Thu.Dec 19, 2024

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STAT+: FDA confirms shortage of weight loss drug tirzepatide is over, gives compounders a grace period

STAT

The Food and Drug Administration on Thursday confirmed that a shortage of Eli Lilly’s obesity drug tirzepatide has been resolved, a move that will soon put a stop to companies making cheaper copies of the injection. The agency said it would give these compounders a grace period of 60 to 90 days before enforcing rules that would put a halt to their work, in an effort to avoid disruption for patients.

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Merck’s RSV antibody could soon paddle into the rough waters of a crowded market

PharmaVoice

A new antibody from Merck would join a market teeming with new entries, but plenty of regulatory and financial uncertainty.

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STAT+: Health plan formularies lowered barriers to fair access to some drugs, analysis finds

STAT

Most of the formularies run by some of the largest health plans in the U.S. generally provide “fair access” to 11 treatments for several serious diseases, although transparent coverage information is often lacking for some medicines, a new analysis has found. Almost uniformly, the 11 formularies made the drugs available fairly when judged on three criteria: eligibility based on clinical data, restrictions placed on prescribers, and step therapy, which requires patients to try other

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Mesoblast finally pushes GvHD cell therapy over finish line

pharmaphorum

At its third attempt, Mesoblast has secured FDA approval for the first-ever mesenchymal stem cell (MSC) therapy, Ryoncil for acute GvHD in children.

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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+: Feds accuse CVS of filling ‘thousands’ of illicit opioid prescriptions

STAT

CVS Health was accused of contributing to a nationwide epidemic of opioid addiction and overdose by filling illegal opioid prescriptions and billing federal health insurance programs, according to a lawsuit unsealed Wednesday by the U.S. Department of Justice. The lawsuit alleged that, since October 2013, CVS knowingly filled prescriptions for “dangerous and excessive quantities” of controlled substances that lacked a legitimate medical purpose, were not valid, and were not issued

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Atomoxetine and stimulants best treatments for adult ADHD, study suggests

The Pharmacist

The drug atomoxetine and stimulants are the most effective treatments for adults with attention deficit hyperactivity disorder (ADHD), a new study has found. Researchers said their landmark systematic review, which included over 14,800 participants, sets a new benchmark for treatment of ADHD, and should inform future guidelines. However, they noted that the studys applicability to […] The post Atomoxetine and stimulants best treatments for adult ADHD, study suggests appeared first on The P

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Lonza expands Capsule Manufacturing Capacity in India and China

Express Pharma

Lonza, a global manufacturing partner for the pharmaceutical, biotech, and nutraceutical sectors, has announced capacity expansions at its facilities in Rewari, India, and Suzhou, China. The expansion includes additional hard gelatin capsule (HGC) production lines to support the manufacture of high-quality capsules for the pharmaceutical and nutraceutical industries.

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STAT+: Gilead plans to halt free access to an HIV drug, worrying patient advocates

STAT

Gilead Sciences will no longer provide four HIV medicines for free as part of a patient assistance program starting at the end of January, alarming community activists who worry the move will limit access and, consequently, impede nationwide efforts to combat the infectious disease. The list includes Truvada, a widely prescribed medicine that is used to treat and prevent HIV, but for which lower-cost generic versions are now available.

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Novo completes $16.5bn takeover of Catalent

pharmaphorum

Novo Holdings' $16.

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STAT+: Pharmalittle: We’re reading about a Vertex pain drug, the Feds suing CVS over opioids, and more

STAT

Top of the morning to you, and a fine one it is. Clear blue skies and chilly breezes are wafting across 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 blueberry cobbler.

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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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India’s pharma industry showcased at CPHI & PMEC India 2024

Express Pharma

CPHI & PMEC India 2024 concluded successfully at the India Expo Centre in Greater Noida, Delhi-NCR, from November 26th to 28th. The three-day event brought together pharmaceutical innovations in machinery, analytical instruments, laboratory technologies, equipment, and ingredients. With over 60,000 attendees from 120 countries and more than 2,000 exhibitors, the event set new records for participation and exhibits.

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Neuralink rival Precision raises $102m, and other financings

pharmaphorum

Neuralink rival Precision Neurosciences raises $102m for its brain-computer interface tech, plus financings for Redesign, DeepLife, TG0 and Tuva.

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Zepbound, Mounjaro shortages are resolved, FDA confirms

BioPharma Dive

The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

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Responsible antibiotic use: How the industry can lead the way for evidence-backed guidelines

Express Pharma

Antibiotics have long been essential in treating common infections and supporting complex medical interventions like surgeries, cancer chemotherapy, and organ transplants. However, the misuse and overuse of these critical drugs have catalysed a global health crisis: antimicrobial resistance (AMR). The 2023 annual report from the Indian Council of Medical Research (ICMR) has raised an alarm (1) , revealing increasing antibiotic resistance for common infections, including urinary tract infections

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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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Biotech stocks hammered after Fed rate projections

STAT

Want to stay on top of the science and politics driving biotech today?  Sign up  to get our biotech newsletter in your inbox. Good morning. This is my last newsletter this year. Meghana will be writing the one tomorrow, and then we will be off for the next two weeks. Wishing everyone happy holidays and I’ll see you in the new year.

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Ottimo raises $140m for its PD-1/VEGF cancer drug

pharmaphorum

Ottimo raises $140m for PD-1 and VEGF-targeting jankistomig, which the startup says is differentiated from bispecific antibodies in the class.

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A venture firm breathes new life into an old NGM drug

BioPharma Dive

An startup formed by KdT Ventures intends to test the drug, which was once licensed to Merck and evaluated in multiple metabolic disorders, for an unspecified rare conditon.

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Vertex weakens after neuropathic pain trial reads out

pharmaphorum

A trial of Vertex's suzetrigine in neuropathic back pain met its primary objective, but shares in the company fell as investors reacted to the data

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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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Regeneron says study data support big bet on new blood thinners

BioPharma Dive

The company is planning a “broad Phase 3 program” for two anticoagulants after they outperformed marketed medicines in a pair of mid-stage trials.

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Novartis sheds MorphoSys staff, sites after pelabresib delay

pharmaphorum

Novartis has confirmed it will shut down two MorphoSys sites in Germany and the US, with the loss of around 330 jobs, by the end of next year.

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Vertex’s stock hurt after non-opioid pain drug shows benefit similar to placebo

Pharmaceutical Technology

Vertex said the Phase II trial met its primary endpoint, however there was only a minor difference to placebo.

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Novartis shutters MorphoSys sites, lays off staff

BioPharma Dive

While the pharma is still developing a MorphoSys drug acquired in its $2.9 billion deal for the biotech, it is closing down sites in the U.S. and Germany.

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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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FDA approves Mesoblast’s Ryoncil for SR-aGvHD treatment

Pharmaceutical Technology

Mesoblast has gained US FDA approval for its mesenchymal stromal cell (MSC) therapy, Ryoncil (remestemcel-L), to treat SR-aGvHD.

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Vertex ‘ends the year in pain’ as latest non-opioid drug data disappoint

BioPharma Dive

Mixed results from a study focused on lower back pain left analysts wanting as well as confused about Vertex's plans to forge ahead in the indication.

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BioAge and Novartis seek drug targets for ageing-related diseases

Pharmaceutical Technology

BioAge Labs has entered a multi-year research partnership with Novartis to seek therapeutic drug targets for ageing-related conditions.

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Roche's Parkinson's hope fails second clinical trial

pharmaphorum

Roche and Prothena's alpha-synuclein-targeting prasinezumab for Parkinson's fails again, leaving them sifting through the data for efficacy signals

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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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MSD makes obesity play in up to $2bn deal for Hansoh’s GLP-1RA asset

Pharmaceutical Technology

MSD has entered an exclusive global licence agreement with Hansoh Pharma for a preclinical oral small molecule GLP-1RA.

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Adopting AI for R&D in 2025 – what needs to be addressed?

European Pharmaceutical Review

With the life sciences and healthcare sectors increasing integration of artificial intelligence (AI) into their infrastructure, according to research by GlobalData, one-third of healthcare professionals considered data privacy is the primary obstacle, citing challenges such as robust safeguards, workflow integration, and stakeholder acceptance [being] essential to ensure AIs ethical implementation and long-term success. 1 These concerns are held alongside the promise of this technology and its p

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Novo Holdings completes Catalent acquisition for $16.5bn

Pharmaceutical Technology

Novo Holdings has completed the previously announced acquisition of Catalent in an all-cash transaction valued at around $16.5bn.

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Gilead recruits Terray in AI-driven drug discovery pact

Outsourcing Pharma

Gilead teams up with Terray for AI-powered drug discovery, leveraging Terrays tNova platform to accelerate the development of innovative treatments through generative AI and lab experiments.

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Pharmacy First: A year of the service in England

The Pharmacist

The launch of Pharmacy First in England this year was hailed a significant milestone for the sector and a game-changer for increasing patient access to healthcare. Pharmacies across the country have stepped up to the task, providing thousands of consultations and countless support to patients. But it has not come without its challenges. It started […] The post Pharmacy First: A year of the service in England appeared first on The Pharmacist.

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