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

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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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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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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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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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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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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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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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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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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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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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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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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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Risk-sharing agreements are growing at a rate of 24%

Pharmaceutical Technology

On November 22, 2022, the FDA approved CSL Behring’s Hemgenix (etranacogene dezaparvovec), the first gene therapy treatment for hemophilia B, with a staggering manufacturer price of $3.5 million, according to GlobalData’s Price Intelligence (POLI), making it the most expensive drug in the world. This is not the first treatment to come with a high price tag.

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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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Disruptive Factors Shape RA Landscape

Pharmaceutical Commerce

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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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.

Immunity 105
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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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7 Don’t-Miss Conferences for Pharmacists in 2023

Digital Pharmacist

Are you already geared up for upcoming conferences or has planning out your show attendances this year fallen by the wayside in the midst of an already-busy 2023? Whether you need opportunities for continuing education, want to explore new services, discover industry trends, or just network with other professionals like yourself, there are several shows that provide those opportunities and more!

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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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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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New patent for Optinose Us drug XHANCE

Drug Patent Watch

Annual Drug Patent Expirations for XHANCE Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. It is available from one supplier. There are thirteen… The post New patent for Optinose Us drug XHANCE appeared first on DrugPatentWatch - Make Better Decisions.

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Alvotech proposed biosimilar to Stelara accepted by EMA

Pharma Times

The companies anticipate that the EMA could also recommend marketing authorisation for AVT04

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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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Taking Steps to Right the Wrongs: The Impact of Racial Bias in Healthcare and Medicine

PharmExec

Health disparities brought on by racial bias remain quite prevalent in areas such as drug access, use of diagnostics, and representation in clinical trials, but society-jarring events in recent years have sparked renewed efforts by industry to tackle these issues with tangible and hopeful gains.

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The Top Indicators That a Hub Launch Will Succeed: Discovery and Partnership

Drug Channels

Today’s guest post comes from ConnectiveRx’s Lauren Cole, Senior VP of Launch Excellence at ConnectiveRx. Lauren outlines key success factors when transitioning or launching a patient hub. To learn more, join Lauren on April 4th at 1:00 p.m. ET for a free online panel discussion: Lessons from the Edge—Six Things That Can Make a Hub Launch Go Wrong. Lauren will also be exploring hub launch excellence at Informa Connect’s Hub and Specialty Pharmacy Models East conference on March 20-22.

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‘They were his best shot. And they failed to help’: Why did EMS workers neglect Tyre Nichols?

STAT

By the time medics arrived, Tyre Nichols was sitting on the ground, handcuffed and propped against a police car. The 29-year-old’s face was bloody and he was groaning in pain. On Jan. 7, after pulling Nichols over for a traffic stop, Memphis police officers had tased him, pepper-sprayed him, punched him, kicked him in the head, and beaten him with a baton.

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Leaps in vax tech — researchers find new ways to tackle old problems like fungal infections and cancer

PharmaVoice

A growing number of fungal infections has caused a stir in the research community, and new vaccines could be the answer down the road.

Vaccines 130
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Teva Pharmaceutical reports 5% fall in Q4 2022 revenue

Pharmaceutical Technology

Teva Pharmaceutical Industries has reported $3.9bn revenue in the fourth quarter (Q4) of 2022, representing a 5% decline in US dollars or a 1% increase in local currency terms, from $4.1bn in the same quarter of the previous year. During the quarter, higher revenues from Anda, generic products in the Europe segment, AJOVY and AUSTEDO were partially offset by fewer revenues from COPAXONE, generic products and certain respiratory products in the North America segment.

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State policymakers can protect American innovation and help Americans live longer, healthier lives

PhRMA

For the second year in a row, life expectancy is on the decline in America. The leading causes of death across the United States include cancer and chronic diseases. Even when patients are able to manage these conditions — e.g., overall cancer survivability has increased 33% since 1991 — their quality of life may still be diminished.

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