Fierce Pharma
NOVEMBER 18, 2022
With Sanofi as its marketing partner, Provention Bio grabs long-awaited FDA nod for diabetes drug. kdunleavy. Fri, 11/18/2022 - 10:21.
European Pharmaceutical Review
NOVEMBER 18, 2022
Upstaza (eladocagene exuparvovec) is the first and only approved treatment for aromatic L-amino acid decarboxylase (AADC) deficiency and is the first marketed gene therapy for direct infusion into the brain. The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. It has been granted marketing authorisation by the Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain.
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Fierce Pharma
NOVEMBER 18, 2022
Apellis' closely watched eye drug gets new FDA goal date after changes to its filing scared investors. aliu. Fri, 11/18/2022 - 11:21.
MedCity News
NOVEMBER 18, 2022
By taking a few simple steps, practices can help ensure that their patients get the care they need while reducing unnecessary losses of revenue and time within the business model.
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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
Fierce Pharma
NOVEMBER 18, 2022
Fierce Pharma Asia—BioNTech, GSK grow in Singapore; Astellas' stomach cancer win; Daiichi's mRNA vaccine readout. aliu. Fri, 11/18/2022 - 09:44.
MedCity News
NOVEMBER 18, 2022
Type 1 diabetes patients now have a new therapeutic option for the autoimmune disorder. Provention Bio drug Tzeild has received FDA approval for delaying the onset of the most severe stage of this chronic disease.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
NOVEMBER 18, 2022
Instead of building its own network of providers and bringing hybrid care services to employers like it did with Amazon Care, the new Amazon Clinic model is direct-to-consumer and outsources to third-party providers. It will likely be the more successful route for the retailer, after failing with Haven and Amazon Care, experts said.
Medgadget
NOVEMBER 18, 2022
Researchers at Oregon State University created a new type of hyperthermic magnetic nanoparticle that is intended to assist in destroying tumors through localized heating under an alternating magnetic field. Previous iterations of such technologies could heat up to about 44 degrees Celsius (111 F), which was only effective in easy-to-access tumors that can be reached with a hypodermic needle, allowing a clinician to inject a large number of the nanoparticles directly into the tumor.
MedCity News
NOVEMBER 18, 2022
About 22,000 nurses and nurse practitioners reached a tentative agreement with Kaiser Permanente,, averting what would have been the biggest private sector nurses strike in American history. These workers have been in negotiations since June, but they will soon vote to ratify a new four-year contract, which includes provisions for a 22.5% raise, increased nurse staffing and more.
Spotio
NOVEMBER 18, 2022
Looking to level-up your door to door sales process in 2022? This guide is for you. Let’s be honest. There is a stigma around door to door sales and that it’s an antiquated way of selling. As the next generation of outside sales reps join the workforce, the majority are unaware just how powerful door to door selling can be. We know the reason D2D prospecting is still relevant: It works.
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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.
MedCity News
NOVEMBER 18, 2022
The shifting of services to outpatient settings will likely cause hospitals to unwind their contractual relationships with cardiologists, sending the physicians back into private practice. Astute hospital administrators will have already anticipated the migration of cardiologists away from hospital inpatient care and started to prepare for a different type of alignment with cardiologists.
Medgadget
NOVEMBER 18, 2022
At the University of California Los Angeles, scientists have developed a handheld lab kit that can conduct automated pooled testing for viral diseases, including COVID-19. The technology consists of a microfluidic platform that relies on swarms of magnetic discs, which the researchers have termed “ferrobots”, to shuttle samples through the device and mix them with reagents before reaching an area where a loop-mediated isothermal amplification assay takes place.
European Pharmaceutical Review
NOVEMBER 18, 2022
Tzield (teplizumab-mzwv), the first drug to help prolong the onset of stage 3 type 1 diabetes in adults and children over eight years old with stage 2 type 1 diabetes, has been approved by the US Food and Drug Administration (FDA). “Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” remarked Dr John Sharretts, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research.
pharmaphorum
NOVEMBER 18, 2022
Regeneron Pharmaceuticals, Inc. and CytomX Therapeutics, Inc. have announced a strategic research collaboration within the field of conditionally activated bispecific therapeutics for the treatment of cancer. Using CytomX’s Probody and Regeneron’s Veloci-Bi platforms, the collaboration and licensing agreement aims to enable the development of investigational next-generation bispecific immunotherapies.
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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.
MedCity News
NOVEMBER 18, 2022
The group complains that the FDA never studied the safety of the drugs under the labeled conditions of use. .
pharmaphorum
NOVEMBER 18, 2022
Takeda has a chance of breaking into new territory with its blood cancer therapy Iclusig, after the drug performed better than mainstay therapy imatinib in a phase 3 study of adults with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The PhALLCON trial compared Iclusig (ponatinib) to imatinib – sold by Novartis as Glivec/Gleevec, but also available as a generic – on top of a reduced-intensity chemotherapy regimen in 230 patients with this type of leukae
European Pharmaceutical Review
NOVEMBER 18, 2022
The World Health Organization (WHO)’s Global Vaccine Market Report 2022 , the first report to examine the impact of COVID-19 on the global vaccine market, shows that inequitable distribution is not unique to COVID-19 vaccines, with poorer countries consistently fighting to access vaccines in demand by wealthier countries. The WHO stated limited vaccine supply and unequal distribution is driving global inequalities.
pharmaphorum
NOVEMBER 18, 2022
Gene-testing specialist Editas Medicine has halted development of its lead clinical programme for congenital eye disorders after it generated lacklustre results in a phase 1/2 trial. The BRILLIANCE study of EDIT-101 in Leber congenital amaurosis type 10 (LCA10) – an inherited form of blindness – was reported to be the first ‘in vivo’ CRISPR/Cas9 medicine to be administered to a patient when it started in 2020.
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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.
Pharma IQ
NOVEMBER 18, 2022
Pharma IQ takes a look at how the drug discovery process can be improved.
Copyright Clearance Center
NOVEMBER 18, 2022
The post In Arkansas and Michigan, Voters “Defund” Public Libraries appeared first on Copyright Clearance Center.
PharmaTimes
NOVEMBER 18, 2022
The charity commissioned a two-year service quality audit of over 18,000 kidney cancer patients
PharmaVoice
NOVEMBER 18, 2022
Executives across the life sciences share their tips for navigating the new norm of remote work.
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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.
PharmaTimes
NOVEMBER 18, 2022
Primary ITP is a rare autoimmune condition characterised by high platelet destruction
Pharmaceutical Technology
NOVEMBER 18, 2022
The European Commission (EC) has approved BeiGene’s Brukinsa (zanubrutinib) to treat chronic lymphocytic leukaemia (CLL) in adult patients. The small-molecule Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa has been approved to treat treatment-naïve (TN) or relapsed/refractory (R/R) CLL in adult patients. It was specifically designed to provide targeted and sustained BTK protein inhibition by optimising bioavailability, selectivity, and half-life.
Contrarian Sales Techniques
NOVEMBER 18, 2022
What I Learned on The Way to The Top is an inspiring, motivating, and challenging book that will keep you going back for more. It's also a good read for people who like to take heart and learn more. The book starts with a selection of quotes from the Scriptures, and then it goes on to teach other life lessons through a variety of quotes. There are also a couple of short stories that are representative of both the principles and the personal experiences of the author, such as those from his own l
LEVO Health
NOVEMBER 18, 2022
Marketing teams in the medical industry have been asked to do more with less due to shrinking marketing budgets. As healthcare executives slash media spending ahead of an anticipated recession, medical practices and their marketing teams need to be more creative in their advertising strategies. Selecting a healthcare marketing agency skilled at optimizing these types of campaigns is critical to success.
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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
Contrarian Sales Techniques
NOVEMBER 18, 2022
A good, satisfied customer is referred to as a "WOMBAT." This individual can replicate the success of another person. The concept of " WOMBAT Selling " is a sales and marketing strategy that uses a customer-focused approach. It eliminates the myth that salespeople merely close sales. For decades now, salespeople have been told by their managers to close sales.
Pharmaceutical Technology
NOVEMBER 18, 2022
Regeneron Pharmaceuticals has entered a collaboration and licensing agreement with CytomX Therapeutics for developing conditionally-activated bispecific cancer therapies. Under the deal, the companies will work together on the discovery activities for identifying and validating the conditionally active bispecific antibodies. This collaboration will use Regeneron’s Veloci-Bi bispecific antibody development platform and CytomX's Probody therapeutic platform.
pharmaphorum
NOVEMBER 18, 2022
At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. The US regulator has approved the anti-CD3 antibody as Tzield to delay the onset of stage 3 T1D in people eight years and older who currently have stage 2 disease, which according to the FDA “may provide patients with months to years without the burdens of disease.
Pharmacy Times
NOVEMBER 18, 2022
Both of Moderna's bivalent boosters showed neutralizing activity against BQ.1.1, an increasingly dominant emerging variant, confirming that updated vaccines have the potential to offer protection as the virus continues to evolve.
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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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