Bio Pharma Dive

NOVEMBER 24, 2021

Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.

Drugs 278

Drugs Trials 278

World of DTC Marketing

NOVEMBER 24, 2021

SUMMARY: The U.S. needs to take substantial steps to address the high costs of cancer drugs. From 2009 to 2019, the median monthly treatment costs for new drugs at launch reached $11,755 in the U.S… Does the question become how much is a month(s) of other life worth? According to an analysis published by JAMA Oncology, prices for new drugs approved for use in the treatment of cancer in the United States more than doubled over the past decade.

Drugs 266

Drugs FDA Approval Research Medicine 266

Bio Pharma Dive

NOVEMBER 24, 2021

The antiviral drug, which has been a research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.

Drugs 169

Drugs Research 169

Pharma Times

NOVEMBER 24, 2021

With the latest approval from the EC, patients in Europe suffering from metastatic triple-negative breast cancer can now receive Gilead Science’s Trodlevy as part of their treatment.

Marketing 122

Marketing 122

Advertisement

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

Clinical Research

Scienmag

NOVEMBER 24, 2021

In sub-Saharan Africa, 7 million people with HIV live more than 10 minutes from health care services and 1.5 million people with HIV live more than 60 minutes from a healthcare facility, according to a new study published this week in the open-access journal PLOS Global Public Health by Diego Cuadros of the University of […].

Research 111

Research Medicine 111

pharmaphorum

NOVEMBER 24, 2021

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Livtencity (maribavir) has been cleared for use in transplant patients aged 12 or over with CMV infections that do not respond to first-line treatment with current antiviral drugs for CMV, such as ganciclovir, valganciclovir, foscarnet and cidofovir.

Drugs 105

Drugs Sales FDA Approval Licensing 105

pharmaphorum

NOVEMBER 24, 2021

The pandemic has propelled issues for the pharmaceutical industry to the top of the political and public agenda, from clinical trial recruitment to the journey required for medicines or vaccines to reach patients. The public knows now more than ever that the Medicines and Healthcare products Regulatory Agency (MHRA) ensures the safety and quality of vaccines and medicines, and that evidence from clinical trials is required for any treatment to be approved.

Life Science 98

Life Science Regulation Medicine Vaccination 98

Pharma Times

NOVEMBER 24, 2021

The leading UK preganancy and baby loss charity Tommy’s have said with the approval of the hormonal drug, as many as 8,450 miscarrages a year could be prevented.

Hormones 93

Hormones Drugs 93

BioSpace

NOVEMBER 24, 2021

With the Thanksgiving holiday upon us, BioSpace felt it was important to give thanks for some of the positive things that have happened this year. And there are many!

98

98

Scienmag

NOVEMBER 24, 2021

Research led by the Centenary Institute and University of Technology Sydney (UTS) has identified a small RNA molecule called microRNA-21 as a therapeutic target and its inhibition as a potential treatment for chronic obstructive pulmonary disease (COPD). Credit: Supplied by Centenary UTS Centre for Inflammation Research led by the Centenary Institute and University of Technology […].

Research 93

Research RNA 93

Advertisement

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

Clinical Trials

pharmaphorum

NOVEMBER 24, 2021

Large biomanufacturing facilities, including some that may be involved in producing COVID-19 vaccines and drugs, are being targeted by a malware threat that seems to have an unprecedented level of sophistication, according to a cybersecurity group. The Bioeconomy Information Sharing and Analysis Center (BIO-ISAC) has gone public with its findings after it launched an investigation of a ransomware attack on an unidentified facility in the spring.

Production 80

Production Vaccination Vaccine Engineer 80

Scienmag

NOVEMBER 24, 2021

Exploring the mechanisms involved in sleep-dependent memory storage, a team of University of Michigan (U-M) cellular biologists found that RNAs associated with an understudied cell compartment in hippocampal neurons vary greatly between sleeping and sleep-deprived mice after learning. Credit: Sara Aton Exploring the mechanisms involved in sleep-dependent memory storage, a team of University of Michigan […].

Medicine 91

Medicine 91

pharmaphorum

NOVEMBER 24, 2021

Patient engagement in pharma is evolving, with some companies doing it better than others. Envision Pharma Group’s Dawn Lobban and Sarah Avent discuss the need to engage with patients at every level for holistic inclusion of the patient voice in order for pharma to become truly patient-centric. The Covid pandemic has sparked people’s interest in science and medicine and empowered the public to make important health choices.

Medicine 59

Medicine Development Production Drugs 59

Scienmag

NOVEMBER 24, 2021

An experimental compound reduced complications of type 1 and type 2 diabetes in mice – not by lowering blood sugar – but by countering its consequences: cell death, inflammation, and organ damage. Credit: Reprinted with permission from A. Schmidt et al., Sci. Transl. Med. 13, eabf7084 (2021). An experimental compound reduced complications of type 1 […].

Medicine 89

Medicine 89

Advertisement

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.

Clinical Supply

pharmaphorum

NOVEMBER 24, 2021

Roche trumpeted a top-line results of the POLARIX trial of its Polivy therapy in previously-untreated B-cell lymphoma, and a first look at the data suggests it is on track for approval in what could be a highly lucrative new market. An abstract of the results published ahead of the upcoming American Society of Haematology (ASH) meeting shows that when added to a standard first-line treatment regimen, Polivy (polatuzumab vedotin) reduced the risk of disease progression, relapse, or death by 27% i

Antibody 59

Antibody Sales Drugs Trials 59

Scienmag

NOVEMBER 24, 2021

Researchers at Stockholm University have developed a resource-efficient method to produce new lignin-based materials that can be thermally reprocessed and used to substitute thermosetting resins and adhesives. Credit: Mika Sipponen Researchers at Stockholm University have developed a resource-efficient method to produce new lignin-based materials that can be thermally reprocessed and used to substitute thermosetting resins […].

Development 89

Development Research 89

pharmaphorum

NOVEMBER 24, 2021

Digital health company Pear Therapeutics has won FDA breakthrough device status for reSET-A, its development-stage prescription digital therapeutic (DTx) for people with alcohol-use disorder. The DTx – also known as Pear-009 – is still in the proof-of-concept trial stage, but draws on the same cognitive behavioural therapy (CBT) deployed in Pear’s commercial-stage products reSET and reSET-O for people living with substance and opioid use disorders. reSET-O was the first prescription DTx ev

Production 59

Production Development Trials 59

Scienmag

NOVEMBER 24, 2021

A new statistical analysis supports beliefs that COVID-19 became more lethal in the U.K. in late 2020, while also suggesting that multiple factors—not just the alpha variant of the virus that causes COVID-19—were to blame. Patrick Pietzonka of the University of Cambridge, UK, and colleagues present these findings in the open-access journal PLOS ONE on […].

Engineer 88

Engineer 88

Advertisement

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.

Clinical Trials

Drug Patent Watch

NOVEMBER 24, 2021

Annual Drug Patent Expirations for SELZENTRY Selzentry is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. There are three patents…. The post New patent expiration for Viiv Hlthcare drug SELZENTRY appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

Drugs Marketing 52

Scienmag

NOVEMBER 24, 2021

CABI and the Rainforest Alliance have signed a Memorandum of Understanding (MoU) to collaborate on ways to help smallholder farmers around the world grow safer and higher quality food – and increase their incomes in the process – through more sustainable agricultural practices. Credit: CABI CABI and the Rainforest Alliance have signed a Memorandum of […].

Engineer 87

Engineer 87

Drug Patent Watch

NOVEMBER 24, 2021

Annual Drug Patent Expirations for JAKAFI Jakafi is a drug marketed by Incyte Corp and is included in one NDA. It is available from one supplier. There are eight patents…. The post New patent for Incyte Corp drug JAKAFI appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52

Drugs Marketing 52

Scienmag

NOVEMBER 24, 2021

The Arctic Ocean has been getting warmer since the beginning of the 20th century – decades earlier than records suggest – due to warmer water flowing into the delicate polar ecosystem from the Atlantic Ocean. Credit: Sara Giansiracusa The Arctic Ocean has been getting warmer since the beginning of the 20th century – decades earlier […].

87

87

Advertisement

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.

Clinical Supply

pharmaphorum

NOVEMBER 24, 2021

Norwegian biotech Vaccibody has changed its name to Nykode Therapeutics, and celebrated its new identity with a sizeable deal with Regeneron to develop vaccines for cancer and infectious diseases. The Oslo-based company is getting $50 million upfront from Regeneron – split between cash and an equity investment – with another $875 million on the table if the partnered projects make headway through development and reach the market.

Vaccination 52

Vaccination Vaccine In-Vivo Manufacturing 52

Scienmag

NOVEMBER 24, 2021

Archaeologists have unearthed the first Roman mosaic of its kind in the UK. Today (Thursday 25th November 2021), a rare Roman mosaic and surrounding villa complex have been protected as a Scheduled Monument by DCMS on the advice of Historic England. The decision follows archaeological work undertaken by a team from University of Leicester Archaeological […].

86

86

pharmaphorum

NOVEMBER 24, 2021

We are excited to share the official programme for the hotly anticipated mRNA- Based Therapeutics Summit Europe ! Taking place in-person in Berlin, Germany on 25 – 27 January 2022 , this is your roadmap to expanding the therapeutic applicability of mRNA- based drugs and vaccines. Check out the official programme here. This meeting will showcase the pioneering work of 25+ European and global leaders across 3 days of content sharing new data and allowing you to stay ahead of the curve.

Vaccination 52

Vaccination Vaccine Gene Therapy RNA 52

Scienmag

NOVEMBER 24, 2021

Retrofitting an existing masonry cavity walled building with a green or living wall can reduce the amount of heat lost through its structure by more than 30%, according to new research. Credit: University of Plymouth Retrofitting an existing masonry cavity walled building with a green or living wall can reduce the amount of heat lost […].

Research 86

Research 86

Advertisement

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.

Clinical Trials

BioTech 365

NOVEMBER 24, 2021

Natural Asthma Symptom Management – AirPhysio OPEP Breathing Device Relaunched Natural Asthma Symptom Management – AirPhysio OPEP Breathing Device Relaunched The award-winning AirPhysio device has been relaunched on the Life Wellness Healthcare online store.

52

52

Scienmag

NOVEMBER 24, 2021

The International Osteoporosis Foundation (IOF) is the world’s largest non-governmental organization dedicated to the prevention, diagnosis, and treatment of osteoporosis, fragility fractures, and related bone diseases. Together with its more than 290 national and regional member societies as well as institutions and hospitals with an interest in musculoskeletal health, IOF carries out projects and programmes […].

86

86

BioTech 365

NOVEMBER 24, 2021

GlycoMimetics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4) GlycoMimetics Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4) ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc.

52

52

Scienmag

NOVEMBER 24, 2021

Immune cells play a key role in mediating inflammatory responses. Dysregulation in signaling mechanisms that operate across immune cells can trigger chronic inflammatory diseases like rheumatoid arthritis that cause pain and swelling in joints. One such immune cell known to be involved in autoimmune diseases is the dendritic cell. The activity of dendritic cells is […].

Regulation 85

Regulation Medicine 85

Advertisement

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.

Clinical Trials