Tue.Apr 06, 2021

article thumbnail

New CAR-T therapy from Bristol, Bluebird effective but too costly, ICER finds

Bio Pharma Dive

The influential drug cost watchdog recommended a discount of between 37% and 54% to the $419,500 list price the companies charge for Abecma, a multiple myeloma cell therapy cleared by the FDA in March.

Drugs 296
article thumbnail

Is disability the last bastion of the representation debate?

pharmaphorum

From #MeToo to Black Lives Matter, as a society we have been discussing the relationship between representation and equality more than ever over the last few years. . But while progress is being made in so many areas, people with disabilities are still struggling to find a voice above the accepted narrative, says Ross Lannon, the 27-year-old blogger and multi-media content creator behind A Life on Wheels.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Ionis cuts jobs at a former spinout and inks new deal with Sobi

Bio Pharma Dive

Some seven months after acquiring the rest of Akcea Therapeutics, Ionis is laying off most of its subsidiary's staff and turning to Sobi to sell its drugs.

Drugs 273
article thumbnail

How COVID-19 Impacted the Food Supply Chain For Better and for Worse

XTalks

Most grocery shoppers won’t soon forget the perplexing moment last spring when shelves were suddenly bare. Where flour, pasta and other shelf-stable goods once sat in abundance quickly emptied to nothing but price tags. The same went for meat and dairy. It was a shocking, yet humbling, sight for most. The news of farmers dumping milk, letting crops rot and euthanizing chickens only added to the disarray.

article thumbnail

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

article thumbnail

New data push a biotech's muscle disease drug closer to a key test

Bio Pharma Dive

An experimental medicine from Scholar Rock could complement drugs from Biogen, Novartis and Roche, though its benefit needs to be proven in further study.

Drugs 208
article thumbnail

First Non-Surgical Heart Valve Wins FDA Approval for Severe Pulmonary Valve Regurgitation

XTalks

The US Food and Drug Administration (FDA) has granted approval to the world’s first non-surgical pulmonary valve to treat severe pulmonary valve regurgitation, a condition often resulting from congenital heart disease. The device, developed by world-leading medical technology company Medtronic , is indicated for both pediatric and adult patients who have severe pulmonary valve regurgitation.

More Trending

article thumbnail

Best Lacri-Lube alternative eye ointments

Druggist

Lacri-lube has been out of stock for months. Still, after all this time, some patients get repeat prescriptions issued with Laci-Lube on it. Patients who have Lacri-Lube eye ointment on their ‘repeats’ should contact their surgery and ask to remove it and replace it with Lacri-lube alternative eye ointments. I will list in this post the best Lacri-Lube alternative eye ointments and gels.

article thumbnail

Could Moderna shot save UK’s under-50s COVID vaccination push?

pharmaphorum

People in the UK will start receiving doses of Moderna’s COVID-19 vaccine in around two weeks’ time, according to vaccines minister Nadhim Zahawi. The roll-out of the third coronavirus shot will come as the UK exits its second lockdown round, and in time to offset an anticipated dip in supply of the Oxford University/AstraZeneca AZD1222 vaccine in the coming weeks.

article thumbnail

BioNTech’s ambitions for 2021 and beyond: ‘We will apply the capabilities we have developed with COVID-19 to rapidly advance other innovative medicines to the market’

BioPharma Reporter

When BioNTech calls 2020 a transformational year, itâs something of an understatement: with the company partnering with Pfizer to bring the first mRNA COVID-19 vaccine to market. So whatâs next? BioNTech pledges to accelerate and expand its innovation pipeline with projects such as new mRNA vaccines and a boosted oncology pipeline to âbuild a 21st century global immunotherapy powerhouseâ.

article thumbnail

PharmaTimes announces the launch of the Communications Awards for 2021

Pharma Times

The 2021 Communications Awards have opened their doors for entry, inviting the very best in pharma communications to come forward and claim first prize.

65
article thumbnail

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

article thumbnail

‘Brain glue’ helps repair circuitry in severe TBI

Scienmag

Reparative hydrogel mimics the composition and mechanics of the brain Credit: University of Georgia At a cost of $38 billion a year, an estimated 5.3 million people are living with a permanent disability related to traumatic brain injury in the United States today, according to the Centers for Disease Control and Prevention. The physical, mental […].

article thumbnail

Four Biopharma Companies Raise Big Bucks in Series B Financing Rounds

BioSpace

It takes money to develop new, innovative treatments and this morning, multiple companies have announced significant fundraises. A summary of each financing round is below.

article thumbnail

SwRI’s 100-kg small satellite platform added to NASA’s RDSO catalog

Scienmag

SwSP-100 now available through the $6 billion Rapid Spacecraft Acquisition IV contract Credit: SwRI SAN ANTONIO — April 6, 2021 — NASA has selected Southwest Research Institute’s 100 kg-class small satellite (SmallSat) platform to be listed in the Rapid Spacecraft Development Office (RSDO) IV catalog used by the U.S. government to rapidly contract for flight-proven […].

article thumbnail

COVID-19 Long Haulers: Real-Time Research Clarifying the Condition

BioSpace

The landscape may begin to become clearer as real-time research continues to emerge about the long-term effects of COVID-19 infection.

article thumbnail

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.

article thumbnail

IN SILICO chronicles the promises and pitfalls of big neuroscience

Scienmag

Credit: Couple 3 Films April 6, 2021 – NEW YORK – With major funding from the Alfred P. Sloan Foundation, the film IN SILICO is bringing the opportunities and challenges of “big data” neuroscience to virtual screens across North America on April 30th. The independent documentary chronicles an audacious 10-year quest to simulate the entire […].

article thumbnail

NIH to Back First Phase II Trials for COVID-19 Therapy Targeting Viral Proteases

BioSpace

The $3.1 million NCATS grant will help the company test SPI-1005 in two trials, both OK’d by the U.S. Food and Drug Administration (FDA) last August.

Trials 70
article thumbnail

‘The Futures of Feminism’, a new book by Professor Emerita Valerie Bryson

Scienmag

Credit: Manchester University Press WHO needs feminism? The short answer to this question is everyone. This and the issues involved were discussed when a panel of inspirational women came together to celebrate the launch of a new book titled, The Futures of Feminism written by the University of Huddersfield’s Professor Emerita of Politics, Valerie Bryson. […].

59
article thumbnail

Marketing to HCPs as We Emerge From the COVID-19 Pandemic

Intouch Solutions

In the face of relentless trauma, how can pharma more effectively convey important information while also building, improving, and sustaining relationships with HCPs as they care for patients? An Intouch MD weighs in. The post Marketing to HCPs as We Emerge From the COVID-19 Pandemic appeared first on Intouch Solutions.

article thumbnail

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.

article thumbnail

FDA green lights Oxehealth vital signs monitoring software

pharmaphorum

UK digital health company Oxehealth has claimed FDA approval for software that can be used to remotely measure vital signs like heart and breathing rates from a camera feed. . Oxehealth Vital Signs – which has been approved as a class IIa medical device in Europe since 2018 – operates as part of the company’s Oxevision platform, which consists of an optical sensor installed in a patient’s room and provides continuous remote monitoring.

Nurses 59
article thumbnail

New super parallel computer system ‘KAGAYAKI’ based on Dell at JAIST now in operation

Scienmag

Provides 2.24x higher performance than previous system Credit: JAIST and Dell Technologies Japan Advanced Institute of Science and Technology (“JAIST”; Nomi City, Ishikawa Prefecture ; President: Minoru Terano) and Dell Technologies Co., Ltd. (Kawasaki City, Kanagawa Prefecture ; President: Toshihiko Otsuka ) announced JAIST adopted Dell EMC PE R6525 SCS, a supercomputer system based on […].

article thumbnail

Wales forms authority to drive digital health in NHS

pharmaphorum

A new organisation dedicated to increasing the use of digital health in the NHS in Wales has come into being, 18 months after the move was first unveiled by the Welsh government. . Digital Health and Care Wales (DHCW) – which has emerged from the now defunct NHS Wales Informatics Service (NWIS) – will be tasked with providing the national technology and data services needed by patients and clinicians.

article thumbnail

Healthy Ways to Resolve Workplace Conflict and Preserve Your Business Relationships

BioSpace

Workplace conflict is bound to happen throughout your career. Learn how to take advantage of moments of discord to identify opportunities for growth, learning, and collaboration while also steering clear of highly toxic people who thrive on conflict.

57
article thumbnail

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.

article thumbnail

Discovery is key to creating heat-tolerant crops

Scienmag

Researchers identify gene that helps plants sense heat Credit: Meng Chen/UCR By 2050 global warming could reduce crop yields by one-third. UC Riverside researchers have identified a gene that could put the genie back in the bottle. Warmer temperatures signal to plants that summer is coming. Anticipating less water, they flower early then lack the […].

Gene 56
article thumbnail

Twice-weekly coronavirus tests for all

Pharma Times

Everyone in England, including those without symptoms, will be able to take a free rapid coronavirus test twice a week

65
article thumbnail

Artios, Novartis Aim to Develop and Discover DDR Targets for Cancer in New Partnership

BioSpace

Artios Pharma Limited has entered into a global research collaboration with Novartis for the purpose of discovering and validating next-generation DDR targets and enhancing Novartis’ radioligand therapies.

article thumbnail

Key brain molecule may play role in many brain disorders

Scienmag

Scientists discovered microRNA-29 is an important cellular switch controlling late-stage brain development, a foundational discovery that will help researchers explore new therapeutic approaches for neurodevelopmental conditions. Credit: Deshmukh Lab, UNC School of Medicine CHAPEL HILL, NC – A team led by scientists at the UNC School of Medicine identified a molecule called microRNA-29 as a […].

article thumbnail

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.

article thumbnail

Vaccitech Confidentially Files for IPO in the US

BioSpace

At this time Vaccitech hasn’t priced its offering, although the report suggests they might sometime this month.

76
article thumbnail

The incredible bacterial ‘homing missiles’ that scientists want to harness

Scienmag

A Berkeley Lab-led team is digging into the bizarre bacteria-produced nanomachines that could fast-track microbiome science Credit: Antara Mutalik Imagine there are arrows that are lethal when fired on your enemies yet harmless if they fall on your friends. It’s easy to see how these would be an amazing advantage in warfare, if they were […].

article thumbnail

NICE backs restricted use of Ondexxya

Pharma Times

Funding backed for reversal of gastrointestinal bleeds but not for intracranial haemorrhage

72
article thumbnail

New research evaluates effects of pregnancy-related hormones on hepatic drug-metabolizing enzymes

Scienmag

Research provides insight into mechanistic factors that alter hepatic drug disposition during pregnancy Credit: BioIVT BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it will be hosting a webinar on April 8 at 11 a.m. ET entitled “Effect of Pregnancy-related Hormones on CYP Induction: Implications for […].

article thumbnail

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.