Sat.Feb 01, 2025 - Fri.Feb 07, 2025

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Patent Expirations: Seizing Opportunities in the Generic Drug Market

Drug Patent Watch

The Multi-Billion Dollar Opportunity in Generic Drugs: How to Seize the Moment As a business leader in the pharmaceutical industry, you're likely no stranger to the importance of staying ahead of the curve. One key trend that's been gaining momentum in recent years is the rise of generic drugs. With the patent expiration of many blockbuster medications, the generic drug market is poised for significant growth.

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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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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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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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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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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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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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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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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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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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99 per cent of life sciences leaders see AI boosting revenue management in 2025: Report

Express Pharma

Model Ns 2025 State of Revenue Report reveals shifts toward use of generative AI and automation to bolster pharmaceutical, medtech, and high-tech revenue programs Model N published its seventh annual State of Revenue Report, highlighting how executives in these industries are transforming their revenue operations. The report reveals that while 87 per cent of industry leaders are shifting toward automated revenue management operations, nearly 60 per cent still rely on multiple solutions.

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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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New rules for online pharmacies supplying weight-loss injections

The Pharmacist

Prescribers must independently verify a persons weight, height and/or body mass index before prescribing weight-loss medication, new guidance from the General Pharmaceutical Council (GPhC) has mandated. And for all high-risk medicines, prescribing decisions cannot solely be based on information provided through an online questionnaire. Any information provided by a patient must be independently verified, either […] The post New rules for online pharmacies supplying weight-loss injections a

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STAT+: The CRISPR companies are not OK

STAT

A strange thing happened weeks before the Food and Drug Administration approved the first treatment made with CRISPR gene editing , an all-but cure for certain patients with sickle cell disease. CRISPR Therapeutics, the biotech that co-developed the therapy, laid off about 50 employees. “We were dumbfounded,” said a scientist who was let go.

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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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Lupin’s Somerset facility clears U.S. FDA Pre-Approval Inspection for Edaravone Oral Suspension

Express Pharma

Lupin has announced that the United States Food and Drug Administration (U.S. FDA) has completed a Pre-Approval Inspection (PAI) of Edaravone Oral Suspension, 105 mg/5 mL, at its manufacturing facility in Somerset, New Jersey. The inspection was conducted from January 28 to February 1, 2025, and concluded with zero 483 observations. Commenting on the development, Nilesh Gupta, Managing Director, Lupin, said, The successful outcome of the U.S.

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Tariffs raise concern among generic drugmakers, and advocacy groups are seeking exemptions

PharmaVoice

While the 10% tariff on Chinese goods won’t have too much impact on branded drugs, generics are struggling to pivot.

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Weight-loss jabs: Concerns over 'significant risk' if GP records can't be accessed

The Pharmacist

There is still the potential for 'significant risk' to patient safety in new guidance about online prescribing of weight-loss injections and other high-risk medicines, the Pharmacists' Defence Association (PDA) has said. In particular, it raised concerns that medication might be prescribed inappropriately where a patient does not give consent for their GP to be contacted […] The post Weight-loss jabs: Concerns over 'significant risk' if GP records can't be accessed appeared

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Opinion: Former surgeon general: America needs a better discourse on DEI

STAT

Across the country, state legislatures are considering or enacting bans on state-funded diversity, equity, and inclusion (DEI) initiatives. National leaders have broadly criticized DEI efforts, with the current administration working to dismantle decades of federal programs. Businesses that once championed diversity after the deaths of George Floyd and Ahmaud Arbery are retreating from prior commitments.

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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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Areteia’s dexpramipexole holds potential to redefine respiratory health: GlobalData

Express Pharma

During the J.P. Morgan 43rd Annual Healthcare Conference in January 2025, Areteia Therapeuticss CEO, Jorge Bartolome, presented a detailed review of its achievements in 2024 and outlined its 2025 plans to advance innovation in the respiratory space with its flagship candidate dexpramipexole dihydrochloride, the first oral therapy targeting eosinophilic asthma.

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Moderna reports record for UK clinical trials in 2023/24

European Pharmaceutical Review

Two years after signing its strategic partnership with the UK government, Moderna, Inc. has made substantial R&D investment and progress in the UK, the company has declared. The Moderna Innovation and Technology Centre (MITC) began construction in April 2023 as the companys state-of-the-art R&D and manufacturing facility. [Moderna] was the biggest industry sponsor of clinical trials in the UK in 2023/24″ The site is anticipated to be fully operational later in 2025, ready to delive

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The Pharmacist’s senior reporter crowned ‘Pharmacy Writer of the Year’

The Pharmacist

The Pharmacists senior reporter Joanna Robertson has been crowned Pharmacy Writer of the Year during Avicennas annual media awards. Judges praised Joanna for her work in highlighting the challenges faced within community pharmacy and for the incredible speed in which she gets the latest news to the sector. The awards hosted by Avicenna at […] The post The Pharmacists senior reporter crowned Pharmacy Writer of the Year appeared first on The Pharmacist.

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Opinion: U.S. taxpayers should stop funding clinical trials of industry-owned drugs

STAT

The National Cancer Institute (NCI) has had a taxpayer-funded drug development program for nearly 70 years, initiated at a time when there was no private investment in oncology drugs.  I worked closely with NCI’s Investigational Drug Branch (IDB) from 1990-2016, including as a principal investigator of one of only six contracts with NCI to conduct Phase 1 clinical trials from 1990-1995, and serving as co-chair of NCI’s Investigational Drug Steering Committee from 2005-2008.

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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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Dr Archana Hingorani completes tenure as Independent Director at Alembic Pharmaceuticals

Express Pharma

Alembic Pharmaceuticals has announced that Dr Archana Hingorani has completed her second consecutive term of five years as an Independent Director of the company. Following the completion of her tenure, she ceases to be a Director with effect from the end of the day on 3 February 2025. The company disclosed this development in a regulatory filing under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.

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Today’s Rare Disease Launches Require the Right Specialty Pharmacy Partner

Drug Channels

Todays guest post comes from Richard Faris, Chief Strategy & Growth Officer at PANTHERx Rare Pharmacy. Richard outlines the key factors for commercialization success when a manufacturer launches treatments for rare and orphan diseases. He explains the key considerations for choosing a specialty pharmacy network design, selecting the right pharmacy partners, and establishing patient services HUBs.

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Biologic could reduce treatment burden for children with haemophilia A

European Pharmaceutical Review

Interim results from a Phase III trial have demonstrated promising efficiency of Novo Nordisks Factor VIIIa (FVIIIa) mimetic bispecific antibody in children living with haemophilia A with and without inhibitors.The FRONTIER3 trial evaluating Mim8 enrolled a total of 70 children aged between one and 11 years old. Key outcomes from the FRONTIER3 trial Part one of the study involved participants receiving once-weekly doses of the treatment.

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STAT+: Lawmakers ask FDA to review Hims’ Super Bowl ad for ‘misleading’ patients

STAT

Ahead of the Super Bowl, telehealth company Hims & Hers on Jan. 28 released a provocative commercia l attacking the weight loss industry to get attention. And it’s done just that: Lawmakers now want the Food and Drug Administration to review whether the ad runs afoul of pharmaceutical advertising rules.  In a letter sent Friday morning to FDA acting Commissioner Sara Brenner, Sens.

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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.

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Eli Lilly appoints Winselow Tucker as President and General Manager for India

Express Pharma

Eli Lilly and Company (Lilly) has announced the appointment of Winselow Tucker as President and General Manager for Lilly India, effective immediately. He will oversee all of Lillys operations in India, including the Lilly India commercial organisation and the Lilly Capability Centre India (LCCI) in Bengaluru and Hyderabad. As part of this transition, Vineet Gupta, Associate Vice President and Managing Director, India, will move to a new leadership role at Lillys headquarters in Indianapolis, US

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Bristol Myers gives first peek at closely watched launch of schizophrenia drug

PharmaVoice

Cobenfy, the main asset acquired through Bristol Myers’ $14 billion purchase of Karuna, had $10 million in sales in the fourth quarter and around 1,000 prescriptions weekly by late January.

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Pharmacy Law and Licensing Highlights 2025

FDA Law Blog: Biosimilars

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements.