Pharma loses a court battle in its bid to block states from importing drugs from Canada

STAT

In a setback to the pharmaceutical industry, a federal judge has tossed a lawsuit that sought to prevent state governments from importing medicines from Canada. The decision is likely to embolden more states to now consider the approach as they look to lower the cost of prescription drugs In a 26-page opinion , U.S. District Court Judge Timothy Kelly ruled that drug companies failed to prove they would face a “concrete risk of harm” from a federal rule that would allow states to im

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Rocket Pharmaceuticals is ready for liftoff in the rare disease space

PharmaVoice

With two rare disease products on the launch pad for FDA submission in 2023 and a growing pipeline, Rocket is fueled for its next era of growth.

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UK MHRA approves Takeda’s dengue vaccine Qdenga

Pharmaceutical Technology

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Takeda ’s dengue virus vaccine candidate, Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]). The vaccine candidate has been approved for active immunisation against the infection in people from four years of age. Qdenga has been developed based on a live-attenuated dengue serotype 2 virus that offers the genetic backbone for four dengue virus serotypes.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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AstraZeneca’s Forxiga approved in EU for chronic heart failure

Pharmafile

AstraZeneca has announced that its drug, Forxiga, has been approved in the EU for the treatment of symptomatic chronic heart failure. This follows an approval from the EMA’s Committee for Medicinal Products for Human Use in December. The drug is already approved in the EU for the treatment of type 2 diabetes as well as chronic kidney disease. It has also received regulatory approvals in Britain, Japan and Turkey, as well as the US and now the EU.

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Study suggests DNA sequencing could reduce infant deaths, often caused by genetic disease

STAT

Researchers who believe genomics can transform human health love to recount success stories. They’ll tell you about the 3-month-old boy whose heart was failing until researchers pinpointed what was ailing him. Or the baby girl who could have had a life-threatening reaction to anesthesia had researchers not sequenced her DNA ahead of time. But a new study focuses on a much more somber set of stories: those of infants who died with genetic diseases and who in some cases could have been trea

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Entact Bio’s CEO is leading the company out of stealth and into a new age of protein enhancement

PharmaVoice

Victoria Richon’s latest venture is in the burgeoning field of protein-regulated drugs that could target a range of diseases.

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FDA grants approval to Gilead Sciences’ breast cancer therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Gilead Sciences ’ Trodelvy (sacituzumab govitecan-hziy) to treat unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer adult patients. Trodelvy has been approved for HR+/HER2- breast cancer adult patients who have previously received endocrine-based therapy and a minimum of two additional systemic therapies

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Novel two-chamber setup could predict HPAPI dustiness

European Pharmaceutical Review

Researchers have shown that a newly developed two-chamber setup (TCS) for containment investigations consisting of an emission and a detection chamber may predict highly potent active pharmaceutical ingredient (HPAPI) dustiness in a sealed system at different flow conditions. These different flow conditions include the plain diffusive transport and the diffusive transport with the oppositely directed convective flow of airborne particles of the safe surrogate substance acetaminophen (ACAM).

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Opinion: Pregnant people with substance use disorders need treatment, not criminalization

STAT

Though it may be hard for many to fathom, even pregnant people and new parents can have active substance use disorders. They need support, not criminalization. The addiction and overdose crisis, which now claims more than 100,000 lives a year , shows little sign of abating, and emerging data highlight its startling impact on pregnant people: Overdose is now a leading cause of death during or shortly after pregnancy.

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Why are there gaps in mental healthcare? Often it’s flawed trial methodology

PharmaVoice

Sunovion Pharmaceuticals has developed a more precise way to track symptoms that could be broadly adopted across the industry.

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.

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FDA gives first RMAT designation to a cardiac gene therapy

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to RP-A501, an adeno-associated virus (AAV)-based gene therapy for Danon disease. “RP-A501 is the first cardiac gene therapy to receive RMAT designation from the FDA,” commented Dr Gaurav Shah, Chief Executive Officer at Rocket Pharmaceuticals.

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After ‘losing my life’ caring for a sick partner, a professor examines the U.S. caregiver crisis

STAT

“Living With”  explores the contours of life with chronic illness, from the prelude to diagnosis to new patterns of living, to wrestling with big questions about illness and health. Laura Mauldin was immersed in Deaf culture from childhood — but she’s not deaf. She went to a school that happened to educate many deaf children, and so she grew up learning American Sign Language.

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Roche, Chiesi and the FDA change major leadership roles as they strive for growth in 2023

PharmaVoice

From Roche’s new pharma chief to the departure of the FDA’s gene therapy head, these moves are bound to shake up the industry.

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Feinstein Institutes researchers discover new protein for sepsis treatment

Pharmaceutical Technology

Researchers at the Feinstein Institutes for Medical Research have discovered a new protein that can be a potential therapeutic target for lethal sepsis. Led by Feinstein Institutes researcher Haichao Wang, the new study focuses on detecting protein mediators that might contribute to uncontrolled immune responses to lethal infections. It explores the monoclonal antibody detection that may work against procathepsin-L (pCTS-L), a pro-inflammatory protein mediator, as the potential remedy.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Farming, pharmaceutical and health pollution fuelling rise in superbugs, UN warns

The Guardian - Pharmaceutical Industry

Sewage, poor sanitation and a lack of regulation give rise to antimicrobial resistance and threaten global health, report says Pollution from livestock farming, pharmaceuticals and healthcare is threatening to destroy a key pillar of modern medicine, as spills of manure and other pollution into waterways are adding to the global rise of superbugs, the UN has warned.

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New mouse study shows genes aren’t only way to pass obesity to next generation

STAT

From the color of our eyes to our odds of developing cancer, we’re all shaped by the genetic legacy of our ancestors. But a new study in mice provides the clearest evidence yet that acquired traits can be passed down from one generation to the next in mammals without DNA changes, challenging centuries of evolutionary dogma and raising fresh questions about the factors that affect our health.

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Bayer, Astellas switch CEOs amid major inflection points

PharmaVoice

Bayer’s Bill Anderson and Astellas’ Naoki Okamura will be charged with setting the companies on growth trajectories for 2023.

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CGT Catapult to bolster new UK life sciences campus

European Pharmaceutical Review

The Cell and Gene Therapy Catapult (CGT Catapult) has announced its involvement in the development of a major new campus for life science businesses in Stevenage, Hertfordshire. This announcement follows news from July 2022 of an intended £900m joint venture investment by two property firms, to develop a new life sciences campus in Stevenage. The new campus extension will deliver one of the largest campuses of its kind in the UK and Europe.

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AbbVie reports rise in full-year 2022 net revenues

Pharmaceutical Technology

AbbVie has reported full-year 2022 net revenues of $58.054bn, representing a 3.3% rise on a reported basis and 5.1% on an operational basis. The company reported an increase of 1.6% on a reported basis in global net revenues to $15.121bn for the fourth quarter (Q4) of 2022. For the full-year, worldwide net revenues from the Immunology portfolio stood at $28.924bn, increasing 14.4% on a reported basis.

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