Drug Patent Watch
NOVEMBER 18, 2024
The concept of a blockbuster drug, defined as a medication generating at least $1 billion in annual sales, has long been a cornerstone of the pharmaceutical industry. However, the question arises whether a drug can achieve blockbuster status without heavily relying on U.S. sales.
STAT
NOVEMBER 19, 2024
When Makena, a drug designed to prevent preterm births, hit the market in 2011 at $1,500 per dose, it drew rife backlash. The drug was based on an active ingredient that had been available for many years at a much lower cost. Confronted with the public outcry, the FDA took an unusual step: It allowed pharmacies to continue making their own copies of the drug through the practice of pharmacy compounding, selling it at a fraction of Makena’s price.
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ALiEM - Pharm Pearls
NOVEMBER 18, 2024
A 48-year-old male with no significant past medical history presented to the Emergency Department with a left-sided facial rash and associated burning left eye pain that started four days prior. He was seen at an ophthalmology clinic when his symptoms started and given oral valacyclovir which he took for three days without improvement. He also endorsed left-sided facial weakness and diplopia for the last eight days.
The Pharmacist
NOVEMBER 22, 2024
A pharmacy-led sore throat treatment service in Wales has been found to result in fewer same-day antibiotic prescriptions than those given during GP consultations, according to a new study. The study, published in the Journal of Antimicrobial Chemotherapy, found that pharmacy-led sore throat treatment provides a safe, effective, and cost-efficient alternative to GP consultations.
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.
PharmaVoice
NOVEMBER 21, 2024
A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.
STAT
NOVEMBER 19, 2024
Although more pharmaceutical companies are tailoring their business models to focus on low-income countries, a new analysis finds that overall industry efforts remain limited and patient access continues to suffer as a result. Notably, momentum has stalled in reaching licensing deals that are designed to make lower-cost generic drugs available in parts of the world where brand-name medicines are unaffordable, and few companies have pursued technology transfer agreements.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
The Pharmacist
NOVEMBER 18, 2024
NICE is consulting on a proposal to add cytisine as a treatment option to its stop smoking guidelines. This proposal follows a review of recent evidence which suggests patients who received cytisine were 30% more likely to not smoke for six months or longer, when compared to placebo or no medication. The drug was made […] The post Cytisine pill could be added to stop smoking guidelines appeared first on The Pharmacist.
PharmaVoice
NOVEMBER 19, 2024
AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.
STAT
NOVEMBER 20, 2024
Schrödinger CEO Ramy Farid wants you to know that his company isn’t an AI company…but he’ll call it that if you want to. The company, founded in 1990, started out by making software that used the basic laws of physics to laboriously and exactly predict how molecules will interact with each other in space. Those calculations, rooted in the field of computational physics, needed lots of expensive and time-consuming computing power to run, and many people abandoned those t
Express Pharma
NOVEMBER 21, 2024
China’s National Medical Products Administration (NMPA) approval of Zai Lab and argenx’s Vyvgart Hytrulo (efgartigimod alfa injection) marks a transformative milestone in chronic inflammatory demyelinating polyneuropathy (CIDP) care, offering the first targeted therapy for this debilitating autoimmune disorder. This approval signals a paradigm shift in CIDP management, underscoring innovation’s role in improving patient outcomes, says GlobalData, a leading data and analytics company.
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
The Pharmacist
NOVEMBER 18, 2024
Local systems need to talk to community pharmacies about how they can help improve population health, a local pharmaceutical committee (LPC) leader has urged. Pharmacies are well placed to provide anecdotal feedback about their local communities and what they need to their local systems, Shilpa Shah said at the Public Policy Projects (PPP) Integrated Health […] The post Local systems must involve community pharmacy to improve population health appeared first on The Pharmacist.
PharmaVoice
NOVEMBER 19, 2024
The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.
STAT
NOVEMBER 19, 2024
Robert Califf has made no secret of the Food and Drug Administration’s struggles to regulate generative AI. Large language models and their application to health care “provide a massive example of a technology with novel needs,” FDA commissioner Califf said in an address earlier this year to the Coalition for Health AI. This week, the agency will turn toward that challenge, focusing the first-ever meeting of its Digital Health Advisory Committee on the question of whet
European Pharmaceutical Review
NOVEMBER 21, 2024
In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults. With the recent failure of Lykos’ trial, how do you see the future of psychedelic therapies in research, especially in treating disorders like depression, PTSD, and substance use diso
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The Pharmacist
NOVEMBER 19, 2024
A temporary pharmacy could be set up in a shipping container in Warminster to address an ‘immediate need’ for services in the area while a permanent facility is developed. The proposal comes after local councillors earlier this year called for urgent action to address a pharmacy ‘crisis’ in the area. A planning application for a […] The post Proposal for temporary pharmacy in shipping container to address access issues appeared first on The Pharmacist.
Express Pharma
NOVEMBER 21, 2024
On 19 November 2024, Lupin announced that it had received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Extended-Release Capsules. The approval covers dosage strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg, which are the generic equivalent of Adderall XR Extended-Release Capsules marketed by Takeda Ph
STAT
NOVEMBER 21, 2024
Novartis said Thursday it purchased gene therapy startup Kate Therapeutics for up to $1.1 billion in upfront payments and milestones. It’s a rare buyout for a field that has quieted over the last couple years, amid a wider biotech downturn and questions about both the effectiveness and profitability of these one-time treatments. With the deal, Novartis will acquire a pipeline of preclinical gene therapies for three different genetic neuromuscular diseases, along with the under
Drug Patent Watch
NOVEMBER 19, 2024
The pharmaceutical industry is undergoing significant transformations, particularly in the realm of generic drug development. Recent trends and advancements in technology, research, and collaboration are reshaping the landscape of generic drug development, leading to new opportunities and challenges for pharmaceutical companies.
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
NOVEMBER 19, 2024
Nathan Burley argues that younger pharmacists have a distinct perspective on the challenges they face in pharmacy – that all require a strong sense of optimism to navigate. As a millennial healthcare professional, I often find myself caught between two conflicting worlds. On one hand, there’s the relentless pressure of healthcare — burnout, staff shortages […] The post Finding hope and purpose as a millennial pharmacist appeared first on The Pharmacist.
Express Pharma
NOVEMBER 18, 2024
In pharmaceutical packaging, where quality and safety are requisites for a shelf-stable formulation, Cilicant has understood this concern very well and is committed to providing the right solutions to protect the formulations from the harmful effects of moisture and oxygen, which are well-known factors affecting stability. Over the years, CILICANT has established itself as an innovative manufacturer of active packaging solutions with notable patented technologies.
STAT
NOVEMBER 18, 2024
Cancer cases are on the rise among people under 50 — and researchers aren’t sure why. A recent study by the American Cancer Society found that 17 out of 34 cancer types were increasing among younger people. At the Milken Institute’s Future of Health Summit on Thursday, researchers and health care executives talked about efforts to detect cancers earlier, save lives, and get to the root of why cancers have begun to rise in this population.
ID Stewardship
NOVEMBER 18, 2024
This article discusses ways to celebrate the annual observance of antibiotic awareness week 2024. Written by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Each year for one week the United States Centers for Disease Control and Prevention (CDC) observes U.S. Antibiotic Awareness Week (USAAW) and encourages others to participate in the event. The USAAW theme this year is “Fighting Antibiotic Resistance Takes All Of Us.” This same week the World Health Organization observes World Antimic
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
NOVEMBER 20, 2024
Antibiotic use rose by 2.4% year-on-year in 2023 and prescribing levels are now in line with those seen in 2019, according to national surveillance data published by the UK Health Security Agency (UKHSA). The increases were seen across the majority of antibiotic groups, with penicillins accounting for the most frequently prescribed antibiotic group in primary […] The post Latest UKHSA figures show rise in both antibiotic use and resistance appeared first on The Pharmacist.
Express Pharma
NOVEMBER 21, 2024
360 ONE Asset announced an investment in OneSource Specialty Pharma, a pharma CDMO in India. 360 ONE Asset is acquiring a stake from an existing investor. OneSource is a player in biologics, drug-device combinations, complex injectables, and soft gelatin capsules. OneSource has the expertise to develop and manufacture complex products such as GLP-1 drugs and novel biologics.
STAT
NOVEMBER 19, 2024
Top of the morning to you, and a fine one it is. Clear blue skies and cool breezes are wafting over the Pharmalot campus, where the official mascots are snoozing after foraging for their breakfast. This means we are free to focus on the matters at hand — rummaging through our to-do list and making cups of stimulation. Our choice today is Mexican cinnamon.
Drug Channels
NOVEMBER 19, 2024
In Medicare Part D in 2025: Preferred Pharmacy Networks Fade in a Collapsing PDP Market , I documented the Inflation Reduction Act’s (IRA) disruption to Medicare Part D prescription drug plans (PDPs). Today, we examine the seven largest retail chains’ participation in the 12 major 2025 Part D networks that the five largest plan sponsors will offer. As always, we provide you with a handy table for tallying each chain’s participation and changes from 2024 to 2025.
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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
NOVEMBER 21, 2024
The government has published draft legislation outlining a ‘permanent’ cut in business rates for retail, hospitality and leisure (RHL) properties from 2026, including pharmacies. The tax cut will be funded by a tax rise for the very largest business properties, such as online sales warehouses. Until then, 250,000 RHL properties will receive 40% relief off […] The post Draft legislation sets out steps for cutting business rates for pharmacies from 2026 appeared first on The Pharmacist.
Express Pharma
NOVEMBER 18, 2024
In pharmaceutical packaging, where quality and safety are requisites for a shelf-stable formulation, Cilicant has understood this concern very well and is committed to providing the right solutions to protect the formulations from the harmful effects of moisture and oxygen, which are well-known factors affecting stability. Over the years, CILICANT has established itself as an innovative manufacturer of active packaging solutions with notable patented technologies.
STAT
NOVEMBER 19, 2024
Merck said a new formulation of the best-selling drug, Keytruda, appears to deliver similar blood levels of the medicine when it is given as a shot as when it is given intravenously. For Merck, the new under-the-skin, or subcutaneous, formulation of Keytruda could represent a major way of holding on to a larger share of Keytruda’s $25 billion in annual sales than would otherwise occur when the medicine’s U.S. patent expires in 2028.
Drug Patent Watch
NOVEMBER 22, 2024
The pharmaceutical industry has increasingly turned to contract development and manufacturing organizations (CDMOs) to optimize their facilities and outsource non-core production. Effective CDMO vendor management is crucial for the success of these partnerships. Here, we outline best practices for selecting, qualifying, and managing CDMOs.
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