MedCity News
SEPTEMBER 2, 2022
Medable recently launched a software solution to shorten the launch times for decentralized vaccine trials. The company says the software can reduce trial deployment timelines from more than 12 weeks on average to as short as five weeks.
Integrity Solutions
SEPTEMBER 2, 2022
One of the first big workforce catchphrases to go viral after the onset of the pandemic was “The Great Resignation,” as employees began to reevaluate their careers and leave their jobs in record numbers. This max exodus of talent may be slowing down a bit, but it’s far from over. More than two years later, even with the threat of a recession looming in the background, companies continue to struggle with finding talent to fill open positions.
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MedCity News
SEPTEMBER 2, 2022
A new Stanford study revealed that among Medicaid patients who had never taken an opioid, 30% developed an opioid dependency following their first prescription. The research showed that opioids that have historically marketed as “safe,” such as tramadol, actually carry quite a high addiction risk for vulnerable populations.
Pharmaceutical Technology
SEPTEMBER 2, 2022
Novo Nordisk has signed a definitive agreement for the acquisition of clinical-stage biopharmaceutical firm Forma Therapeutics for $20 for each share in cash or a total equity price of $1.1bn. Forma focuses on researching, developing and marketing new therapies for patients with sickle cell disease (SCD), rare hematologic diseases and cancers. Through the acquisition, Novo Nordisk plans to boost its presence in sickle cell disease and rare blood disorders.
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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
SEPTEMBER 2, 2022
By augmenting the embryologist in selecting the most viable embryo, there is potential for AI to help a patient conceive in one or two cycles, reducing the inherent cost of IVF therapy, and making the treatment more accessible to diverse populations that often don’t have ease of access to treatments today.
pharmaphorum
SEPTEMBER 2, 2022
The EMA’s human medicines committee (CHMP) has recommended authorisation of two COVID-19 vaccines from Moderna and Pfizer/BioNTech that include sequences coding for Omicron spike protein as booster shots. The European Commission said it will move ahead with an accelerated authorisation of the bivalent shots, which include mRNA for the wild-type SARS-CoV-2 spike protein, as well as the original BA.1 subvariant of Omicron, in a divergence from the approach taken by the authorities in the US.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
European Pharmaceutical Review
SEPTEMBER 2, 2022
To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. This provides information on a medicine’s safety profile, describing the activities of the marketing authorisation holder to further characterise its safety profile during pharmacovigilance activities and explaining the measures that will be taken to prevent or minimise risks in patients – these are known as risk minimisation measures (RMMs). .
MedCity News
SEPTEMBER 2, 2022
Novo Nordisk announced that it will buy Forma Therapeutics, a clinical-stage biotech focused on rare hematologic diseases, in an deal valued at $1.1 billion. The deal is the second billion-dollar sickle cell disease deal the pharmaceutical industry has seen in the last 30 days — Pfizer forked over $5.4 billion in August to buy Global Blood Therapeutics.
Pharmaceutical Technology
SEPTEMBER 2, 2022
Multiple myeloma (MM) therapeutics comprise a multi-billion dollar market, among the most valuable in oncology. This is a result of intensive research efforts that have produced regimens that have prolonged patient survival, most of which are a combination of a proteasome inhibitor + an immunomodulatory drug (ie. lenalidomide) + a steroid ± an anti-CD38 antibody.
Pharmacy Times
SEPTEMBER 2, 2022
AI-based technologies are increasingly being used for things such as virtual screening, physics-based biological activity assessment, and drug crystal-structure prediction.
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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.
PharmaTimes
SEPTEMBER 2, 2022
AI company has its breast cancer and colorectal therapies approved for use in Europe
PharmaTech
SEPTEMBER 2, 2022
It is important to understand regulatory requirements and study challenges to develop and validate the appropriate methods for a bioanalytical study program at the clinical stage.
Rep-Lite
SEPTEMBER 2, 2022
The employment rate in the United States has been steadily improving. As of July 2022, the unemployment rate has decreased to 3.5%. Moreover, healthcare has been one of the most prominent leaders in jobs widespread in the same period. Recruiters aggressively look for people who would be a good match for their firm using various techniques, including web research, networking, and referrals, among many others.
PharmaTech
SEPTEMBER 2, 2022
By eliminating the waste involved in traditional approaches to project set-up and execution, integrated project delivery helps innovators in the European life sciences market meet their fast-track delivery targets.
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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.
LEVO Health
SEPTEMBER 2, 2022
Healthcare marketing is a unique specialty that requires an understanding of the various industry personas and how they each interact with your digital marketing strategy. Healthcare personas embody real people who act as representatives for different patients within your target market. Personas allow you to understand what motivates your patient, their goals, frustrations, and desires.
Rep-Lite
SEPTEMBER 2, 2022
The employment rate in the United States has been steadily improving. As of July 2022, the unemployment rate has decreased to 3.5%. Moreover, healthcare has been one of the most prominent leaders in jobs widespread in the same period. Recruiters aggressively look for people who would be a good match for their firm using various techniques, including web research, networking, and referrals, among many others.
Pharmaceutical Technology
SEPTEMBER 2, 2022
The rate of drug approvals could be on the rise. In a recent report, GlobalData revealed that the US Food and Drug Administration (FDA) approved 122 new drug applications (NDAs) and biologic license applications (BLAs) in 2021. This figure represents a 2.4% increase over the 2016–2020 period average. Yet despite this promising data, it’s a well-known fact that drug launches are under-performing – with around two-thirds of new drugs successfully navigating the long and rocky approval process only
pharmaphorum
SEPTEMBER 2, 2022
Novo Nordisk has doubled down on position in the sickle cell disease (SCD) category with a $1.1 billion agreement to acquire Forma Therapeutics, and its therapeutic candidate etavopivat, in phase 2/3 testing. The $20-per-share agreement was a premium of 92% over Forma’s closing share price yesterday, but its stock leaped after the deal was announced from $13.40 to just under the deal price.
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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.
Pharmaceutical Technology
SEPTEMBER 2, 2022
The US Food and Drug Administration (FDA) has granted approval for Azurity Pharmaceuticals’ Konvomep (omeprazole and sodium bicarbonate for oral suspension) to treat active benign gastric ulcer. Konvomep is also indicated for lowering the upper gastrointestinal bleeding risk in critically ill patients. It is a combination of a proton pump inhibitor (PPI), omeprazole, and sodium bicarbonate.
pharmaphorum
SEPTEMBER 2, 2022
A judge in the US has ruled in favour of Illumina in a dispute with the Federal Trade Commission (FTC) over its multibillion-dollar takeover of cancer diagnosis specialist Grail, which had been challenged on the grounds to could create a monopoly. The FTC as well as antitrust authorities in the EU filed objections to the merger, which would bring Grail back into Illumina after being spun out of the group a few years earlier, arguing that it would slow down the development of multi-cancer early d
PharmaTimes
SEPTEMBER 2, 2022
Research is evaluating the therapy among paediatric patients with severe malaria
PharmaTech
SEPTEMBER 2, 2022
A process flow diagram can help create an agreed-upon process flow for a third-party standard operating procedure, says Siegfried Schmitt, VP Technical at Parexel.
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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.
Pharmacy Times
SEPTEMBER 2, 2022
DNA and RNA sequencing could provide insight about resistance to chemotherapy in patients suffering from triple-negative breast cancer.
PharmaTech
SEPTEMBER 2, 2022
As winter approaches, the next generation of COVID-19 vaccines are being prepared and scheduled, ready for distribution across Europe and the world.
Pharmacy Times
SEPTEMBER 2, 2022
Bill Schimmel, CEO and executive director of the Pharmacy Technician Certification Board (PTCB), discusses how pharmacists and pharmacy technicians can advocate for the certification of pharmacy technicians.
PharmaTech
SEPTEMBER 2, 2022
The IQ Working Group has defined a pragmatic risk-based approach to audit trail review, where it is only required for high impact GxP data.
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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
Pharmacy Times
SEPTEMBER 2, 2022
The FDA approved Azurity Pharmaceutical’s omeprazole and sodium bicarbonate for oral suspension to treat benign gastric ulcers and it is predicted to reach commercial markets by next year.
PharmaTech
SEPTEMBER 2, 2022
FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.
The Marketing Advantage
SEPTEMBER 2, 2022
September 2, 2022 One of the biggest challenges biopharma companies face around designing a sales compensation plan for a multi-product bag is ensuring that all products in the bag get sufficient attention without taking focus away from the product(s) deemed most important. However, too often, sales representatives abandon one or more products in favor of the product(s) with which they believe they can earn the largest bonus.
PharmaTech
SEPTEMBER 2, 2022
Cleanroom monitoring may be in a state of flux after many recent technological advancements.
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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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