Mon.Sep 02, 2024

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STAT+: At major cardiology conference, Wegovy’s the word

STAT

LONDON — When Europe’s largest cardiology conference opened here this past Friday, one of the first sessions centered entirely on a single drug. It cut the risk of complications from a common form of heart failure, researchers reported. It helped improve the structure of the heart as well as its function. It even saved the lives of people with Covid-19 — a respiratory infection of all things.

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Zydus receives USFDA warning letter for Jarod facility

Express Pharma

Zydus Lifesciences has received a Warning Letter issued by the US Food and Drug Administration for its Injectables manufacturing facility at Jarod near Vadodara, Gujarat. The Warning Letter summarises violations concerning Current Good Manufacturing Practice (cGMP) regulations. The letter does not contain any data integrity-related violations. Earlier, on July 18, the facility received an OAI status.

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High-dose psilocybin may be effective in treating depression

The Pharmacist

High doses of psilocybin – the psychedelic ingredient in magic mushrooms – appear to have a similar effect on depressive symptoms as an antidepressant, according to a meta-analysis of the evidence. But some of the promise of psychedelic treatment for depression may have been overestimated due to issues with trial design, the results suggest. The […] The post High-dose psilocybin may be effective in treating depression appeared first on The Pharmacist.

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FDC ban exposes fault lines once again

Express Pharma

Emcure Pharma became one of the first pharma companies to apply for and get some interim relief from the union health ministry’s recent prohibition of the sale and distribution of fixed dose combinations (“FDC”). Emcure had filed a writ petition before the Delhi High Court seeking the quashing of the August 12, 2024 notification, which prohibited the manufacture for sale and distribution of the company’s pain relief FDC of S (+)-Etodolac + paracetamol for human use with immediate eff

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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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Novavax wins FDA emergency approval for updated Covid-19 vaccine

Pharmaceutical Technology

The US regulatory agency has also approved updated versions of Covid-19 vaccines from Moderna and Pfizer / BioNTech’s in the past two weeks.

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Cannes Lions 2024 showcase highlights key trends shaping future pharma marketing

Express Pharma

In a historic first, the award-winning work and critical insights from Cannes Lions, the International Festival of Creativity, were presented last week at a series of events held across Mumbai, Bengaluru, and Gurugram. Hosted in collaboration with Medulla Communications, a healthcare advertising agency, the events brought together industry leaders to explore the creative and strategic trends that will shape the future of pharma and healthcare marketing in India.

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Merck administers dose to first patient in Phase III study of Oral Cladribine in Generalised Myasthenia Gravis (gMG)

Express Pharma

Merck announced that the first patient has been dosed in the Phase III MyClad trial evaluating the efficacy and safety of oral cladribine for the treatment of generalised Myasthenia Gravis (gMG). Cladribine capsules have the potential to be the first oral treatment for gMG patients. gMG is a rare, neuromuscular disorder causing muscle weakness that can be severe and have a significant impact on patients’ lives.

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Aptose Biosciences secures funds for AML treatment development

Pharmaceutical Technology

Aptose Biosciences has secured a loan of $10m through a facility agreement with Hanmi Pharmaceutical to develop tuspetinib.

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Zeon Lifesciences secures patent for phyto-product extraction method

Express Pharma

Zeon Lifesciences, a manufacturer of nutraceutical and herbal products in India, has received a patent titled “A Method for the Preparation of a Phyto-Product Using Plant Material.” This patent marks a development in the field of phyto-products and reflects Zeon’s focus on scientific research and solutions in natural products. The patented method involves extracting leaves and fruit from Annona muricata, known for its anti-cancer properties.

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Diabetes drugs found to lower risk of dementia in large analysis

The Pharmacist

A class of drugs used to treat type 2 diabetes have been shown to be associated with a reduced risk of dementia, say researchers. Analysis of a large database of people aged 40-69 with type 2 diabetes found a 35% reduced risk of dementia associated with use of sodium-glucose cotransporter-2 (SGLT2) compared with dipeptidyl peptidase-DPP-4 […] The post Diabetes drugs found to lower risk of dementia in large analysis 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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As mpox cases rise over 18,000, UNICEF tenders for vaccines

pharmaphorum

UNICEF has issued an emergency tender to secure mpox vaccines for countries dealing with the brunt of the current outbreak

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Epi-pen shortage affected pharmacist’s response to fatal Costa allergy

The Pharmacist

A child who died after an anaphylactic reaction to a dairy hot chocolate was given the wrong dose of adrenaline due to a national shortage of Epi-pens, a coroner has found. Dr Shirley Radcliffe, assistant coroner for East London, called for NHS England, the General Pharmaceutical Council (GPhC) and other bodies to take action to […] The post Epi-pen shortage affected pharmacist’s response to fatal Costa allergy appeared first on The Pharmacist.

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Two of three trials fail, but Sanofi will still file MS drug

pharmaphorum

Sanofi eyes filings for multiple sclerosis therapy tolebrutinib, although two of three phase 3 trials miss their primary endpoints

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Innovative hypertension polypill study achieves “significant” outcomes

European Pharmaceutical Review

Three anti-hypertensive drugs combined in low doses into a single pill has been shown to be superior to standard care for lowering blood pressure in patients with uncontrolled hypertension. The oral treatment GMRx2 is biopharma George Medicines’ lead drug candidate. The once-daily, three-in-one pill contains telmisartan, amlodipine and indapamide at a quarter, half or standard doses.

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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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iRhythm wearable heart monitor raises AFib diagnoses by 52%

pharmaphorum

iRhythm's Zio XT wearable heart monitor raises AFib diagnoses by 52%, but doesn't reduce stroke hospitalisations in GUARD-AF trial.

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Novavax’s updated Covid-19 vaccine receives FDA emergency use authorisation

Pharmaceutical Business Review

The Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) [NVX-CoV2705] is now authorised for active immunisation against Covid-19. Following the EUA, the vaccine is also recommended by the US Centers for Disease Control and Prevention (CDC). Pre-filled syringes of the vaccine will soon be distributed across a variety of locations, including pharmacies and regional grocers, once the Center for Biologics Evaluation and Research approves the vaccine batches.

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BIA sends message to UK chancellor on R&D tax credits

pharmaphorum

Biotech industry body BIA calls for new UK Chancellor Rachel Reeves to take sector-specific approach to R&D tax credits to tackle widespread fraud and abuse of the system.

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Nxera wins $35m after Phase II schizophrenia trial success

Pharmaceutical Technology

Nxera will receive $35m from Neurocrine triggered by the successful completion of the Phase II trial of NBI-568 in schizophrenia.

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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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Panel Discussion: Fueling growth and innovation with R&D

Express Pharma

Panelists in this video: + Prof Pravin Wakte, Director, Central Facility for Advanced Research and Training, Dr Babasaheb Ambedkar Marathwada University (Moderator + Mr Dinesh Shinde, Associate Director – Formulation Development & Tech Transfer, Wockhardt + Mr Sachin Salampure, Associate Director – CMC & Formulations, VedTechBio + Mr Jitendra Chordiya, Head-Formulation R&D, Harman Finochem + Mr Sachin Kulkarni, Works Manager, FDC Key Highlights: [1] AMR is a rapidly gr

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More pharmacies miss Pharmacy First thresholds as rise to 20 begins

The Pharmacist

Support is 'urgently needed' to help community pharmacies meet Pharmacy First thresholds, as the number of consultations required for a monthly payment rises to 20 this month, Community Pharmacy England (CPE) has said. This comes as the latest available data shows that in May 2024, an increasing number of pharmacies failed to meet the rising […] The post More pharmacies miss Pharmacy First thresholds as rise to 20 begins appeared first on The Pharmacist.

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Pradipkumar Patil, VP – Quality, Ajanta Pharma

Express Pharma

In this video: Pradipkumar Patil, VP – Quality, Ajanta Pharma Topic: Innovations in pharma manufacturing Key Takeaway: Automation plays a crucial role in moderinising and optimising pharma operations, expediting investigation and decision making The post Pradipkumar Patil, VP – Quality, Ajanta Pharma appeared first on Express Pharma.

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How Long Until AI Starts to Replace Pharmacists

pharmacy mentor

Artificial Intelligence (AI) in pharmacies represents a transformative technology that enhances various aspects of pharmaceutical practice. By leveraging AI, pharmacies can already optimise drug dispensing processes, improve medication management, and enhance patient safety. AI algorithms can analyse patient data to predict potential drug interactions, customise treatment plans, and even identify early signs of adverse reactions.

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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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Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries

Express Pharma

In this video: Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries Topic: Tablet compressability, MCC and techtonic shift Key Takeaway: Excipient performance is rarely understood fully and often underestimated. MCC is the time tested and proven multi-functional exicipient. Sigachi can be a trusted formulation partner and solutions provider The post Dr Abhijit Gothoskar, Technical Expert, Sigachi Industries appeared first on Express Pharma.

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Targeted deal sourcing delivers 70% closure rate and over $350m in M&A deals for boutique investment bank

Fuld & Company Blog

A West Coast boutique investment bank engaged Fuld & Company to develop a comprehensive business development plan tailored to its sector and geographic focus. By optimizing sell-side M&A deal sourcing and expanding its market presence, the bank significantly increased its pipeline of high-quality opportunities. Objective The bank wanted to enhance its sell-side M&A deal sourcing capabilities and strengthen its brand presence to ensure a robust pipeline of high-quality opportunities.

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Zoher Sihorwala, Sr VP & Head – Global Regulatory Affairs, Wockhardt

Express Pharma

In this video: Zoher Sihorwala, Sr VP & Head – Global Regulatory Affairs, Wockhardt Topic: Uniting industry leaders for innovation and collaboration Key Takeaway: As a fraternity of pharma professionals within the organisation, we are strongly united and work in unison to yield the products to serve patients. However, as pharma industry, we still need to collaborate deeper on problem statements and cross science/technology breeding to see innovation happening The post Zoher Sihorwala, Sr VP

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PHC uses LiCellGrow prototype for cell and gene therapy manufacture

Pharmaceutical Technology

PHC Corporation has introduced a prototype of LiCellGrow, a cell expansion system designed to manufacture cell and gene therapy products.

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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.

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Komal Bhavsar, AGM – Business Development, CILICANT

Express Pharma

In this video: Komal Bhavsar, AGM – Business Development, CILICANT Topic: Innovations in active packaging Key Takeaway: Cilicant’s Accuflip is an ERH regulator that protects medications from over-desiccation. It does this through a specialised sorbent that has the ability to absorb and desorb The post Komal Bhavsar, AGM – Business Development, CILICANT appeared first on Express Pharma.

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Cardinal Health Introduces New Tennessee Advanced Therapy Innovation Center

Pharmaceutical Commerce

The 8,000 square-foot facility—located within the wholesaler’s Le Vergne distribution center— is expected to help tackle cell and gene therapy logistical challenges.

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Panel Discussion: Aurangabad’s role in Maharashtra’s pharma leadership

Express Pharma

Panelists in this video: + Dr Prashant Musmade, Data Reliability Officer, Glenmark Pharmaceuticals (Moderator) + Dr Varda Bapat, COO, RV Lifesciences + Mr Anshu Manocha, Site Head (Executive GM), Indoco Remedies + Dr Sanjay Toshniwal, Central Council Member, Pharmacy Council of India, New Delhi + Mr Manoj Patil, DGM-Production, Ajanta Pharma Key Highlights: [1] Automation and digitalisation in the pharma industry has ushered real-time monitoring of systems and equipment, reduced manual errors, a

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New pharmaceutically active substances from billions of newly combined molecules

World Pharma News

Nowadays, there's lots of buzz about spectacular new medical treatments such as personalised cancer therapy with modified immune cells or antibodies. Such treatments, however, are very complex and expensive and so find only limited application. Most medical therapies are still based on small chemical compounds that can be produced in large quantities and thus at low cost.

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Krystal Integrated Services announces partnership with Nicomac Taikisha Clean Rooms

Express Pharma

Krystal Integrated Services, announces a strategic partnership with Nicomac Taikisha Clean Rooms. This collaboration aims to enhance operational efficiency and service quality by deploying a workforce that specialises in contamination control, sterilisation techniques, clean rooms and safety protocols to support Nicomac Taikisha’s diverse operations.

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