European Pharmaceutical Review
JULY 8, 2022
As established facilities age, various risk considerations emerge. While some may continue to function effectively without any additional considerations, many will require additional checks and assessment. In an article published in the Journal of Validation Technology (JVT), pharmaceutical microbiologist and contamination control expert Tim Sandle identified ten categories of risk presented by aging.
pharmaphorum
JULY 8, 2022
The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. That’s the conclusion of a GlobalData report , which notes that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting a new drug to market.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
MedCity News
JULY 8, 2022
The AMA believes physicians should still be the main prescribers, while advocates for provider status for pharmacists say it’s a win for health equity and will expand treatment access.
Pharmaceutical Technology
JULY 8, 2022
Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The treatment is indicated as extended adjuvant treatment for adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.
Advertisement
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
JULY 8, 2022
Most federally qualified health centers are committed to remaining independent of hospital affiliation. In order to maintain their independence, it is critical that FQHCs face work together more closely on data pooling and and sharing best practices for improving community health, according to a recent report.
Star OUTiCO
JULY 8, 2022
We took some time to congratulate Jon Woodrow on his promotion, and talk next steps for Star OUTiCO MedTech Resourcing. Hi Jon, congratulations on your promotion! Just outline for us your previous role, and how the opportunity to progress came about. I was a Senior Recruiter working in medical devices (MedTech), alongside Sarah, and the two of us were covering the whole of the UK for all commercial & clinical markets.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
PharmExec
JULY 8, 2022
Dealing with discrimination and bias throughout her career, Otsuka Pharmaceutical’s Christine Sakdalan has forged a strong leadership path built around a two-pronged mission—finding true meaning in the patient journey through market research and data analytics, and mentoring and supporting the development of today’s aspiring professionals.
MedCity News
JULY 8, 2022
The breakthrough device designation for Oxford VR follows a clinical trial that demonstrated the effectiveness of its VR therapy.
pharmaphorum
JULY 8, 2022
The COVID-19 pandemic has catalysed significant changes in the way pharma develops drugs, particularly in the clinical trial space. Hybrid or decentralised clinical trials (DCTs) have gained traction as technology, infrastructure and knowledge have evolved to support their use. Preliminary research suggests that hybrid DCTs can reduce trial timing and resources , improve patient-centricity and patient engagement , and expand access and recruitment and increase diversity , mitigate bias, and re
MedCity News
JULY 8, 2022
While there is a heightened awareness about closing the gaps in the system and creating equality, one of the influential groups that suffer from this injustice is the LGBTQ community.
Advertisement
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.
PharmExec
JULY 8, 2022
COVID-19 pandemic, the challenging capital-markets climate in biotech, and a more innovative and specialty treatment focus has increased reliance on the finance arm as a key strategic cog.
Pharmaceutical Technology
JULY 8, 2022
Swedish Orphan Biovitrum AB (Sobi) has signed an exclusive licence agreement with ADC Therapeutics to develop and market Zynlonta (loncastuximab tesirine) for hematologic and solid tumour indications in Europe and mostinternational markets, for up to $435m. The deal, however, excludes the US, Greater China, Singapore and Japan. Zynlonta is a CD19-directed antibody-drug conjugate (ADC).
Pharmaceutical Commerce
JULY 8, 2022
How did the industry get here and what alternatives can be sought out?
PharmaTimes
JULY 8, 2022
The therapy will be used for specific muscle invasive urothelial cancer patients
Advertisement
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.
PharmExec
JULY 8, 2022
Continent has shed its ‘emerging’ status on world biopharma stage.
Pharmaceutical Technology
JULY 8, 2022
Over recent years, bispecific T-cell engagers (BiTEs) have attracted significant attention for their potential in treating a plethora of haematological and solid tumours by enhancing the anti-tumour responses of endogenous T-cells. BiTEs are a relatively nascent modality and have yet to benefit from the identification of robust biomarkers and novel combination approaches, such as in combination with anti-CD20 therapies, with the view to attenuate malignant B-cell survival and enhance clinical re
MedCity News
JULY 8, 2022
Check out news from Equiva, Vida Health, Canaery, and DocPanel.
Pharmaceutical Technology
JULY 8, 2022
Europe was the fastest growing region for cloud hiring among pharmaceutical industry companies in the three months ending April. The number of roles in Europe made up 16.2% of total cloud jobs - up from 13.6% in the same quarter last year. That was followed by North America, which saw a 0.3 year-on-year percentage point change in cloud roles. The figures are compiled by GlobalData, who track the number of new job postings from key companies in various sectors over time.
Advertisement
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.
PharmExec
JULY 8, 2022
A proactive and tailored compliance department—with the nimbleness to adapt strategies on the fly—is a critical shield for life sciences companies during government investigations.
Pharmaceutical Technology
JULY 8, 2022
Digitalization related jobs that were closed during Q1 2022 had been online for an average of 34 days when they were taken offline. This was an increase compared to the equivalent figure a year earlier, indicating that the required skillset for these roles has become harder to find in the past year. Digitalization is one of the topics that GlobalData, our parent company and from whom the data for this article is taken, have identified as being a key disruptive technology force facing companies i
Nixon Gwilt Law
JULY 8, 2022
The much-anticipated 2023 Medicare Physician Fee Schedule Proposed Rule (“2023 Proposed Rule”) from the Centers for Medicare & Medicaid Services (“CMS”) has arrived! Despite a slight reduction in reimbursement amounts across the board, the rule includes new reimbursement opportunities for managing the care of behavioral health and chronic pain patients, along with much-needed fixes to the Remote Therapeutic Monitoring (“RTM”) codes introduced last year.
Pharmaceutical Technology
JULY 8, 2022
Xenetic Biosciences and Catalent Pharma Solutions have signed an agreement for the cGMP manufacturing of the Xenetic’s recombinant protein, Human DNase I. Under the deal, Catalent will use its biomanufacturing capabilities in Madison, Wisconsin to advance Xenetic’s DNase clinical development programme and progress it to first-in-human studies. The interventional DNase based oncology platform of Xenetic is intended to boost outcomes of current therapies, including immunotherapies.
Advertisement
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.
PharmExec
JULY 8, 2022
Pharma companies should review their commission-based compensation arrangements with independent contractors to address enforcement risk under the Anti-Kickback Statute, in light of recent Department of Justice enforcement.
Pharmaceutical Technology
JULY 8, 2022
In the first half of 2022 the number of deals relating to regenerative medicine decreased significantly by 40% from the same period in 2021. This marks a deceleration in growth from the 27.6% decrease in deals that occurred in H2 2021 relative to the same period a year earlier. GlobalData's deals database looks at mergers, acquisitions and venture capital and private equity investments taking place daily between thousands of companies across the world.
Rep-Lite
JULY 8, 2022
The quota is a sales target that a company demands a sales rep or sales team to achieve over a specific period. These sales quotas can be set monthly, quarterly, and yearly. Depending on the size of your company, you can select your sales quotas by region or business unit. Revenue-based sales quotas are the most typical. The quota can be a fixed number of medical devices you want your medical sales rep to achieve in the medical and pharmaceutical fields.
pharmaphorum
JULY 8, 2022
Swedish rare disease specialist Sobi is paying $55 million upfront to license rights to ADC Therapeutics’ lymphoma therapy Zynlonta – approved in the US last year – in Europe and other international markets. The deal expands Sobi’s position in orphan diseases within haematology, one of its core focus areas, and also includes a $50 million payment Zynlonta (loncastuximab tesirine) is approved in the EU and another $330 million in milestone payments tied to other regulatory and sales o
Advertisement
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
Pharmaceutical Commerce
JULY 8, 2022
Willis Chandler, AmerisourceBergen’s recently named President of Biopharma Services, Strategic Global Sourcing and Commercial Solutions, talks about the new investments AB is making to build out its capabilities and its new cell and gene therapy service line.
pharmaphorum
JULY 8, 2022
PharmStars , the pharma-focused accelerator for digital health startups, is pleased to announce that it is now accepting applications for its Fall 2022 cohort with the theme, “Innovations in Real-World Evidence.”. Data gathered from wearables, mobile devices, and other digital tools can yield reliable, usable clinical and health-related information as well as evidence.
PharmExec
JULY 8, 2022
With heightened government scrutiny on educational forums, biopharma manufacturers need a sound framework that demonstrates they are following best practices.
pharmaphorum
JULY 8, 2022
NICE has recommended routine use of Bristol-Myers Squibb’s Opdivo for the adjuvant treatment of some patients with urothelial carcinoma (UC), the most common form of bladder cancer. The guidance allows Opdivo (nivolumab) to be used after surgery in patients with muscle-invasive UC who are at high risk of the cancer coming back, and whose tumours express PD-L1 at a level of 1% or more.
Advertisement
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.
Expert insights. Personalized for you.
125 
Let's personalize your content