Merck drug for chronic cough rejected by FDA
Bio Pharma Dive
JANUARY 24, 2022
According to the drugmaker, the FDA asked in a complete response letter for more information related to how the drug's efficacy was measured.
Mon.Jan 24, 2022
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The downside of VC funding for biotech
World of DTC Marketing
JANUARY 24, 2022
Venture capitalists have poured $42 billion into drug development over the past three years. Most small biotech companies rely on venture capitalist funding to develop new drugs but is that a good way to go? not necessarily. VCs invest money in biotech because they see a potential windfall via a profitable acquisition or sale, but when the FDA weighs in with delays, VCs can be ruthless.
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US turns to Gilead's COVID-19 drug to help counter omicron
Bio Pharma Dive
JANUARY 24, 2022
With other COVID treatments ineffective against the variant or in short supply, the FDA is expanding its approval of Veklury to include outpatient use.
Chronic kidney disease: treating a silent killer
pharmaphorum
JANUARY 24, 2022
In November, NICE backed NHS use of AstraZeneca’s diabetes and heart failure drug Forxiga for the treatment of chronic kidney disease. pharmaphorum caught up with AZ’s Joris Silon to discuss unmet needs in the condition. “Many times, I have talked to nephrologists who take care of patients with chronic kidney disease in the later stages, and they have a very simple message – and that is, if we really want to do something for these patients then we need to intervene earlier,” says Joris Silon, se
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
Iowa's institutions on the leading edge of next-gen vaccines and therapies
Bio Pharma Dive
JANUARY 24, 2022
Learn more about Iowa's efforts in the ongoing fight against pandemics and other threats to human and animal health.
Is Vegan Casein the Next Big Plant-Based Innovation?
XTalks
JANUARY 24, 2022
Fooditive Group , a plant-based ingredient manufacturer, recently developed a vegan version of casein, one of the main animal proteins in milk. The Dutch startup used precision fermentation to create vegan casein, making it possible to replace cow’s milk in dairy products without losing flavor, texture or quality. In developing the vegan casein, Fooditive aims to eradicate the downsides of factory farming, antibiotics, hormones and lactose.
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IBM sells off large parts of Watson Health business
pharmaphorum
JANUARY 24, 2022
A private equity group has agreed to take over most of IBM Watson Health, seven years after the business was launched with a pledge to revolutionise healthcare data analysis. Francisco Partners is picking up a range of databases and analytics tools – including Health Insights, MarketScan, Clinical Development, Social Programme Management, Micromedex and other imaging and radiology tools – for an undisclosed sum estimated to be in the region of $1 billion.
New patent expiration for Genentech Inc drug ESBRIET
Drug Patent Watch
JANUARY 24, 2022
Annual Drug Patent Expirations for ESBRIET Esbriet is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are twenty-one patents…. The post New patent expiration for Genentech Inc drug ESBRIET appeared first on DrugPatentWatch - Make Better Decisions.
Should we be worried about Omicron ‘stealth variant’ BA.2?
pharmaphorum
JANUARY 24, 2022
With healthcare systems around the world labouring under the strain of dealing with the Omicron wave of COVID-19 infections, attention is already turning to a new sub-variant that is starting to emerge in some countries, including the UK, India and Denmark. Dubbed BA.2, the sub-variant of Omicron (BA.1) hasn’t been classed as a variant of concern (VoC) by the World Health Organisation (WHO) yet, but is under investigation by the UK’s Health Security Agency with more than 400 cases detected
Gilead Sues Distributors Selling Counterfeit HIV Drugs
XTalks
JANUARY 24, 2022
Gilead Sciences has been seizing counterfeit versions of its HIV drugs Biktarvy and Descovy since last year and is now suing distributors who have been behind selling the illicit medications. The counterfeit drugs were being sold across several states in the US over the past two years. The drugs were sold to US pharmacies by an unauthorized web of distributors who faked bottle labels and documentation, threatening patient safety.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Team behind RECOVERY trial of COVID drugs casts its net wider
pharmaphorum
JANUARY 24, 2022
The UK scientists that ran one of the largest trials of experimental COVID-19 drugs have formed a non-profit company that will apply the methodology to other disease areas – with $6.8 million in funding from French drugmaker Sanofi. The non-profit – called Protas – is led by Sir Martin Landray, professor of medicine and epidemiology at Oxford University and one of the chief investigators of the RECOVERY trial, which showed that dexamethasone was an effective treatment for COVD-19 and that hydro
Enrol call: Verona recruits 800 patients for COPD trial
Pharma Times
JANUARY 24, 2022
The phase 3 trial involved over 800 candidates to assess ensifentrine when administered as a maintenance therapy to patients diagnosed with COPD.
Charles River joins with immunology lab on COVID-19 research
Outsourcing Pharma
JANUARY 24, 2022
The CRO's work with La Jolla Institute for Immunology, centered on a unique mouse model, is intended to increase understanding of how the COVID-19 virus operates.
Current vaccines teach T cells to fight Omicron
Scienmag
JANUARY 24, 2022
LA JOLLA, CA—Scientists at La Jolla Institute for Immunology (LJI) have found that four COVID-19 vaccines (Pfizer-BioNTech, Moderna, J&J/Janssen, and Novavax) prompt the body to make effective, long-lasting T cells against SARS-CoV-2. These T cells can recognize SARS-CoV-2 Variants of Concern, including Delta and Omicron. Credit: La Jolla Institute for Immunology LA JOLLA, CA—Scientists at […].
Roles and Responsibilities of Specialized Clinical Supply Experts
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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.
Training begins for psychedelic-assisted clinical trial
Pharma Times
JANUARY 24, 2022
Beckley Psytech leads a new project focused on addressing psychiatric and neurological conditions through the use of psychedelic medicines.
New strategic partnership to explore four-dimensional first order controls on nickel mineral systems
Scienmag
JANUARY 24, 2022
Researchers at the University of Leicester have signed a major research agreement with BHP, one of the world’s largest mining companies, to identify new areas for the discovery of metals critical to the electric vehicle (EV) revolution. Credit: David Holwell/University of Leicester Researchers at the University of Leicester have signed a major research agreement with […].
Screening for Atrial Fibrillation—New Devices, Same Challenges
JAMA Internal Medicine
JANUARY 24, 2022
In an updated Recommendation Statement, supported by an updated evidence review, the US Preventive Services Task Force (USPSTF) has concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for atrial fibrillation (AF) in asymptomatic adults 50 years and older. The I statement, meaning insufficient evidence, remains unchanged from the 2018 recommendation statement.
nTIDE December 2021 COVID Update: Unemployment trends lower for people with disabilities as pandemic continues to affect labor market
Scienmag
JANUARY 24, 2022
Credit: Kessler Foundation National Trends in Disability Employment (nTIDE) – issued semi-monthly by Kessler Foundation and the University of New Hampshire East Hanover, NJ. January 24, 2022. Small rises in furloughs affected workers with and without disabilities in December, indicating the early impact of the omicron variant on some business sectors, according to […].
The New Age of Decentralized Clinical Trials
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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.
New patent for La Jolla drug GIAPREZA
Drug Patent Watch
JANUARY 24, 2022
Annual Drug Patent Expirations for GIAPREZA Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. It is available from one supplier. There are nine…. The post New patent for La Jolla drug GIAPREZA appeared first on DrugPatentWatch - Make Better Decisions.
Forest geneticist awarded $1.2 million NSF CAREER grant to study Douglas fir hybridization, genomics and adaptation to climate change
Scienmag
JANUARY 24, 2022
The Douglas fir is one of the most economically important timber trees in the U.S. Harvested for the strength of its wood in a wide variety of uses, especially in fencing, home construction and decking, it’s considered the backbone of the western timber industry. But warming temperatures and more severe and frequent heat events are posing significant challenges […].
New patent for Sun Pharm drug WINLEVI
Drug Patent Watch
JANUARY 24, 2022
Annual Drug Patent Expirations for WINLEVI Winlevi is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Sun Pharm drug WINLEVI appeared first on DrugPatentWatch - Make Better Decisions.
COVID-19 vaccines don’t cause infertility or harm pregnancy chances, Boston University research shows
Scienmag
JANUARY 24, 2022
Having a COVID-19 vaccine doesn’t impact a couple’s chances of becoming pregnant—but skipping the shots and landing a coronavirus infection might reduce male fertility. Credit: Photo by Aditya Romansa on Unsplash Having a COVID-19 vaccine doesn’t impact a couple’s chances of becoming pregnant—but skipping the shots and landing a coronavirus infection might reduce male fertility. […].
Accelerating Clinical Supply Through Integrated Drug Development
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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.
After FDA setback, Ipsen gets first OK for rare disease drug palovarotene
pharmaphorum
JANUARY 24, 2022
After regulatory hold-ups in the US and Europe, Ipsen has claimed a confidence-boosting approval in Canada for palovarotene, a rare disease therapy acquired via its $1.3 billion takeover of Clementia Pharma in 2019. Health Canada has given the drug a green light – under the Sohonos brand – to treat fibrodysplasia ossificans progressiva (FOP), making it the first treatment for the ultra-rare genetic disorder.
New control technique uses solar panels to reach desired Mars orbit
Scienmag
JANUARY 24, 2022
A satellite on a science mission to Mars aims for a low-altitude orbit, but the lower the orbit, the more propellant is required to enter orbit when arriving from Earth. To save propellant, a technique called aerobraking uses a small propulsive maneuver for orbit insertion to enter a large orbit; the satellite then makes many […].
SMi’s 3rd Annual AI in Drug Discovery Conference
pharmaphorum
JANUARY 24, 2022
Exploring the Impact of Machine Learning and Artificial Intelligence in Drug Development from Discovery to Healthcare. SMi Group is proud to present its 3rd Annual AI in Drug Discovery Conference , taking place on the 14th and 15th March 2022 in London, UK. Chaired by: Darren Green, Director of Computational Chemistry, GSK. Sponsored by: Optibrium. With the recent pandemic highlighting the need for rapid drug discovery, AI has become an area of increased interest.
A soft, stretchable thermometer
Scienmag
JANUARY 24, 2022
The next generation of soft robotics, smart clothing and biocompatible medical devices are going to need integrated soft sensors that can stretch and twist with the device or wearer. The challenge: most of the components used in traditional sensing are rigid. Credit: Harvard SEAS The next generation of soft robotics, smart clothing and biocompatible medical […].
How Machine Learning Drives Clinical Trial Efficiency
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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.
How Patient Recruitment can be optimized with Salesforce Marketing Cloud
Cloudbyz
JANUARY 24, 2022
Organizations in the healthcare and life sciences sector are striving continuously to drive efficiency and improve health outcomes. However, the use of disparate, legacy systems continues to present formidable setbacks for innovation and collaboration in the healthcare and life sciences sector. With the growing demand for clinical trials, patient recruitment needs to scale up in terms of personalization.
Orbital insertion burn a success, Webb arrives at L2
Scienmag
JANUARY 24, 2022
Today, at 2 p.m. EST, Webb fired its onboard thrusters for nearly five minutes (297 seconds) to complete the final postlaunch course correction to Webb’s trajectory. This mid-course correction burn inserted Webb toward its final orbit around the second Sun-Earth Lagrange point, or L2, nearly 1 million miles away from the Earth. Credit: NASA Today, at 2 p.m. […].
SMi’s 6th Annual Highly Potent Active Pharmaceutical Ingredients
pharmaphorum
JANUARY 24, 2022
SMi’s 6th Annual. Highly Potent Active Pharmaceutical Ingredients. 9th and 10th May 2022. London, UK. www.highlypotentapi.com/pharmaphorum. Ensuring Risk-Based, Safety-Driven, High-Quality Operation. The Global High Potency API/HPAPI Market is projected to reach 37 billion USD by 2027, growing at an ever-increasing CAGR of 8.43%. The expanding production of high potency APIs, along with the increase in associated toxicities, are driving requirements for more effective containment solutions and m
Antibody with engineered peptide targets bone metastasis
Scienmag
JANUARY 24, 2022
HOUSTON – (Jan. 24, 2022) – A moderate amount of a peptide-enhanced, biological cancer drug goes a long way in treating breast cancers that metastasize to the bone. Credit: Illustration by the Xiao Research Group/Rice University HOUSTON – (Jan. 24, 2022) – A moderate amount of a peptide-enhanced, biological cancer drug goes a long way […].
The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric
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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.
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