Mon.Jun 10, 2024

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Millions fewer people may need statins, a new study suggests. But guidelines have yet to agree

STAT

It’s a familiar scene for patients during a routine primary care visit. The doctor scans blood test results, notes high cholesterol flagged by a standard calculator to assess risk of heart attack or stroke, then decides — and ideally discusses — whether to recommend taking a statin to cut the risk over time. That conversation may happen less often if changes in the risk model presented by the American Heart Association in November translate into new guidelines for prescribin

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From Collision to Clarity: PECARN cervical spine injury prediction rule for injured children

ALiEM - Pharm Pearls

For years, adult literature has provided clear guidelines for cervical spine imaging through the NEXUS and Canadian C-spine Rule (CCR) tools. These have been invaluable in helping clinicians decide when to image the neck in trauma patients. Similarly, the Pediatric Emergency Care Applied Research Network (PECARN) has developed robust tools for assessing blunt head trauma in children.

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STAT+: Moderna says data show its combination Covid-flu vaccine generates a strong immune response

STAT

Moderna announced Monday that, in a Phase 3 clinical trial, its combination Covid-19 and influenza vaccine generated stronger immune responses in older adults than individual vaccines that target those viruses. The findings, disclosed in a press release, suggest the company may be on track to bring a combination flu and Covid vaccine to the market, potentially as early as autumn 2025.

Immunity 360
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Behind Big Pharma’s layoffs — is there an end in sight?

PharmaVoice

A slew of major companies, including BMS, have announced cost-cutting measures in recent months. What will it take to turn the tide?

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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+: FDA advisers unanimously recommend approval of Eli Lilly’s Alzheimer’s disease treatment

STAT

Advisers to the Food and Drug Administration voted 11-0 on Monday to recommend the approval of a drug for early Alzheimer’s disease made by Eli Lilly — ruling that the treatment’s ability to slow the cognitive decline in patients outweighed its safety risks. The unanimous outcome of the daylong advisory panel was the best-case scenario for Lilly, making it likely that the FDA will approve the drug, called donanemab, for a broad population of people diagnosed with mild cognit

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What can pharma companies do to quicken the pace of digital disruption?

pharmaphorum

Discover how pharmaceutical companies can leverage digital technologies to accelerate innovation and disrupt the industry. Learn about regulatory considerations and engagement with healthcare professionals (HCPs) for successful digital transformation.

More Trending

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Our aim is to tailor our oncology portfolio to address the most pressing needs in India

Express Pharma

What are the therapeutic focus areas of Merck’s Oncology division? Do they match the unmet medical need in India for oncology treatment? WHO states that cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths and is set to increase. This drives us at Merck to develop innovations that matter most to people living with cancer.

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Opinion: Curing rare childhood diseases will falter unless Congress steps up

STAT

When our son Peter was diagnosed with an ultra-rare form of muscular dystrophy at the age of 10, the first question we asked was: Is there a treatment? The answer was no. By the time our daughter Maggie, then just 6, received the same diagnosis, that answer hadn’t changed. We soon learned that our situation is tragically common. As many as 30 million Americans live with some type of rare disease, defined as a disease that affects fewer than 200,000 people.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

FDA Law Blog: Biosimilars

By Sarah Wicks & Anne K. Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program.

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STAT+: Watch: How Harvard researchers boosted an ALS patient’s independence with a box and a balloon

STAT

John Goodson practiced medicine for almost 50 years at Massachusetts General Hospital in Boston. As a primary care physician, he saw thousands of patients and ailments, so when he struggled to raise the front of his foot in 2021, he felt a knowing dread. “As a physician, I had made the diagnosis of a patient with ALS and developed a close relationship and followed this patient right through to his death at home,” said Goodson.

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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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Last places on FDA START rare disease programme filled

pharmaphorum

The last three slots for projects that will be included in the FDA’s new programme to accelerate the development of therapies for rare diseases have been taken by Moderna, Myrtelle, and Calico Life Sciences.

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STAT+: Medical device trials still don’t enroll enough women, study finds

STAT

Women have always been underrepresented in medical research. A new study reveals that not much has changed, especially when it comes to tests of cardiovascular devices.  In a paper published in JAMA Internal Medicine on Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase from 2010 to 2020.

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J P Nadda appointed as Minister of Chemicals and Fertilisers

Express Pharma

Jagat Prakash Nadda takes charge as the Minister of Chemicals and Fertilisers, following his induction into Prime Minister Narendra Modi’s cabinet. Additionally, he also holds the portfolio of the Ministry of Health and Family Welfare. Nadda holds a law degree and previously served as the Health Minister during the Modi government’s first term, from 2014 to 2019.

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STAT+: Humana scores a win in a Medicare Advantage case

STAT

You’re reading the web version of Health Care Inc., STAT’s weekly newsletter following the flow of money in medicine. Sign up to get it in your inbox every Monday. Always watch the courts There’s a joke that all reporters essentially are legal reporters. But it’s kind of true, especially within the health care beat. Congress can’t get anything done, and the federal agencies have their routine rule-making powers.

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Scotland first UK nation to clear Mounjaro use for obesity

pharmaphorum

Scotland has become the first country in the UK to back NHS use of Eli Lilly’s obesity therapy Mounjaro, with a lower BMI threshold than draft NICE guidance

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Opinion: How faith leaders like me can help address America’s obesity epidemic

STAT

Many factors drive America’s obesity epidemic — environment, genetics, eating habits, and more. Solving the problem isn’t solely about getting people to lose weight. What’s also needed is overcoming the stigma and systemic bias directed at people living with obesity. Most people are dealing with a world of emotional stress.

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New paediatric blood test to prevent sudden death from hereditary heart condition

Pharma Times

Hypertrophic cardiomyopathy is a rare condition that affects up to 1,000 children in the UK

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The biotech news you missed from the weekend

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Lots on vaccines this morning: Moderna says its combination shot for Covid and flu works well, and might help improve uptake in the broader population. And the FDA just cleared GSK’s RSV vaccine for younger at-risk adults.

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FDA OKs wider use of Almirall’s actinic keratosis drug

pharmaphorum

With actinic keratosis (AK) diagnoses on the rise, there is some good news for patients, with the FDA approval of expanded use of Almirall’s topical therapy Klisyri. First approved in 2020, first-in-class microtubule inhibitor Klisyri (tirbanibulin 1%) reached the market in early 2021, joining a short list of therapies in the US that are available for AK, which is a major public health concern as it can be a precursor to skin cancer.

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STAT+: Pharmalittle: We’re reading about a Moderna Covid-flu vaccine, a paused Pfizer study, and more

STAT

Good morning, everyone, and welcome to another working week. We hope the weekend respite was invigorating and inspiring, because that oh-too predictable routine of online meetings, phone calls, and deadlines has returned. But what can you do? The world, such as it is, continues to spin. So to give it a nudge in a better direction, we are firing up the coffee kettle to brew some cups of stimulation.

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Health economics and outcomes research: Biopharma and the shift to value-based care

BioPharma Dive

Of the changes sparked by value-based care, perhaps the most valuable for the biopharmaceutical industry to embrace is the use of health economics and outcomes research (HEOR) to better understand a product’s value.

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STAT+: Teladoc names insurance, finance exec as its new CEO

STAT

Virtual care company Teladoc has a new chief executive officer following the abrupt departure of its long-time leader in April. Chuck Divita, who took on the role Monday, previously led the commercial markets business at GuideWell, the parent company of health plan Florida Blue. He was also previously chief financial officer at FPIC Insurance group, a publicly traded insurance company focused on medical liability.

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Informa Markets announces the launch of India Health 2024

Express Pharma

Aims to bring together over 300 brands and healthcare industry experts for the three-day conference Informa Markets in India announces the launch of India Health 2024, set to take place from June 13 to 15, 2024, at the India International Convention Centre (IICC) in Dwarka, New Delhi. The event aims to bring together over 300 brands and healthcare industry experts for a comprehensive three-day conference.

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Boehringer, Lilly face off in MASH at EASL

pharmaphorum

Eli Lilly's tirzepatide and Boehringer Ingelheim's survodutide grab the spotlight at EASL with new phase 2 data in metabolic dysfunction-associated steatohepatitis (MASH)

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ABHA’s Scan and Share service facilitates 3 crore OPD registrations nationwide

Express Pharma

The service enables patients to conveniently register for OPD appointments by scanning a QR code displayed at the OPD registration counter The National Health Authority (NHA), in its mission towards digitising healthcare services has generated over three crore tokens for Out-Patient Department (OPD) registrations through the ABHA-based Scan and Share service.

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NPA: Protest action must put safety first

The Pharmacist

Any action that pharmacies take to raise awareness of the financial crisis facing the sector should put patient and staff safety first, the National Pharmacy Association (NPA) has said. This comes as the Pharmacists’ Defence Association (PDA) called for any action within the sector to safeguard patient safety and protect the autonomy of responsible pharmacists, […] The post NPA: Protest action must put safety first appeared first on The Pharmacist.

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Roche’s Vabysmo showcases stronghold across wAMD and DME spaces : GlobalData

Express Pharma

Roche recently presented post-hoc analysis results of the TENAYA (NCT03823287) and LUCERNE (NCT03823300) trials of Vabysmo (faricimab), a VEGF and Ang2 inhibitor, at the Association for Research in Vision and Ophthalmology (ARVO) conference. The data showcases Vabysmo’s efficacy in wet age-related macular degeneration (wAMD) and diabetic macular edema (DME), as well as the Swiss pharma major’s eagerness to establish the prescription injection as a leading therapy for multiple ophthalmology indic

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Aligos Therapeutics gets grant for patent granted for compounds treating diseases and conditions

Pharmaceutical Technology

Discover the groundbreaking patent by Aligos Therapeutics for compounds targeting hepatitis B and D. Learn about the innovative methods for treatment and synthesis.

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India emerges as a global leader in Nutraceuticals

Express Pharma

India is rapidly becoming the epicentre of the global nutraceutical market. Transitioning from a latent player a decade ago to a leading market for nutraceutical ingredients and finished products, India is now attracting significant attention from innovators and investors worldwide. This transformation was prominently showcased at the Global Nutrify Today C Suite Sumflex 2024, where over 360 decision-makers from around the globe gathered to explore and discuss the burgeoning opportunities within

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Crucial Insights on Patent Litigation Strategies in Pharma Industry

Drug Patent Watch

In the “Patent Effect” podcast, Mustafa introduces his guest, Hakan Yum, the IP Director of Exrain Pharma, based in Sweden.

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Syntegon acquires Telstar

Express Pharma

Telstar, previously owned by Azbil Coropration, joins Syntegon after an acquisition agreement closes between Azbil and the German company. After the Share Purchase Agreement (SPA) signed on June 6, 2024, the acquisition will be effective after receiving customary regulatory approvals. Upon acquisition, Telstar will share their knowledge in the field of development of new innovative high-value solutions for aseptic production to reinforce synergies operating within common markets and aim to stren

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Moderna says combination flu, COVID shot succeeds in study

BioPharma Dive

Positive results from the trial could position Moderna to bring the two-in-one vaccine to market in 2025.

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Innovative radioligand manufacturing facility inaugurated

European Pharmaceutical Review

The first industrial-scale pharmaceutical manufacturing facility for production of lead-212-based radioligand therapies has been inaugurated. Orano Med (a subsidiary of the Orano Group)’s ATLab (Alpha Therapy Laboratory) facility in Brownsburg, near Indianapolis, Indiana, US, is set to help address the production and supply challenges of lead-212 radioligand therapies.

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Dana-Farber Cancer Institute and OncoHost partner for renal cell carcinoma research

Pharma Times

Accounting for 4% of all cases, kidney cancer is currently the sixth most common cancer diagnosed in the UK

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Five-year data from Genentech SMA study released

European Pharmaceutical Review

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). What did the FIREFISH extension study find? The study found that after five years without treatment, 91 percent of children were alive.