Fri.Oct 13, 2023

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Pfizer to cut costs, lay off staff on waning demand for COVID products

Bio Pharma Dive

Sales of Pfizer's antiviral Paxlovid and shot Comirnaty have been slower than it anticipated, while a shift to the commercial market for the antiviral has been delayed.

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FDA fast tracks MimiVax’s glioblastoma vaccine SurVaxM

Pharmaceutical Technology

The Phase IIb SurVaxM vaccine study will enrol 265 patients and has an estimated completion date in Q2 2024.

Vaccine 279
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Pfizer wins FDA approval for its $7B colitis drug

Bio Pharma Dive

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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FDA lifts clinical hold on PepGen’s myotonic dystrophy type 1 candidate

Pharmaceutical Technology

The dose-selection Phase I trials for evaluating PepGen’s peptide-conjugated antisense oligonucleotide have been cleared to begin in the US.

Trials 279
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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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‘Project NextGen’ picks new mRNA, intranasal COVID vaccines for funding

Bio Pharma Dive

The awards, to biotechs Gritstone, Codagenix and CastleVax, are part of the program’s plan to develop vaccines with broader or longer-lasting benefits.

Vaccine 294
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Amneal partners with mAbxience for denosumab biosimilars

Pharmaceutical Technology

Amneal adds Prolia and Xgeva biosimilars to its oncology portfolio which already has three biosimilars products launched in the US.

More Trending

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BioNTech licenses MediLink’s anti-cancer antibody-drug conjugate

Pharmaceutical Technology

MediLink will receive $70m upfront and will be eligible for up to $1bn in additional milestone-based payments from BioNTech.

Licensing 147
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Amylyx’s ALS drug knocked back again in Europe

Bio Pharma Dive

Following a re-examination, the EMA again concluded that Albrioza — known as Relyvrio in the U.S. — should not be cleared for the European market.

Drugs 189
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UKRI awards three projects £25m for vaccine development

Pharma Times

The projects will support the development of new and longer-lasting vaccines - News - PharmaTimes

Vaccine 146
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Merck’s Keytruda receives approval greenlight from EU CHMP

Pharmaceutical Technology

Keytruda was recommended by the EU CHMP based on results from KEYNOTE-859 study and is also under review in the US.

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

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UCL researchers recommend AI language models for schizophrenia diagnosis

Pharma Times

Automated analysis of language could help diagnose and assess psychiatric conditions - News - PharmaTimes

Research 142
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Specialised Therapeutics licenses CanariaBio’s ovarian cancer antibody

Pharmaceutical Technology

Specialised Therapeutics has entered an agreement to license Korea-based CanariaBio’s oregovomab for treating ovarian cancer.

Licensing 130
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Amylyx's ALS drug Albrioza rebuffed by EU regulator—again

Fierce Pharma

Even as Amylyx’s ALS drug gains steam in the U.S. after a long-awaited FDA approval, the company is struggling with regulatory hurdles overseas. | Europe's drug regulator wasn't swayed by Amylyx's phase 2 data. The European Commission will make the final call on the drug's approval in the bloc by the end of the year.

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South Rampart Pharma gains FDA fast track status for pain treatment

Pharmaceutical Technology

South Rampart Pharma has received the US Food and Drug Administration (FDA) fast track designation for SRP-001 to treat acute pain.

Drugs 130
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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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High-flying Novo Nordisk again dials up its 2023 sales and profit expectations

Fierce Pharma

The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again. | The popular diabetes med Ozempic and its sister weight-loss drug Wegovy are boosting Novo Nordisk to new highs again and again.

Sales 124
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Patient comfort in AI-driven healthcare linked to familiarity with technology

Pharmaceutical Technology

AI-powered chatbots or virtual assistants are used to provide basic medical information and answer common patient healthcare queries.

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Eying Incyte's Opzelura, Leo Pharma shares data for JAK cream in hand eczema

Fierce Pharma

Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s appro | Back in February, Leo Pharma revealed that its JAK-inhibitor cream delgocitinib met its primary and secondary endpoints in a phase 3 trial in chronic hand eczema, putting pressure on Incyte’s approved topical Opzelura.

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FDA rejects Alvotech’s BLA for Stelara biosimilar

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has rejected to approve Alvotech’s biologics licence application (BLA) for AVT04.

Drugs 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Pfizer takes aim at BMS' first-in-class Zeposia with FDA nod for ulcerative colitis drug Velsipity

Fierce Pharma

Bristol Myers Squibb’s Zeposia is no longer the only S1P receptor modulator on the market for ulcerative colitis, thanks to an FDA approval for what appears to be a more effective drug from Pfizer. | Bristol Myers Squibb’s Zeposia is no longer the only S1P receptor modulator on the market for ulcerative colitis, thanks to an FDA approval for what appears to be a more effective drug from Pfizer.

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US FDA grants approval for Pfizer’s lung cancer combination treatment

Pharmaceutical Technology

The US FDA has granted approval for Pfizer’s Braftovi and Mektovi combination to treat metastatic non-small cell lung cancer (NSCLC).

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Sugar Free Cranberry Juice: NewTree Fruit Company’s De-Sugaring Technology

XTalks

In the era of health-consciousness, sugar free cranberry juice is a product that consumers are eagerly looking for on the shelves. However, truly achieving this goal without compromising the nutrition and taste of the juice has been challenging. Enter NewTree Fruit Company (NTFC), which has successfully pioneered a method to give juice lovers exactly what they’ve been looking for.

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Santhera closes on first approval for DMD drug vamorolone

pharmaphorum

Santhera closes on first approval for DMD drug vamorolone Phil.

Drugs 105
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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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How Pharma Companies Can – And Should – Improve Social Determinants of Health

Intouch Solutions

Social determinants of health (SDOH) are the non-medical factors that affect people’s health. They can include the conditions in which people are born, live, learn, work, play, worship, and age 1,2 — as well as factors like economic policies and systems, development agendas, social norms, social policies and political systems. 1 Why are SDOH important?

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Lilly to file mirikizumab in Crohn’s after FDA colitis snub

pharmaphorum

Lilly to file mirikizumab in Crohn’s after FDA colitis snub Phil.

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AGC Biologics Unveils Completed pDNA and mRNA Expansion Project

Pharmaceutical Commerce

CDMO’s Heidelberg facility will house the newly-completed manufacturing line.

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Growing health inequality in UK prompts call for ‘joined up strategy’

pharmaphorum

Growing health inequality in UK prompts call for ‘joined up strategy’ Mike.

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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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For Health Literacy Month, a look into effective patient communication

Antidote

For more than 20 years, October has been deemed Health Literacy Month , a designation aimed at highlighting the importance of health literacy in the United States. An individual's health literacy, including their ability to understand doctors’ guidelines, follow medication instructions, and discuss their symptoms, has a major impact on how individuals interact with the healthcare system — and for medical organizations, it is important to understand how to tailor messaging, collateral, and inform

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Multichannel Marketing: Coordinating Digital Efforts for Pharma Success

Pharma Marketing Network

Multichannel marketing is an effective digital strategy for pharmaceutical companies to reach consumers and encourage them to purchase products. By utilizing multiple channels such as social media, email, and mobile applications, pharma companies can reach a wider audience and coordinate their efforts to create a unified message. In this article, we will explore the concept of multichannel marketing, discuss digital strategies for pharma success, and examine the benefits and challenges of this a

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Patient organisations 'a major source of R&D funding'

pharmaphorum

Patient organisations 'a major source of R&D funding' Phil.

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Which pharmaceutical drugs have the most drug patents in Philippines?

Drug Patent Watch

This chart shows the drugs with the most patents in Philippines. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is desired.… The post Which pharmaceutical drugs have the most drug patents in Philippines? appeared first on DrugPatentWatch - Make Better Decisions.

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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.