Thu.Jan 23, 2025

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GlobalData tracks 40 yrs of innovation in USFDA review designations

Express Pharma

Regulatory authorities, particularly the US FDA, have played a crucial role in accelerating and incentivising the development of innovative treatments through review designations. Since the first designation in 1984, the FDA has seen a substantial rise in the number of designations granted, reaching 694 in 2020. This surge reflects key pharmaceutical milestones, including the biotech boom and the advent of groundbreaking scientific advancements over the past four decades, observes GlobalData Jas

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Tris Pharma, looking to compete with Vertex, reports acute pain trial success

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. We’ve got lots of news coming out of D.C. today — let’s get straight into it.

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Trending Sources

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BridgeBio’s Neil Kumar on an underdog drug launch and wooing deal-hungry investors

BioPharma Dive

In an interview, the CEO discussed trying to gain support from investors hyper-focused on M&A, and competing with Pfizer and Alnylam in a closely watched commercial battle.

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Tris Pharma announces positive results from ALLEVIATE-1 trial of cebranopadol

Pharma Times

Phase 3 trial shows promising pain relief for acute pain patients

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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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One of the largest global surveys of society's attitudes toward breakthrough technologies

World Pharma News

As leaders gather for the World Economic Forum Annual Meeting 2025 in Davos, Leaps by Bayer, the impact investing arm of Bayer, and Boston Consulting Group (BCG) announced the launch of one of the largest surveys examining global public sentiment towards transformative technology. The field work was conducted by market research company Ipsos.

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J&J is all in on tau-targeted Alzheimer’s candidates. Will the approach lead to more effective treatments?

PharmaVoice

Anti-tau candidates haven’t crossed the regulatory threshold like their anti-amyloid counterparts, but J&J’s clinical efforts could lead in the right direction.

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FDA approves Amneal Pharmaceuticals’ Alzheimer’s and oncology treatments

Pharmaceutical Business Review

Memantine/donepezil 14-10 mg and 28-10 mg capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. This product, referencing NAMZARIC of AbbVie, has been launched with 180-day exclusivity. Adverse events associated with memantine hydrochloride include diarrhoea, dizziness, and headache while those for donepezil are anorexia, vomiting, bruising, nausea, and diarrhoea.

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Reflecting on a decade at CES: Has digital health really transformed?

pharmaphorum

This article reflects on the past decade at CES to assess how digital health innovations, including AI, have transformed the healthcare industry.

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FDA adds boxed warning to multiple sclerosis drugs after anaphylaxis cases

Pharmaceutical Technology

The FDA reported that six patients died after being injected with Tevas Copaxone or Sandozs Glatopa.

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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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AMR biotech BioVersys plans to float on Swiss stock exchange

pharmaphorum

BioVersys has filed to list on the Swiss Stock Exchange, hoping to raise CHF80m for its novel antibacterial candidates.

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Adults with ADHD ‘living shorter lives than they should’, finds study

The Pharmacist

Adults with ADHD are living shorter lives than they should, say researchers who analysed life expectancy in GP patient records. The UK study found a reduction in life expectancy for men with diagnosed ADHD of between 4.5 and 9 years, and between 6.5 and 11 years for women. It is likely to be a result […] The post Adults with ADHD living shorter lives than they should, finds study appeared first on The Pharmacist.

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Tris cues up filing for non-opioid pain drug on phase 3 win

pharmaphorum

Tris Pharma has set its sights on an FDA filing for non-opioid pain drug cebranopadol this year after hitting the mark in an abdominoplasty trial.

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The largest pharma acquisitions of 2024

Outsourcing Pharma

From Novo Holding's purchase of Catalent to BMS's Karuna acquisition, here are 10 of the most significant M&A moments of 2024.

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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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Study finds big life expectancy deficit in adults with ADHD

pharmaphorum

UK study finds adults with ADHD have a big shortfall in life expectancy, raising questions about diagnosis rates and treatment access.

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Ask the Expert: Product Inspection, Part One; Risk Mitigation in Secondary Packaging

PharmaTech

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

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Ascentage prices first biotech IPO of 2025, raising $126M

BioPharma Dive

The China-based cancer drug developer’s offering will fund testing of medicines for several blood malignancies — one of which is part of an alliance with Takeda.

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Viralgen and Axovia to develop gene therapy for retinal dystrophy

Pharmaceutical Technology

Viralgen and Axovia are set to form a partnership to progress the development and manufacturing of gene therapy for retinal dystrophy

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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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Time Management Strategies for Highly Disruptive Work Environments

The Script

Many work environments can be very distracting. Our team at Rx relief breaks down a few time management strategies to consider adopting.

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Pharmapack Award Winners 2025 redefining pharmaceutical packaging and drug delivery

Pharmafile

Award winners by category DELIVERY AND DEVICE INNOVATION SHL Medical for Elexy reusable electromechanical autoinjector ECO-DESIGN WINNER Huhtamaki for Omnilock Ultra PAPER PACKAGING INNOVATION WINNER Mitsubishi Gas Chemical Company for new OXYCAPT Multilayer Plastic Vial PATIENT-CENTRIC DESIGN WINNER UCB Pharma for Bimzelx 160mg 2ml autoinjectors product for US START-UP INITIATION WINNER Active Label for non-electric […] The post Pharmapack Award Winners 2025 redefining pharmaceutical pack

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Bladder cancer: Shaping the future of global clinical trials

Pharmaceutical Technology

A new report dives into the evolving clinical trial landscape and transformative therapies changing lives for bladder cancer patients.

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AI in medtech is taking off. Here are 4 trends to watch in 2025.

BioPharma Dive

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain around insurance coverage and generative AI.

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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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Pharmaceutical Technology Excellence Awards 2024 – Winners Announced!

Pharmaceutical Technology

The Pharmaceutical Technology Excellence Awards winners have been announced!

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FDA Warns Sanofi About API CGMP Deviations, Issues Clinical Hold on Atara Immunotherapies

PharmaTech

The agencys newly issued letter to Sanofi amends one sent in December 2024, and stems from inspections at its Massachusetts drug manufacturing facility in June and July 2024.

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FDA grants ODD status to Zai Lab’s lung cancer treatment

Pharmaceutical Technology

The FDA has granted orphan drug designation (ODD) to Zai Labs ZL-1310, aimed at treating small cell lung cancer (SCLC).

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Two AstraZeneca Treatments Recommended for Lung Cancer Patients in England and Wales

PharmaTech

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

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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.