Sat.Apr 24, 2021 - Fri.Apr 30, 2021

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FDA panel largely backs speedy cancer drug approvals, forcing tough choice for agency

Bio Pharma Dive

Over three days of meetings, a group of FDA advisers discussed the tough trade-offs of accelerated immunotherapy approvals. Their decisions could escalate an already intense debate.

Drugs 334
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Pharma websites tracking visitors

World of DTC Marketing

WHAT”S UP WITH THAT: A quick analysis of two pharma websites shows that Facebook, and others, are tracking users. Does pharma even know or care? With the release of Apple’s latest updates, privacy has suddenly become a big issue, especially for Facebook. So why then are some pharma websites tracking visitors for Facebook? As the diagrams below indicate both Enbrel.com and Humira.com are allowing Facebook to track visitors so they can serve them ads.

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Plant-based COVID-19 vaccine candidate starts rolling review with Health Canada

BioPharma Reporter

Medicago has started a rolling submission with Health Canada for its plant-derived adjuvanted COVID-19 vaccine candidate: championing a unique and versatile platform that can also be scaled up easily.

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Death, Disability Among Side Effects of Chinese COVID-19 Vaccines, Leaked Documents Reveal

BioSpace

Leaked documents from provincial and municipal governments in China reveal a slew of previously unreported severe adverse events related to COVID-19 vaccines made and administered in China.

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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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BioMarin partners with Allen Institute to develop gene therapies for the brain

Bio Pharma Dive

Far along in testing for a hemophilia treatment, BioMarin is expanding its gene therapy research into diseases of the central nervous system and aims to use some of the institute's technology.

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Doctors don’t have time for digital

World of DTC Marketing

QUICK READ: Patients are returning to their doctor’s office, and it’s not uncommon for appointments, or routine visits, to be scheduled weeks or months in advance. I talked to some thought leaders, and they said that they don’t have time for either virtual patient visits or online pharma detailing. About this time, every year, I get my annual physical, which is more like a request for a blood workup.

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Positive topline results for nirsevimab in RSV

Pharma Times

Monoclonal antibody reduced lower respiratory tract infections due to RSV in healthy infants

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Wall Street fears Amgen's tough first quarter is just the start

Bio Pharma Dive

Product sales fell by 5% in the first quarter, keeping the pressure high for Amgen to deliver on expectations for its KRAS cancer drug Lumakras.

Sales 321
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Using PK Modeling and Simulation to Plan Studies for Pediatric Patient Populations

Camargo

Conducting a clinical study in a pediatric patient population requires careful planning, as providing a benefit to a child without causing harm is a weighty responsibility. The first tasks in striking this balance are dose selection and dosing interval determination, and this blog post offers an overview on how PK modeling and simulation can be applied to optimize the safety and efficacy of a product for pediatric populations in clinical trials.

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CPhI post-pandemic executive pharma survey: COVID-19 driving manufacturing and CDMOs driving growth

Pharma Mirror

Ahead of CPhI Discover (17th-28th May, 2021) – global pharma’s largest ever virtual gathering – the CPhI executive post-pandemic pharma survey[i] predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next five years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.

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

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Chiesi's Raxone recommended for use within NHS Wales

Pharma Times

Medicine recommended for the treatment of visual impairment in Leber’s Hereditary Optic Neuropathy

Medicine 123
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Merck, GSK vaccine sales hit by pandemic as competitors' business booms

Bio Pharma Dive

Both companies blamed the impact of COVID-19 on sharp declines in sales of their shingles, pneumonia and HPV shots.

Sales 312
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Jolly Good/Teijin Pharma develop VR digital therapeutics for depression

pharmaphorum

Technology firm Jolly Good and Teijin Pharma have begun a partnership to develop virtual reality digital therapeutics (VR DTx) for major depressive disorder. The goal of the partnership for approval for the Japanese market from the Pharmaceuticals and Medical Devices Agency (PMDA). Jolly Good has already won a “Home Healthcare Award” in a programme held by Teijin in December last year.

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AavantiBio and Catalent Announce Partnership to Support Development and Manufacturing of Gene Therapies for Rare Genetic Diseases

Pharma Mirror

AavantiBio, a gene therapy company focused on transforming the lives of patients with rare genetic diseases, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced a partnership to support the development and manufacturing of AavantiBio’s gene therapies, including its lead program in Friedreich’s Ataxia (FA).

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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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Over a quarter of UK adults have received both COVID-19 vaccine doses

Pharma Times

UK government has also offered a first vaccine dose to all individuals in cohorts one to nine

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FDA gives first citation to biotech for failure to report clinical trial details

Bio Pharma Dive

The agency threatened to fine Acceleron for not posting study results to clinicaltrials.gov. Whether the action is a sign of a larger crackdown is unclear.

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AstraZeneca Hits Another Bump in the Road to COVID-19 Vaccine Approval in the US

BioSpace

AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth.

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CPhI Japan celebrates return, as cell & gene therapies and digital innovation highlighted

Pharma Mirror

Tokyo 27th April 2021: CPhI Japan, the first large pharma event to trade in 2021, played host to 7214 attendees at the exhibition and a further 7204 virtual users from across the globe. The event, a key marker for the strength of the regional industry, has rebounded quickly with some 216 exhibitors searching for pharma partners. In fact, such has been the demand, CPhI Japan Connect – the event’s digital platform for international audiences – will remain open until the end of May.

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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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NHS England announces the departure of chief executive Simon Stevens

Pharma Times

Stevens will step down from the leadership role officially on 31 July

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Vertex moves pain drug into mid-stage testing

Bio Pharma Dive

VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain.

Drugs 304
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Not just COVID-19 vaccines: 5 things that cause blood clots

pharmaphorum

Reports of COVID-19 vaccinations causing blood clots has caused alarm in the general population. However due to the rarity of incidences from vaccination, myGP explores the most common causes of blood clots and how we can prevent them. Over 11 million doses of COVID-19 vaccines have been given across the UK, with blood clotting observed in a small sample of patients.

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Scivita Medical Raises Nearly RMB0.4 Billion in Series A Funding Round and Strives to Build A World-leading Platform for Innovative Products in Endoscope and Related Fields

Pharma Mirror

Scivita Medical Technology Co., Ltd. (“Scivita Medical”) announced that it has raised nearly RMB0.4 Billion in Series A funding round, which has become one of the highest financing projects in the field of endoscope in China in recent years. The investment was jointly led by GL Ventures and Lilly Asia Ventures, with contribution from Matrix Partners China, Medtronic, Chengwei Capital and Shanghai Innochip Investment.

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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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Tagrisso moves closer towards EU approval for early-stage lung cancer

Pharma Times

Therapy wins a positive CHMP opinion for the adjuvant treatment of early-stage EGFR-mutated NSCLC

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Under pressure, Biogen will allow some patients early access to experimental ALS drug

Bio Pharma Dive

Biogen plans to start a compassionate use program in July that would let a small group of patients with rapidly progressing disease access its drug.

Drugs 279
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The role of data science and text mining in the search for new therapies

pharmaphorum

Today, most drug discovery programmes begin with the identification and validation of disease modifying biological targets. The primary way to uncover these targets is through searching and reviewing published scientific literature. Eric Gilbert explores how data science techniques like text mining are speeding up research into areas such as pancreatic cancer.

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Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy

XTalks

After years of disappointing malaria vaccine trials, a malaria shot developed by researchers at the Jenner Institute at the University of Oxford has demonstrated an unprecedentedly high efficacy of 77 percent, and may be the magic bullet the world has been waiting for against the deadly disease. The results come from a Phase II trial of the vaccine, called R21/Matrix-M (MM), which have been published in a pre-print study in the journal The Lancet.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Government injects £37m into genomics and data-driven initiatives

Pharma Times

Health Secretary reveals government’s plans for UK life sciences 'transformation'

Genome 114
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Pfizer buys infectious disease biotech Amplyx

Bio Pharma Dive

The deal is another sign of Pfizer's interest in infectious disease beyond COVID-19, following the pharma's participation in an industry investment fund.

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Cognoa files paediatric autism diagnosis device with FDA

pharmaphorum

Cognoa has filed for FDA approval of a digital device that could be used to diagnose autism, which the company argues could redefine care standards. . Autism can be difficult to diagnose as there are no medical markers to show its presence – instead doctors look at the child’s developmental history and behaviour to make a diagnosis. Cognoa hopes to change this with an efficient and accurate approach that could allow diagnosis in primary care that won’t require a lengthy referral to a specialist.

Doctors 105
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Health Care in the U.S., as Seen From Abroad

NY Times

We asked eight people around the world what they thought. It didn’t go well.

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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.