Thu.Dec 14, 2023

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Apellis eye drug likely to be rejected in Europe, company says

Bio Pharma Dive

According to Apellis executives, reviewers in Europe are skeptical of the benefits of its geographic atrophy medicine, Syfovre, and appear poised to recommend against approval at a meeting next month.

Medicine 321
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Acadia victorious in court for Parkinson’s drug Nuplazid patent litigation

Pharmaceutical Technology

Acadia received two patent rulings that strengthen Nuplazid’s patent position and protect the drug into 2038.

Drugs 173
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New Moderna cancer vaccine data spurs share rally

Bio Pharma Dive

Shares climbed by double digits after new evidence led to speculation among analysts that Moderna and partner Merck could seek an approval before completing Phase 3 testing.

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PharmaKure and UiTM enter research partnership for Alzheimer’s disease

Pharma Times

The collaboration aims to develop biomarker-based diagnostics for the condition - News - PharmaTimes

Research 150
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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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Editas cashes in on CRISPR patent with Vertex deal

Bio Pharma Dive

The deal, struck after Editas was awarded ownership of a key patent for the landmark gene editing technology, could be the first of many like it.

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Done deal: Pfizer completes $43B acquisition of Seagen, doubling its oncology pipeline

Fierce Pharma

Pfizer’s $43 billion acquisition of Seagen is in the books, the company said on Thursda | It’s a done deal. Pfizer’s $43 billion acquisition of Seagen is in the books, as it becomes the largest M&A transaction in the biopharma industry since AbbVie snatched up Allergan for $63 billion in 2019. The buyout of the antibody-drug conjugate specialist has doubled Pfizer’s pipeline to 60 programs.

Antibody 145

More Trending

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Sano Genetics launches ‘Light the Way’ programme for MND

Pharma Times

The free programme will be offered to those who are affected by the condition - News - PharmaTimes

Genetics 139
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Mission Therapeutics forges ahead with Phase II study for DUB inhibitor 

Pharmaceutical Technology

A Phase II clinical trial treating 160 acute kidney injury patients with MTX652 is expected to be initiated in Q1 2024.

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Bluebird signs major coverage deal for sickle cell gene therapy Lyfgenia, easing some price concerns

Fierce Pharma

Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease (SCD) gene therapy less than a week after its

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Novo Nordisk acquires Alkermes’s Irish plant to expand manufacturing capacity

Pharmaceutical Technology

Novo Nordisk will pay $92.5m in one-time cash payment to Alkermes, and the deal is expected to close in mid-2024.

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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Reinventing drug invention

pharmaphorum

Reinventing drug invention Mike.

Drugs 122
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Pharma readies for climate disasters amidst supply chain concerns

Pharmaceutical Technology

Experts discussed the potential impacts of climate change on the pharma supply chain and how companies can prepare for them.

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AI drug discovery: Where we are and where we’re going

pharmaphorum

AI drug discovery: Where we are and where we’re going Mike.

Drugs 119
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Vertex licenses Editas’ gene editing technology in $100m deal

Pharmaceutical Technology

The payment, which encompasses newly approved Casgevy, is the latest deal in a long line of CRISPR licensing twists and turns.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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White House says 48 drugs are heading for Medicare rebates

pharmaphorum

White House says 48 drugs are heading for Medicare rebates Phil.

Drugs 111
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Insights from ISPOR Europe 2023: Copenhagen

Pharmaceutical Technology

At ISPOR 2023, where GlobalData had the opportunity to share some of our key insights across a variety of subject matters.

Marketing 130
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US WorldMeds' Iwilfin bags FDA nod as 1st oral maintenance treatment for high-risk neuroblastoma

Fierce Pharma

While existing neuroblastoma treatments can help patients achieve remission, sustaining that remission has proven tricky. But now, patients and doctors have a new oral option. | The U.S. FDA has approved US WorldMeds’ Iwilfin—also known as eflornithine—as a new oral maintenance therapy for high-risk neuroblastoma. The drug, cleared in 192 mg tablets, is indicated to cut the risk of relapse in kids and adults with high-risk neuroblastoma who’ve had at least a partial response to prior treatment.

Doctors 111
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Eight evolving patient communication risks in pharma and biotech

Pharmaceutical Technology

In this article, we’ll explore the patient communication risks that now confront life science organisations and provide insights into how to navigate them effectively.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Hemgenix first drug to clear France’s ‘direct access’ route

pharmaphorum

Hemgenix first drug to clear France’s ‘direct access’ route Phil.

Drugs 111
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Abbisko tenosynovial giant cell tumour therapy gains fast track status

Pharmaceutical Technology

Abbisko Therapeutics has received fast track designation from the US FDA for pimicotinib to treat tenosynovial giant cell tumour (TGCT).

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FDA starts speedy review of Amgen’s lung cancer BiTE therapy

pharmaphorum

FDA starts speedy review of Amgen’s lung cancer BiTE therapy Phil.

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FDA grants fast track status for Kyverna’s myasthenia gravis treatment

Pharmaceutical Technology

The US FDA has granted fast track designation for Kyverna Therapeutics’ CAR T-cell therapy KYV-101 to treat myasthenia gravis (MG).

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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Twin Health raises $50m, and other digital health financings

pharmaphorum

Twin Health raises $50m, and other digital health financings Phil.

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Pharmaceutical Technology Excellence Awards 2023: Accord Healthcare

Pharmaceutical Technology

Accord Healthcare is a Category Award Winner in four areas in the 2023 Pharmaceutical Technology Excellence Awards

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MindMed says LSD-based therapy effective in anxiety

pharmaphorum

MindMed says LSD-based therapy effective in anxiety Phil.

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Amgen receives FDA priority review for tarlatamab BLA

Pharmaceutical Technology

Amgen has received US FDA priority review for its biologics licence application for tarlatamab to treat advanced small-cell lung cancer.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Trade & Channel Strategies 2023: An Interview with Douglas Bock of Archbow Consulting

Pharmaceutical Commerce

Partner for Archbow Consulting discusses the conference, the IRA, and specifics of PAP business rules

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FDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates

BioSpace

The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.

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Trade & Channel Strategies 2023: An Interview with Bill Trombetta, PhD, Professor Emeritus, St. Joseph's University

Pharmaceutical Commerce

Bill Trombetta, PhD, discusses successfully navigating what he calls “the coming perfect storm” in healthcare.

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Celadon securing contracts for supply of pharma-grade medicinal cannabis

Outsourcing Pharma

Celadon Pharmaceuticals has today (December 14) announced its first supply of it pharmaceutical-grade breakthrough cannabis-based medicine.

Medicine 103
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.