STAT
MARCH 22, 2024
The Food and Drug Administration on Friday authorized a new antibody to protect immunocompromised individuals against Covid-19. The drug, known as Pemgarda and marketed by the biotech Invivyd, is the first such drug to become available since the agency pulled AstraZeneca’s Evusheld off the market in January 2023. New Omicron variants had rendered Evusheld ineffective.
ALiEM - Pharm Pearls
MARCH 22, 2024
A 53-year-old woman with no significant past medical history presented to the emergency department with a 3-day history of double vision on leftward gaze. She initially presented to urgent care with a chief complaint of chest heaviness and concern that her blood pressure was too high, but was sent to the emergency department for further cardiac and neurological evaluation after her urgent care provider noticed abnormal eye movement.
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STAT
MARCH 22, 2024
Pregnancy is a known stressor on the body. But a new study published on Friday in Cell Metabolism found that while pregnancy accelerates the body’s biological clock, much of that effect is reversed after delivery, especially in people who breastfeed. The results add to growing evidence that molecular aging, a process by which our cells accrue damage and dysfunction over time, doesn’t progress in a linear fashion — nor only forward.
PharmaVoice
MARCH 22, 2024
After getting her start as a nurse, Debra Weiss worked her way up the corporate ladder and is now COO of Gates MRI, which just launched its first phase 3 trial for tuberculosis.
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.
STAT
MARCH 22, 2024
FOXBOROUGH, Mass. — Jodi Cullity calls herself a pickleball fanatic. The 29-year-old is the founding CEO of Eleven-0, an organization devoted to the sport, in which players dart across a space smaller than a tennis court to dink a small ball over a net with a paddle. “It’s the fastest-growing sport in America because you could be any shape, size, age,” Cullity said.
BioPharma Dive
MARCH 22, 2024
The approval of Italfarmaco’s Duvyzat is the first for an oral, non-steroidal Duchenne drug and was issued for all patients at least six years of age, regardless of their genetic underpinnings.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
pharmaphorum
MARCH 22, 2024
Explore the three major mistakes commonly made in clinical operations that impact patient care, clinical research, and data integrity. Learn how to avoid these pitfalls for successful clinical operations.
STAT
MARCH 22, 2024
Medicare confirmed this week that it will cover Novo Nordisk’s obesity drug Wegovy if prescribed to prevent heart problems, but policy experts said Medicare patients are still likely to encounter significant barriers getting access to the highly popular and expensive drug. Medicare previously wasn’t reimbursing for Wegovy, since the federal payer is legally barred from covering weight loss drugs.
Pharmafile
MARCH 22, 2024
Idorsia has announced that the US Food and Drug Administration (FDA) has approved Tryvio (aprocitentan) for the treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adult patients who are not adequately controlled on prior treatments. The drug is an ‘endothelin receptor antagonist that inhibits the binding of endothelin (ET)-1 […] The post FDA approves Idorsia’s Tryvio for treatment of high blood pressure appeared first on Pharmafile.
STAT
MARCH 22, 2024
Drug development is more of a sprint than a marathon these days, thanks to more and better ways to target underlying biology and a more nuanced interpretation of precision medicine, three biotech leaders said at the STAT Breakthrough Summit East in New York Thursday. “We used to say, well, you may spend five years in the research phase, another five in development.
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pharmaphorum
MARCH 22, 2024
Medicare has loosened restrictions on the reimbursement of obesity drugs, thanks to clinical data showing they can improve cardiovascular outcomes, but their price could be up for negotiation.
STAT
MARCH 22, 2024
In a recent survey of U.S. companies, medical device makers reported spending $31 million on average to bring a new product to market under the Food and Drug Administration’s 510(k) pathway for those similar to devices already approved. These costs balloon to more than $90 million for new Class III devices that progress through the more rigorous premarket approval pathway.
pharmaphorum
MARCH 22, 2024
First report from PHTI concludes that digital health technologies for diabetes management deliver minimal clinical benefit and raise healthcare costs
STAT
MARCH 22, 2024
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going. And here is our regular feature in which we highlight a different person each week.
Pharmaceutical Commerce
MARCH 22, 2024
In an interview with Pharma Commerce Associate Editor Don Tracy, Amy Niles, Chief Mission Officer, The PAN Foundation discusses the overall mission of the organization.
STAT
MARCH 22, 2024
Protesters in the tiny Mediterranean nation of Malta converged last October on the 18th-century Baroque palace housing the prime minister’s offices chanting “thieves,” and unfurled a massive banner on the steps emblazoned with the words: “Bring back the €400 million now.” The object of their furor wasn’t just the government.
pharmaphorum
MARCH 22, 2024
Idorsia Pharmaceuticals has claimed FDA approval for aprocitentan as a treatment for resistant hypertension, becoming the first drug in the endothelin receptor antagonist class for that indication.
STAT
MARCH 22, 2024
The Texas Medical Board, responding to pressure from the state Supreme Court and widespread uncertainty among physicians, proposed draft guidance Friday in an attempt to clarify what constitutes emergency grounds for a legal abortion. A summary of the proposed rules were read out by board president Sherif Zaafran, who summarized the proposed rules at a regularly scheduled meeting.
pharmaphorum
MARCH 22, 2024
It has been a bumper week for biotech financings, with a $400m Series A for Mirador heading, topping impressive rounds for Capstan, Clasp, Engrail, Enliven, and Nouscom.
STAT
MARCH 22, 2024
Following a blockbuster year of dealmaking and a recent uptick in biotech stocks, top investors see more good news on the horizon. Driving the momentum? Economics 101. Biotechs rely on borrowing capital, which is a more tenuous task when interest rates are high. But interest rates have most likely peaked, with Federal Reserve officials signaling earlier this week they expected to make three cuts this year.
Express Pharma
MARCH 22, 2024
Clinical trials attest to the safety and efficacy of pharmaceuticals. But, they’re not cheap to conduct. By 2020, out of the mammoth $200 billion pumped into pharma research, a whopping $48.4 billion went into clinical trials. Given the current trajectory, the figures could balloon to $68.9 billion by 2025 and approach $84.44 billion by 2030. CROs: The torchbearers To strike a balance between quality and cost, global pharmaceutical giants have, since 2005, leaned towards Indian clinical re
STAT
MARCH 22, 2024
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox. Hi, it’s Meghana. Today, Illumina finally finds an advocate in the EU, a CRISPRed pig kidney is transplanted into a living human, and more.
pharmaphorum
MARCH 22, 2024
Italfarmaco’s non-steroidal drug Duvyzat (givinostat) has been approved in the US as a treatment for Duchenne muscular dystrophy (DMD)
STAT
MARCH 22, 2024
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda so far appears quite modest. We plan to catch up on our reading, take a few needed naps and promenade with the official mascots, weather permitting. We also hope to hold another listening party where the rotation will likely include this , this , this , this and this.
Pharma Times
MARCH 22, 2024
Dementia is estimated to affect 850,000 people in the UK and costs the nation around £23bn a year
Drug Channels
MARCH 22, 2024
Today’s guest post comes from Adam Stotts, SVP of Customer Success at AssistRx. Adam discusses how patients seeking to access specialty therapies can benefit from a digital intake approach. He then explains three ways that specialty pharmaceutical companies can use digital intake strategies to speed patient enrollment. To learn about AssistRx’s digital intake solutions, download Digital Intake for Specialty Drug Programs: Q1 2024 Progress Report.
The Pharmacist
MARCH 22, 2024
Licensing new community pharmacy premises should be made ‘as convenient as possible’ for contractors, Conservative MP for South Swindon Sir Robert Buckland has told The Pharmacist. And the sector must be supported to deliver ‘frontline’ healthcare services like Pharmacy First, he said. Speaking to The Pharmacist at the recent Fight4Pharmacies event outside parliament, Sir Robert […] The post Make it easier to open new pharmacies, says Tory MP appeared first on The Pharmacist.
Pharmaceutical Technology
MARCH 22, 2024
The EMA CHMP has recommended marketing authorisation for Novo Nordisk's Awiqli for treating diabetes in adult patients.
Drug Patent Watch
MARCH 22, 2024
A recent article in Communications of the ACM explores opportunities for “Permissionless innovation” in pharmaceuticals.
Pharmaceutical Technology
MARCH 22, 2024
The US FDA has granted ODD to HI-Bio's felzartamab to treat antibody-mediated rejection (AMR) in kidney transplant recipients.
Pharma Times
MARCH 22, 2024
These types of conditions are responsible for 25% of all UK deaths and affect 7.
European Pharmaceutical Review
MARCH 22, 2024
Research suggests that combining ribociclib with hormone therapy improved invasive-free survival in stage 2 or 3 HR-positive, HER2-negative early breast cancer. The study data showed that distant disease-free survival and recurrence-free survival improved when the small molecule CDK4/6 inhibitor ribociclib was used alongside a nonsteroidal aromatase inhibitor (NSAI).
pharmaphorum
MARCH 22, 2024
Stay informed about the legal risks associated with AI in the life sciences sector. Understand how AI systems are being used in this industry and the potential legal implications that come with it.
Welltopia Pharmacy
MARCH 22, 2024
Understanding the Link Between Vitamin D and Gut Health Vitamin D and Gut Health: Maintaining optimal gut health is essential
World Pharma News
MARCH 22, 2024
Some anti-cancer treatments not only target tumour cells but also healthy cells. If their effects on the latter are too strong, their use can become limiting. A team from the University of Geneva (UNIGE), in collaboration with Basel-based FoRx Therapeutics, has identified the mechanism of action of PARP inhibitors, used in particular for breast and ovarian cancer in patients carrying the BRCA gene mutation.
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