Sat.Jun 18, 2022 - Fri.Jun 24, 2022

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Biogen, citing insurance challenges, shutters one of its Aduhelm studies

Bio Pharma Dive

The company says a recent coverage decision by Medicare has forced it to end an observational trial of the Alzheimer's drug after enrolling just 29 participants.

Trials 323
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Covid-19 vaccines targeting Omicron variants expected to be ready for this autumn

Pharmaceutical Technology

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. In addition to providing protection against the Omicron BA.1 variant, on 22 June, Moderna said its booster also showed a “potent” antibody response against Omicron subvariants BA.4 and BA.5.

Vaccine 264
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Disruption in healthcare is coming

World of DTC Marketing

Advanced economies typically spend about 10% of GDP on keeping their citizens in good health, a share that is rising as populations age. America’s profit-riddled healthcare-industrial complex consumes 17% of GDP, equivalent to $3.6trn a year. That is unsustainable. However, changes are slowly being implemented that could lower healthcare costs.

Pharmacy 227
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University of Strathclyde develops 3D breast cancer screening tool

Pharma Times

Pre-clinical screening technology could increase cancer test numbers by 50 times

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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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Radius, maker of bone and cancer drugs, to be bought in take-private deal

Bio Pharma Dive

Two investment firms, Gurnet Point Capital and Patient Square Capital, have agreed to pay as much as $890 million for Radius, which has come under pressure amid share price declines.

Drugs 319
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EC approves Novartis’ Tabrecta for non-small cell lung cancer

Pharmaceutical Technology

The European Commission (EC) has approved Novartis’ Tabrecta (capmatinib) as a monotherapy to treat advanced non-small cell lung cancer (NSCLC) in adults. The treatment is intended for patients with NSCLC harbouring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping and for those who need systemic therapy after previous treatment with immunotherapy and/or platinum-based chemotherapy.

Medicine 263

More Trending

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Eisai’s brain health tool NouKNOW used in Tokyo dementia project

pharmaphorum

Eisai’s digital tool to allow self-assessment of cognitive performance – NouKNOW – will be used in a Japanese project aimed at improving the management of dementia. The smartphone app – which uses a cognition-checking algorithm developed by Australian digital health company Cogstate – will be deployed in Bunkyo City, Tokyo in a dementia monitoring programme.

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Mixed results for PTC Duchenne drug put spotlight on EU approval

Bio Pharma Dive

A confirmatory study of PTC Therapeutics’ muscular dystrophy treatment Translarna missed its main goal, although the company highlighted the trial’s overall positive results.

Drugs 317
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Novavax’s Covid-19 vaccine gets Taiwan FDA EUA for use in adults

Pharmaceutical Technology

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain. Developed utilising Novavax’s recombinant nanoparticle technology to generate antigen obtained from the coronavirus spike (S) protein, the vaccine is also formulated with the company’s saponin-

Vaccine 263
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Blood vessel breakthrough is major step towards Alzheimer’s treatment

Pharma Times

The discovery may lead to development of drugs that halt disease progression and stop memory loss

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

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Lilly’s Verzenios gets NICE blessing for early-stage breast cancer

pharmaphorum

Thousands more people with breast cancer in England look set to be eligible for routine treatment with Eli Lilly’s Verzenios, after new guidance from NICE backed use of the drug after surgery for early-stage tumours. The new advice means that around 4,000 people with hormone receptor-positive, HER2-negative, node-positive early breast cancer who are considered at high risk of recurrence after surgery can receive Verzenios (abemaciclib) in combination with standard hormone therapy, said the

Hormones 116
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Galapagos, with latest deals, charts an unexpected journey to cell therapy

Bio Pharma Dive

The Belgian drugmaker will spend more than $100 million to acquire two companies, CellPoint and AboundBio, in a move meant to “disrupt” CAR-T treatment.

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invoX Pharma agrees to acquire biopharma firm F-star Therapeutics for $161m

Pharmaceutical Technology

invoX Pharma has signed a definitive agreement for the acquisition of all issued and outstanding shares of clinical-stage biopharma firm F-star Therapeutics, in a deal valued at nearly $161m or $7.12 for each share in cash. invoX Pharma is a fully owned Sino Biopharmaceutical subsidiary. The latest deal will expedite the strategy of invoX to develop the International Biopharmaceutical R&D Platform of Sino Biopharm outside of China to transform the lives of patients globally.

Antibody 162
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Novartis lung cancer drug Tabrecta gets approval

Pharma Times

Novartis receives approval from the European Commission for Tabrecta for the treatment of non-small cell lung cancer

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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AZ preps FDA filing for $3.6bn amyloidosis drug eplontersen

pharmaphorum

Armed with new phase 3 data, AstraZeneca is preparing to file for regulatory approval of eplontersen, an antisense drug for one of the complications of the disease transthyretin amyloidosis (ATTR) it licensed from Ionis in a $3.6 billion deal last year. Eplontersen – previously known as IONIS-TTR-LRX – is designed to switch off the production of transthyretin (TTR), a protein which builds up in the disease to toxic levels causing heart problems (cardiomyopathy) and nerve damage (polyneuropathy).

Drugs 111
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Novartis hunting for sickle cell cure with Precision deal

Bio Pharma Dive

The pharma will pay $75 million to access Precision’s gene editing technology, adding another program to the lengthening list of drug development efforts targeting the inherited blood condition.

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Non-stop investment from CMOs and US Government into continuous manufacturing

Pharmaceutical Technology

In the last year, well-known contract manufacturing organisations (CMOs) such as Agilent Technologies (Santa Clara, California) and Abzena (Cambridge, UK) have expanded their continuous manufacturing capabilities. US Congress is also making substantial investments to improve the continuous manufacturing of pharmaceuticals. As more drugs are approved with continuous manufacturing, this production method is becoming increasingly mainstream.

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Pharma poised but no recorded monkeypox deaths

Pharma Times

Global surveillance systems show that recorded cases do not include any deaths

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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.

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Ultra-thin film creates vivid 3D images with large field of view

Scienmag

WASHINGTON — Researchers have developed a new ultra-thin film that can create detailed 3D images viewable under normal illumination without any special reading devices. The images appear to float on top of the film and exhibit smooth parallax, which means they can be clearly viewed from all angles. With additional development, the new glass-free approach […].

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BioMarin's hemophilia gene therapy recommended for approval in Europe

Bio Pharma Dive

The decision brings what could be the first approved hemophilia gene therapy, Roctavian, closer to market, after a series of regulatory setbacks that have delayed its arrival.

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BioMarin’s Voxzogo obtains Japan’s MHLW approval for achondroplasia

Pharmaceutical Technology

BioMarin Pharmaceutical has obtained Japan’s Ministry of Health, Labor and Welfare (MHLW) approval of the registration for its Voxzogo (vosoritide) for injection to treat achondroplasia in children whose growth plates are not closed. A modified C-type natriuretic peptide (CNP), Voxzogo acts on achondroplasia’s underlying pathophysiology. It works by down-regulating fibroblast growth factor receptor 3 (FGFR3) signalling and subsequently boosting endochondral bone formation.

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NICE opts to reject Acorda’s MS drug Fampyra

Pharma Times

The MS Society responds as MS therapy Fampyra is rejected

Drugs 119
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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Machine learning predicts oral cancer risk

Scienmag

The Interactive Talk presentation, “Predicting Oral Cancer Risk using Machine Learning”, will take place on Saturday, June 25th, 2022 at 2 p.m. China Standard Time (UTC+08:00) during the “e-Oral Health Network I” session. The study, undertaken by John Adeoye of the University of Hong Kong, SAR China, aims to develop a machine learning-based platform to […].

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UniQure buoyed by early data for Huntington's gene therapy

Bio Pharma Dive

After one year, researchers detected important protein changes in patients who received a low dose of the experimental treatment. Further testing and functional data are needed to assess its potential, however.

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GSK to invest $1.2bn in infectious diseases R&D in lower-income countries

Pharmaceutical Technology

GlaxoSmithKline (GSK) has announced plans to invest $1.2bn (£1bn) over a decade to expedite research and development (R&D) for infectious diseases in lower-income countries. New vaccines and therapies for the prevention and treatment of malaria, tuberculosis, human immunodeficiency virus (HIV), neglected tropical diseases (NTDs) and anti-microbial resistance (AMR) will be the focus of this research.

Vaccine 147
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Positive MHRA decision for Briviact

Pharma Times

MHRA extends UCB’s therapy for the treatment of partial-onset seizures

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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The Benefits of an Augmented Consumer Platform Purpose-Built for the Life Sciences

XTalks

WhizAI brings an augmented consumer platform to the life sciences industry to deliver better, smarter and faster business decisions at lower TCO with contextual, AI-powered analytics. Last year, Gartner Research published a report titled “Top Trends in Data and Analytics for 2021: The Rise of the Augmented Consumer.” In this report, it was anticipated that organizations will need to broaden their analytics initiatives to augment end-consumers of data insights.

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Pfizer takes stake in Lyme disease partner ahead of key study

Bio Pharma Dive

Valneva will receive $95 million from Pfizer to support development of a vaccine candidate as the French company’s COVID-19 work sputters.

Vaccine 299
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New pricing rules lower access barriers for orphan drugs in France

Pharmaceutical Technology

As recent changes to the price setting of drugs have improved the market access risk environment in France, GlobalData looks at their impact on the pricing of orphan drugs. Changes to price negotiations positive for orphan drugs. The changes in question were introduced via the new contractual agreement signed by the French Pharmaceutical Companies Association (LEEM) and the Ministry of Health’s (MoH’s) Economic Committee for Health Products (CEPS) in March 2021.

Drugs 147
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Sanofi and GSK report successful efficacy results against Omicron

Pharma Times

COVID-19 Beta-containing vaccine provides 75.

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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.