February, 2025

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STAT+: How much weight loss is too much? Pharma is pushing the limit with new obesity drugs

STAT

In ongoing trials of Eli Lilly’s next-generation obesity drug, several trial participants are running into an issue they never expected: They are losing too much weight. One participant lost 22% of her weight in nine months — substantially faster than the rate seen with approved GLP-1 drugs like Wegovy or Zepbound. Her weight dropped so much that researchers reduced her dose of the treatment, called retatrutide.

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FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain

LifeProNow

January 30, 2025: “The U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. Journavx reduces pain by targeting a pain-signaling pathway involving sodium channels in the peripheral nervous system, before pain signals reach the brain.

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Medicines shortages causing 'moral injury', suggests RPS survey

The Pharmacist

Pharmacists are experiencing 'moral injury' with more than half of pharmacy professionals reporting that medicines shortages have impacted their mental health and wellbeing, according to the Royal Pharmaceutical Society (RPS). Its most recent workforce wellbeing survey also found that inadequate staffing was affecting wellbeing for 70% of pharmacy professionals, with just 35% of pharmacists able […] The post Medicines shortages causing 'moral injury', suggests RPS survey appeared

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November-December 2024

Safe Biologics

Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications. The opinion highlights concerns that this bill might be included in the end of year continuing resolution bill, without properly considering the impacts on patients.

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Navigating Payroll Compliance: Future-Proofing Payroll in an Evolving Regulatory Landscape

Speaker: Jennifer Hill

Payroll compliance is a cornerstone of business success, yet for small and midsize businesses, it’s becoming increasingly challenging to navigate the ever-evolving landscape of federal, state, and local regulations. Mistakes can lead to costly penalties and operational disruptions, making it essential to adopt advanced solutions that ensure accuracy and efficiency.

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Pharma’s strategic path to growth in the nutra maze

Express Pharma

The nutraceutical market is expanding rapidly, valued at $6.11 billion in 2024 and projected to reach $11.55 billion by 2030, according to a GlobeNewsWire report. However, pharma companies eager to tap into this growth, face a complex road ahead. Regulatory ambiguity, for instance, serves as a double-edged sword. On the one hand, relatively less regulatory control eases market entry; on the other, they expose pharma players to intense competition from both established FMCG brands and agile start

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STAT+: Class action suit over UnitedHealth’s AI care denials nears key moment

STAT

A federal judge will soon decide whether a class action lawsuit against UnitedHealth Group and its algorithm-based care denials can move forward, which would potentially open the door for attorneys to sift through the company’s internal communications. The lawsuit, in U.S. District Court in Minnesota, alleges that UnitedHealth and its subsidiary NaviHealth relied on flawed algorithms to cut off essential rehabilitative care to sick and injured Medicare Advantage beneficiaries.

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Could novel 3D printing method enhance intestinal drug delivery?

European Pharmaceutical Review

A study has demonstrated a new approach to prepare tablets for intestinal drug delivery by combining two 3D printing techniques. Using both selective laser sintering (SLS) and fused deposition modelling (FDM), the technique has potential to achieve delayed and prolonged drug release, according to the findings. Key findings from the 3D printing drug delivery study [a] laser speed of 90 mm s1 was suitable for producing [3D printed tablet] cores with relatively short disintegration time and suffici

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Seven million hours of pharmacy access lost in two years

The Pharmacist

Patients in England have lost around seven million hours of pharmacy access in the last two years, analysis from the National Pharmacy Association (NPA) has suggested. And around one in eight have seen their local pharmacy close for good, the NPA said. Inadequate funding could force pharmacies to reduce access by a further one million […] The post Seven million hours of pharmacy access lost in two years appeared first on The Pharmacist.

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Using Drug Patents to Block Competitors: The Tactics and Consequences

Drug Patent Watch

The Dark Side of Innovation: How Companies Use Drug Patents to Block Competitors As we celebrate the breakthroughs in medical research and the development of life-saving treatments, it's essential to acknowledge the complex landscape of pharmaceutical innovation. Behind the scenes, companies are employing clever tactics to protect their intellectual property and block competitors from entering the market.

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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

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Zydus Chairman Pankaj Patel highlights people-centric leadership at SOUL launch

Express Pharma

Chairman of Zydus, Pankaj Patel, emphasised the importance of people in organisational success during the launch of the School of Ultimate Leadership (SOUL) in Gujarat on Friday. Speaking at the event, formally inaugurated by Prime Minister Narendra Modi, Patel stated, People are the core to anything you do. The only mantra to succeed in any business is to take care of your people; other things will follow.

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The kids are alright: How pharma can make inroads with Gen Z

PharmaVoice

As drug development priorities shift, pharma companies need to understand younger patients to improve their reputation.

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Opinion: Want to keep schools safe? Hire more nurses

STAT

In an era punctuated by school shootings and ongoing debates about gun control and gun rights, America’s public schools continue to be riddled with safety concerns. According to the New York Times, “Since 2017, tens of millions have been spent by the federal government on mass shooter training, and states have spent even more.”  The result of our culture’s focus on crisis management over prevention is more  security staff  in high schools than there are

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AstraZeneca, Whitehall, and a failed £450m deal for the next generation in vaccines. What went wrong?

The Guardian - Pharmaceutical Industry

When the pharma firm cancelled plans for a major expansion of its Merseyside plant last month, there was no shortage of questions or blame over responsibility At a tense meeting with senior civil servants on the afternoon of 29 January, the chair of AstraZeneca, Shaun Grady, pulled the plug on a planned 450m expansion of its childhood flu vaccine factory in Merseyside bringing a year and a half of negotiations to an abrupt halt.

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Why Every Small Business Needs an HCM Solution: A Comprehensive Guide

Managing HR tasks like payroll, compliance, and employee data can overwhelm small businesses. That’s where a Human Capital Management (HCM) solution comes in. Our eBook, Why Every Small Business Needs an HCM Solution: A Comprehensive Guide , shows how an HCM system automates tedious processes, ensuring your business stays compliant and efficient. You’ll learn how to simplify payroll, eliminate costly errors, and empower your employees with self-service tools.

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Nitrofurantoin recall as extra tablet found in packs of UTI antibiotics

The Pharmacist

Two batches of nitrofurantoin 100mg prolonged-release capsules have been recalled after a small number of packs were found to contain an additional tablet of nitrofurantoin. Nitrofurantoin is used to treat Urinary Tract Infections (UTIs), and six 100mg modified release capsules can be supplied under the NHS England Pharmacy First Patient Group Direction (PGD) for uncomplicated […] The post Nitrofurantoin recall as extra tablet found in packs of UTI antibiotics appeared first on The Pharmac

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How to Achieve High-Quality Standards in Generic Drugs

Drug Patent Watch

The Unseen Heroes of the Pharmaceutical Industry: Achieving High-Quality Standards in Generic Drugs As we navigate the complex world of healthcare, it's easy to overlook the unsung heroes who work tirelessly behind the scenes to bring affordable, high-quality medications to the masses. I'm talking about the generic drug manufacturers who play a vital role in making life-saving treatments accessible to people worldwide.

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Motilal Oswal Alternates invests up to INR 460 crores for majority stake in Megafine

Express Pharma

MO Alternate Investment Advisors (MO Alts) has agreed to invest up to INR 460 crores for a majority stake in Mega Fine Pharma (Megafine).The Sanghvi Family, one of the founding-promoter groups, has also participated in this transaction, increasing their stake in the Company. Megafine, established in 1995, is an export-focused Active Pharmaceutical Ingredient (API) company based in Mumbai.

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Drugmakers prep for bird flu outbreak, despite continued low risk

PharmaVoice

While the virus hasn’t made a sustained leap into humans, vaccines and treatments are coming through the pipes if it does.

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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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Opinion: The NIH’s drastic cut to indirect cost rates is a critical threat to U.S. research infrastructure

STAT

The National Institutes of Health has made a landmark decision that could irreparably damage the backbone of American scientific innovation: a dramatic reduction in the indirect cost rate for research grants. This sweeping policy change sets the indirect rate to 15%, a stark contrast with the 60% or more that many institutions currently rely on for essential administrative and operational costs.

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MHRA approves SARCLISA for newly diagnosed multiple myeloma

European Pharmaceutical Review

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for SARCLISA (isatuximab), making it the first and only anti-CD38 quadruplet therapy available for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). This decision provides a new first-line treatment option for thousands of patients in the UK facing this blood cancer.

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'Vital' health secretary intervenes over medicines shortages, urge MPs

The Pharmacist

Action on medicine shortages is vital to prevent another tragedy, the health and social care secretary has been urged. Charities and MPs have said the death of a man with epilepsy whose pharmacy was unable to supply his medication adds urgency to their calls for a review into the issue. David Crompton, aged 44, died […] The post 'Vital' health secretary intervenes over medicines shortages, urge MPs appeared first on The Pharmacist.

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How to Manage Generic Drug Development Timelines: Strategies for Success

Drug Patent Watch

Accelerating Generic Drug Development: Strategies for Success As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of generic drug development. With the increasing demand for affordable medications, generic drug manufacturers are under pressure to expedite their development timelines without compromising on quality.

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Best Practices to Streamline Compensation Management: A Foundation for Growth

Speaker: Joe Sharpe and James Carlson

Payroll optimization can be one of the most time-consuming and complex factors of small business management. Yet, organizations that crack the code on streamlining employee compensation often discover innovative avenues for growth. With the right strategies in place, outsourcing and streamlining payroll processes can result in substantial time and resource savings.

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Pharma M&A and venture capital deals reach $33.7 billion in Jan 2025

Express Pharma

The healthcare industry reported 107 mergers and acquisitions (M&A) deals worth $29.2 billion in January 2025, according to data from GlobalData. This is higher than the last 12-month (January 2024 to December 2024) average of 99 deals worth $14 billion. Johnson & Johnson announced the acquisition of Intra-Cellular Therapies, a biopharmaceutical company, for a total equity value of approximately $14.6 billion.

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AI deals are surging, and Recursion’s ongoing Exscientia merger points to a new world of integration

PharmaVoice

Recursion CFO Ben Taylor discusses the state of AI M&A and what companies should look for as the industry moves to new data technologies and systems.

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Opinion: NIH must address the twin crises of long Covid and ME/CFS — together

STAT

The National Institutes of Health is at a crossroads with the RECOVER Initiative, its flagship program to address long Covid. Designed to provide answers and treatments for the millions suffering from long-term effects of SARS-CoV-2 infection, the initiative has already received significant criticism for failing to prioritize the needs of patients and advance meaningful clinical trials.

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Warning Letters: An Untapped Source for Understanding When Device Changes Require a New 510(k)

FDA Law Blog: Biosimilars

By Steven J. Gonzalez & Allyson B. Mullen As the device industry is well aware, one of the greyest areas in device regulation (of which there are many) is determining when changes to a 510(k)-cleared device trigger the need for a new clearance. FDA requires a new 510(k) clearance when a modification to an existing 510(k)-cleared device (or other existing device subject to 510(k) requirements) could significantly affect the safety or effectiveness of the device.

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Enhance Healthcare Efficiency With Top Payroll & HCM Services

Running a healthcare facility requires precision and care, not just for patients but also for your staff. Our guide, "A Buyer’s Guide to Payroll & HCM Services," helps healthcare providers choose the best provider. Efficient payroll management ensures timely, accurate payments, critical for maintaining staff morale and trust. Compliance support helps navigate complex healthcare regulations and avoid costly fines.