Bio Pharma Dive
AUGUST 8, 2022
The legislation, which would allow Medicare to negotiate prices on up to 60 drugs by 2029, passed on a party-line vote and now goes to the House, where it is expected to pass.
Pharmaceutical Technology
AUGUST 8, 2022
AstraZeneca and Daiichi Sankyo ’s Enhertu (trastuzumab deruxtecan) has received expanded approval from the US Food and Drug Administration (FDA) to treat adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer. The treatment is indicated for patients who have previously received chemotherapy in the metastatic setting or recurred during or within six months of receiving adjuvant chemotherapy.
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Bio Pharma Dive
AUGUST 8, 2022
Highly anticipated trial results for Lumakras combinations with immunotherapy fell short of expectations, showing significant liver toxicity that limited dosing.
Pharmaceutical Technology
AUGUST 8, 2022
The US Food and Drug Administration (FDA) has granted approval for a supplemental New Drug Application (sNDA) of Orion and its partner Bayer ’s Nubeqa (darolutamide) plus docetaxel to treat metastatic hormone-sensitive prostate cancer (mHSPC) patients. The latest approval is based on positive data from the multicentre, double-blind, randomised, placebo-controlled Phase III ARASENS clinical trial that analysed the safety and efficacy of oral darolutamide plus androgen deprivation therapy (ADT) an
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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
Bio Pharma Dive
AUGUST 8, 2022
After Indiana’s governor signed a near-total abortion ban into law, the drugmaker said it will rethink future hiring in the state.
World of DTC Marketing
AUGUST 8, 2022
Consumers have changed their shopping behavior due to the pandemic, and some of those changes are relevant for pharma marketers. The days of someone seeing an ad for a prescription drug and rushing to ask their doctor about it have replaced the quest for more information, usually online. CPG brands have finally admitted that consumers are changing how they purchase products and brands.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 8, 2022
In mammals, blood carries oxygen and nutrients to the body’s organs and cells. But if blood flow stops, these cells will quickly die and organs are injured. This death can be slowed in organs and tissues removed from the body, buying time for organ transplantation. However, preserving entire organ systems minutes after the heart stops […].
Bio Pharma Dive
AUGUST 8, 2022
The acquisition gives Pfizer access to Oxbryta, an approved drug for the blood condition, as well as two experimental medicines.
Pharmaceutical Technology
AUGUST 8, 2022
The US Food and Drug Administration (FDA) has granted approval for Pfizer and Myovant Sciences ’ Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) to manage moderate-to-severe pain linked with endometriosis in pre-menopausal women. Myfembree is a one-pill treatment indicated to be administered once daily for a treatment period of up to 24 months.
NPR Health - Shots
AUGUST 8, 2022
Wastewater testing has proved a reliable early alarm bell for COVID-19 outbreaks. U.S. researchers are now adapting the approach to track the explosive spread of monkeypox, and maybe other viruses.
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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
Pharmaceutical Technology
AUGUST 8, 2022
The proportion of pharmaceutical companies hiring for future of work related positions rose in July 2022 compared with the equivalent month last year, with 48.5% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 42.9% of companies who were hiring for future of work related jobs a year ago and an increase compared to the figure of 46.6% in June 2022.
pharmaphorum
AUGUST 8, 2022
A study of a mobile health app used to support patients hospitalised with heart failure has concluded that it provided a modest improvement in quality-of-life scores, as well as better clinical outcomes. The finding comes from the large-scale CONNECT-HF cluster study, which looked at various patient engagement and education interventions to see if they could help patients with heart failure do better after discharge from hospital.
NPR Health - Shots
AUGUST 8, 2022
When it comes to disability, a lot of ableist language and tropes are perpetuated by the media. Here's what experts have to say about how to talk about disability.
STAT News
AUGUST 8, 2022
Climate hazards such as flooding, heat waves, and drought have worsened more than half of the hundreds of known infectious diseases in people, including malaria, hantavirus, cholera, and anthrax, a study says. Researchers looked through the medical literature of established cases of illnesses and found that 218 out of the known 375 human infectious diseases, or 58%, seemed to be made worse by one of 10 types of extreme weather connected to climate change, according to a study in Monday’s
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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.
NPR Health - Shots
AUGUST 8, 2022
Insured or not, one in five said they couldn't get treated for serious illness, while preventive and elective procedures were neglected. Disruptions in care hit Black and Native Americans the hardest.
STAT News
AUGUST 8, 2022
Recent federal crackdowns on Medicare fraud linked to telehealth have raised concerns in Washington that virtual care introduces new opportunities for criminals to defraud vulnerable patients. But lobbyists and researchers say risks aren’t necessarily greater than in-person, and warn that fear could drive lawmakers to make virtual care harder to access.
NPR Health - Shots
AUGUST 8, 2022
In an effort to reduce the high price of prescription drugs, some states and companies are taking their own measures. A not-for-profit company says it aims to introduce low-cost insulin by 2024.
pharmaphorum
AUGUST 8, 2022
Pfizer’s reported interest in acquiring sickle cell disease specialist Global Blood Therapeutics (GBT) has been confirmed, with the $68.50-per-share deal valuing GBT at $5.4 billion. As we reported this morning, the deal gives Pfizer already-approved SCD therapy Oxbryta (voxelator) – which industry watchers reckon could see a dramatic uptick in sales with Pfizer’s marketing muscle – plus a phase 3 antibody candidate, a phase 1 follow-up to Oxbryta that could offer improved dosing.
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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.
NPR Health - Shots
AUGUST 8, 2022
A new poll indicates 27% of Black Americans saw someone in their household become seriously ill in the past year. Among them, 18% say they were unable to get needed care.
BioPharma Reporter
AUGUST 8, 2022
Biopharmaceutical company Global Blood Therapeutics specializes in conditions that often disproportionately impact underrepresented communities, such as SCD.
STAT News
AUGUST 8, 2022
For only the second time, Pfizer is offering a warranty for a medicine that will cover the cost for any patient or health plan if the medication fails to work, a move that expands an effort to appease concerns about high drug costs. The newest warranty program began last month and covers Panzyga , which was approved last year in the U.S. to treat a rare neurological disorder called chronic inflammatory demyelinating polyneuropathy, or CIPD.
Antidote
AUGUST 8, 2022
Medical research is how new treatments and therapies move forward, but challenges surrounding patient recruitment can often lead to delays. Patients often have misconceptions about participating in a clinical trial — and if they are interested, they often aren’t sure where to begin.
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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.
STAT News
AUGUST 8, 2022
A drug that has been used to slow progression of kidney and cardiovascular disease in people with type 2 diabetes may also help people with chronic kidney disease who do not have diabetes, according to findings published Monday in the European Heart Journal. Aldosterone, a hormone produced by the triangular adrenal glands, might be the key target. In the observational study, researchers analyzed health data from 3,680 people with chronic kidney disease for nearly 10 years.
XTalks
AUGUST 8, 2022
Medicxi is a prominent international life sciences investment firm that invested in over 60 portfolio companies such as Versanis Bio, Rivus Pharmaceuticals, Capella Bioscience and more. One of Medicxi’s portfolio companies called MiroBio is set to be acquired by Gilead Sciences for approximately $405 million in cash. MiroBio’s Research Pursuits.
STAT News
AUGUST 8, 2022
There’s really no ignoring the inexorable math that led the Senate to approve a plan that will give Medicare unprecedented power to set the prices of some drugs. By the 1990s, a course of a breakthrough cancer drug like Taxol might already cost about $10,000 in inflation-adjusted dollars. By the early 2000s, Gleevec, one of the most potent cancer medicines ever, would be about $30,000.
Pharma Times
AUGUST 8, 2022
Study involved patients with locally advanced, unresectable stage 3 non-small cell lung cancer
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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.
STAT News
AUGUST 8, 2022
Scientist Jim Wilson is synonymous with gene therapy — and for good reason. For decades, the celebrated researcher has been a pioneer in the field, focused on the development of treatments for rare, often overlooked diseases. His work has generated millions of dollars for his employer, the University of Pennsylvania, and made Wilson a towering figure in the gene therapy world, with the wealth and fame to match.
pharmaphorum
AUGUST 8, 2022
Bayer has won a key FDA approval to extend the use of its prostate cancer therapy Nubeqa, as it tries to claim market share from rival drugs and fulfil its aim of building the drug into a €3 billion ($3.1 billion) blockbuster. The US regulator has approved Nubeqa (darolutamide) in combination with docetaxel chemotherapy for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC), adding to its earlier indication in non-metastatic castration-resistant prostate cancer (nmCRPC).
STAT News
AUGUST 8, 2022
Deaths from breast cancer create huge holes in families and communities that cannot be filled. This disease kills nearly 44,000 people in the U.S. each year, and a staggering 685,000 around the world. In the U.S., breast cancer disproportionately affects women of color. Black women are 41% more likely to die of breast cancer than white women and have a 39% higher risk of recurrence.
Trialfacts
AUGUST 8, 2022
Contents. About the Study. Why Participate? Your Rights. Who Can Participate? More Study Details. About the Research Center: Location. Research Center: University of British Columbia. Location: This is a Kelowna/Vancouver-wide research study. Lead Researcher: Dr. Jonathan Little. About the Study. Did you know that ketone bodies can be an alternative fuel and energy source?
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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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