Fierce Pharma
NOVEMBER 9, 2022
Troubled Clovis telegraphs bankruptcy amid FDA hardball on key cancer drug, difficulty in fundraising. aliu. Wed, 11/09/2022 - 11:33.
MedCity News
NOVEMBER 9, 2022
More than 31% of people with employer-sponsored insurance stuck with a job they disliked for the company’s health insurance, a Forbes Advisor survey found. Another 8% of respondents left a job they liked to seek better coverage.
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Fierce Pharma
NOVEMBER 9, 2022
FDA signs off on Sobi's Kineret for COVID patients with pneumonia who are on oxygen. kdunleavy. Wed, 11/09/2022 - 16:21.
Pharmaceutical Technology
NOVEMBER 9, 2022
Despite their potential multi-million-dollar sticker price, if haemophilia treatments by BioMarin and CSL Behring prove durable, they could help patients save money compared to current treatments, experts note. On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies.
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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 9, 2022
Ipsen's $1B Onivyde buy proves its worth in earlier pancreatic cancer. zbecker. Wed, 11/09/2022 - 11:23.
Pharmaceutical Technology
NOVEMBER 9, 2022
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Pfizer and BioNTech’s bivalent Covid-19 booster vaccine that targets the SARS-CoV-2 virus’ original strain and the Omicron BA.4 and BA.5 sub-variants. Indicated for usage as a booster in people aged 12 years and older, the modified vaccine is the second bivalent shot of the companies to obtain approval in the region.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
MedCity News
NOVEMBER 9, 2022
A customer of Cost Plus Drugs received an email from the company in October stating that “due to skyrocketing demand,” shipping times have been delayed. Marley Drug, a competitor, said its company has not experienced delays and presented itself as an alternative for Americans.
Fierce Pharma
NOVEMBER 9, 2022
GSK's Zejula FDA oncology AdComm cancelled, leaving ovarian cancer nod in Schrodinger’s box. aliu. Wed, 11/09/2022 - 09:56.
PharmaVoice
NOVEMBER 9, 2022
29-year-old biotech founder Joe Landolina is hoping to capitalize on major possibilities in the human health market through his startup Cresolin and just inked a research partnership with Walter Reed.
Fierce Pharma
NOVEMBER 9, 2022
Novavax narrows revenue projection as COVID vaccine uptake continues to lag. kdunleavy. Wed, 11/09/2022 - 09:48.
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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.
PharmaVoice
NOVEMBER 9, 2022
Welcome to the Woman of the Week podcast, a weekly discussion that illuminates the unique stories of women leaders who are catalyzing change throughout the life sciences industry. You can check out all our podcast episodes here. Not every leader makes it their mission to go where the fire.
Fierce Pharma
NOVEMBER 9, 2022
Plastics reborn: Inside Novo Nordisk's pre-filled pen recycling pilot. fkansteiner. Wed, 11/09/2022 - 09:42.
MedCity News
NOVEMBER 9, 2022
With these APIs, data scientists, developers and analysts can free themselves from frustrating, tedious, and manual efforts to code and clean unstructured data. This is particularly valuable in healthcare where as much as 80% data is locked in unstructured text.
pharmaphorum
NOVEMBER 9, 2022
GSK has revealed updated results from its phase 2b trial of its antisense drug for hepatitis B virus (HBV) infections, which reveal a sharp decline in the proportion of patients with undetectable levels of the virus compared to an earlier readout. In the latest results from the 457-patient B-Clear study, published in the New England Journal of Medicine, bepirovirsen at a dose of 300 mg per week over 24 weeks resulted in sustained hepatitis B surface antigen (HBsAg) and HBV DNA loss to below the
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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 9, 2022
Telemedicine company TytoCare launched a new offering that promises to give providers and health plans the range of products and services needed to operate successful virtual primary care programs. Gilad said the offering, named Home Smart Clinic, can give customers a clear picture of ROI because of its high utilization and patient engagement rates.
European Pharmaceutical Review
NOVEMBER 9, 2022
GSK has announced study results from its Phase IIb trial ( NCT04449029 ) of bepirovirsen for chronic hepatitis B (CHB), indicating that the antisense oligonucleotide therapy could help treat CHB independently or in combination with nucleoside/nucleotide analogues (NAs). Bepirovirsen demonstrated clearance of hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) DNA long term, in patients on concurrent NA and those not-on-NA therapy.
pharmaphorum
NOVEMBER 9, 2022
It goes without saying that The Economist’s 8th Annual World Cancer Series congress was well-attended in Brussels this week, the unofficial capital of the European Union. Held at the Marriott Hotel Grand Place, the event’s sponsors included diamond sponsor AstraZeneca, platinum sponsors MSD and Takeda, and gold sponsor Janssen, as well as silver sponsors Guardant and Pfizer, and associate sponsor onko.
MedCity News
NOVEMBER 9, 2022
Amgen posted positive Phase 2 data for olpasiran, further building the case for the drug’s blockbuster potential in heart disease as it proceeds to a pivotal test. Arrowhead Pharmaceuticals, which originally developed olpasiran and licensed it to the big pharma company, is cashing in now by selling its royalty rights to the molecule.
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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.
pharmaphorum
NOVEMBER 9, 2022
If we look back just 70 years, the prognosis for patients with haemophilia was remarkably different to what it is today. In fact, in the 1950s and 1960s, life expectancy for the disease was around just 30 years.* However, medical innovations over recent decades have significantly improved the length and quality of life for people with the condition, transforming what was once a devastating disease into a condition that can be mostly well-managed.
MedCity News
NOVEMBER 9, 2022
Requiring that PBMs bid on a per member per month guarantee would reduce the employer’s uncertainty by securing the actual per member per month cost to the employer.
Copyright Clearance Center
NOVEMBER 9, 2022
The post Exploring the Challenges in the Shift to Open Access: Part 2 – Pricing appeared first on Copyright Clearance Center.
Pharmaceutical Technology
NOVEMBER 9, 2022
The proportion of pharmaceutical companies hiring for artificial intelligence related positions dropped in October 2022 compared with the equivalent month last year, with 37.4% of the companies included in our analysis recruiting for at least one such position. This latest figure was lower than the 38.6% of companies who were hiring for artificial intelligence related jobs a year ago and a decrease compared to the figure of 39.8% in September 2022.
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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 9, 2022
Onivyde regimen demonstrated statistically significant improvement in overall survival
PharmExec
NOVEMBER 9, 2022
This segment conveys the importance of decentralizing clinical trials to increase diversity and serve all types of people in the United States, as well as the industry. In addition, it touches on the importance of having diverse investigators to help recruit and communicate with all types of people.
PharmaTimes
NOVEMBER 9, 2022
Data demonstrates that secukinumab shows a significantly longer time to flare versus placebo
pharmaphorum
NOVEMBER 9, 2022
AstraZeneca has moved a step closer to bringing a first-in-class drug to market in the US that can be used to reduce severe asthma attacks, after an FDA advisory committee voted in favour of approval. PT027 is based on beta agonist albuterol and corticosteroid budesonide – two well-established therapies – combined into a fixed-dose inhaler that can be used as rescue medication when a patient with asthma is in the throes of an attack.
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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
PharmExec
NOVEMBER 9, 2022
Today’s labs are not sufficient to handle tomorrow’s challenges. What will labs in 2030 or 2040 look like? Mikael Hagstroem, CEO at LabVantage Solutions and expert in harnessing data and analytics, discusses the three phases of digital transformation needed to reimagine business models, achieve better performance, and create long-term sustainable advantage.
pharmaphorum
NOVEMBER 9, 2022
ADC Therapeutics has said it will not seek accelerated approval of its Hodgkin lymphoma drug camidanlumab tesirine (cami) based on phase 2 results, as the FDA will not review it unless a confirmatory trial is already “well underway and fully enrolled.”. The Swiss biotech said that enrolling such a study would take up to two years, and its plan to file for approval of the drug next year is on hold while it is in dialogue with the FDA about a path forward for the programme.
PharmExec
NOVEMBER 9, 2022
There are three phases of digital transformation needed to reimagine business models, achieve better performance, and create long-term sustainable advantage. It starts with changing our labs—the technologies, processes, ways of working, and data solutions.
Contrarian Sales Techniques
NOVEMBER 9, 2022
In SPIN Selling book, Neil Rackham, a former president of Huthwaite corporation, shares his 12 years of research and 35,000 sales calls to guide you through becoming a successful salesperson. It's an essential reading for anyone who is interested in learning more about how to improve their sales skills. According to Neil, there are four phases to every sale: opening, investigating, demonstrating capability, and need-payoff.
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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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