Sat.Oct 26, 2024 - Fri.Nov 01, 2024

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Top 10 CDMO Services You Didn’t Know You Needed

Drug Patent Watch

The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to streamline the drug development and manufacturing process. CDMOs provide a wide range of services that cater to the diverse needs of pharmaceutical companies, from early-stage development to commercial manufacturing.

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STAT+: Teva fined $503 million for disparaging a rival and using patents to thwart competition

STAT

Teva Pharmaceutical, the world’s largest generic drugmaker, was fined $503 million by European antitrust regulators for delaying competition to a blockbuster multiple sclerosis medicine. The European Commission found the company had artificially extended the patent protection of Copaxone and systematically spread misleading information about a rival product.

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Trending Sources

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Tranq dope (fentanyl-xylazine combination): A new horizon in opioid withdrawal treatment

ALiEM - Pharm Pearls

‘Dope’ is no longer heroin in an increasing number of our communities. The biggest change has been the gradual replacement of diacetylmorphine (heroin) by fentanyl and other synthetic opioids. Due in large part to the proliferation of anonymous chemical factories able to produce industrial volumes of inexpensive synthetic opioids without opium or other controlled precursors, fentanyl spilled into the United States, Canada, and Europe, heroin soon fell to market forces [1, 2].

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On the front lines of the superbug war, new treatments can’t arrive soon enough

PharmaVoice

As antimicrobial resistance rises, researchers are running out of time to fight each new wave of superbugs. And the funding isn’t enough.

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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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Pharmacies must contact labetalol patients following manufacturing mix-up

The Pharmacist

Pharmacies must contact all patients dispensed a specific batch of the beta blocker labetalol that may contain the wrong medication, the Medicines and Healthcare Products Regulatory Agency (MHRA) has instructed. If batch traceability is not possible, all patients dispensed this product in the last six months must be contacted. In a class two medicines recall […] The post Pharmacies must contact labetalol patients following manufacturing mix-up appeared first on The Pharmacist.

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STAT+: Drug may make chemotherapies less effective in cancer patients with obesity — but many doctors are in the dark

STAT

A drug used to combat fungal infections in cancer patients comes with a big caveat — research shows the medicine can last twice as long as in people with obesity. This means chemotherapies may be less effective when interacting with the medicine, but some clinicians, and their patients, are unaware of that possibility. The information, however, is not in the label because the drug — originally manufactured by Merck — was never fully tested in this population.

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Where Big Pharma’s campaign cash is flowing in this election

PharmaVoice

Big Pharma CEOs are hedging all bets by supporting both sides of the aisle in the 2024 election.

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Informal referrals deprive pharmacies of 'more than £115m a year'

The Pharmacist

Informal referrals to community pharmacies deprive pharmacies of more than £115 million each year, Community Pharmacy England (CPE) has estimated. This is the amount that would have been paid if existing referral routes had been used appropriately by GPs and NHS 111, rather than patients being signposted informally to their local community pharmacy.

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STAT+: Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA

STAT

All doses of Novo Nordisk’s blockbuster diabetes and obesity treatments are listed as available on the Food and Drug Administration’s drug shortage list as of Wednesday, raising the possibility that the medications could soon be taken off the list entirely, a development that could affect compounding pharmacies and patients relying on compounded drugs.

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Green manufacturing in pharma: Sustainable oligonucleotide production on an industrial scale

Express Pharma

Oligonucleotides are at the forefront of modern medicine and have emerged as powerful tools in treating diseases in recent years. Oligonucleotides – short DNA or RNA molecules that host a range of applications in genetic testing, research, and forensics – have seen a marked growth in significance as therapeutics. As their clinical application widens, methods of production must be robust to ensure demand is met.

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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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Backlash builds against Novo’s Catalent takeover

PharmaVoice

Roche recently joined naysayers who argue the deal threatens competition in the burgeoning weight loss and diabetes drug market.

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See how your pharmacy compares as July Pharmacy First data released

The Pharmacist

July 2024 saw the highest number of pharmacies meeting the Pharmacy First monthly threshold since it increased to 10 consultations in May, according to the latest Pharmacy First data. Nationally, clinical pathway consultations and urgent medicine supply referrals increased overall. But minor illness referrals decreased in July 2024. Scroll down for our interactive Pharmacy First […] The post See how your pharmacy compares as July Pharmacy First data released appeared first on The Pharmacis

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STAT+: Warren wants close FTC scrutiny of drug distributors buying cancer medical groups

STAT

Sen. Elizabeth Warren (D-Mass.) is urging the Federal Trade Commission to scrutinize recent deals from McKesson and Cardinal Health to buy oncology practices, saying those transactions pose “clear, anticompetitive risks.” McKesson, Cardinal Health, and Cencora are the three dominant wholesalers that distribute drugs and medical products.

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The quest for quality continues

Express Pharma

Quality was once again in the spotlight at two recent industry meets. While regulators kept their sights on raising the compliance bar, industry chiefs pledged adherence to these codes. Not surprisingly, most speakers focused on the importance of trust. At the Indian Pharmaceutical Alliance’s (IPA) virtual 9th Advanced Good Manufacturing Practices (GMP) Workshop Dr Rajeev Raghuvanshi, Drugs Controller General of India, CDSCO, Government of India commented, “At the heart of the pharmaceutic

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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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HIV vaccine candidate successfully optimised for industrial production

Pharmafile

Sumagen Canada Inc, a biotech company based in both South Korea and Canada has partnered with CDMO Naobios to industrialise Sumagen’s human immunodeficiency virus (HIV) -1 vaccine candidate (SAV0001) at bench scale. First of its kind in human vaccine trials, SAV001 is a whole-killed and genetically modified HIV vaccine. During phase 1 of the clinical […] The post HIV vaccine candidate successfully optimised for industrial production appeared first on Pharmafile.

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What does this week's Budget mean for pharmacists in general practice?

The Pharmacist

In the Autumn Budget this week, chancellor Rachel Reeves committed to providing an additional £22.6bn to the ‘day-to-day health budget’ – including £100m to use on upgrades to 200 general practice estates in England. The budget also outlined minimum wage increases which may have a knock-on impact across the board, but are currently unfunded in […] The post What does this week's Budget mean for pharmacists in general practice?

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Opinion: I’m the director of the Center for Medicare. Here’s how we executed the first round of drug price negotiation

STAT

The historic Inflation Reduction Act of 2022 has fundamentally improved the affordability of and access to prescription drugs for millions of people with Medicare. The law laid out aggressive timelines for implementing the Medicare Drug Price Negotiation Program. As the director of Medicare, my team and I worked thoughtfully and diligently to stand up the program — on time and successfully.

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A sickle cell cure exists. But patients need more than just gene therapy.

PharmaVoice

Almost a year after two historic approvals, Pfizer is pulling a sickle cell disease treatment from the market, and the outlook for patients feels shakier. But there’s still hope in the pipeline.

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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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Handling Drug Patent Abandonment: Opportunities and Challenges

Drug Patent Watch

The pharmaceutical industry is known for its complex regulatory environment and lengthy product development processes. One often overlooked aspect of this industry is the potential benefits of abandoned and expired patents. These patents can provide opportunities for companies to bring new products to market at a lower cost and with reduced development time.

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'Regional spikes' in scabies reported

The Pharmacist

Pharmacists have highlighted the cost to patients of treating scabies, as the Royal College of General Practitioners (RCGP) has reported 'regional spikes' in cases. In a statement issued on Friday (25 October), RCGP chair Professor Kamila Hawthorne said GPs were seeing scabies presentations at a rate 'above the five-year average and rising', with 'the north […] The post 'Regional spikes' in scabies reported appeared first on The Pharmacist.

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5 questions about the next U.S. dietary guidelines, and the ‘impossible restriction’ on them

STAT

Here’s the paradox: The most influential set of rules for the foods we eat are the ones most of us ignore. But they still matter for millions of  Americans. The Dietary Guidelines for Americans, reviewed and issued by the federal government every five years, have broad impact on what goes into federal nutritional assistance programs, from WIC for women and young children to school lunches to meals for veterans or seniors.

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Big Pharma earnings hang hope on the next generation of blockbusters

PharmaVoice

Pfizer, J&J, Biogen and Novartis are banking on new products to make up for maturing blockbusters, but future growth is not guaranteed.

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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 Reddy’s launches BixiBat to treat chronic constipation in India

Express Pharma

Dr Reddy’s Laboratories announced the launch of Elobixibat, a first-in-class drug to treat chronic constipation, in India. Dr Reddy’s will market Elobixibat under the brand name BixiBat in India. The launch follows approval granted to Dr Reddy’s by the Central Drugs Standard Control Organisation (CDSCO) after submission of the company’s successful Phase-3 clinical trial to the Subject Expert Committee of the CDSCO.

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'More we could do' to collaborate across professions, House of Commons event hears

The Pharmacist

The barriers and opportunities involved in working collaboratively across different healthcare professions – including how pharmacists can work across the multidisciplinary team – have been explored during a House of Commons event. The event was hosted by Watford MP Matt Turmaine, sponsored by Dr Bharat Shah of Sigma Pharmaceuticals, and chaired by Professor Mahendra Patel, […] The post 'More we could do' to collaborate across professions, House of Commons event hears appeared fi

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Opinion: Fecal transplants are saving lives — but are now at risk

STAT

Twenty years ago, a respected colleague asked me to perform a “poop transplant” on a local schoolteacher with multiply recurrent C. difficile infection.  I was incredulous and skeptical, but my colleague (a friend but a forceful one) persisted until I ultimately acquiesced.  Soon I was in a hazmat suit blenderizing stool and performing my first (subsequently named) fecal microbiota transplant, or FMT.

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How CDMOs are Transforming the Industry

Drug Patent Watch

The pharmaceutical industry has undergone significant transformations in recent years, driven by the COVID-19 pandemic and the subsequent need for rapid innovation and adaptation.

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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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9th Advanced GMP Workshop 2024 was organised by IPA

Express Pharma

Reinforcing its commitment to global manufacturing excellence, Indian Pharmaceutical Alliance convened the 9 th Advanced Good Manufacturing Practices (GMP) Workshop. The two-day workshop held virtually featured over 25 distinguished industry leaders, subject matter experts, and global regulators, including USFDA and CDSCO. The workshop was attended by over 2,500 professionals including CXOs of the pharma industry, academia, and leaders from WHO, USFDA, CDSCO, IGBA, PDA, USP, and other industry a

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First UK case of Clade IB mpox could prompt ‘quick vaccine expansion’

The Pharmacist

The first confirmed human case of Clade Ib mpox in the UK has been detected in London, the UK Health Security Agency (UKHSA) has said. But it stressed that the risk to the UK population 'remains low'. And Steve Russell, NHS national director for vaccination and screening, said there were 'plans in place to expand […] The post First UK case of Clade IB mpox could prompt ‘quick vaccine expansion’ appeared first on The Pharmacist.

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STAT+: Two generic drugmakers pay $49 million to settle price-fixing charges

STAT

Two generic drugmakers, Apotex and Heritage Pharmaceuticals, have agreed to pay a combined $49 million to settle allegations they fixed prices on numerous medicines, the first such agreements since state attorneys general began probing price-fixing in the generics industry a decade ago. In 2016, a number of states filed what eventually became the first in a trio of lawsuits against many of the largest generic companies for allegedly coordinating efforts to fix and maintain prices for dozens of m

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Unlocking the Full Potential of Your CDMO Partnership: Strategies for Success

Drug Patent Watch

In the rapidly evolving landscape of biotechnology and pharmaceutical development, contract development and manufacturing organizations (CDMOs) have become essential partners for companies seeking to bring innovative medicines to market. However, navigating the complexities of these partnerships can be daunting, especially for smaller biotech companies.

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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.