Tue.Aug 08, 2023

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Senators push IRS to launch nonprofit hospital probe

STAT

WASHINGTON — A bipartisan group of senators wants federal tax regulators to probe nonprofit hospitals’ compliance with community benefit requirements, ratcheting up a longtime campaign to hold the tax-exempt providers accountable. Nonprofit hospitals are often subsidized by state or federal funding and exempt from many taxes. In exchange, they are required to aid their surrounding area through public health programs and providing free or discounted care to low-income patients.

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In the era of blockbuster obesity drugs, a personalized approach could boost outcomes

PharmaVoice

Ozempic and Wegovy have become household names for weight loss. But obesity is complex, and Phenomix Sciences is looking to bring a personalized medicine approach to the field.

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STAT+: Novo’s obesity drug Wegovy lowers cardiovascular risk by 20%, landmark trial finds

STAT

Novo Nordisk’s obesity drug Wegovy cut the risk of major heart complications by 20% in a closely watched trial, results that could streamline insurance coverage and spur even greater demand for the highly popular therapy. The milestone Select trial of about 17,500 patients with obesity and heart disease is the first to show that a weight loss medication leads to long-term cardiovascular benefits.

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Emergent to lay off around 400 in pivot away from contract manufacturing

BioPharma Dive

The job cuts will affect “all areas of the company” and, combined with other cost-reduction efforts, lead to annualized savings of over $100 million, Emergent said.

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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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Half of people worldwide at risk of developing mental health condition by age 75, per new study

STAT

By the age of 75, half of people worldwide can expect to experience a mental health disorder, according to the finding of a large study of more than 156,000 people across 29 countries. The study, published last week in The Lancet Psychiatry , analyzed answers that participants provided between 2001 and 2022 in response to a World Health Organization survey designed to assess the prevalence of major mental health disorders.

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Lilly market value soars on higher sales, obesity drug potential

BioPharma Dive

The Indianapolis drugmaker is now worth more than $500 billion, higher than any other pharmaceutical company, as analysts project lucrative markets for its obesity and Alzheimer's drugs.

More Trending

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Embracing Programmatic Advertising to Enhance Targeting of HCPs

PharmExec

The precision of programmatic advertising is reshaping the way life sciences brands engage with healthcare professionals, offering enhanced personalization, scale, and optimization in today's digital landscape.

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Ransomware attack shuts down hospital emergency rooms in several states

STAT

You’re reading the web edition of STAT Health Tech, our guide to how tech is transforming the life sciences.  Sign up to get this newsletter  delivered in your inbox every Tuesday and Thursday.

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Solutions to Optimize Cell Therapy Development and Manufacturing

PharmaTech

Catalent's Martin De Brauwere and Maria Lopez react to cell therapy innovations and highlight strategies to optimize the drug development and manufacturing process with assistance from a CDMO.

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STAT+: More regulation could be coming for drug ads

STAT

WASHINGTON — Government regulators may soon decide whether to crack down on distracting visuals in television drug commercials or require subtitles about side effects, a regulation that’s been 13 years in the making. White House budget experts are reviewing changes to the regulation of broadcast drug advertisements that the Food and Drug Administration proposed in 2010 , according to the Office of Management and Budget website.

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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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Semaglutide demonstrates cardiovascular benefit

European Pharmaceutical Review

Headline results from Novo Nordisk’s “landmark” SELECT trial in cardiovascular outcomes has demonstrated a 20 percent reduction in major adverse cardiovascular events (MACEs) for semaglutide 2.4mg (Wegovy ® ) compared to a placebo. “People living with obesity have an increased risk of cardiovascular disease but to date, there are no approved weight management medications proven to deliver effective weight management while also reducing the risk of heart attack, stroke or cardio

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From windows to wall art, hospitals use virtual reality to design more inclusive rooms for kids

STAT

BERKELEY, Calif. — For many young patients, harsh lights, bare walls, and windows facing parking lots or brick buildings make already painful hospital visits more unpleasant, stoking fear and uncertainty instead of hope. Often, those patients say, it makes recovery harder. Their perspectives — historically overlooked in hospital design — are at the heart of a budding movement to make architecture more inclusive for the people who actually spend time there.

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Engagement Ring Q&A

The Luxe Pharmacist

Hi loves! First, I just wanted to say thank you from the bottom of our hearts for the outpouring of love and well wishing surrounding our engagement! We couldn’t be happier or more excited and we are so blessed to share it with you. Also, huge thank you to everyone who submitted questions on Instagram, this post is based on everything you asked!

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STAT+: Wegovy cardiovascular study has doctors seeing new possibilities in weight loss drug

STAT

The momentum around weight loss drugs is about to get even bigger in the wake of Novo Nordisk’s announcement that its semaglutide drug Wegovy cut the risk of cardiovascular disease by 20% in its large SELECT trial. The full results of the study, funded by Novo, will be presented at the American Heart Association meeting in November. Doctors and researchers say they expect the findings to have a big impact on how clinicians approach the treatment of both obesity and cardiovascular disease,

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Novo obesity drug protects heart health in large trial

BioPharma Dive

Treatment with Wegovy led to a 20% reduction in the relative risk of cardiovascular complications or death, a finding that could further shift how doctors treat obesity.

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STAT+: Pharmalittle: Novo’s Wegovy obesity drug lowers cardiovascular risk in key trial; Nektar accuses Lilly of ‘misconduct’ in development deal

STAT

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.

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Prevalence and timing of authorized generics in the US market

Drug Patent Watch

A recent study explores the landscape of authorized generics in the United States pharmaceutical market. Authorized generics are brand-name drugs that are marketed without their original branding. The article sheds… The post Prevalence and timing of authorized generics in the US market appeared first on DrugPatentWatch - Make Better Decisions.

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STAT+: Beleaguered drug manufacturer Emergent cuts jobs, executive role in business shake-up

STAT

Emergent BioSolutions, the manufacturing company that fell into hot water in 2021 due to a contamination issue involving millions of doses of Covid vaccines, is pivoting its business and cutting hundreds of jobs, including a C-suite role. The company announced Tuesday that it will cut 400 jobs and eliminate the role of chief operating officer as part of a shift away from its contract manufacturing services business.

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143 pharma companies get show cause notices from CDSCO post inspections

Express Pharma

The Central Drugs Standard Control Organisation (CDSCO), along with state licensing authorities, issued show cause notices in 143 cases after risk-based inspections of 162 pharma firms, informed Mansukh Mandaviya, Union Health Minister. He further informed that stop production orders have been issued in 40 cases, cancellation and suspension of product/section licenses in 66 cases, issuance of warning letter in 21 cases and in one case, an FIR has been lodged and three persons have been arrested

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Are biotech VCs headed for better times? In one firm’s success, lessons for turning crisis into profit

STAT

This article is adapted from STAT’s latest report, “2023 Update: ranking biotech’s top venture capital firms.” Right now, venture capital firms are struggling with the impact of a persistently anemic biotech market. But if past downturns are any indication, some VCs will steer out of the slump into brighter times.

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WHO flags Cold Out cough syrup over higher limits of diethylene and ethylene glycol

Express Pharma

The World Health Organization flagged a batch of contaminated common cold syrup, manufactured by an Indian company on Monday. The agency said the batch of the syrup, branded Cold Out, found in Iraq was manufactured by Fourrts (India) Laboratories for Dabilife Pharma, and had higher than acceptable limit of contaminants diethylene and ethylene glycol.

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STAT+: More drugmakers are filing continuation patents that sideline generic competition

STAT

Amid concerns that the pharmaceutical industry unfairly wins monopolies on medicines, a new analysis finds there has been a whopping 200% increase in patents filed by companies that made few substantive changes to their drugs during a 15-year period. Pharmaceutical companies often file what are known as continuation patents in order to extend their window to thwart lower-cost generic competitors from reaching the market.

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CEPI to support development of selfamplifying mRNA vaccine technology for use against Disease X

Express Pharma

The Coalition for Epidemic Preparedness Innovations (CEPI) and Gennova Biopharmaceuticals announced a new funding agreement to advance the development of their self-amplifying mRNA (saRNA) platform to develop vaccine candidates against unknown pathogenic threats, also referred to as Disease X. CEPI will provide up to $3.6 million to support the optimisation of the saRNA-platform technology, the production process, and yield.

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Jacobio Pharma receives breakthrough therapy designation for glecirasib

Pharmaceutical Technology

Jacobio Pharma received breakthrough therapy designation (BTD) for glecirasib to treat pancreatic cancer patients with the KRAS G12C mutation.

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AstraZeneca’s tezepelumab and dapagliflozin accepted for use in Scotland

European Pharmaceutical Review

Two of AstraZeneca’s key medicines have been recommended for use within NHS Scotland by the Scottish Medicines Consortium (SMC). Tom Keith-Roach, President of AstraZeneca UK announced: “We are pleased that the SMC has now accepted Forxiga (dapagliflozin) for use in patients with chronic heart failure with preserved or mildly reduced ejection fraction and Tezspire (tezepelumab) has been accepted for restricted use in severe asthma within NHS Scotland.

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Artificial intelligence is set to power the future of healthcare provision

Pharmaceutical Technology

An increasing amount of information make artificial intelligence (AI) stand out as a promising solution to improve the provision of healthcare.

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Dyslipidemia market to grow to $15.53 bn in 2032 across 7MM: GlobalData

Express Pharma

The dyslipidemia market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK and Japan) is forecast to increase at a compound annual growth rate (CAGR) of 10.8 per cent from $5.56 billion in 2022 to $15.53 billion in 2032, driven by the launch of therapies with promising efficacies and new mechanism of actions, as well as the growth of the dyslipidemia population, according to GlobalData.

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Two AstraZeneca therapies accepted in Scotland

Pharma Times

Tezspire is a drug for severe asthma and Forxiga is used to treat chronic heart failure - News - PharmaTimes

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Astellas invests $50m in Poseida’s CAR-T cell therapy

Pharmaceutical Technology

As part of the agreement, Astellas will have exclusive negotiation and first refusal for licencing P-MUC1C-ALLO1 in solid tumours.

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Infex candidate nominated for COV-X programme

Pharma Times

Therapy targets the coronavirus PLPRO enzyme essential for the evasion of host immune response - News - PharmaTimes

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The potential of AI and gamification in nutraceutical industry

Express Pharma

The nutraceutical industry is experiencing significant growth, driven by the increasing popularity of nutritional supplements and functional foods due to their potential health benefits. The combination of artificial intelligence (AI) and gamification in this sector has the potential to revolutionise the way people engage with and benefit from these products.

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Collaboration at the Forefront

Pharmaceutical Commerce

As Pharma Commerce continues to increase its conference exposure, it all could not have been possible without the help of colleagues.

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What I (and Others) Told the Senate about the 340B Drug Pricing Program

Drug Channels

Recently, a bipartisan group of six U.S. senators issued a request for information (RFI) for “input on bipartisan policy solutions that would provide stability and appropriate transparency to ensure the 340B program can continue to achieve its original intent of supporting entities serving eligible patients.” Click here to read the full letter. I submitted a 14-page letter, which you can read below.

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FDA Sets a Recommended Framework for Predicting the Mutagenic and Carcinogenic Potential of Nitrosamine Drug Substance-Related Impurities

FDA Law Blog: Biosimilars

By Douglas B. Farquhar & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — Please sing to the tune of “ Honesty ,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs that may be nitrosamines, even having a deviation in pH of an Active Pha

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Sanofi asks ‘What If?’: Why the ‘big questions’ must be asked

pharmaphorum

Sanofi asks ‘What If?’: Why the ‘big questions’ must be asked Mike.

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