Tue.May 02, 2023

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Opinion: Do masks work? Randomized controlled trials are the worst way to answer the question

STAT

Early in the Covid-19 pandemic, before we had vaccines and effective medical procedures, the only ways to prevent transmission of the virus were behavioral measures like face masks and social distancing. There was (and continues to be) a desperate hunger for definitive studies telling us how well specific measures would work, with specific publics, in specific settings, for specific strains of the novel and changing virus.

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Taking your biotech global? Here’s how you can navigate cultural norms

PharmaVoice

What’s so different about doing pharma business in the U.K. versus Japan? One of Moderna’s top brass shares her tips for navigating choppy cultural waters.

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Trending Sources

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Opinion: Long waits to see a doctor are a public health crisis

STAT

In 2004, the physician search firm Merritt Hawkins first issued their Survey of Physician Appointment Wait Times. That year, the national average wait to get in to see a new physician was 21 days, an unacceptable amount of time to wait to access care. But that number has only gotten worse. In their 2022 survey , the wait for a new patient appointment increased to an average of 26 days.

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From science to strategy, this exec is painting Genmab’s bigger picture into the next decade

PharmaVoice

Martine van Vugt, recently named Genmab’s chief strategy officer and executive vice president, aims to usher in the company’s next wave of "knock your socks off" antibodies.

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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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STAT+: What to know about the upcoming readout of Eli Lilly’s experimental Alzheimer’s therapy

STAT

Eli Lilly is nearing the readout from a pivotal study of its experimental treatment for Alzheimer’s disease. The approval of a similar medicine earlier this year has wrung risk from the outcome, but for the same reason, expectations for strong results are higher. The Lilly drug, called donanemab, is an antibody that targets accumulated plaques in the brain called amyloid.

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'Utterly devastating’: Cost-of-living crisis hits OTC medicines access

The Pharmacist

In Shilpa Shah’s area of North-East London, people ‘can't afford to be ill’. With many people accessing free prescriptions, community pharmacists in the area tend to give advice and recommend home remedies for self-limiting minor ailments, instead of over-the-counter treatments that patients would have to pay for. For a sore throat, patients might be told […] The post 'Utterly devastating’: Cost-of-living crisis hits OTC medicines access appeared first on The Pharmacist.

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J&J, building on CAR-T success, strikes another cell therapy deal

BioPharma Dive

Fresh off its success with the multiple myeloma treatment Carvykti, J&J is paying Cellular Biomedicine Group $245 million upfront for rights to two experimental cell therapies for blood cancer.

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Report on medical access finds one-third of Black Americans live in ‘cardiology deserts’

STAT

Many Black Americans would have to travel across county lines just to find an open spot with a cardiologist, a new analysis found. About 16.8 million Black Americans — roughly 1 in 3 — live in counties with little or no access to heart specialists, according to a report from GoodRx, a telehealth company that provides drug discounts and also researches health trends.

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Pfizer turns focus to new drugs as COVID vaccine revenue falls

BioPharma Dive

The drugmaker beat Wall Street’s first quarter forecasts despite a sales drop that puts pressure on it to succeed with upcoming market launches.

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Wealth, not health: For this hospital, closing Chicago’s alarming ‘death gap’ didn’t mean more clinics

STAT

CHICAGO — When internal medicine physician David Ansell started his career in 1978 at “County,” the sprawling public hospital that treated many of this city’s poorest residents, he didn’t question why so many of them were so sick, and their cases so complicated. “I just thought these were conditions they just had,” he said in a recent interview.

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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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Why R&D innovation holds the key to greater patient impact

European Pharmaceutical Review

Cancer remains a global threat with around 10 million people dying from the disease each year worldwide, making it the second leading cause of death. 1,2 In the EU, an estimated 2.7 million people are diagnosed with cancer annually and the number is growing. 3 With greater scientific understanding of cancer, the industry has made significant progress in developing innovative medicines to help patients.

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Loneliness poses risks as deadly as smoking, surgeon general warns

STAT

WASHINGTON — Widespread loneliness  in the U.S. poses health risks as deadly as smoking a dozen cigarettes daily, costing the health industry billions of dollars annually, the U.S. surgeon general said Tuesday in declaring the latest public health epidemic. About half of U.S. adults say they’ve experienced loneliness, Vivek Murthy said in a report from his office.

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FDA accepts Bristol Myers Squibb’s Reblozyl sBLA for anaemia  

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has accepted the supplemental biologics licence application submitted by Bristol Myers Squibb for Reblozyl (luspatercept-aamt) as a first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes (MDS). The regulatory body has also granted priority review to the application and set 28 August 2023 as a target date for the prescription drug user fee act (PDUFA).

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For Spanish-speaking Latinas, language gaps — real or perceived — tied to discrimination during labor

STAT

The research question that pursued Jessica Valdez, an OB-GYN resident physician at the University of California, San Francisco, stemmed from her mother’s womb: How important is it to a birthing woman’s experience to be seen by health care providers who share her primary language? Valdez’s mother was 17 when she immigrated to California from Mexico in the 1970s.

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Pharmaceutical Sciences Conference 2023

PharmaState Academy

DATE: 04 – 06 December 2023 Venue: Dubai, UAE PharmaState Academy has announced its collaboration with the Pharmaceutical Conference 2023 as a media partner. This highly esteemed event is all set to take place in Dubai, UAE, and will be the eighth edition of the conference. It promises to be an extraordinary three-day event that will bring together industry experts, researchers, and practitioners from around the world.

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STAT+: Tobacco control groups oppose a bill targeting disposable vapes — because they worry RJ Reynolds is behind it

STAT

WASHINGTON — There’s a new bill in Congress meant to crack down on the cheap disposable vapes, like Puff Bar, that are increasingly popular with kids. But nearly all of the leading tobacco-control groups don’t want anything to do with it. They say the bill is being pushed by the makers of competing vapes, namely RJ Reynolds, the maker of Vuse e-cigarettes, to take attention off of its products’ growing popularity, and to push competition out of business.

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Candles lit in Lithuania to mourn loss of pharmacist profession

The Pharmacist

People in Lithuania have placed lit candles outside community pharmacies to symbolise mourning, after parliamentarians voted to allow remote supervision – a move that campaigners fear would spell the death of the pharmacist profession. On Tuesday 25 April 2023, 64 members of the Seimas (Lithuanian parliament) voted to allow pharmacy technicians who qualified before 2006 […] The post Candles lit in Lithuania to mourn loss of pharmacist profession appeared first on The Pharmacist.

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STAT+: Legal battle between Apple and Masimo over trade secrets ends in mistrial

STAT

A California jury was unable to reach a verdict in a messy, drawn-out legal battle between Apple and patient-monitoring company Masimo. James Selna, the judge presiding, announced the case a mistrial on Monday. “While we are disappointed that the jury was unable to reach a verdict, we intend to retry the case and continue to pursue legal redress against Apple,” Masimo told STAT in a statement.

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Travere set back by study failure of kidney disease drug

BioPharma Dive

Shares in the biotech, formerly Retrophin, sank after the company disclosed its newly approved drug sparsentan failed a study meant to expand its use.

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STAT+: A battle between Gilead and the U.S. government over patents on HIV prevention pills goes to trial

STAT

After years of sparring, the federal government and Gilead Sciences will square off in a Delaware courtroom this week in a bid to settle dueling claims over the rights to a pair of groundbreaking and lucrative HIV prevention pills. The case has drawn attention because a central theme is the extent to which taxpayer-funded research may be used by a pharmaceutical company to reap enormous profits, and whether the prices charged for any resulting medicine are out of reach for many Americans.

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FDA releases draft guidance for decentralised clinical trials

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The publication includes recommendations for sponsors, investigators and other stakeholders regarding the implementation of DCTs to advance medical product development and research.

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How Discount Cards Work: A Primer on GoodRx and Its Competitors (video)

Drug Channels

In my most recent video webinar , I explored how the rapid expansion of patient-paid prescriptions—via cash-pay pharmacies and discount card vendors—is transforming the prescription market. Below, I follow the dollar when a patient uses a discount card to pay for a generic drug prescription. As you’ll see, a discount card can save money for consumers by leveraging several quirks of U.S. retail pharmacy pricing.

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Using Smart Tools for Smart Development

PharmaTech

The use of smart tools in early drug discovery can have an impact on downstream phases of drug development.

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VYNE and Tay Therapeutics reach licence agreement

Pharma Times

Deal involves an oral BET inhibitor which treats fibrotic and immuno-inflammatory disorders

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Astellas Reaches Agreement to Obtain Iveric Bio

PharmExec

Acquisition expected to support pharmaceutical’s blindness regeneration campaign.

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SporeGen and Destiny advance research collaboration

Pharma Times

Duo have partnered on developing a biotherapeutic therapy for flu and COVID-19

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Laurus gets tentative USFDA nod for paediatric ARV oral dispersible film drug, Dolutegravir 5mg and 10mg

Express Pharma

Laurus Labs announced the receipt of the USFDA tentative approval of their Oral Dispersible Film (ODF) Dolutegravir 5mg and 10mg for paediatric ARV treatment. A company release informed, “This paediatric drug administration through Oral Dispersible Film technology developed by Laurus Labs will simplify the drug administration in children. It will help in bringing a significant benefit in compliance with ARV medication in paediatric HIV treatment.

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ODAIA wins $25m funding to boost commercial insights platform for pharma

Pharmaceutical Technology

ODAIA, a life sciences predictive analytics and commercial insights provider, has secured an investment of $25m in its Series B funding round. The round was led by Threshold Ventures and co-led by Monograph Capital. Another new investor to take part in Series B round was Wittington Ventures. Existing investors including Flint Capital, StandUp Ventures, Graphite Ventures and BDC Capital’s Women in Technology Venture Fund, also participated in this round.

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Envisioning Digital Pharma Manufacturing

PharmaTech

Digital transformation to the Pharma 4.0 paradigm moves forward in process development and clinical and commercial manufacturing.

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Chances of eliminating HIV infection increased by novel dual gene-editing approach

World Pharma News

Gene-editing therapy aimed at two targets - HIV-1, the virus that causes AIDS, and CCR5, the co-receptor that helps the virus get into cells - can effectively eliminate HIV infection, new research from the Lewis Katz School of Medicine at Temple University and the University of Nebraska Medical Center (UNMC) shows. The study, published online in the journal The Proceedings of the National Academy of Sciences (PNAS), is the first to combine a dual gene-editing strategy with antiretroviral drugs t

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Drug Patent Expirations for the Week of April 30, 2023

Drug Patent Watch

PROAIR DIGIHALER (albuterol sulfate) Teva branded pharm Patent: 7,540,282 Expiration: May 6, 2023 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs,… The post Drug Patent Expirations for the Week of April 30, 2023 appeared first on DrugPatentWatch - Make Better Decisions.

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PMPRB Update: Federal Standing Committee on Health begins review of the Board

Pharma in Brief

The Standing Committee on Health ( HESA ) has begun a study on the Patented Medicine Prices Review Board ( PMPRB ). HESA is made up of 12 Members of Parliament representing the four main parties in the House of Commons. In connection with this study, HESA has conducted two meetings to ask questions of witnesses regarding the PMPRB: The first meeting on the PMPRB was held on Thursday, April 27.

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LEON Sets Lab Facilities at IZB in Munich

PharmaTech

The new research and development capacities set the stage for completion of product development for LEON’s manufacturing devices and will be used to showcase the devices and provide process development services to clients using LEON’s equipment.

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Express Pharma May 2023

Express Pharma

Ahmedabad Pharma Summit 2023: Charting India Pharma Inc’s Growth Path Click to download: May 2023 Digital Magazine The post Express Pharma May 2023 appeared first on Express Pharma.

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Total Analytical Error in Validation of Analytical Procedures of Pharmaceuticals

PharmaTech

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors.

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