World of DTC Marketing
AUGUST 12, 2022
PhRMA is lying to protect its profits, and the lies have reached a new height as the Senate moved to adopt modest drug pricing negotiation measures in the Inflation Reduction Act. The bill “could propel us light-years back into the dark ages of biomedical research,” Dr. Michelle McMurry-Heath, president of the Biotechnology Innovation Organization, said last month.
Pharmaceutical Technology
AUGUST 12, 2022
In June this year, it was announced that the US Food and Drug Administration (FDA) had granted UK-based OxfordVR a breakthrough device designation for its gameChangeVR treatment to deliver immersive cognitive behaviour therapy (CBT) to people suffering from schizophrenia and other mental illnesses. The FDA’s breakthrough device programme is for medical devices or device-led combination products that provide more effective treatment or diagnosis of diseases.
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PharmExec
AUGUST 12, 2022
Mindy will be the creative voice of the agency, responsible for providing Greater Than One clients with strategic creative direction and oversight from inception through execution.
Pharmaceutical Technology
AUGUST 12, 2022
The US Food and Drug Administration (FDA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (fam-trastuzumab deruxtecan-nxki) to treat unresectable or metastatic non-small cell lung cancer (NSCLC) in adults. The treatment is indicated for such patients whose tumours have activating HER2 (ERBB2) mutations and previously received systemic therapy. .
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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 12, 2022
Materna Medical, a company that sells Ob-gyn medical devices, recently raised $22 million in Series B funding. The round was raised by CEO Tracy MacNeal, which stands out because female founders raised just 2% of all venture capital money last year.
Pharmaceutical Technology
AUGUST 12, 2022
In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The plan, which was released in late June, outlines a science strategy to improve research efforts for ALS. Its content is pertinent given the upcoming FDA Advisory Committee (AdCom) for Amylyx Pharmaceuticals’ ALS drug AMX0035 on 7 September.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
European Pharmaceutical Review
AUGUST 12, 2022
According to researchers, binding nasal vaccine antigens to albumin enables them to bypass mucosal barriers, and could lead to better protection against pathogens like HIV and Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2; the virus that causes COVID-19). The University of Minnesota researchers tested the technology on mice and non-human primates and found that the vaccine generated strong immune responses, paving the way for further study and development of nasal vaccines.
MedCity News
AUGUST 12, 2022
Through the partnership, BCBSM members will have access to Maven Clinic’s app, which provides 24/7 virtual support. They can choose three program types: family building, maternity or parenting and pediatrics.
European Pharmaceutical Review
AUGUST 12, 2022
Since ophthalmic preparations are typically manufactured aseptically, with sterility ensured by sterile filtration rather than terminal sterilisation, literature about the effects of terminal sterilisation on these products is limited. Thus, researchers set out to establish whether the quality of common ophthalmic active pharmaceutical ingredients (APIs) still complies with the specifications of the European Pharmacopoeia (Ph.
MedCity News
AUGUST 12, 2022
The two deaths reported following treatment with Novartis’s Zolgensma mark the first fatal cases of acute liver failure associated with the gene therapy. Liver complications are a known side effect risk of Zolgensma and other genetic medicines that are delivered by engineered viruses.
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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.
Copyright Clearance Center
AUGUST 12, 2022
The post Big 5 CEOs Testify in Antitrust Case appeared first on Copyright Clearance Center.
MedCity News
AUGUST 12, 2022
Check out new developments from Carrum Health, Equiva, imaware, Elo, Paige, Gozio Health and WELL Health.
PharmaTimes
AUGUST 12, 2022
Treatment becomes an option for treating visual impairment caused by diabetic macular oedema, regardless of lens status
pharmaphorum
AUGUST 12, 2022
Recent history should have the pharmaceutical industry questioning some of its fundamental assumptions. The COVID-19 pandemic led to skyrocketing demand for some products while simultaneously constraining supplies due to logistical breakdowns and protectionist practices. The logic of outsourcing production to other countries, primarily China, suddenly looked dubious as Western countries struggled to import the drugs they needed.
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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.
PharmaTimes
AUGUST 12, 2022
Radioligand therapy involves patients with advanced prostate cancer in Great Britain
Rep-Lite
AUGUST 12, 2022
Improve the candidate’s application experience Looking for jobs can be a challenging experience. However, it can be an opportunity for job hunters to meet people in the same industry. You can leverage this as a company looking for the best pharmaceutical sales representative or other vital positions. If the candidates applying for your vacant positions have a positive experience, they will recommend your company to their colleagues.
Impetus Digital
AUGUST 12, 2022
Register for Impetus’ upcoming live webinar on August 24, 10-11 AM ET: A Fireside Chat with Kaitlin Anstett, Senior Medical Advisor at Theratechnologies. About the webinar. Kaitlin Anstett , Senior Medical Advisor at Theratechnologies , will sit down with Natalie Yeadon , Co-founder & CEO of Impetus Digital , to share her unique insights into the way Medical Affairs teams are changing the way they are engaging and interacting with their most important stakeholders in the “new normal.
Rep-Lite
AUGUST 12, 2022
Improve the candidate's application experience. Looking for jobs can be a challenging experience. However, it can be an opportunity for job hunters to meet people in the same industry. You can leverage this as a company looking for the best pharmaceutical sales representative or other vital positions. If the candidates applying for your vacant positions have a positive experience, they will recommend your company to their colleagues.
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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
AUGUST 12, 2022
Johnson & Johnson has said it will stop selling talc-based baby powder products globally next year, two years after halting sales in the US and Canada. The company said the decision to replace its talc Baby Powder with a cornstarch-based version has been taken as “part of a worldwide portfolio assessment,” and reiterated that its position on the safety of talc – the subject of ongoing and expensive litigation – remains unchanged. “We stand firmly behind the decades of indep
Pharmaceutical Technology
AUGUST 12, 2022
Ceapro has extended a partnership underway to carry out a further research project with McMaster University for developing an inhalable immuno-therapeutic/-prophylactic for Covid-19-induced lung fibrosis. This project is intended to develop therapies for people suffering from Covid-19’s long-term effects. In August 2019, the parties entered a partnership for new drug delivery system development leveraging the disruptive Pressurized Gas eXpanded Liquid technology (PGX) to streamline drug formulat
pharmaphorum
AUGUST 12, 2022
Patient recruitment specialist Clariness will deploy an app aimed at helping asthma patients monitor environment triggers and report symptoms in the clinical trials its support, thanks to a partnership with digital health firm DailyBreath. The app – also called DailyBreath and available via Google Play or the App Store – gives people with asthma data on environmental conditions that can affect their illness, like pollution, weather conditions and allergens such as pollen.
PharmaTech
AUGUST 12, 2022
Moderna and the European Commission have amended their agreement to convert contractually agreed doses of Moderna’s COVID-19 vaccine to the company’s Omicron-containing bivalent vaccines for supply in 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.
PharmExec
AUGUST 12, 2022
Expert naming process valued in fast-tracked approval as drug clears FDA regulatory hurdles.
PharmaTech
AUGUST 12, 2022
Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.
Pharmaceutical Commerce
AUGUST 12, 2022
In deal to be finalized by October, purchases B Medical Systems for $423 million.
Pharmacy Times
AUGUST 12, 2022
The Prescription Information Modernization Act seeks to modernize health care with up-to-date digital prescribing information to pharmacists.
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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
AUGUST 12, 2022
Multi-year initiative will leverage NFL Alumni events and educational opportunities to raise awareness about effective opioid alternatives.
Pharmacy Times
AUGUST 12, 2022
A daily serving of meat can increase the risk of cardiovascular disease by 22% and our own gut microbes may contribute to this risk.
PharmaTech
AUGUST 12, 2022
Roche announced that FDA has approved Roche’s Xofluza (baloxavir marboxil) to treat influenza in children aged five years and older.
Pharmacy Times
AUGUST 12, 2022
Lyme disease has reportedly spread geographically and increased in rural and urban populations during the past 15 years.
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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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