Wed.Mar 23, 2022

article thumbnail

GSK partners with LifeMine as startups advance plans to make drugs from fungi

Bio Pharma Dive

The deal, announced alongside a $175 million round, makes biotech entrepreneur Greg Verdine's startup the most well-funded among an emerging group of companies searching for drugs in fungal DNA.

DNA 317
article thumbnail

Do patients care about accelerated approval drugs?

World of DTC Marketing

Accelerated Approval allows for early access to drugs and biologics based on initial evidence of safety and effectiveness, while confirmatory studies required to verify clinical benefits are ongoing. Do patients care? No. Accelerated Approval was developed in 1992 in response to the HIV/AIDS crisis and has led to expedited drug and biologic approvals in several disease areas across the FDA.

Drugs 200
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 claims study success for drug key to Arena buyout

Bio Pharma Dive

Etrasimod, the basis of the $7 billion acquisition and a potential rival to Bristol Myers Squibb's Zeposia, has cleared the first of two trials in ulcerative colitis.

Drugs 282
article thumbnail

Join the annual conference 2022

Deltaclinical

Don’t miss us at the Annual Conference by Healixia on March 24th! A great opportunity to network with likeminded in the field of patient centric solutions for healthcare. ???? ???? Our managing director Geert Briers will be hosting a break-out session about Home Therapy. ???? Afterward Geert will be able to answer any additional questions regarding his vast experience in the field of clinical home studies.

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

Moderna, with new data, to seek clearance for COVID-19 vaccine in young children

Bio Pharma Dive

Study results showed two shots of Moderna's vaccine led to similar immune responses as has been observed in young adults, although protection versus omicron was modest.

article thumbnail

Join the annual conference 2022

Deltaclinical

Don’t miss us at the Annual Conference by Healixia on March 24th! A great opportunity to network with likeminded in the field of patient centric solutions for healthcare. ?. ? Our managing director Geert Briers will be hosting a break-out session about Home Therapy. ? Afterward Geert will be able to answer any additional questions regarding his vast experience in the field of clinical home studies.

More Trending

article thumbnail

Join the annual conference 2022

Deltaclinical

Don’t miss us at the Annual Conference by Healixia on March 24th! A great opportunity to network with likeminded in the field of patient centric solutions for healthcare. Our managing director Geert Briers will be hosting a break-out session about Home Therapy. Afterward Geert will be able to answer any additional questions regarding his vast experience in the field of clinical home studies.

article thumbnail

Pharma’s ambition in connected health not yet matched by execution

pharmaphorum

Four out of five biopharma companies think that the market opportunity for connected health products exceeds their traditional drug business, but adoption remains low, with only 20% of use cases at present going beyond proof of concept. That’s one of the conclusions of a new study by Capgemini, which suggests that the number of approved connected health offerings – digital health products and services including wearables, digital therapeutics and software-as-a-medical-device (SaMD) – will

article thumbnail

Moderna to Seek Authorization of Its Coronavirus Vaccine for Young Children

NY Times

The company said the vaccine produced a strong immune response in children younger than 6, but proved only about 40 percent effective in preventing symptomatic Covid-19.

article thumbnail

Is your digital communication strategy up to par?

pharmaphorum

Whether you’re a large pharma company or a small, emerging one, communication is key. Success or failure hinges on communicating the advantages of your offerings to both prescribing providers and patients. Join us on Tuesday 12 th April at 13:00 BST / 14:00 CET / 8:00 am EDT as panelists lay out how a better approach to communication can lead to improved patient outcomes, preventing drop-off rates, better predicting product forecasts, increasing script volume, integrating localised digital strat

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

Specific lung cancer screening and treatment policies urgently needed to address international disparities in survival

Scienmag

Lugano, Switzerland, 23 March 2022 – A consensus reached by a lung clinical community within the International Cancer Benchmarking Partnership (ICBP), (1) presented at the European Lung Cancer Congress (ELCC), 30 March – 2 April 2022, has highlighted international disparities in management and outcomes of patients with lung cancer in high-income countries, and has provided a […].

90
article thumbnail

Etrasimod data suggests Pfizer’s $6.7bn gamble on Arena will pay off

pharmaphorum

It’s only been two weeks since Pfizer closed its $6.7 billion takeover of Arena Pharmaceuticals, and it already has the positive data it was hoping for with etrasimod, the main asset in the deal. In its first phase 3 readout, oral S1P receptor modulator etrasimod met its objectives in patients with moderately-to-severely active ulcerative colitis, who had previously failed or were intolerant to at least one prior conventional, biological or JAK inhibitor therapy.

Sales 98
article thumbnail

New study reveals pandemic-specific depression and anxiety among individuals with multiple sclerosis

Scienmag

East Hanover, NJ, March 23, 2022. Kessler Foundation researchers published results of a survey of the emotional outcomes of individuals with multiple sclerosis (MS) during the COVID-19 pandemic. Comparison of data collected during the pandemic with pre-pandemic data for the study sample suggests the occurrence of pandemic-specific depression and anxiety.

article thumbnail

Handover of senior R&D roles at Merck continues, as Roy Baynes exits

pharmaphorum

Merck & Co’s chief medical officer and head of clinical development Dr Roy Baynes has announced his retirement from the company to take up a new role alongside his former colleague Roger Perlmutter at biotech Eikon Therapeutics. Baynes will bring a nine-year stint at Merck, known as MSD outside North America, to an end in July, when he will be replaced by Dr Eliav Barr, currently senior vice president of global clinical development.

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

A model that mimics malformation associated with severe epilepsy paves way to novel therapies

Scienmag

Focal cortical dysplasia is a malformation of the cerebral cortex associated with one of the most severe types of epilepsy. Treatment is difficult owing to a lack of effective drugs or access to surgery. A new human model developed by researchers at the University of Campinas (UNICAMP) in the state of São Paulo, Brazil, using […].

article thumbnail

Huma and AstraZeneca collaborate to advance digital innovation

Pharma Times

Digital-first patient care is a priority as the companies join forces to improve patients' lives

110
110
article thumbnail

Women left in the dark when faced with a breech birth

Scienmag

New Edith Cowan University (ECU) research has revealed Western Australian women with a breech presenting baby may feel pressure to have a caesarean section, without being informed of all options available to them. Credit: Unsplash New Edith Cowan University (ECU) research has revealed Western Australian women with a breech presenting baby may feel pressure to […].

article thumbnail

NHS contacting five million people for fourth COVID-19 vaccination

Pharma Times

Groups including those aged over 75-years-old, care home residents and the immunocompromised will be entitled to a fourth jab

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

Combining Black racial groups hides health disparities in breastfeeding

Scienmag

Combining Black Racial Groups Hides Health Disparities in Breastfeeding A new study from Amira Roess in the Department of Global and Community Health highlights the differences in breastfeeding initiation between African Americans and Black immigrants enrolled in the Washington, D.C. WIC supplemental nutrition program. Illnesses such as sudden infant death syndrome, asthma, and obesity disproportionally […].

84
article thumbnail

Government pledges to work with industry to make UK a genomics leader

pharmaphorum

With initiatives like The 100,000 Genome Project, the UK has led the world on genomic research. In a bid to maintain that position, the governments of all four UK nations have now pledged their support for the sectors’ industry players. Representatives from industry associations and the governments and NHS in all four UK nations will meet to discuss the future of the country’s genomics sector.

Genome 72
article thumbnail

Targeted demand response reduces price volatility of electric grid

Scienmag

Demand response, a measure taken to reduce the energy load in response to supply constraints, within the Texas electric grid has been a topic of recent conversation after the wake of Winter Storm Uri just one year ago. Demand response can enhance the reliability of the grid through renewable energy penetration and also significantly reduce […].

article thumbnail

Unlocking the potential of healthcare data for commercial clinical research

pharmaphorum

In this webinar, speakers from the NIHR and Roche will discuss what data is available to life science companies and CROs, how it’s currently being used for research planning and placement, and what more could be done with that data. They’ll also look at what culture and process changes will be required to make sure this data can be readily translated into insights to improve commercial research delivery.

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

New tests and treatments developed in mice for pulmonary fibrosis

Scienmag

URBANA, Ill. – Scientists at the University of Illinois at Urbana-Champaign and Mie University in Japan have developed monoclonal antibodies that prevent lung cell death in mouse models for idiopathic pulmonary fibrosis (IPF) and acute respiratory disease syndrome (ARDS). The advance, along with new, non-invasive diagnostic tools presented in the same study, could be a […].

article thumbnail

Roche donates additional medicines and diagnostics for Ukraine

The Pharma Data

Roche today announced the donation of additional medicines and diagnostics to Ukraine. Beyond the already communicated 150,000 packs of an antibiotic medicine the new donation includes another 4,600 packs of specialized medicines for the treatment of influenza, rheumatoid arthritis, SMA and various cancers. We are also donating reagents and consumables for automatic testing of up to 120,000 blood donations and 31,000 units for diabetes management.

article thumbnail

American Gastroenterological Association selects 18 future leaders

Scienmag

Bethesda, MD (March 23, 2022) – The American Gastroenterological Association (AGA) has selected 18 distinguished early career gastroenterologists and hepatologists for its 2022-2023 class of AGA Future Leaders. The 18-month program cultivates effective leadership skills for professional advancement in AGA and within the field of digestive diseases. Credit: American Gastroenterological Association Bethesda, MD (March 23, […].

84
article thumbnail

Janssen Initiates First-of-its-Kind Clinical Study to Bridge Critical Gaps in Care for People of Color with Moderate to Severe Plaque Psoriasis

The Pharma Data

The only large-scale prospective study in dermatology designed to generate key disease insights among Black, Hispanic, Asian, Indigenous and other people of color Study reinforces Janssen’s commitments to inclusive clinical research and addressing health inequities. Psoriasis (PsO) can take a physical, psychological, and emotional toll on the more than 8 million Americans living with the disease; and for people of color, there are additional challenges due to limited medical research and educati

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

Lack of transparency over cost of conservation projects hampers ability to prioritise funds for nature protection

Scienmag

A new study has found that costs of conservation projects are rarely reported, making it difficult for others to make decisions on the most cost-effective interventions at a time when funding for biodiversity conservation is severely limited. A review of 1,987 published reports of conservation interventions has found that only 8.8% reported the total cost […].

84
article thumbnail

Merck Announces Retirement of Dr. Roy D. Baynes; Dr. Eliav Barr Appointed Head of Global Clinical Development and Chief Medical Officer

The Pharma Data

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that Dr. Roy D. Baynes, head of Global Clinical Development (GCD) and Chief Medical Officer, Merck Research Laboratories (MRL), will be retiring from Merck in July. Dr. Baynes will be succeeded by Dr. Eliav Barr, effective April 1, 2022. Dr. Baynes will continue to report to Dr.

article thumbnail

Development of a new high-precision ai-based translation engine specialized for the financial sector

Scienmag

[Points] Credit: National Institute of Information and Communications Technology (NICT) & Financial Services Agency of Japan (JFSA) [Points] ?The NICT and the JFSA have developed a new high-precision AI-based translation engine that can translate documents in the financial sector between Japanese and English. ?The JFSA has collected a large quantity of bilingual documents from a […].

article thumbnail

Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients

The Pharma Data

– ELEVATE 12 study met primary and key secondary endpoints of improving clinical remission at week 12 – – Safety profile consistent with previous Phase 2 studies – Pfizer Inc. (NYSE: PFE) today announced positive topline results from a Phase 3 study of etrasimod, an investigational, oral, once-a-day, selective sphingosine 1-phosphate (S1P) receptor modulator in development for the treatment of moderately to severely active ulcerative colitis (UC).

Trials 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.