Thu.Apr 14, 2022

article thumbnail

AbbVie, Genmab, with new data, prep FDA application for dual-acting cancer drug

Bio Pharma Dive

Fresh trial results intensify competition with Roche to deliver the first lymphoma drug that marries antibody technology with an immunotherapy pathway.

Drugs 361
article thumbnail

Covid comments hurt survivors

World of DTC Marketing

Over 70% of people have been exposed to medical or health-related misinformation. Of those exposed, almost half are not confident in their ability to discriminate between accurate health information and misinformation. Social media is cited as the most common source of misinformation. People on the right use social media to purposely hurt family members who lost loved ones to Covid.

Branding 218
Insiders

Sign Up for our Newsletter

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

article thumbnail

Pfizer, BioNTech to seek FDA OK for booster dose in 5- to 11-year-olds

Bio Pharma Dive

A third shot sparked a strong immune response in clinical testing, positioning the companies to make boosters available to the roughly 28 million kids in the U.S. who became eligible for their first two doses late last year.

article thumbnail

Pfizer set to acquire COVID-19 smartphone detection app for $100m

BioPharma Reporter

Pfizer is set to acquire Australiaâs ResApp - a company developing a smartphone app to detect COVID-19 and other respiratory diseases based on the userâs cough - for $100m AUD ($74m USD).

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

Editas CEO to step down in latest executive change-up

Bio Pharma Dive

A little more than a year after taking on the role, Jim Mullen is preparing to pass the torch to Gilmore O'Neill, who has served as the chief medical officer at Sarepta Therapeutics.

258
258
article thumbnail

Moving away from genetic continental ancestry categories in research and medicine

Scienmag

In a Policy Forum, Anna Lewis and colleagues argue that, for researchers and others who want to invoke genetic ancestry, there is a scientific and ethical imperative to move away from continental ancestry categories and to instead embrace a view of genetic ancestry that reflects continuous variation and historical depth. Such change is a “prerequisite […].

Genetics 123

More Trending

article thumbnail

New patent for Alkermes Inc drug ARISTADA

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are fifteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97
article thumbnail

Xtalks Voices with Laura Dunn Nelson, Alchemy’s Food Safety Expert

XTalks

In this video, Xtalks spoke with Intertek Alchemy’s Laura Dunn Nelson, Vice President of Food Safety and Global Alliances. Laura spoke about her role at Intertek Alchemy and shared the most rewarding aspects of her work. Xtalks also asked Laura to discuss the challenges that companies are having today with their food safety culture. Laura has more than 30 years of experience implementing food safety and quality control programs for packaging, processing, retail operations and food service.

article thumbnail

Ultrasonic tech to develop safer railway track lubrication measurement system

Scienmag

THE University of Huddersfield has forged a partnership with an innovative technology business to work with Network Rail on developing a safer and more reliable track lubrication measurement system. Credit: University of Huddersfield THE University of Huddersfield has forged a partnership with an innovative technology business to work with Network Rail on developing a safer […].

article thumbnail

FDA draft guidance outlines path to increased trial inclusivity

BioPharma Reporter

The US agencyâs latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

Trials 98
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

WVU researcher develops data-driven approach to help reduce drug costs and treat diseases

Scienmag

A new data-driven mechanistic approach that predicts cell types within tissue will help to reduce drug costs and treat diseases that were difficult to develop drugs for, according to a West Virginia University scientist. Credit: West Virginia University A new data-driven mechanistic approach that predicts cell types within tissue will help to reduce drug costs […].

article thumbnail

NICE recommends Merck’s Tepmetko for lung cancer treatment

Pharma Times

Approval demonstrates significant step forward in the treatment of adult advanced NSCLC patients with METex14

100
100
article thumbnail

Brazilian study finds COVID-19 cases and deaths higher in areas with electoral support for President Bolsonaro

Scienmag

In a study to be presented at this year’s European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Lisbon, Portugal (23-26 April), researchers from Sociedade Mineira de Infectologia and Associação Mineira de Epidemiologia e Controle de Infecções show a correlation between the Brazilian President Jair Bolsonaro’s denialist attitude to COVID-19 and higher COVID-19 incidence […].

article thumbnail

Patient backlog caused by COVID ‘could take six years to clear’

pharmaphorum

The massive backlog in patient care across Europe resulting from the pandemic will take at least three years to clear and in some cases as long as six years, says a new study. The research from Censuswide stems from surveys of oncologists and surgeons across six European countries, which found that 20% of them estimate clearing the backlog will take between four and six years.

Doctors 78
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

Urgent action required to protect world’s coral reefs from disappearing within three decades, warn experts

Scienmag

An international team of environmental scientists have published a series of significant recommendations to protect, conserve and study the world’s coral reefs – the ‘canaries in the coal mine’ of climate change. Credit: Tom Vierus © WCS An international team of environmental scientists have published a series of significant recommendations to protect, conserve and study […].

article thumbnail

Pfizer makes bid for ResApp and its respiratory diagnosis apps

pharmaphorum

Pfizer’s Australian unit has tabled an offer to buy ResApp Health and its smartphone apps for the management and diagnosis of respiratory diseases in a deal that values the digital health company at around A$100 million (around $75 million). Pfizer is offering A$0.115 per share in cash for ResApp, a deal which has been accepted by the company’s directors and recommended to shareholders ahead of a vote scheduled in June.

article thumbnail

Paper on the geography of innovation awarded prize from the royal economic society

Scienmag

Toronto – A paper co-authored by Prof. Ruben Gaetani of the University of Toronto is the recipient of the 2021 Austin Robinson Memorial Prize from the Royal Economic Society. The prize is awarded annually for the best paper published in The Economic Journal by authors who are within five years of receiving their PhDs.’ Credit: […].

88
article thumbnail

ISA Pharmaceuticals announce new trial testing technology for cancers

Pharma Times

Trial of Amplivant will begin in a number of cancer patients including those with ovarian cancer

Trials 98
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

Development of metastable-phase advanced material synthesis technology

Scienmag

Similar to the widespread interest in “graphite” and “diamond,” there is growing interest in metastable phases, which have different physical properties than those of stable phases. However, processes to fabricate metastable-phase materials are highly limited. Novel findings have been published about the development of a new metastable-phase synthesis method, which can drastically improve the physical […].

article thumbnail

AbbVie preps filings for lymphoma bispecific licensed from Genmab

pharmaphorum

Two years after signing a $3.9 billion alliance with Genmab to find new cancer therapies, AbbVie has said it is ready to start talking to regulators about filing for approval of the lead drug in the partnership – epcoritamab for large B-cell lymphoma (LBCL). The drugmaker has reported top-line results from the phase 1/2 EPCORE trial of epcoritamab as a third-line therapy for relapsed/refractory LBCL, revealing an overall response rate of 63% and a median duration of response of 12 months.

article thumbnail

Factors including extreme winds, topography and vegetation influenced the severity of burns from Oregon’s devastating 2020 megafires

Scienmag

In early September 2020, severe winds, high heat, and prolonged drought conditions led to the explosive growth of wildfires along the western slopes of the Cascades Mountains in the Pacific Northwest. The fires engulfed enormous tracts of forestland, destroyed communities, took dozen of lives, and cost hundreds of millions to fight. Credit: Cody Evers In […].

87
article thumbnail

ICER says bluebird bio’s $2.1m gene therapy is cost-effective

pharmaphorum

US cost-effectiveness watchdog ICER has handed bluebird bio some good news ahead of its FDA advisory committee meeting for rare blood disorder gene therapy beti-cel in June, by endorsing its proposed $2.1 million price tag. ICER’s assessment is still at the draft stage and could be changed after an ongoing comment period, but will be welcomed by bluebird and other gene therapy developers as they try to set a price for their one-shot treatments that will be accepted by payers.

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

MAGIC telescopes observe nova explosion

Scienmag

Light on, light off – this is how one could describe the behavior of the nova, which goes by the name RS Ophiuchi (RS Oph). Every 15 years or so, a dramatic explosion occurs in the constellation of the Serpent Bearer. Birthplaces of a nova are systems in which two very different stars live in […].

article thumbnail

New patent for Teva Pharm drug AIRDUO DIGIHALER

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+DIGIHALER Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are twenty-two…. The post New patent for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Going beyond the limit: WVU researcher develops novel exposure assessment statistical methods for Deepwater Horizon oil spill study

Scienmag

Nearly 12 years after the Deepwater Horizon oil spill, scientists are still examining the potential health effects on workers and volunteers who experienced oil-related exposures. Credit: Submitted Photo/NIEHS Nearly 12 years after the Deepwater Horizon oil spill, scientists are still examining the potential health effects on workers and volunteers who experienced oil-related exposures.

article thumbnail

New patent for Teva Pharm drug AIRDUO RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from four suppliers. There are sixteen…. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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

Scientists identify novel approach to preventing seizures

Scienmag

Scientists at Trinity College Dublin have announced a significant advance in our understanding of epilepsy, as they have identified a potential method of preventing damaging seizure activity. Credit: Trinity College Dublin Scientists at Trinity College Dublin have announced a significant advance in our understanding of epilepsy, as they have identified a potential method of preventing damaging seizure […].

article thumbnail

New patent for Teva Pharm drug ARMONAIR RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
article thumbnail

Drug reduced frequency of breathing pauses in sleep apnea

Scienmag

A new University of Gothenburg study has paved the way for the first drug treatment for sleep apnea. Compared to before receiving the treatment, breathing pauses decreased with on average more than 20 per hour for patients given the drug. Credit: Photo by Johan Wingborg A new University of Gothenburg study has paved the way […].

Drugs 84
article thumbnail

New patent for Alkermes Inc drug ARISTADA INITIO KIT

Drug Patent Watch

Annual Drug Patent Expirations for ARISTADA+INITIO+KIT Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Alkermes Inc drug ARISTADA INITIO KIT appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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.