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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Clinical Trials Clinical Trials Marketing Development 354

Bio Pharma Dive

AUGUST 10, 2022

The deal, worth as much as $2 billion, is the latest sign of industry interest in treatments that harness regulatory T cells, an approach behind several recent biotech startups.

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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.

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Drugs Research Development Regulation 255

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2022

When babies in the African countries of Guinea Bissau and Uganda were given the tuberculosis vaccine, something remarkable happened. Instead of the vaccine only protecting against the target bacteria – Myocbacterium tuberculosis – the tuberculosis vaccine offered broad protection against a range of unrelated infections, including respiratory infections and serious complications such as sepsis.

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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

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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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Bio Pharma Dive

AUGUST 9, 2022

The CEO recently led Upstream through a $200 million financing that will support development of an inflammatory disease drug. “We have what investors probably want at this time,” she told BioPharma Dive.

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Development Drugs 324

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 […].

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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 9, 2022

Boston-based Cerevance uses samples of healthy and diseased human brain tissue to find new targets for central nervous system diseases.

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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.

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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

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 10, 2022

There are more than a thousand different ways that climate change can cause outbreaks of infectious disease in humans, according to a new review. When analyzing the literature on 375 human pathogens, researchers from the University of Hawai?i at M?noa and the University of Wisconsin-Madison in the US found 58 percent of these diseases were, at […].

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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.

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Bio Pharma Dive

AUGUST 9, 2022

The experimental vaccine is the most advanced candidate for the tick-borne disease and, if successful, would be the first to reach the market since withdrawal of GSK’s Lymerix.

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Trials Vaccination Vaccine Marketing 295

Rethinking Clinical Trials

AUGUST 11, 2022

The Helping to End Addiction Long-Term Initiative?, or NIH HEAL Initiative?, recently published 2 funding opportunity announcements soliciting applications focused on sickle cell disease (SCD) pain management. The effort is co-led by the National Center for Complementary and Integrative Health and the National Heart, Lung, and Blood Institute, with support from other NIH Institutes, Centers, and Offices.

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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.

Clinical Trials

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 7, 2022

Imagine you’ve just completed a tough upper-body workout. Your muscles feel a bit tired, but all in all, you’re able to go about the rest of your day just fine. The next morning, you wake up and realize the back of your shoulder blade feels stiff. When you rub your shoulder muscles, it feels like […].

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Clinical Trials Clinical Trials Trials 180

Pharmaceutical Technology

AUGUST 9, 2022

Health Canada has accepted the New Drug Submission (NDS) of Endo International subsidiary Paladin Labs for cenobamate tablets as an adjunctive treatment to manage partial-onset seizures in adult epilepsy patients. The treatment is intended for such patients who are not well-controlled with standard therapy. The regulatory agency is anticipated to provide a decision on whether cenobamate tablets can be commercialised and sold in Canada under this NDS in the middle of next year.

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Life Science Clinical Development Trials Marketing 246

Bio Pharma Dive

AUGUST 10, 2022

Abecma, which 2Seventy bio helps develop and sell, is currently approved for patients who have tried at least four other medicines for the blood cancer.

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Rethinking Clinical Trials

AUGUST 10, 2022

Steven Joffe, MD, MPH, will give a keynote presentation on Sept. 9. The NIH Pragmatic Trials Collaboratory is launching a special Grand Rounds series to examine ethical and regulatory challenges in pragmatic clinical trials. Over the past decade, the program’s Ethics and Regulatory Core has worked with investigators to navigate ethical and regulatory complexities associated with research conducted within healthcare systems.

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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.

Clinical Research

AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 10, 2022

The amount released by the Central government towards drug development and research and development (R&D) through the Biotechnology Industry Research Assistance Council (BIRAC) has come down by almost 50 per cent in the last two fiscal years. The disbursement declined drastically in 2020-21, during when the Covid-19 pandemic hit the country and the government allocated […].

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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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Hormones Clinical Trials Clinical Trials Licensing 246

Bio Pharma Dive

AUGUST 10, 2022

The biotech’s failed attempt to develop an eye disease drug has ended in a reverse merger that gives startup Disc Medicine a fast path to the public markets.

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Medicine Marketing Development Drugs 293

NPR Health - Shots

AUGUST 10, 2022

Dr. Caitlin Bernard was publicly vilified for providing abortion care to a 10-year-old rape victim. And that's got some medical residents who were open to practicing in Indiana thinking again.

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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.

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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.

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Doctors Doctor Clinical Trials Clinical Trials 145

Pharmaceutical Technology

AUGUST 10, 2022

Cerevance has entered a multi-year strategic research partnership with Merck (MSD outside North America) to discover new targets for Alzheimer’s disease. Under the alliance, the companies will use the Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform of Cerevance to identify the targets. Furthermore, Cerevance will simultaneously out-license a discovery-stage programme to Merck under the partnership.

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Bio Pharma Dive

AUGUST 9, 2022

A treatment that AstraZeneca acquired for up to $6 billion in 2020 is showing early promise as a combination agent in lung cancer, where it’s being tested alongside Merck & Co.’s Keytruda.

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Drugs 278

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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Research 145

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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.

Clinical Trials

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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Research 130

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.

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FDA Approval Drugs Trials Marketing 189

Bio Pharma Dive

AUGUST 11, 2022

The companies could face liability related to their sales of the heartburn drug, which was withdrawn from market in the U.S. and other countries after impurities related to a likely carcinogen were detected.

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Sales Marketing Drugs 278

NPR Health - Shots

AUGUST 9, 2022

Some object to paying for health insurance plans that cover preventive services that they say violate their religious beliefs, which could cause millions to lose access to care if the courts agree.

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Medicine 144

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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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