Bio Pharma Dive
JUNE 3, 2021
Study results disclosed ahead of ASCO could make Lynparza a standard "adjuvant" treatment for people with an inherited form of breast cancer — as long as they know they have it.
World of DTC Marketing
JUNE 4, 2021
SUMMARY: The U.S. is one of the wealthiest countries in the world and accordingly has high obesity rates; one-third of the population has obesity plus another third is overweight. The cost of doing nothing is not an option. Yes, there are root causes for obesity that can’t be fixed quickly, but among the causes that we can try and change is our personal responsibility to live a healthier life.
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pharmaphorum
JUNE 1, 2021
Novo Nordisk is paying $55 million upfront to secure rights to a cell therapy for heart failure developed by Japanese startup Heartseed. The Danish drugmaker has acquired exclusive rights outside Japan to Heartseed’s HS-001 therapy based on heart muscle cells (cardiomyocytes) derived from human stem cells, and is due to start the phase 1/2 LAPiS trial in Japan later this year.
Pharma Times
JUNE 4, 2021
The radioligand therapy was linked with a significant increase in progression-free survival and a clinically relevant increase in overall survival in patients with midgut neuroendocrine tumours
Bio Pharma Dive
JUNE 3, 2021
The German drugmaker will add an experimental prostate cancer medicine to its pipeline through the deal, which reflects growing industry interest in the field.
World of DTC Marketing
JUNE 3, 2021
IN SHORT : Out-of-control health care spending exact an enormous and growing toll on Americans. The scale of the broken US health care system reveals itself in tragic ways. Fraud accounts for about $300 billion of annual US health care spending. Many employers no longer try to contain health care spending, but many more are fighting back. The Future of Health Care is Local, Open, and Independent.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JUNE 2, 2021
Updated study results showed an overall response rate of 98% with a longer-term follow-up at a median of 18 months
Bio Pharma Dive
JUNE 3, 2021
Results from the Phase 3 trial, which Novartis plans to use to ask for approval, help validate the pharma's bet on the therapy's original developer, Endocyte.
World of DTC Marketing
MAY 30, 2021
SUMMARY: Amazon has set its sights on healthcare as it smells another profit opportunity. Google has signed an agreement with the Mayo clinic to help analyze data as they want a slice of healthcare dollars but what’s missing from these tech companies is “the human touch” that patients want. Via The New Republic “whether it believes its own rhetoric—or just smells another profit opportunity—the tech industry shows little sign of slowing its march into the world of commerci
pharmaphorum
JUNE 3, 2021
The FDA has approved a digital device developed by Cognoa that can be used to diagnose autism spectrum disorder (ASD), just a few weeks after it was filed for approval. Cognoa says the artificial intelligence (AI) based device is the first to be authorised by the US regulator that can help doctors diagnose autism in primary care, and will be launched “in the coming months” At the moment, autism can be difficult to diagnose as there are no medical markers to confirm its presence.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Pharma Times
JUNE 4, 2021
Officials warned that early evidence suggests there may be an increased risk of hospitalisation for Delta compared to the Alpha (Kent) strain
Bio Pharma Dive
JUNE 2, 2021
Royalty Pharma will effectively fund MorphoSys' acquisition of the cancer biotech through a separate agreement to buy MorphoSys' shares of royalties on several marketed and experimental medicines.
World of DTC Marketing
JUNE 1, 2021
SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post , says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?
pharmaphorum
JUNE 3, 2021
The UK government is talking to AstraZeneca about ordering additional doses of its COVID-19 vaccine that will target the beta variant of SARS-CoV-2 virus first identified in South Africa, according to Health Secretary Matt Hancock. The AZ/Oxford University vaccine and other shots from Pfizer/BioNTech and Moderna are known to have less efficacy against the beta variant – also known as B.1.351 – which is estimated to be around 50% more transmissible than earlier strains.
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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.
BioSpace
JUNE 1, 2021
Calliditas is developing Nefecon, a down regulator of IgA1 and proprietary, novel oral formulation of budesonide – a potent and established immunosuppressant – for the treatment of IgAN.
Bio Pharma Dive
JUNE 3, 2021
VenBio has previously invested in a range of treatment areas and technologies, including cell and gene editing companies like Precision Bio and Artiva.
World of DTC Marketing
JUNE 2, 2021
SUMMARY: Doctors said they were dissatisfied were marketing emails (46%), telephone sales calls with sales reps (42%), and both webinars and websites (each at 39%) from pharma companies, according to Indegene. That should, however, not discourage the use of email to HCPs. If you follow some basic testing, email can be an effective tool for communicating information. 100 percent of U.S. pharma marketers use email marketing, and research shows that 73 percent of in-house marketers believe email m
Pharma Times
JUNE 3, 2021
Combination immunotherapy treatment approved in the EU for first-line treatment of adults with unresectable MPM
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
BioSpace
MAY 31, 2021
The FDA gave the green light to Amgen's Lumakras under accelerated approval as a treatment for patients with KRAS mutation whose disease has worsened over time.
Bio Pharma Dive
JUNE 1, 2021
A deal with Kyowa Kirin gives Amgen rights to an experimental treatment aimed at an autoimmune target that has drawn interest from multiple drugmakers.
pharmaphorum
JUNE 2, 2021
In the latest edition of What HCPs Think , CREATION.co’s Laura Marsh looks at what healthcare professionals are saying about blood clots linked to COVID-19 vaccines. The formation of blood clots is a necessary process in order for the body to repair damage caused by injury and to slow down bleeding. However, when blood clots form inappropriately, this limits blood flow through vessels and can pose a significant health risk.
BioPharma Reporter
JUNE 1, 2021
The EMPHATHY clinical trial will enroll patients with COVID-19 to test the drugâs effectiveness in preventing worsening of symptoms and hospitalization.
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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
BioSpace
JUNE 3, 2021
Bayer will nab exclusive rights to a differentiated alpha radionuclide, actinium-225 investigational compound, and a small molecule targeting prostate-specific membrane antigen.
Bio Pharma Dive
JUNE 4, 2021
Marc Dunoyer, the U.K. drugmaker's longtime finance chief, will move over to a strategy role and run Alexion as a rare disease unit within AstraZeneca.
Scienmag
JUNE 3, 2021
Credit: CABI Researchers have re-animated specimens of a fungus that causes coffee wilt to discover how the disease evolved and how its spread can be prevented. Coffee Wilt Disease is caused by a fungus that has led to devastating outbreaks since the 1920s in sub-Saharan Africa, and currently affects two of Africa’s most popular coffee […].
Pharma Times
JUNE 2, 2021
Alkermes said that it is expecting to make Lybalvi available for patients in the fourth quarter of 2021
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioSpace
JUNE 3, 2021
Nanobiotix is developing a way for its locally-injected radioenhancer for solid tumors to treat metastasized cancers, in combination with checkpoint inhibitors, and also deliver results distally.
Bio Pharma Dive
JUNE 1, 2021
Lybalvi is meant to be as effective as marketed antipsychotics but without the weight gain patients typically experience. Alkermes will introduce the drug into a competitive market, however.
Drug Patent Watch
JUNE 4, 2021
Annual Drug Patent Expirations for VELPHORO Velphoro is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are seven patents…. The post New patent for Vifor Fresenius drug VELPHORO appeared first on DrugPatentWatch - Make Better Decisions.
pharmaphorum
JUNE 4, 2021
AstraZeneca and Merck & Co’s Lynparza is primed for even wider use in the treatment of breast cancer after a phase 3 trial showed it could extend the time for the cancer to return when used as adjuvant therapy. Giving Lynparza (olaparib) to women with BRCA-positive, HER2-negative breast cancer straight after chemotherapy and surgery to remove the tumour reduced the risk of recurrence, secondary cancers or death by 42% compared to placebo after 2.5 years of follow-up.
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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.
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