MedCity News
AUGUST 24, 2022
This is the second time Amazon has failed to crack the employer market said an industry observer, after the company loudly touted the novelty of its approach. The first was the high-profile dissolution of Haven created as a joint venture between Amazon, JPMorgan Chase and Berkshire Hathaway. But does this latest failure even matter?
pharmaphorum
AUGUST 24, 2022
The FDA has given a novel anticoagulant from Merck & Co a fast-track designation as a treatment for people with end-stage renal disease (ESRD) who need dialysis, firing a warning short over the bows of a rival programme in development at Ionis and Bayer. The anticoagulant – codenamed MK-2060 – is a monoclonal antibody designed to inhibit Factor XI and is currently in a phase 2b trial in ESRD patients on dialysis, who often need to be treated with anticoagulants to prevent blood clots.
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MedCity News
AUGUST 24, 2022
Following litigation battles and multiple iterations of the Act, the final rules address the arbitration process for insurers and provide more transparency for patients.
PharmaVoice
AUGUST 24, 2022
Diversity in clinical trials isn’t only important for the health of the overall patient population — it can save millions in lost profits.
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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
MedCity News
AUGUST 24, 2022
A new California law that took effect in July requires health plans regulated by the state to provide return appointments no more than 10 days after a previous mental health or substance use session — unless a patient’s therapist approves less frequent visits.
European Pharmaceutical Review
AUGUST 24, 2022
A strategic approach to optimisations of testing bacterial endotoxins. Given industry’s recent focus on the sustainability of bacterial endotoxin testing (BET), here, AstraZeneca colleagues Miriam Guest, Karen Capper, Dennis Wong and Phil Duncanson share how they worked to establish a short-, mid- and long-term strategy to optimise BET across the global enterprise.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Integrity Solutions
AUGUST 24, 2022
If you’ve implemented sales training this year, you’re not alone. Studies have shown that upwards of $15 billion is spent annually on sales training in the United States alone. Several thousand dollars per salesperson is spent annually. But the question is, what kind of a return are organizations getting on that huge investment? And are there specific sales training strategies behind that critical investment to help ensure its success and strong ROI?
European Pharmaceutical Review
AUGUST 24, 2022
Included in this issue: NITROSAMINES. Risks presented by active pharmaceutical ingredient nitrosamines. David Elder, David P Elder Consultancy. ENVIRONMENTAL MONITORING. Progress in the implementation of biofluorescent particle counters. Hannah Balfour with comment from Mike Russ at Genentech. REGULATORY INSIGHT. The EU HTA regulation: a new frontier for access to innovative technologies.
MedCity News
AUGUST 24, 2022
Third Harmonic Bio, which emerged from stealth early this year with a lead drug from Novartis and a $105 million round of funding, has not yet set any financial terms for its planned IPO. But the biotech plans to use the IPO cash for clinical early and mid-stage clinical tests of its small molecule in multiple inflammatory indications.
PharmaTimes
AUGUST 24, 2022
Using the system, the researchers are able to divide DNA and RNA from an already extracted clinical sample into as many as 100,000 microscopic individual reactions
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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.
European Pharmaceutical Review
AUGUST 24, 2022
With companies striving to produce cost-effective and high?quality therapeutics, utilising the most efficient methods possible has become a critical focus. Thus, the lengthy incubation periods needed with traditional culture?based microbiological monitoring techniques have long been a source of frustration. The introduction of alternative and rapid microbiological methods (ARMMs), without such extensive time requirements, is therefore helping companies overcome such limitations.
pharmaphorum
AUGUST 24, 2022
Amgen has reported positive phase 3 results with its biosimilar version of AstraZeneca/Alexion’s blockbuster rare disease drug Soliris, setting up a regulatory filing with the FDA. The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.
MedCity News
AUGUST 24, 2022
Here are the eight companies selected by professional investors to pitch at the upcoming INVEST Digital Health conference in Dallas on September 28.
European Pharmaceutical Review
AUGUST 24, 2022
The topic of bacterial endotoxin testing (BET), while a unique requirement for the pharmaceutical industry, has far?reaching impact. In recent years, articles on the reliance on the horseshoe crab within the pharmaceutical industry 1-3 and considerations for alternative testing strategies have been widely discussed. 4-7 Here, the approach taken at AstraZeneca to optimise test methodology to provide assurance of patient safety, reduce the burden on a natural resource and continue to improve in th
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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.
Map My Customers
AUGUST 24, 2022
You may have the perfect product or service with amazing benefits for your customers. You could even have the highest quality leads who could really use what you have to sell. But, if you can’t close these deals, your sales will suffer. No matter if you are working outside sales or inside sales, the entire sales process culminates in the right close.
European Pharmaceutical Review
AUGUST 24, 2022
ANTIBODY-DRUG conjugates (ADCs) are therapeutic molecules designed as highly targeted medicines with the promise of changing the way we treat cancer and other diseases. An ADC combines the specificity of an antibody and the potent power of an anti?cancer agent or disease-relevant toxin. In total, there are 14 approved ADCs on the global market, all for oncology indications, and over 140 ADCs currently in clinical development. 1 While the first successes underscored the potential of this class of
PharmExec
AUGUST 24, 2022
The two technologies are helping HCPs spread information and collect data in new ways.
PharmaTimes
AUGUST 24, 2022
The phase 2/3 trial results showed that the vaccine was effective in protecting children
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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.
MedCity News
AUGUST 24, 2022
Richard Cusolito believes he’s saving lives by distributing clean syringes and needles to people who […].
Pharmacy Times
AUGUST 24, 2022
Analysis includes nearly 43 million individuals aged 13 year and older who received at least 1 dose in England between December 1, 2020, and December 15, 2021.
Rep-Lite
AUGUST 24, 2022
A company must hire the best people for medical and pharmaceutical businesses to thrive. These people can form a powerful team that can help your company grow. However, this process does not end in hiring the best people. After filling your vacancies in sales job positions, your company must learn how to retain these talents. Retaining talents will be beneficial in the long run because you can save on training costs.
PharmExec
AUGUST 24, 2022
In this paper, learn about a variety of genetic analysis methods and how they’re valuable in ensuring that ex vivo human cells used for cell?based therapies are correctly identified, have the correct characteristics, and are free of contaminants. Download the white paper and read more about the importance of quality control (QC) for isolated human cells and tissues.
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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.
Rep-Lite
AUGUST 24, 2022
A company must hire the best people for medical and pharmaceutical businesses to thrive. These people can form a powerful team that can help your company grow. However, this process does not end in hiring the best people. After filling your vacancies in sales job positions, your company must learn how to retain these talents. Retaining talents will be beneficial in the long run because you can save on training costs.
Pharmaceutical Technology
AUGUST 24, 2022
Lacerta Therapeutics has entered a new licensing and research partnership agreement with Eli Lilly and Company subsidiary, Prevail Therapeutics, to discover and develop adeno-associated virus (AAV) capsids for treating central nervous system (CNS) diseases. . Under the collaboration, Prevail will obtain rights to use one of the new AAV capsids of Lacerta for selected CNS targets that are currently undisclosed. .
pharmaphorum
AUGUST 24, 2022
An experimental digital therapy for tinnitus based on counselling and personalised passive and active game-based sound therapy has showed some encouraging results in a randomised clinical trial in New Zealand. The UpSilent prototype, developed by researchers at the University of Auckland, consisted of a smartphone app, Bluetooth bone conduction headphones and neck pillow speaker and a cloud-based dashboard that clinicians can use to enable messaging and personalise the digital treatment.
Pharmaceutical Technology
AUGUST 24, 2022
Mode rna has submitted an application to the US Food and Drug Administration (FDA) to obtain emergency use authorization (EUA) for mRNA-1273.222, its BA.4/BA.5 Omicron-targeting bivalent booster vaccine for Covid-19. The submission is made for a 50µg booster dose of the vaccine for usage in adults aged 18 years and above. mRNA-1273.222 acts on the SARS-CoV-2 virus’ initial strain and the Omicron’s subvariants BA.4/BA.5.
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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
pharmaphorum
AUGUST 24, 2022
The team at Oxford University behind the landmark RECOVERY trial of COVID-19 therapies now has monkeypox in its sights, with a study that will see if Siga Technologies’ smallpox drug Tpoxx can be used to fight the outbreak. The UK is a good place to run such a study, as around 3,000 of the 38,000-plus cases of monkeypox worldwide have been reported within its borders since the first patients were identified in May.
Pharmaceutical Technology
AUGUST 24, 2022
Abstract. In roller compaction, the ribbon density, being the result of a specified force and gap, is a key driver for ribbon and granule quality. Therefore, GERTEIS ® offers their Density Control feature to monitor and control the at-gap density on their PACTOR ® line of roller compactors. To reduce batch-to-batch variations, the preferred control parameter is ribbon strength.
pharmaphorum
AUGUST 24, 2022
Indivior has failed in its bid to prevent a lawsuit claiming that it illegally blocked competition to opioid addiction drug Suboxone from coming to court in the US. A federal judge has ruled that a jury trial will be needed to resolve allegations that Indivior attempted to preserve a monopoly by switching to a sublingual film formulation of Suboxone (buprenorphine/naloxone) in 2009 from an older pill version of the product.
PharmaVoice
AUGUST 24, 2022
How the chief medical officer of the emerging diagnostic company is using the patient perspective as a guiding light.
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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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