Mon.Oct 05, 2020

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From no drugs to 3: Patients with spinal muscular atrophy now face hard choices

Bio Pharma Dive

The availability of three vastly different, cutting-edge medicines for the rare disease has put patients, families and doctors in an unfamiliar position.

Doctors 312
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Full CPhI & Pharmapack Europe schedule returns in 2021 with live & hybrid events

Pharma Mirror

Informa Markets announces its complete listing of pharma event dates for 2021 at the opening of the first CPhI Festival of Pharma (05 – 16 October 2020) – the largest ever virtual pharma event. The pharma schedule includes one further event in 2020: CPhI China, 16-18 December (hybrid event, combining “live” in-person with “virtual”). In. The post Full CPhI & Pharmapack Europe schedule returns in 2021 with live & hybrid events appeared first on Pharma Mirror Magazine.

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Bristol Myers to buy MyoKardia in $13B bet on targeted drugs for the heart

Bio Pharma Dive

The buyout validates MyoKardia, which parted ways with partner Sanofi in early 2019 and then saw its top medicine succeed in a late-stage study this May.

Medicine 213
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Your.MD secures $30m to expand self-care app Healthily

pharmaphorum

Digital health firm Your.MD has secured $30 million in a Series A round investment led by the consumer health giant Reckitt Benckiser (RB). Your.MD is the company behind the medical-grade, augmented intelligence self-care app Healthily, and will use the funding to accelerate the platform through a series of clinically-validated “health hubs”. Following a seed funding round led by RB and existing shareholders, the now completed Series A funding round will allow the app to reach other markets incl

Doctors 124
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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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With a sweetened offer, BridgeBio plans to reel in a subsidiary

Bio Pharma Dive

After an unsuccessful buyout attempt in 2019, BridgeBio aims to acquire the roughly one-third of Eidos Therapeutics that it doesn't already own.

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Older people first to receive COVID-19 vaccine in UK, says government

pharmaphorum

As European regulators begin a rolling review of AstraZeneca’s COVID-19 vaccine, the focus in the UK has shifted to the government’s plans to distribute any vaccine that is deemed to be a safe and effective way of preventing the disease. According to weekend press reports a rollout of a vaccine could be just three months away – but the feedback from the government is that not everyone will get it, with the target group being around 30 million older people and health workers, less than half the p

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Perspectives on a Post-pandemic World

Pharma Marketing Network

An interview with Mark Bard, Co-Founder of The DHC Group and Justin Grossman, CEO/Managing Partner, meltmedia. In response to this week’s DHC Virtual Summit with Novartis, Mark Bard, Co-founder/Managing Partner, DHC, talked one-on-one with Justin Grossman about how the COVID pandemic will change the world of digital healthcare marketing. Here are some highlights from their discussion.

Sales 98
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BIO: A lack of transparency could threaten confidence in the vaccine development process

BioPharma Reporter

The release of the FDA guidance on emergency use authorization (EUA) for vaccines to prevent the spread of COVID-19 would provide regulatory clarity to scientists and strengthen public confidence in any vaccine authorized by the US regulator, says the Biotechnology Innovation Organization (BIO).

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Perspectives on a Post-pandemic World

Pharma Marketing Network

An interview with Mark Bard, Co-Founder of The DHC Group and Justin Grossman, CEO/Managing Partner, meltmedia. In response to this week’s DHC Virtual Summit with Novartis, Mark Bard, Co-founder/Managing Partner, DHC, talked one-on-one with Justin Grossman about how the COVID pandemic will change the world of digital healthcare marketing. Here are some highlights from their discussion.

Sales 98
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Telemedicine Adoption is on the Rise

VirTrial

The rate of change across today’s clinical research landscape is breathtaking, especially for an industry that has historically been considered slow to adopt. As we face a world-wide pandemic the likes of which we’ve never seen before, our industry plays a critical role in finding a solution. As such, new approaches are required – and the industry is responding.

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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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Wildlife conservation undermines the rights of indigenous people in India

Scienmag

A new EJAtlas map launched by the ICTA-UAB denounces that the current model puts growth and gains before human lives and the nature it is intended to protect Credit: @ashishkothari An interactive map undertaken by the Environmental Justice Atlas team at the Institute of Environmental Science and Technology of the Universitat Autònoma de Barcelona (ICTA-UAB) […].

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White House Blocks FDA's New Proposed COVID-19 Vaccine Guidelines

BioSpace

The sticking point for the White House is a provision in the guidance that calls for vaccine manufacturers to follow people participating in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.

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Grant to help researchers prevent apple fire blight in U.S.

Scienmag

Credit: Allison Usavage, Cornell University ITHACA, N.Y. – The U.S. Department of Agriculture’s National Institute of Food and Agriculture has awarded a $779,000 grant to Cornell AgriTech researchers to combat fire blight, one of the most devastating bacterial diseases for the apple and pear industries. This fall, Awais Khan and Kerik Cox, associate professors of […].

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BMS’ Opdivo plus Yervoy misses the mark in high-risk melanoma

Pharma Times

Combination treatment did not achieve statistical significance in all-comer population

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Diagnosing COVID-19 in just 30 minutes

Scienmag

Credit: POSTECH The year 2020 can be summarized simply by one word – COVID-19 – as it was the culprit that froze the entire world. For more than 8 months so far, movement between nations has been paralyzed all because there are no means to prevent or treat the virus and the diagnosis takes long. […].

Gene 96
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COVID-19 Vaccine Update: Rolling Submissions in EU, Side Effects and Minority Enrollment

BioSpace

A few days ago, CNBC reported that five patients, three in Moderna’s and two in Pfizer’s Phase III trials, had experienced more severe, although transient side effects.

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SWOG Cancer Research Network shines at ASCO Quality of Care Symposium

Scienmag

Credit: SWOG Cancer Research Network Researchers from SWOG Cancer Research Network, a cancer clinical trials group funded by the National Cancer Institute (NCI), part of the National Institutes of Health, will make five presentations as part of the 2020 ASCO Quality Care Symposium, a virtual program of the American Society of Clinical Oncology (ASCO) which […].

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Janssen/MeiraGTx showcase nine-month data for sight loss gene therapy

Pharma Times

Gene therapy demonstrated improvement in retinal sensitivity

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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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Lighting the path to recycling carbon dioxide

Scienmag

Credit: © 2020 KAUST Semiconductive photocatalysts that efficiently absorb solar energy could help reduce the energy required to drive a bioelectrochemical process that converts CO2 emissions into valuable chemicals, KAUST researchers have shown. Recycling CO2 could simultaneously reduce carbon emissions into the atmosphere while generating useful chemicals and fuels, explains Bin Bian, a Ph.D. student […].

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UK startup secures capital to develop its nanosyringes

BioPharma Reporter

Emerging biotech, NanoSyrinx, has announced the closing of a pre-seed financing round to continue developing its ânanosyringesâ, a selective non-viral peptide and protein delivery system.

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University of Alberta virologist awarded Nobel Prize in Physiology or Medicine

Scienmag

Michael Houghton discovered hepatitis C virus and now is developing a vaccine Credit: Photo: Michael Holly Michael Houghton was awarded the 2020 Nobel Prize in Physiology or Medicine today in recognition of his discovery of the hepatitis C (HCV) virus. His discovery with colleagues Qui-Lim Choo and George Kuo in 1989 opened a new field […].

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The tools and techniques making virtual patient simulations more realistic than ever

pharmaphorum

Patient simulations have been a key tool for educating physicians in some form for hundreds of years – and now cutting-edge technologies are helping them become more realistic and informative than ever. Medscape’s Martin Warters tells us more. Learning from a textbook can only take you so far, and when doctors need to put theory into practice in a safe environment, they often turn to patient simulations that use a case study approach to emulate real life clinical scenarios.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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Twisting magnetization with light

Scienmag

Laser pulses enable faster creation of skyrmions in magnets Credit: MBI A team of scientists led by the Max Born Institute (MBI), Berlin, Germany, and the Massachusetts Institute of Technology (MIT), Cambridge, USA, has demonstrated how tiny magnetization patterns known as skyrmions can be written into a ferromagnetic material faster than previously thought possible.

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GSK vs. Teva Patent Infringement Decision Reversal Could Have Broader Implications

BioSpace

In the October 2 verdict, Circuit Judge Pauline Newman said that promotional materials, press releases, product catalogs, FDA labels and witness testimony did support the “induced infringement” judgement against Teva.

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Ludwig study finds a common nutritional supplement might boost cancer immunotherapy

Scienmag

Credit: Ludwig Cancer Research OCTOBER 5, 2020, NEW YORK – A Ludwig Cancer Research study has uncovered a mechanism by which the tumor’s harsh internal environment sabotages T lymphocytes, leading cellular agents of the anticancer immune response. Reported in Nature Immunology, the study describes how a variety of stressors prevalent in the tumor microenvironment disrupt […].

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Investors bet on decentralized trial technology

Outsourcing Pharma

Companies like Biofourmis, THREAD and other virtual tech specialists have seen infusions of funds from investors bullish on decentralized clinical trials.

Trials 72
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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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The best of both worlds: A new take on metal-plastic hybrid 3D printing

Scienmag

Scientists develop a novel and surprisingly simple method to print 3D structures made of metal and plastic, paving the way for 3D electronics Credit: Waseda University Three-dimensional (3D) printing technology has evolved tremendously over the last decade to the point where it is now viable for mass production in industrial settings. Also known as “additive […].

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Amgen's KRAS Inhibitor Sotorasib Effective in Non-Small Cell Lung Cancer

BioSpace

Amgen presented positive topline data from the Phase II CodebreaK 100 trial of sotorasib in KRAS G12C-mutant advanced non-small cell lung cancer (NSCLC).

Trials 75
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Cyanobacteria as “green” catalysts in biotechnology

Scienmag

Cyanobacteria are environmentally friendly and readily available biocatalysts for the production of new chemicals and, thanks to researchers at TU Graz, could soon be used in large-scale technological applications. Credit: Lunghammer – TU Graz Cyanobacteria, despite staining water green through their special pigments, are colloquially known as “blue-green algae”, and convert light energy into chemical […].

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BMS bulks up in cardio with $13.1bn takeover deal for MyoKardia

pharmaphorum

Bristol-Myers Squibb has said it will buy biotech MyoKardia in a $13.1 billion takeover that marks a step up in its development of cardiovascular drugs. The all-cash deal is mainly about MyoKardia’s mavacamten drug that BMS thinks could be a first-in-class treatment for hypertrophic cardiomyopathy (HCM) – a form of heart disease – based on clinical data reported in the spring.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.