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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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 7, 2022

According to a 2021 study , 1.1 million deaths—including one in two of those under 65, thanks in large part to our abysmal health care system—”would have been averted if the U.S. had the mortality rates of other wealthy nations. One in three GoFundMe campaigns is now for healthcare-related costs, and it’s getting worse. The passage of the Inflation Control bill is an excellent first step in limiting high drug costs, but our healthcare system is still built for profit at the expense

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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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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Medicine

Pharmaceutical Technology

AUGUST 10, 2022

The US Food and Drug Administration (FDA) has granted Fast-Track designation to Relmada Therapeutics’ REL-1017 as a single agent to treat major depressive disorder (MDD). A new chemical entity and NMDA receptor (NMDAR) channel blocker, REL-1017 acts on hyperactive channels while preserving physiological glutamatergic neurotransmission. Presently, the therapy is being analysed in late-stage studies.

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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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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 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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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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Clinical Supply

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 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 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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pharmaphorum

AUGUST 12, 2022

Half a million people in the UK with conditions like blood cancer that prevents them being protected from COVID-19 vaccines are facing another winter shielding, because the government has shelved plans to offer treatment with AstraZeneca’s antibody therapy Evusheld. That’s the position of multiple patient organisations, clinicians and medical groups, who have criticised the Department of Health’s decision to defer procurement of Evusheld supplies until cost-effectiveness agency

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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 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 236

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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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 Vaccine Vaccination Marketing 305

NPR Health - Shots

AUGUST 11, 2022

Revised guidance from the Centers for Disease Control and Prevention looks to minimize COVID-19's disruption of daily life while conceding that the pandemic isn't over.

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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 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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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 305

STAT News

AUGUST 10, 2022

The explosive trajectory of monkeypox to nearly 90 countries since the current outbreak was detected in the United Kingdom in mid-May has caught many governments off-guard , and created confusion about how monkeypox spreads from person to person. In some ways, the virus is acting differently than it has in the past. For decades, researchers in West and Central Africa, where the virus is endemic, have observed that outbreaks there tend to be self-limiting.

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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 11, 2022

Import of medical devices to the country during the year 2021-22 has seen an increase of 36.8 per cent to $8.54 billion, with the highest growth in terms of imports registered in the category of implants. Exports of medical devices, during the period, grew by 15.4 per cent to $2.92 billion from the $2.53 billion […].

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Clinical Trials Clinical Trials Trials 181

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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NPR Health - Shots

AUGUST 9, 2022

There isn't currently a Lyme disease vaccine on the U.S. market. Researchers are hoping to change that.

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Clinical Trials Clinical Trials Vaccine Vaccination 145

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AuroBlog - Aurous Healthcare Clinical Trials blog

AUGUST 9, 2022

Even though Assisted Reproductive Technology (Regulation) Act, 2021 has been enacted to regulate ART clinics and banks and protect donors and women undergoing ART from the health consequences related to risky and illegal treatments, the Act has fallen short of addressing several grave concerns including costs of the services and prohibiting single men, transgenders and […].

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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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Bio Pharma Dive

AUGUST 8, 2022

The company plans to ask regulators to approve its KarXT therapy based on the results, which one analyst called “as good as one could hope for.

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Regulation Drugs 290

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.

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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