Drug Patent Watch

DECEMBER 11, 2024

Achieving operational excellence in a Contract Development and Manufacturing Organization (CDMO) is crucial to ensure the quality and consistency of products and services. This can be achieved by implementing robust controls, optimizing workflows, and fostering a culture of continuous improvement. Here are some key strategies to achieve operational excellence in a CDMO: Implementing Robust Controls Compliance with Regulatory Guidelines : Ensure compliance with strict regulatory standards set by

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DECEMBER 12, 2024

Like many Americans, Holden Karau said she was fed up with health insurance. The software engineer’s disillusionment began in 2019, when her insurer, UnitedHealthcare, balked at covering physical therapy after she was hit by a car and could not walk. She said the hassles piled on stress, forced her to pay more out of pocket, and delayed access to care she needed to recover from multiple broken bones.

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PharmaVoice

DECEMBER 13, 2024

Amid the DEI backlash in corporate America, pharma leaders are quietly adjusting tactics.

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ALiEM - Pharm Pearls

DECEMBER 13, 2024

An 87-year-old female with a history of hypertension, hyperlipidemia, chronic kidney disease stage IIIB, type 2 diabetes mellitus, and schizophrenia presented for evaluation due to sudden visual loss in her right eye, which began 12 hours before she arrived at the emergency department. She has experienced a sudden loss of vision in her right eye for more than six hours.

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Diabetes 130

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.

Pharma Times

DECEMBER 10, 2024

New cell therapy shows potential in treating advanced blood disorder

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DECEMBER 12, 2024

Testing of samples taken from a child in California thought to have contracted H5N1 bird flu after drinking raw milk turned up no evidence of influenza viruses, the Centers for Disease Control and Prevention said Thursday.  A test run on a sample from the child — who went to a Marin County emergency department last week with a fever and vomiting — had been positive there for flu A.

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Pharmaceutical Technology

DECEMBER 9, 2024

Shares in WuXi AppTec, one of those implicated in the Chinese biotech blacklisting legislation, surged following the omission.

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Pharma Times

DECEMBER 11, 2024

Promising results set stage for European marketing authorization

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STAT

DECEMBER 10, 2024

The Ohio Supreme Court ruled that three of the largest pharmacy chain operators in the U.S. could not be held liable under a state nuisance law for contributing to the long-running opioid crisis. In a 5-to-2 vote, the court determined that the law barred two Ohio counties from obtaining a $650.9 million judgement that was won in a federal court against CVS Health, Walgreens, and Walmart.

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Drug Patent Watch

DECEMBER 11, 2024

Generic drugs play a crucial role in providing affordable healthcare options to millions of patients worldwide. One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product qua

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Drug Development Documentation 95

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

Communication

Express Pharma

DECEMBER 11, 2024

Dr. Reddy’s Laboratories has recently become the first Indian company to launch checkpoint inhibitor Zytorvi (toripalimab) in collaboration with Shanghai Junshi Biosciences. Zytorvi is an immuno-oncology therapy for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). This marks a transformative moment, bringing a next-generation PD-1 inhibitor to India and addressing significant unmet medical needs.

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Biosimilars Chemotherapy 101

Pharma Times

DECEMBER 11, 2024

Successful phase 1 study highlights potential of roginolisib

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DECEMBER 11, 2024

Eli Lilly, which has been directing patients to various telehealth sites as it sells its blockbuster obesity medication Zepbound, is broadening its reach, announcing a partnership Wednesday with major telehealth platform Ro Health. Under the new agreement, patients will be able to order vials of Zepbound through Ro’s app. Previously, Lilly had only made these vials, which are priced lower than its injectable pens, available to patients with prescriptions ordering directly through an onlin

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Compounding Compounding Pharmacies 306

Drug Patent Watch

DECEMBER 10, 2024

India has long been recognized as a significant player in the global pharmaceutical industry, particularly in the production of generic drugs. The country’s pharmaceutical sector has experienced substantial growth over the years, driven by both domestic and international demand for affordable and high-quality medicines. This article delves into India’s growing importance in generic drug API manufacturing, highlighting the key factors contributing to its success and the challenges it

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Pharmaceutical Manufacturing 97

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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.

The Pharmacist

DECEMBER 10, 2024

Non-clinical pharmacy managers in England could come under the scope of regulation proposals launched by the Department of Health and Social Care (DHSC). Itspublic consultation sets out measures that aim to increase accountability of NHS managers and leaders, and set clear and consistent professional standards, including a potential regulatory system.

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Pharmacy Management 102

Pharma Times

DECEMBER 9, 2024

Trial results lead to new treatment option for lung cancer

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DECEMBER 12, 2024

During 2023, drugmakers substantially raised prices on five widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $815 million last year, according to a new report. The drug for which spending increased the most due to a price increase was Biktarvy, which is prescribed to treat HIV and is a franchise product for Gilead Sciences.

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Drug Pricing 302

Drug Patent Watch

DECEMBER 9, 2024

In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents?

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Compounding Drug Development Documentation Pharmaceutical Companies 97

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.

The Pharmacist

DECEMBER 10, 2024

Two serious shortage protocols (SSPs) for cefalexin oral suspension sugar free have been issued, allowing pharmacists to substitute a non sugar free version instead. The antibiotic is used to treat infections including urinary tract infections (UTIs), pneumonia and other chest infections. From today, community pharmacists must supply Cefalexin 125mg/5ml oral suspension (non sugar free) in […] The post Two cefalexin SSPs issued and defective WockAIR inhalers recalled appeared first on The P

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Vaccines 111

Pharma Times

DECEMBER 10, 2024

New findings presented at international SCWD conference

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DECEMBER 11, 2024

A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now. The bipartisan bill , which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the

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Independent Pharmacies Drug Pricing 319

Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles. Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy.

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Documentation Drug Development Pharmaceutical Manufacturing Pharmaceutical Companies 98

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.

The Pharmacist

DECEMBER 12, 2024

New Pharmacy First analysis has suggested pharmacists are treating antimicrobial stewardship with utmost importance and only supplying antibiotics when appropriate. On average, two-thirds (66%) of patients attending pharmacies for earaches, bladder infections, sore throats, sinusitis, infected insect bites or impetigo are provided antibiotics, according to a new report by the Company Chemists Association (CCA).

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Pharma Times

DECEMBER 9, 2024

promising pre-clinical data on preventing cytokine release syndrome

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STAT

DECEMBER 12, 2024

Editas Medicine said Thursday afternoon it will lay off 65% of its staff — around 180 employees — as it shelves its lead gene-editing program for sickle cell disease and shifts focus.  The cuts come amid a prolonged financial downturn for the gene-editing field, as valuations have plummeted and layoffs have become widespread. Editas already laid off staff as part of a restructuring in 2023.

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Drug Patent Watch

DECEMBER 10, 2024

The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers.

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Drug Development Communication Pharmaceutical Companies Pharmaceutical Companies 96

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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.

The Pharmacist

DECEMBER 9, 2024

The government has committed to a 'refreshed' workforce plan with a 'laser-focus on shifting care from hospitals and into the community', to be published in the summer. This comes as the Department of Health and Social Care (DHSC) has told The Pharmacistthat community pharmacies 'will play a vital role helping to shift the focus of […] The post Government commits to new workforce plan with 'laser-focus' on community appeared first on The Pharmacist.

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Pharmaceutical Technology

DECEMBER 12, 2024

In the letter, 77 Nobel Prize winners argue that appointing RFK as Secretary of HHS would put the US publics health in jeopardy.

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DECEMBER 12, 2024

As we approach the end of 2024, First Opinion is publishing a series of essays on the state of AI in medicine and biopharma.  There’s more to life than protein folding.

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Drug Development 304

Drug Patent Watch

DECEMBER 12, 2024

The generic drug market in the United States faces significant challenges, including price volatility, supply chain disruptions, and strategies employed by brand-name manufacturers to delay market entry. These challenges can lead to drug shortages, price spikes, and reduced affordability for patients and payers. To address these issues, several market-based proposals and regulatory reforms have been suggested.

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Generic Medicine 94

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