FDA Warns Against Using At-Home Chemical Peels, Cites Retailers
Drug Topics
AUGUST 1, 2024
Pharmacists should be knowledgeable about the symptoms of chemical peel irritation to effectively advise patients.
Thu.Aug 01, 2024
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Behind the malaria vaccines: A 40-year quest against one of humanity’s biggest killers
STAT
AUGUST 1, 2024
Malaria is one of our most ancient foes — and one of the wiliest. Caused by parasites that certain mosquitoes spread through their bites, malaria overwhelms us, establishing an infection before we can put up a fight. It can go on to destroy red blood cells, batter organs, and even damage the brain.
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FDA to Weigh Bayer’s Treatment for Hot Flashes Associated with Menopause
Drug Topics
AUGUST 1, 2024
In 3 Phase 3 trials, elinzanetant reduced the frequency and severity of moderate to severe vasomotor symptoms, and improved sleep disturbances.
STAT+: Eli Lilly’s obesity drug Zepbound shows benefits in heart failure patients
STAT
AUGUST 1, 2024
Eli Lilly’s obesity drug Zepbound cut the risk of complications and improved symptoms in patients with a common type of heart failure, making it the second GLP-1 drug to show positive results in the disease area after Novo Nordisk’s Wegovy. The Phase 3 trial studied patients who had heart failure with preserved ejection fraction (or HFpEF) and obesity.
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
Bilateral Mastectomy Lowers Risk of Contralateral Breast Cancer But Not Mortality
Pharmacy Times
AUGUST 1, 2024
The findings provide guidance for clinicians and patients when navigating therapeutic options to establish treatment plans.
Morning Rounds: Inside the making of the first malaria vaccine
STAT
AUGUST 1, 2024
Want to stay on top of health news? Sign up to get our Morning Rounds newsletter in your inbox. Okay, I know it’s unoriginal to express awe at the speed at which time passes, but like … how is it already August? Okay, instead I will recall Louise Glück’s “ Matins.” (“You want to know how I spend my time?
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CVS Health now tracks extreme heat to warn at-risk patients with personalized resources
Fierce Healthcare
AUGUST 1, 2024
CVS Health has launched an environmental health impact program to help vulnerable Americans during extreme weather events. | Using advanced environmental data analytics and patients' medical and pharmacy data, CVS Health offers timely excessive heat alerts and outreach to at-risk patients up to a week before the event.
STAT+: Jim Wilson, gene therapy pioneer, departs Penn to set up new companies
STAT
AUGUST 1, 2024
Jim Wilson, a leading gene therapy researcher who has persisted through the field’s ups and downs , is leaving his longtime academic home at the University of Pennsylvania to found two new companies. Penn is spinning out much of the work of its Gene Therapy Program, where Wilson had served as director, to the two new companies. Most of the program’s employees will be offered roles at the new companies, according to a statement released Wednesday night.
Alignment Healthcare raises full-year guidance after favorable star rating recalculations
Fierce Healthcare
AUGUST 1, 2024
Plan membership at Alignment Healthcare is again higher than previously expected, the company announced ahead of its second-quarter earnings call. | Alignment Healthcare says it is on pace for full-year adjusted EBITDA guidance and increasing its membership outlook after its second-quarter earnings call.
STAT+: With new data, Regenxbio advances plan for Duchenne gene therapy
STAT
AUGUST 1, 2024
Regenxbio said Thursday that its experimental gene therapy for Duchenne muscular dystrophy was administered to two more boys and produced high levels of a miniaturized version of the protein needed for muscles to function properly. The updated results from an early study suggest the Regenxbio therapy, called RGX-202, could become the second genetic medicine for Duchenne to reach the market, following the Food and Drug Administration’s approval of Sarepta Therapeutics’ Elevidys in J
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.
OneBlood hit with ransomware attack, state of donors' data unknown
Fierce Healthcare
AUGUST 1, 2024
OneBlood, a non-profit blood donation organization serving hospitals in the southeastern U.S., was hit by a ransomware attack on Wednesday that has impacted its operations. | OneBlood, a non-profit blood donation center servicing the southeastern United States, was attacked by cybercriminals on Wednesday.
FDA Expands Approval of Dostarlimab-Gxly Plus Chemotherapy to All Adults With Primary, Recurrent Endometrial Cancer
Pharmacy Times
AUGUST 1, 2024
The RUBY trial will continue and analyze the overall population survival after treatment with the drug combination.
Bipartisan Policy Center urges Congress to extend Medicare hospital at home, telehealth policies by end of year
Fierce Healthcare
AUGUST 1, 2024
The Bipartisan Policy Center released a report on Wednesday that recommends that C | The Bipartisan Policy Center released a report on Wednesday that recommends Congress extend the Medicare Acute Hospital Care at Home waiver for five years to increase uptake.
4 takeaways from STAT’s story on the development of malaria vaccines
STAT
AUGUST 1, 2024
For the first time, the world is starting to roll out malaria vaccines to children in sub-Saharan Africa. The story of the development of those vaccines, a decades-long effort that stretched from labs in New York, England, and Belgium to clinical research sites in a number of African countries, is detailed in a STAT special report published Thursday.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
Evernorth drives double-digit revenue growth at Cigna in Q2
Fierce Healthcare
AUGUST 1, 2024
Revenue at Cigna grew 25% year over year as its Evernorth division continues to build momentum, according to the company's earnings report.
Another IRA lawsuit bites the dust with ruling on Novo Nordisk case; company pledges to appeal
Fierce Pharma
AUGUST 1, 2024
Like clockwork, another lawsuit challenging the constitutionality of the Inflation Reduction Act's (IRA's) price-setting measures has been shot down in the courts. | The ruling from the New Jersey federal court marks the latest in a string of rejections as various drugmakers have taken to the courts to fight the drug pricing legislation.
TowerBrook, CD&R take health tech company R1 RCM private in $8.9B deal
Fierce Healthcare
AUGUST 1, 2024
R1 RCM, a company that provides revenue cycle and billing services to hospitals, will be acquired for $8.9 billion and taken private. | R1 RCM, a company that provides revenue cycle and billing services to hospitals, will be acquired for $8.9 billion and taken private.
STAT+: Private equity firms to acquire health care billing and payments firm R1 in $8.9 billion deal
STAT
AUGUST 1, 2024
R1 RCM is finally getting taken off the public markets, ending a months-long saga between private equity firms that were trying to take control of the large health care billing and collections company. Private equity firms TowerBrook Capital Partners and Clayton, Dubilier & Rice are teaming up to buy R1 , the companies said Thursday. TowerBrook, in a partnership with the Catholic hospital system Ascension, already owns 36% of R1 — which made TowerBrook and Ascension the company’
5 Reasons to Upgrade Your Pharmacy Management Software
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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.
Many patients are hit with claims denials. But few challenge the decisions, study finds
Fierce Healthcare
AUGUST 1, 2024
Close to half of adults said they received a medical bill or a copayment for a service that they expected to be free or covered by insurance. | Close to half of adults said they received a medical bill or a copayment for a service that they expected to be free or covered by insurance. However, relatively few challenge these bills, a new survey from the Commonwealth Fund shows.
Kyowa Kirin looks to cut small molecule research and manufacturing jobs, slims down in Asia
Fierce Pharma
AUGUST 1, 2024
Like many other biopharma companies, Kyowa Kirin is in restructuring mode. | Kyowa Kirin is planning “a significant reduction” in its small molecule drug discovery research activities and will trim certain manufacturing roles. The company is also divesting its Chinese operations as part of a larger restructuring in the Asia-Pacific region.
Changing Faces: May and June 2024 supplier and digital hires
pharmaphorum
AUGUST 1, 2024
Changing Faces announces new supplier and digital hires for May and June 2024, including AxoSim, ERS Genomics, Newcells Biotech, SHINE Technologies and more. Stay updated with the latest industry developments.
After series of patent lawsuits, Novartis doubles down in Entresto defense with FDA complaint
Fierce Pharma
AUGUST 1, 2024
Two weeks ago, Novartis CEO Vas Narasimhan referred to the initial wave of drug pricing effects tied to the Inflation Reduction Act (IRA) as “manageable.” | Novartis has filed a lawsuit against the FDA, claiming that the U.S. regulator’s approval of a generic version of Entresto is unlawful. The complaint comes a week after the FDA approved an Entresto generic from MSN Laboratories.
Bayer files first application of menopause drug elinzanetant
pharmaphorum
AUGUST 1, 2024
Bayer files elinzanetant as a non-hormonal treatment for menopausal symptoms, with Astellas' first-to-market Veozah in its sights
venBio raises $528 million for its fifth fund
STAT
AUGUST 1, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Good morning. We’ve got another busy day of earnings and new data readouts. Let’s get straight into it.
Changing Faces – Pharma and biotech May and June 2024
pharmaphorum
AUGUST 1, 2024
Stay updated on the latest hiring news and developments from Pfizer, Lilly, Gilead, Epsilogen, and other pharma and biotech companies in May and June 2024 with Changing Faces.
Chronic, New Onset Anxiety Associated with Risk of Dementia
Drug Topics
AUGUST 1, 2024
Researchers aimed to address the association of all-cause dementia risk and 3 separate chronicities of anxiety.
Going beyond the hype: Embracing AI for strategic advantage
pharmaphorum
AUGUST 1, 2024
Discover how AI is revolutionising the medical and pharmaceutical industries. Learn how to leverage AI for strategic advantage and stay ahead of the competition in this insightful article.
Listen: The long journey to make malaria vaccines, and Sarepta’s ties with patient advocates
STAT
AUGUST 1, 2024
Why has it taken so long for the world to get malaria vaccines? What relationship should drug companies have with patient advocates? And who in biotech is having a brat summer? We discuss all that and more in this week’s episode of “The Readout LOUD,” STAT’s biotech podcast. Andrew Joseph, our Europe correspondent, joins us to talk about his special report on the 40-year quest to develop the world’s first malaria vaccines.
South Africa's HIV Research: Unlocking the mysteries of elite controllers
pharmaphorum
AUGUST 1, 2024
South Africa occupies a pivotal position in the global battle against HIV. As of 2022, it is home to around 7.8 million individuals living with HIV, representing the largest HIV burden in the world. However, it is this very challenge that has placed South Africa at the leading edge of innovative HIV research, with potential ramifications for the millions affected by the disease globally - and that starts with elite controllers.
NICE recommends BeiGene’s MZL tablet for NHS use
Pharmaceutical Technology
AUGUST 1, 2024
The UK NICE has recommended BeiGene’s Zanubrutinib for marginal zone lymphoma (MZL) for use on the National Health Service (NHS).
Eli Lilly, after tirzepatide's late-stage cardio win, plots regulatory filings this year
Fierce Pharma
AUGUST 1, 2024
Eli Lilly, after tirzepatide's late-stage cardio win, plots regulatory filings this year esagonowsky Thu, 08/01/2024 - 09:40
Oxford Nanopore rises on Novo Holdings equity stake
pharmaphorum
AUGUST 1, 2024
UK DNA/RNA sequencing specialist Oxford Nanopore raises £80m in a share issue backed with £50m from Novo Holdings
Moderna takes axe to '24 sales guidance, sending shares lower
Fierce Pharma
AUGUST 1, 2024
The post-pandemic period has posed serious challenges for financial forecasters at the top mRNA vaccine makers, as evidenced by Pfizer's
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