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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Beyond Pills: How Pharma is Embracing Diversity, AI, and Compassionate Care

Pharma Leaders

The pharmaceutical industry is in a period of rapid transformation. Driven by innovation and evolving patient needs, companies face challenges balancing competitiveness, regulatory hurdles, R&D improvements, and diversity initiatives. Three key trends define this era: 1. Diversity in Clinical Trials: A Core Priority Diversity in trials is shifting from compliance to a core design element.

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Trending Sources

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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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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 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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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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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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India Ratings and Research maintains Neutral Outlook for pharmaceuticals sector in FY26

Express Pharma

India Ratings and Research (Ind-Ra) has maintained a Neutral Outlook for the pharmaceuticals sector in FY26. The agency projects overall revenue growth of 9 per cent-10 per cent year-on-year, driven by growth in the domestic chronic segment, US generics, and the contract development and manufacturing organisation (CDMO) business. EBITDA margins are expected to remain at historically elevated levels over FY25-FY26, supported by growth in high-value products, moderation in pricing pressures, cost

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Pharmacy Enforcement Division

RX Note

Introduction Pharmacy Enforcement plays an important role in ensuring pharmaceuticals, traditional and cosmetics available in the market are genuine in terms of registration and notification. It also oversees the supply chain, marketing, advertising (including medical services) and usage of these produts, ensuring compliance with existing legislation.

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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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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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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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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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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.

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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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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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Opinion: STAT+: We need a universal approach to sharing biomedical samples   

STAT

Three years ago, I was working at a biotech company leading a drug discovery program focused on metabolic disease. Interested in obtaining liver samples that could help identify potential therapeutic targets, I learned that a tenured professor at a top 10 NIH institution had more than 2,000 samples of tissue from patients they had accumulated over more than a decade of research.

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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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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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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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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: 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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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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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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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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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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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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Sun Pharma appoints Aalok Shanghvi as Chief Operating Officer

Express Pharma

Sun Pharmaceutical Industries has appointed Aalok Shanghvi as its Chief Operating Officer (COO). The company announced the designation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Shanghvi has been with Sun Pharma since 2006, holding various roles across marketing, research and development (R&D), project management, procurement, and communications.

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Vertical Integration Redux: How Pharmaceutical Wholesalers Are Transforming the Buy-and-Bill Market (Video)

Drug Channels

ICYMI, the largest three pharmaceutical wholesalersCardinal Health, Cencora, and McKessonare using vertical integration to build significant market positions in businesses beyond drug distribution. In the video clip below, I review the vertical integration status of the largest three pharmaceutical wholesalers, illustrated in the chart below. [Click to Enlarge] I also: Explain how wholesalers have strengthened their position in buy-and-bill channels for provider-administered drugs through vertic

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Episode 997: The use of methylene blue for the treatment of refractory anaphylaxis without hypotension

Pharmacy Joe

In this episode, I’ll discuss the use of methylene blue for the treatment of refractory anaphylaxis without hypotension. Episode 997: The use of methylene blue for the treatment of refractory anaphylaxis without hypotension Subscribe on iTunes , Android , or Stitcher Methylene blue has some unique uses such as in the treatment of acquired methemoglobinemia and vasoplegia after cardiac surgery.

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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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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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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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Cardinal Health’s Kangaroo OMNI™ Enteral Feeding Pump to launch in new international markets in 2025

Pharmafile

The next generation Kangaroo OMNI enteral feeding pump delivers nutrition and hydration from hospital to home. DUBLIN, Ireland, Feb.4, 2025 – Cardinal Healths innovative new Kangaroo OMNI Enteral Feeding Pump will be launched in Europe, Australia and New Zealand by the first half of 2025, followed by Asia later in the year. It previously launched […] The post Cardinal Healths Kangaroo OMNI Enteral Feeding Pump to launch in new international markets in 2025 appeared first on Pharmafil

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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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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.