Trending Articles

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Michigan stands out for its aggressive bird flu response. Will other states follow its lead?

STAT

For weeks now, as the H5N1 bird flu has been spreading into dairy cattle herds in more and more places, one state continues to lead the pack. With reports of infections in 25 herds, Michigan currently accounts for about one-third of the country’s confirmed cases in livestock. And of the three people known to have contracted the H5N1 virus from sick cows since the outbreak began, two of them are farmworkers in Michigan, including one who experienced respiratory symptoms.

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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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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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Lilly’s Alzheimer’s drug set to join Leqembi after FDA vote

pharmaphorum

An FDA advisory committee has delivered a strong endorsement to Eli Lilly’s Alzheimer’s disease therapy donanemab, voting unanimously that the safety and efficacy of the amyloid-busting drug support its approval. The independent advisors on the Peripheral and Central Nervous System Drugs Advisory Committee voted by 11 to zero that donanemab’s benefits outweigh its risks, and by the same margin that the data submitted by Lilly to support its efficacy was convincing.

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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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In review of Lilly Alzheimer’s drug, FDA staff focus on safety, patient selection

BioPharma Dive

The agency is seeking input from an advisory panel on whether donanemab is effective across different groups of Alzheimer's patients, and on an unusual dosing strategy used by Lilly.

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Four Tops singer’s lawsuit says he visited ER for chest pain, ended up in straightjacket

STAT

When Alexander Morris, a member of the Motown group The Four Tops , visited a Detroit-area Ascension hospital with chest pain and trouble breathing, he said the staff assumed he was mentally ill after he told them he was a famous singer. Instead of treating Morris, a white security guard told him to “sit his Black ass down” and he was placed in a straightjacket, Morris claims in a new lawsuit.

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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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FDA clears Ipsen’s primary biliary cholangitis drug

pharmaphorum

Ipsen has been given accelerated approval by the FDA for Iqirvo, which becomes the dual PPAR alpha/delta agonist for rare cholestatic liver disease primary biliary cholangitis (PBC).

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After ‘sobering’ FDA panel, psychedelics supporters wonder what’s next

BioPharma Dive

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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Opinion: Empathy should guide responses to reported vaccine injuries

STAT

As a co-leader of the team at the National Institutes of Health that developed technologies powering a number of Covid-19 vaccines, I often speak publicly about vaccine science, even though I no longer work for the government. After my talks, people often approach me, almost always thanking me for my work. There is no denying the millions of lives that Covid-19 vaccines saved. sometimes, though, they relate stories of vaccine injuries.

Vaccines 360
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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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As Big Pharma places bigger bets on ADCs, here’s where the field is headed next

PharmaVoice

With more drugmakers getting into the antibody-drug conjugate game, emerging innovations signal a bright future for the technology.

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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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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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Ipsen drug for rare liver disease approved by FDA

BioPharma Dive

The medicine will join Intercept’s Ocaliva as a treatment option for primary biliary cholangitis. Another drug, from the now Gilead-owned CymaBay, could be cleared for the condition by August.

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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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Despite adcomm rejection, Lykos CEO sees future for MDMA drug

PharmaVoice

Although the rebuff makes approval “a bit more challenging,” Lykos is moving forward with the psychedelic-based treatment for PTSD.

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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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GSK et al file appeal to Delaware Zantac order

pharmaphorum

GSK and other drugmakers have lost no time in filing an appeal to a Delaware court’s decision to allow more than 70,000 Zantac-related lawsuits to go ahead. Just over a week ago, Judge Vivian Medinilla of Delaware Superior Court issued an order ruling that cases claiming Zantac (ranitidine) could cause cancer were “admissible”, sparking a sell-off in GSK shares that wiped billions off its market cap.

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DoH expands research partnership with Penn Medicine

Pharmaceutical Business Review

This partnership will focus on developing a translational medicine ecosystem and launching innovative research initiatives in Abu Dhabi. The second MoU outlines plans to design and develop a translational medicine ecosystem inspired by Penn’s Institute for Translational Medicine and Therapeutics (ITMAT). The aim is to utilise Abu Dhabi’s advanced infrastructure alongside Penn Medicine’s expertise to foster new treatments and discoveries within the region.

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Melinda French Gates, going solo, aims to influence reproductive rights in the U.S.

STAT

Last week, Melinda French Gates officially left the Bill & Melinda Gates Foundation with a $12.5 billion check from Bill Gates, per the terms of their separation. Her departure from the foundation she co-founded in 2000 had been announced in May , and on Friday she published a parting memo thanking all who worked with her during her tenure at the foundation.

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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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Statin tops NHS prescribing once again as total number of items continues to increase

The Pharmacist

Atorvastatin was once again the most dispensed chemical substance by community pharmacies in England last year, while the number of items dispensed has continued to increase year on year since 2020/21. Cardiovascular drugs accounted for 30% of all items prescribed by the NHS in the UK and dispensed in the community in England 2023/24, according […] The post Statin tops NHS prescribing once again as total number of items continues to increase appeared first on The Pharmacist.

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UK pharma industry delivers election ‘wish list’

pharmaphorum

The Association of the British Pharmaceutical Industry (ABPI) is calling on political parties contesting the general election to spell out their plans to nurture and drive growth in the life sciences sector and deliver for patients.

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AstraZeneca Tagrisso sNDA gains FDA priority review for lung cancer

Pharmaceutical Technology

AstraZeneca's sNDA for Tagrisso has obtained FDA priority review for unresectable, Stage III EGFRm non-small cell lung cancer.

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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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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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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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Buoyed by new obesity data, Structure files $476m offering

pharmaphorum

Riding high from positive clinical trial results for its oral weight-loss therapy, Structure Therapeutics has filed a public offering that it hopes will raise $476 million

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Underutilized Opportunities: Exploring Patent Term Extensions for Medical Devices

Drug Patent Watch

In a recent study published in the Expert Review of Medical Devices, researchers investigated the utilization of patent term extensions (PTEs) to extend regulatory timeframes for medical devices in the… Source

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STAT+: Biotech co-founded by entrepreneur Bob Langer is testing a new approach to developing obesity treatments

STAT

A new company founded by a group of biotech veterans, including Bob Langer , came out of stealth mode Tuesday with plans to create pills for everything from obesity to rare diseases. The company, Syntis Bio, is based on a technology developed by Langer and MIT professor Giovanni Traverso that can coat the stomach and potentially other organ surfaces, changing the way that drugs are absorbed or, in the case of obesity, which hormones are triggered.

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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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GLP-1 treatment displays best-in-class potential for MASH

European Pharmaceutical Review

New sub-analysis data from a Phase II clinical trial show that after 48 weeks of survodutide treatment, 83.0 percent of adults with liver fibrosis achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH). This is compared to 18.2 percent with placebo. With its novel mechanism of action, the glucagon/GLP-1 receptor dual agonist is the first to show this level of fibrosis benefit in a Phase II MASH trial following 48 weeks of treatment, according

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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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NICE recommends tirzepatide for NHS primary care

The Pharmacist

The National Institute for Health and Care Excellence (NICE) has recommended that tirzepatide be prescribed by NHS primary care services, in draft guidance currently out for consultation. The weekly injection has been recommended alongside diet and exercise advice for people with a BMI of at least 35kg/m2 and one weight-related comorbidty with lower thresholds for […] The post NICE recommends tirzepatide for NHS primary care appeared first on The Pharmacist.

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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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