Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo
Fierce Pharma
DECEMBER 19, 2022
Atara makes history with world-first nod for allogeneic T-cell therapy Ebvallo. fkansteiner. Mon, 12/19/2022 - 14:06.
Mon.Dec 19, 2022
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UK digital health project aims to tackle dysfunctional breathing
pharmaphorum
DECEMBER 19, 2022
A collaboration between academic centres in the UK has won government funding for a digital approach to dysfunctional breathing or dyspnoea, a symptom that affects around 10% of the population. The Engineering and Physical Sciences Research Council (EPSRC) has set aside £400,000 (almost $490,000) for the project, which will help fund work at the Universities of Plymouth, Salford and Stirling, and the Glasgow School of Art.
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Novartis prunes nearly 300 jobs in Garden State as corporate slimdown rolls on
Fierce Pharma
DECEMBER 19, 2022
Novartis prunes nearly 300 jobs in Garden State as corporate slimdown rolls on. fkansteiner. Mon, 12/19/2022 - 10:53.
7 Pet Peeves of a Healthcare Tech Reporter
MedCity News
DECEMBER 19, 2022
Healthcare journalists source a significant amount of the stories they write from emailed pitches. To make the media relations process more fruitful for everyone involved, I laid out my top seven pet peeves as a healthcare technology reporter so public relations representatives have a better understanding of which behavior to avoid.
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
AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression
Fierce Pharma
DECEMBER 19, 2022
AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. zbecker. Mon, 12/19/2022 - 11:13.
What Do Hospitals Want Out of Capacity Optimization Tech?
MedCity News
DECEMBER 19, 2022
As hospitals continue to battle healthcare’s workforce shortage and high levels of staff turnover, capacity is a significant pain point. When it comes to technology to help optimize capacity management, hospital leaders want solutions that can automatically identify and prioritize patients who are ready for discharge using real-time data, according to a new report.
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FDA approves Adstiladrin as first gene therapy for NMIBC
pharmaphorum
DECEMBER 19, 2022
The US Food and Drug Administration (FDA) has approved Swiss drugmaker Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firedenovec-vncg) for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumours. Bladder cancer is one of the more common forms of cancer.
With another FDA nod, Eagle's Pemfexy gets up to speed with Lilly's Alimta
Fierce Pharma
DECEMBER 19, 2022
With another FDA nod, Eagle's Pemfexy gets up to speed with Lilly's Alimta. kdunleavy. Mon, 12/19/2022 - 09:49.
Could ketamine-assisted therapy help treat alcoholism?
European Pharmaceutical Review
DECEMBER 19, 2022
A new £2.4 million Phase III trial will determine if ketamine-assisted therapy can help those with severe alcohol use disorder to stay off alcohol for longer. Led by the University of Exeter and funded by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), “[t]his is the largest trial of its kind in the world and builds on our earlier, smaller positive trial,” stated Professor Anne Lingford-Hughes, Professor of Addiction Biology at Imperial College
Sanofi and Innate Pharma extend cancer therapeutics partnership
Pharmaceutical Technology
DECEMBER 19, 2022
Sanofi has extended the partnership with Innate Pharma for natural killer (NK) cell therapeutics in oncology. With the latest development, Sanofi will licence a NK cell engager programme that acts on B7H3 from the antibody-based NK cell engager therapeutics (ANKET) platform of Innate. Under the latest licence deal, Sanofi will make an upfront payment of $26.4m (€25m) to Innate.
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.
Patient Voice and Patient Choice: Essentials for Successful DCTs
MedCity News
DECEMBER 19, 2022
Historically, clinical trials have not prioritized the experiences of patients, who are required to frequently return on-site and engage with unfamiliar medical technology. They are often left in the dark regarding the data and health outcomes being collected through their participation.
CHMP backs Amicus’ therapy for Pompe disease
pharmaphorum
DECEMBER 19, 2022
Amicus Therapeutics could be just weeks away from getting EU approval for its new Pompe disease therapy Pombiliti after getting a positive opinion on the drug from the EMA’s human medicines committee. The CHMP said late last week it was recommending Pombiliti (cipaglucosidase alfa or ATB200) as an infused therapy for late-onset Pompe disease in adults given in combination with the enzyme stabiliser miglustat in a regimen known as AT-GAA.
FDA Nod Makes Ferring Pharma Gene Therapy the First for Bladder Cancer
MedCity News
DECEMBER 19, 2022
A Ferring Pharmaceuticals gene therapy is now FDA approved for treating bladder cancer that does not respond to an immunotherapy used to treat the cancer in its early stages. The Ferring gene therapy, Adstiladrin, turns bladder wall cells into tiny factories churning out a cancer-fighting therapeutic protein.
Nectar Lifesciences Ltd- Hiring M.Sc, M.Tech ,B.Tech, B.Sc, Diploma for Multiple Positions- Apply Now
Pharma Pathway
DECEMBER 19, 2022
Nectar Lifesciences Ltd- Hiring M.Sc, M.Tech ,B.Tech, B.Sc, Diploma for Multiple Positions- Apply Now. Job Description. Openings for DM/ Manager / Executive/ Sr. Executive/ AM/ Operator/ Officer/ Executive @ Nectar Lifesciences Ltd. DM/ Manager . Qualification: MSc/ M.Tech/ B.Tech Chemical. Experience: 12 to 15 years. Executive/ Sr. Executive/ AM. Qualification: M.Sc/ M.Tech/ B.Tech Chemical.
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.
Madrigal Drug Meets FDA’s Twin Goals for NASH, Paving Way for FDA Filing
MedCity News
DECEMBER 19, 2022
A Madrigal Pharmaceuticals drug for the fatty liver disease NASH has data from a pivotal clinical trial showing improvements in the organ. Based on those results, which sent Madrigal’s stock price soaring more than 200%, the biotech is planning to seek what could become the first regulatory approval of a therapy for this metabolic disorder.
FDA approves first gene therapy for high-risk early bladder cancer
European Pharmaceutical Review
DECEMBER 19, 2022
The US Food and Drug Administration (FDA) has approved Adstiladrin (nadofaragene firadenovec-vncg) as the first gene therapy for non-muscle-invasive bladder cancer (NMIBC) in adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive with carcinoma in situ (CIS) with or without papillary tumours. Dr Peter Marks, PhD, Director of the FDA’s Center for Biologics Evaluation and Research observed that Adstiladrin, the non-replicating adenoviral vector-based therapy provides “… an innovative tr
Debunking 5 Tenacious Patient Engagement Myths
MedCity News
DECEMBER 19, 2022
Through effective and purposeful engagement, frontline caregivers are able to build meaningful relationships with patients, show them that they are seen and heard, and empower them with the information and education they need to be better stewards of their own health.
CHMP meeting highlights – December 2022
European Pharmaceutical Review
DECEMBER 19, 2022
In its latest meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended five drugs for approval, including a gene therapy and two cancer drugs and adopted positive opinions for four therapies. Recommended for approval. The committee recommended granting a conditional marketing authorisation for the advanced therapy medicinal product (ATMP) Hemgenix* (etranacogene dezaparvovec ), the first gene therapy for the treatment of severe and moderate
Deliver Fast, Flexible Clinical Trial Insights with Spotfire
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
This Startup is Proving that Family Caregivers Have the Power to Lower Admissions and Reduce Costs
MedCity News
DECEMBER 19, 2022
Reducing hospitalizations for frail elderly members is a major challenge for Medicare Advantage payers and providers. The key to avoiding any hospitalization is to detect and address a change in condition before it worsens. Ceresti Co-founder and CEO Dirk Soenksen talks about how his company is addressing these needs.
Blood cancer cures aren’t here yet — but incremental combinations bring the field closer
PharmaVoice
DECEMBER 19, 2022
A series of small successes showed promise for the future of blood cancer treatments, particularly in the arena of drug combinations.
Oscar Health: State of the Economy Is Top Health Concern for Consumers
MedCity News
DECEMBER 19, 2022
An Oscar Health survey found that about 93% of respondents are “extremely,” “very” or “somewhat” concerned about the state of the economy. Another 44% of respondents listed the economy as their top healthcare concern.
5 Ways to Generate Medical Sales Leads
MedReps
DECEMBER 19, 2022
Selling products to existing customers is only one part of the medical sales process. In order to keep the sales flowing, thus meeting those quotas and goals, medical sales reps need to generate leads. These leads, which need to consist of medical employees who have the authority to make purchases for their clinics and hospitals, need to be chosen carefully.
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.
All About Access: The Key Trends In Retailers’ Acquisitions in 2022
MedCity News
DECEMBER 19, 2022
Whether it was Amazon’s buy of One Medical or CVS Health’s acquisition of Signify Health, retailers made waves in healthcare this year. Across all of the deals, it’s clear that expanding access to medical services is the key goal, experts said. And this is only the beginning.
Converging knowledge and technology to transform neuromuscular disease treatment
European Pharmaceutical Review
DECEMBER 19, 2022
Neuromuscular diseases (NMDs) are a broad group of conditions in which pathologies affect the peripheral nervous system (PNS), the neuromuscular junction or skeletal muscle. NMDs lead to loss of normal nerve and muscle activity and patients lose function. Many NMDs result in atrophy (wasting) of the voluntary muscles. 1 The resulting weakness can lead to twitching, cramps, pain, and joint and movement problems.
The Future of Alzheimer’s Care: 3 Predictions for 2023
MedCity News
DECEMBER 19, 2022
By 2050 the cost of dementia in the US alone could rise to $1.1 trillion per year. Now more than ever it is critical to address the needs of individuals and families living with dementia. Fortunately, new diagnostic and treatment discoveries are paving the way for significant advancements.
With mpox cases mysteriously dwindling, scientists search for answers
PharmaVoice
DECEMBER 19, 2022
Was it a public health victory? Or did mpox ‘burn itself out?’ An epidemiologist weighs in.
Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
CMS Affirms Value of the Medicare Hospice Benefit’s Unique, Holistic Care
MedCity News
DECEMBER 19, 2022
CMS is to be recognized for taking action to establishing chaplaincy codes along with other core services so that hospice claims data on spiritual care can be collected.
Dr. Reddy’s Laboratories Ltd.-Hiring for Freshers in Production QC/ QA Departments -Apply Now
Pharma Pathway
DECEMBER 19, 2022
Dr. Reddy’s Laboratories Ltd.-Hiring for Freshers in Production QC/ QA Departments -Apply Now. Job Description. Dr. Reddy’s Laboratories Ltd. is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three business-Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products.
Economist Impact: World Cancer Series – pharmaphorum in attendance, day one (part iii)
pharmaphorum
DECEMBER 19, 2022
Taking a brief look back to pharmaphorum’s coverage of Day One of The Economist’s 8th Annual World Cancer Series congress in Brussels, Belgium, in November – where the foci were “innovation, equity, and excellence”. After a panel on the priorities for innovation and excellence in cancer care within Europe, with the essential aim of the conference “universally excellent cancer control and cancer outcomes across the Continent”, came a presentation on ‘Inequalities in cancer – facts and data’ by Fr
AstraZeneca’s Forxiga recommended in EU for chronic heart failure
PharmaTimes
DECEMBER 19, 2022
Drug is the first heart failure medication to provide mortality benefit across entire ejection fraction range
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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