Pharmaceutical Technology

SEPTEMBER 7, 2022

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. A recombinant replication-deficient adenovirus vectored vaccine, iNCOVACC has a prefusion stabilised spike protein and is claimed to be the first intranasal vaccine globally to obtain primary two-dose schedule approvals.

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Vaccination Vaccine Clinical Trials Clinical Trials 263

Bio Pharma Dive

SEPTEMBER 7, 2022

The team behind the Seattle-based startup will launch a new company, Bonum Therapeutics, after the sale to Roche is completed.

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Sales Drugs 285

AuroBlog - Aurous Healthcare Clinical Trials blog

SEPTEMBER 7, 2022

If you’ve ever had a urinary tract infection (UTI) before, you know what a pain it can be. Not just because of the physical pains it causes, but because it can also be such a pain to go to the doctor, provide a urine sample, and wait for your results. Skip advert UTIs are extremely […].

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Doctors Doctor Clinical Trials Clinical Trials 224

Bio Pharma Dive

SEPTEMBER 7, 2022

“We see a huge opportunity in the setting of RNA-based therapies to overcome some of the shortcomings that have been there with the first generation of RNA companies,” said former Alnylam CEO and Orbital Therapeutics co-founder John Maraganore.

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RNA Drugs 228

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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

Clinical Research

World of DTC Marketing

SEPTEMBER 7, 2022

Wall Street wants growth, as do investors, but that may be impossible for pharmaceutical companies. In pharma, growth depends on new products with hefty price tags when over 80% of voters want lower costs for their prescription drugs. Biogen’s failure should be a warning to other pharma companies. They relied so much on a new drug that they tried to market a product with bad science behind it.

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Pharma Companies Marketing Drugs Production 210

Bio Pharma Dive

SEPTEMBER 7, 2022

Seven years after the first copycat biologic drug arrived in the U.S., expected cost savings have been modest at best. The next few years will show whether the knockoff drugs can live up to their cut-price promise.

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Drugs 177

Bio Pharma Dive

SEPTEMBER 7, 2022

The biotech’s Series B fundraising equips it with new cash just as it prepares to advance its first drug candidate into clinical testing.

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Research Drugs 183

Worldwide Clinical Trials

SEPTEMBER 7, 2022

The last time I saw my mom alive, I helped her eat dinner while my son colored her a picture. We were outside, due to Covid-19 restrictions. We were lucky to finally see her in person after almost a year of daily FaceTime videos, and window visits. Of course, none of us knew it would be our last visit. She died on April 3, 2021. My mom was one of the six million Americans living with Alzheimer’s Disease.

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Clinical Trials Clinical Trials Trials Scientist 130

Bio Pharma Dive

SEPTEMBER 7, 2022

While it plans to appeal this week’s EC decision, Illumina say it’s preparing for ‘strategic alternatives’ to its acquisition of early cancer detection firm Grail.

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Rethinking Clinical Trials

SEPTEMBER 7, 2022

Dr. Steven Joffe. In this Friday’s PCT Grand Rounds, Dr. Steve Joffe will kick off our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials, with a keynote presentation, “Building an Academic Learning Health System: Why Is It So Hard?” The Grand Rounds session will be held on Friday, September 9, 2022, at 1:00 pm eastern.

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Trials Clinical Trials Clinical Trials Medicine 130

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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

Pharmaceutical Technology

SEPTEMBER 7, 2022

The health concern over COVID-19 in August 2022 decreased averaging at 22.3%, compared to 27.7% recorded in July 2022 , shows the COVID-19 concern index, which is measured by responses to an ongoing poll Verdict launched in March 2020. The poll has been tracking how the concerns over coronavirus have been changing over time. The poll asked how concerned the respondents were about the spread of coronavirus and included five options to choose from - very concerned, slightly concerned, neither conc

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NPR Health - Shots

SEPTEMBER 7, 2022

A new study finds numbers far higher than previously thought. India has the greatest number of kids affected. The U.S. has 250,000 kids in this category but lags behind in aid for bereaved families.

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Pharmaceutical Technology

SEPTEMBER 7, 2022

Failing to adhere to prescribed medication regimens is one of the prime reasons for poor patient health outcomes. Pharmaceutical and healthcare companies are working continuously to improve patient adherence, which also impacts disease control and pharmaceutical industry revenues directly. The growing prevalence of chronic diseases and rising geriatric population has led to increasing demand for advanced medication adherence systems, personalised healthcare, and mobile health systems, which are

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Pharmacy Containment Manufacturing Compliance 130

NPR Health - Shots

SEPTEMBER 7, 2022

Historic flooding and record droughts are stressing water systems across the country, and experts warn that with climate change intensifying the crisis in Jackson, Miss., may be just the beginning.

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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.

Clinical Supply

Pharmaceutical Technology

SEPTEMBER 7, 2022

The diabetic macular oedema (DME) market is anticipated to reach values of $11.1bn in 2031 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan). This follows the US Food and Drug Administration's (FDA) recent approval, in January this year, of Roche’s Vabysmo (faricimab) for DME, coupled with the anticipated approval of pipeline therapies in the forecast period from 2021 to 2031, which are expected to drive the growth of the DME market in the 7MM.

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Marketing Branding Protein Drugs 130

STAT News

SEPTEMBER 7, 2022

For Illumina, the leading maker of DNA sequencing equipment, there was bad news and worse news Tuesday. The bad news: The European Commission said it was blocking Illumina’s $8 billion acquisition of Grail, a firm focused on the early detection of cancer. The worse news? In its press release on the ruling, Illumina acknowledged that, although it will appeal, that may not prevent the European Commission from forcing it to divest Grail, which it purchased before regulatory approvals were in

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DNA 133

Pharmaceutical Technology

SEPTEMBER 7, 2022

Increasing diagnosis of chronic diseases is expected to lead to fast growth in retail pharmacies. The rising incidence of long-standing diseases such as hypertension, diabetes, cardiovascular diseases, and cancer requires prolonged medication and, thus, drives the growth and need for retail pharmacies in the market. Pharmacies can cater to the needs of individuals with both complex and relatively simple medical conditions, while some also provide customised and highly personalised care to patien

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Pharmacy Generic Drugs Containment Production 147

STAT News

SEPTEMBER 7, 2022

In May, Sarah Fama had to get blood work done before refilling a prescription for an autoimmune disorder. Because her condition put her at high risk for Covid-19, and she lives with her parents, both in their 80s, she checked the lab’s website, which stated that masks were required inside. When she arrived, she was reassured by a sign on the door that said the same thing.

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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

Pharmaceutical Technology

SEPTEMBER 7, 2022

Pharmaceutical benefit managers and management companies serve as intermediaries between insurance companies, pharmacies, and drug manufacturers. They bring together employers/plan sponsors, health insurers, plan members, drug wholesalers, pharmacies, and drug companies to facilitate better health outcomes at an affordable cost. Benefit managers are hired by corporate employers, labour unions, health plans, and other institutions to meet their requirements, which is crucial to ensure the success

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Pharmacy Containment Manufacturing Compliance 130

pharmaphorum

SEPTEMBER 7, 2022

Brainomix has reeled in another pharma partner for its artificial intelligence-powered biomarker software, used to track the performance of therapeutic interventions in clinical trials. South Korea’s Bridge Biotherapeutics has signed up to use the UK medtech firm’s e-ILD software package in a phase 2 trial of BBT-877, its experimental therapy for serious lung disease idiopathic pulmonary fibrosis (IPF).

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Trials Clinical Trials Clinical Trials Packaging 121

STAT News

SEPTEMBER 7, 2022

Studies have repeatedly suggested that physical conditions like immunosuppression and hypertension can increase a person’s risk not only for severe Covid but also long Covid. But in a new study , researchers found that psychological stressors such as depression, anxiety, and loneliness were more predictive of Covid patients’ likelihood of experiencing long Covid than classically associated physical factors.

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Scientist Research 116

XTalks

SEPTEMBER 7, 2022

Starbucks has appointed longtime Reckitt CEO and PepsiCo executive Laxman Narasimhan as their new CEO beginning October 1, 2022 after relocating from London to the Seattle area. Until then, he will work closely with interim CEO, Howard Schultz, through April 1, 2023. Here’s what you need to know about Laxman Narasimhan and what he should be prioritizing in his new role.

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Branding Sales Packaging Packaging 105

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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.

Clinical Supply

STAT News

SEPTEMBER 7, 2022

A federal judge in Texas has ruled that parts of the Affordable Care Act mandating health insurance companies cover many preventive services and drugs for free are unconstitutional. Judge Reed O’Connor also said the ACA’s requirement that health plans cover HIV pre-exposure prophylaxis, or PrEP, at no cost violates religious freedom law.

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Drugs 111

NPR Health - Shots

SEPTEMBER 7, 2022

The puss caterpillar has venomous barbs along its hairy body, and they cause extreme pain for many people who come into contact with one of the fuzzy little bugs.

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STAT News

SEPTEMBER 7, 2022

Good Therapeutics, a private company that raised just $30 million in venture financing since its 2016 foundation, said Wednesday it had signed a deal to sell itself to Roche for $250 million without ever running a clinical trial. The deal provides a roughly eight-fold return for Good’s investors, which included Codon Capital and RiverVest Venture Partners.

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Clinical Trials Clinical Trials Trials Marketing 105

NPR Health - Shots

SEPTEMBER 7, 2022

The skeleton of a young adult found in a cave in Indonesia that is missing its left foot and part of its left leg reveal the oldest known evidence of an amputation, according to a new study.

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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

STAT News

SEPTEMBER 7, 2022

The amputation happened when the individual was perhaps 12 years old, the skeleton indicates. Gone is the lower portion of the left leg. And somehow, the individual survived the surgical procedure — a remarkable feat given that it happened some 31,000 years ago. The skeleton, discovered in a cave on Borneo, in what is now Indonesia, appears to be evidence of the oldest known surgical amputation — 24,000 years earlier than that of a farmer in France, who had his left arm cut off an

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Research 105

NPR Health - Shots

SEPTEMBER 7, 2022

The electronic cigarette maker has agreed to settle a two-year investigation by 33 states and Puerto Rico into the marketing of its vaping products, which have been blamed for a surge in teen vaping.

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Production Marketing 104

STAT News

SEPTEMBER 7, 2022

A new health care company was quietly incorporated last month, with plans to leverage cutting-edge inhalation technology and oral delivery expertise to treat everything from neurology to cardiovascular emergencies. The multibillion-dollar company, Vectura Fertin Pharma , stands out not simply for its ambitions, but because of its financial backer: Philip Morris International, the tobacco behemoth whose cigarettes are sold in more than 180 countries.

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NPR Health - Shots

SEPTEMBER 7, 2022

The COVID-19 vaccine strategy may be shifting toward Americans getting yearly vaccinations, like many do with annual flu shots.

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Vaccination Vaccine 121

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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.

Clinical Trials