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

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The thorniest questions facing pharma, according to a leading bioethicist

PharmaVoice

Bioethics guru Arthur Caplan of NYU gives his outspoken and frank opinion on the industry’s minefield of ethical challenges.

Bioethics 246
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How pharmacy deserts are putting the health of Black and Latino Americans at risk

STAT

Pharmacies were once abundant in the South Side of Chicago. Now, residents living in the majority Black neighborhood often find themselves with few options when it’s time to get a prescription refilled or stock up on cold medicine. Ladell Johnson, a longtime resident of the South Side, drives half an hour from her house to the downtown area every time she needs to pick up her prescription.

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SAEM Clinical Images Series: Wolf in Sheep’s Clothing

ALiEM - Pharm Pearls

A 55-year-old female with a history of hyperlipidemia presents after a syncopal episode. She had mild nausea and diarrhea on the morning of presentation but otherwise had no prodromal symptoms before suddenly losing consciousness in a grocery store. Of note, she recalls a similar syncopal episode in the remote past, also preceded by gastrointestinal symptoms at that time.

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What if a CRISPR cure isn’t such an easy choice?

BioPharma Dive

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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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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What if a CRISPR cure isn’t such an easy choice?

PharmaVoice

A gene editing therapy developed by Vertex Pharmaceuticals and CRISPR Therapeutics can mute sickle cell disease’s most damaging symptoms. Yet treatment may not be as simple as its dramatic benefit makes it seem.

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HPV vaccines are so effective that new screening policies may be in order, suggests study

STAT

Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published today in Cell Host & Microbe. The randomized control study included more than 60,000 women from 33 Finnish communities born in 1992, 1993, and 1994.

Vaccines 363

More Trending

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Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea

Pharma Times

Zoliflodacin inhibits the vital bacterial enzyme for bacterial function and reproduction - News - PharmaTimes

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Shock of the old: 10 scandalous vintage medicines – from asthma cigarettes to cocaine wine

The Guardian - Pharmaceutical Industry

Cure any ailment! Never known to fail! Early medicine adverts made grand claims but they look alarming today The confusion with patent medicines starts with the name, since they were rarely ever patented; manufacturers just thought it sounded cool. Bamboozling was always part of the package: from the 17th century, concoctions of water, alcohol and herbs were sold with wild claims and exotic origin stories.

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Eli Lilly gets FDA approval to sell Mounjaro as obesity drug called Zepbound

STAT

Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes, has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market. The Food and Drug Administration’s long-awaited approval of the drug, which will be marketed under the name Zepbound for obesity, is a major milestone for Lilly.

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Pharmacy inquiry will question NHSE chief exec

The Pharmacist

The chief executive of NHS England (NHSE), Amanda Pritchard, will be called before the Health and Social Care Committee’s (HSCC) pharmacy inquiry, which is expected to begin later this month. The inquiry is set to look at the Additional Roles Reimbursement Scheme (ARRS), workforce issues, proposed legislative changes to pharmacy supervision and hub and spoke […] The post Pharmacy inquiry will question NHSE chief exec appeared first on The Pharmacist.

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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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Samay’s AI-assisted wearable technology accurately diagnoses COPD

Pharma Times

The device successfully diagnosed COPD in patients with 90% accuracy - News - PharmaTimes

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Sanofi Issues Update on Shortages of Beyfortus for Respiratory Syncytial Virus

PharmExec

Due to a higher than anticipated demand, Sanofi is carefully managing distribution of 50 mg doses of Beyfortus in the private market to fulfill existing orders and provide equitable access to remaining doses for the vaccine that protects infants against respiratory syncytial virus.

Vaccines 111
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Cancun abortion clinic will give Americans a new reason to visit the Mexican resort

STAT

MEXICO CITY — More than 5.6 million U.S. tourists head to Cancun every year, drawn to the Mexican port’s white sand beaches, all-inclusive resorts, and raucous nightlife. Soon there’s likely to be another reason to visit: MSI Reproductive Choices , an international reproductive health nonprofit, plans to open an abortion clinic in the city, partly designed to cater to travelers from the U.S. who are unable to get an abortion in their home states.

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Renewed call for national non-referral smoking cessation service

The Pharmacist

A fresh call has been made for a nationally commissioned non-referral smoking cessation service through community pharmacies, as the government announces major investment in local schemes. In the King’s Speech this week, it was revealed that the funding available to local smoking cessation services would ‘more than double’ by next April to £140m, while plans […] The post Renewed call for national non-referral smoking cessation service appeared first on The Pharmacist.

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Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents

Drug Patent Watch

A paper titled “Analysis of Strategy for Extending Patent Protection of Rucaparib” by Zhifeng Wang. discusses the strategies employed by pharmaceutical companies to extend the patent protection period of the… The post Maximizing Intellectual Property Value in the Biomedical Sector: A Case Study on Rucaparib Patents appeared first on DrugPatentWatch - Make Better Decisions.

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Lilly weight loss drug approved by FDA

BioPharma Dive

The pharmaceutical company will sell the GLP-1 drug, branded as Zepbound, at a list price about 20% lower than Novo Nordisk's competing drug Wegovy.

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Pulse oximeters’ inaccuracies in darker-skinned people require urgent action, AGs tell FDA

STAT

More than two dozen attorneys general are urging Food and Drug Administration officials to take urgent action to address disparities in how well pulse oximeters, the fingertip devices used to monitor a person’s oxygen levels, work on people with darker skin. In a Nov. 1 letter, the AGs noted that it had been a year since the FDA convened a public meeting of experts , who called for clearer labeling and more rigorous testing of the devices, and that no action had been taken.

Labelling 359
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RPS supports government proposals to regulate cosmetic procedures

The Pharmacist

The Royal Pharmaceutical Society (RPS) has backed government plans to impose regulations on high-risk non-surgical cosmetic procedures to ensure they can only be undertaken by qualified and regulated healthcare professionals. Responding to a government consultation on how to make non-surgical cosmetic procedures – such as botox and fillers – safer for the public in England, […] The post RPS supports government proposals to regulate cosmetic procedures appeared first on The Pharmacist.

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Bayer and Recursion focus research collaboration on oncology

World Pharma News

Bayer and US-based Recursion Pharmaceuticals, Inc., a clinical stage TechBio company decoding biology to industrialize drug discovery, announced that they have updated the focus of their research collaboration to precision oncology. The oncology-focused collaboration will leverage Bayer's small molecule compound library and expertise in biology and medicinal chemistry as well as Recursion’s purpose-built artificial intelligence-guided drug discovery platform.

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Frontiers Health 2023 Day One

pharmaphorum

Frontiers Health 23 - Day 1 from the marvellous Auditorium della Tecnica in Rome, where we are set to bring you the biggest news stories, trends, and industry insights

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A new study maps the lasting effects of gun violence on children and teens who survive their injuries

STAT

When Christian Pulcini was a pediatric emergency fellow at Children’s Hospital of Philadelphia, he witnessed firsthand the ways that gun violence affected children who survived it. He still remembers one young boy who had been shot in the neck while playing outside his home. Pulcini did not remove the bullet — a routine practice, often safer than removal.

Hospitals 360
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Hub and spoke unlikely to solve sector’s problems, says HSCC chair

The Pharmacist

Former pharmacy minister and chair of the health and social care committee (HSCC) Steve Brine has said he ‘doubts very much’ that changes to hub and spoke legislation is the answer to problems faced by independent community pharmacies. At the Sigma Pharmaceuticals UK conference last weekend, Mr Brine described the government’s silence on hub and […] The post Hub and spoke unlikely to solve sector’s problems, says HSCC chair appeared first on The Pharmacist.

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Developing a first-in-class small molecule drug for inflammatory disease

European Pharmaceutical Review

Following her presentation on age-related disease at BioFuture 2023, Executive Vice President of Drug Development for MyMD Pharmaceuticals ® , Jenna Brager, shares with EPR why the company’s next-generation tumour necrosis factor (TNF)-alpha inhibitor has potential in inflammatory and autoimmune disorders. In July 2023, MyMD Pharmaceuticals released results from its Phase II study in sarcopenia evaluating potential of MYMD-1 ® , its first-in-class oral TNF-α inhibitor.

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100th patient joins ChariotMS trial for multiple sclerosis

Pharma Times

The trial is testing whether Mavenclad could benefit upper limb movement in MS patients - News - PharmaTimes

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Congenital syphilis cases in the U.S. have skyrocketed, CDC says

STAT

The number of babies born with congenital syphilis in the United States has soared over the last decade, leading to an increase in stillbirths, infant deaths, and life-altering birth defects, the Centers for Disease Control and Prevention reported Tuesday. The number of cases of congenital syphilis in 2022 was more than 10 times the number recorded in 2012, the agency said, noting that most of the 3,761 cases reported in 2022 could have been averted, if the babies’ mothers had been adequa

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New patent expiration for APIL drug ACTONEL

Drug Patent Watch

Annual Drug Patent Expirations for ACTONEL Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. It is available from two suppliers. There are… The post New patent expiration for APIL drug ACTONEL appeared first on DrugPatentWatch - Make Better Decisions.

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Sandoz and Teva achieve first-of-a-kind manufacturing certification

European Pharmaceutical Review

Sandoz and Teva have become the first organisations to qualify for the new global Minimized Risk of Antimicrobial Resistance (AMR) certification. This programme was developed by the British Standards Institute (BSI) to verify companies that are taking the necessary steps in ensuring responsible antibiotic manufacturing in the global supply chain, helping to lower the spread of AMR.

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New womb cancer test could prevent need for invasive diagnostic procedures

Pharma Times

The WID-qEC test successfully identified 91% of womb cancer cases - News - PharmaTimes

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As extreme heat soars, laws to protect outdoor workers are bubbling up — and facing resistance

STAT

As weather starts to cool in much of the country, the heat-baked cement and sweaty afternoons from this summer fade from collective memory. But activists and labor groups representing outdoor workers haven’t forgotten. They are pushing lawmakers and regulators to keep facing the heat. On Tuesday, the Miami-Dade Board of County Commissioners will take a final vote on a proposed heat standard to protect outdoor workers.

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Masterclass on Leveraging Real-World Evidence (RWE) for Building Pharma Brands

PharmaState Academy

This is "not to be missed" Masterclass for Pharma Marketers! ???????????: To be awarded with 3CPhE (Continuing Pharma Education) points. Seats Booked: 14 / Seats Left 16 Registrations Open Limited Seats Interest Form For Next Batch We limit the number of participants in a batch so that high-quality interactive learning can happen. In case you have missed this batch, you can fill out the Interest form for the next batch.

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Lots of FDA Guidance, But Few Drug Manufacturing “Remote Interactive Evaluations” (We Would Call Them “Virtual Inspections”)

FDA Law Blog: Biosimilars

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections.

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To Receive or Not to Receive, That is the Question with Patient Gifts

Board Vitals - Pharmacist

Ah, the holidays – the season of giving. It’s the time of year when patients want to express their gratitude for your care with gifts that may range from the ridiculous to the sublime. They are all given with good intentions, but should you accept them? And if you do, are all gifts created equal? Is a tin of cookies the same as a gift certificate or a day of golf?

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U.K. recommendation could lead to world’s first use of meningitis vaccine to curb gonorrhea

STAT

An expert panel that advises the United Kingdom on vaccine policy has recommended using a meningitis B vaccine to try to bring down spiking rates of gonorrhea. If adopted, the U.K. would be the first country to use the meningitis B vaccine for this purpose. The Joint Committee on Vaccination and Immunization released a report Friday saying that targeted use of a meningitis B vaccine — GSK’s Bexsero — in people at high risk of contracting gonorrhea should reduce the inci

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One Time ONLY! $100 Discount and Free Audible Book – BCPS Study Materials

Med Ed 101

We are offering a ONE TIME ONLY discount of $100 on the 1 year BCPS all-access pass and I also have 10 Free Audible books to give away. ONLY the first 10 purchases will get the Free Audible version of my Drug Interaction Book (10+ hours of bonus content) as I only have a limited […] The post One Time ONLY! $100 Discount and Free Audible Book – BCPS Study Materials appeared first on Med Ed 101.

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FDA Approves Zepbound for Chronic Weight Management

PharmExec

Tirzepatide (Zepbound; Eli Lilly and Company) is expected to be available in the United States by the end of 2023 with a list price of $1,059.87.

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