Bio Pharma Dive
OCTOBER 18, 2022
At least five startups have emerged with new ways to genetically modify immune cells within the body, an approach that, if successful, could widen the field of CAR-T treatment.
Pharmaceutical Technology
OCTOBER 19, 2022
Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.
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AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 19, 2022
The liver is known for its ability to regenerate. It can completely regrow itself even after two-thirds of its mass has been surgically removed. But damage from medications, alcohol abuse, or obesity can eventually cause the liver to fail. Currently, the only effective treatment for end-stage liver disease is transplantation. However, there is a dearth […].
Pharma Mirror
OCTOBER 20, 2022
Home care is an indispensable aspect of the health care system that provides individuals with long-term support and services, allowing them to remain in their homes instead of being placed in nursing facilities or hospitals. Medication management is one of the most crucial components of in-home care because it enables the proper execution of treatment plans for various patients.
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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
OCTOBER 18, 2022
The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field.
Pharmaceutical Technology
OCTOBER 17, 2022
Novo Nordisk has concluded the acquisition of all outstanding shares of common stock of clinical-stage biopharmaceutical company Forma Therapeutics for $20 for each share in cash or a deal totalling $1.1bn. In September, Novo Nordisk entered a definitive agreement to acquire Forma. With the conclusion of the merger, Forma became Novo Nordisk’s fully-owned subsidiary. .
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
NPR Health - Shots
OCTOBER 19, 2022
"I'm an abortion doula, I fund people's abortions, I make sure they can get to their appointments, period," said Ash Williams of North Carolina. "I can do that. I just need to keep doing that.
Bio Pharma Dive
OCTOBER 20, 2022
The gene editing startup is one of less than two dozen biotech companies to debut on Wall Street this year, as the pace of IPOs remains far off last year’s trajectory.
Pharmaceutical Technology
OCTOBER 21, 2022
AbbVie has announced the acquisition of UK-based biotechnology firm DJS Antibodies for nearly $255m in cash at closing. DJS focuses on the discovery and development of antibody therapies that act on difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs). The company leverages its HEPTAD platform to facilitate the antibody discovery of GPCRs and other difficult targets. .
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 20, 2022
It’s long been popular advice for people looking to lose weight to avoid late night snacking. It’s no wonder, with a host of research showing that late night eating is linked to greater body weight and increased risk of obesity. But until now, few studies have actually investigated precisely why late night eating is linked […].
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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
STAT News
OCTOBER 17, 2022
Research at Boston University that involved testing a lab-made hybrid version of the SARS-CoV-2 virus is garnering heated headlines alleging the scientists involved could have unleashed a new pathogen. There is no evidence the work, performed under biosecurity level 3 precautions in BU’s National Emerging Infectious Diseases Laboratories, was conducted improperly or unsafely.
Bio Pharma Dive
OCTOBER 21, 2022
The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.
Pharmaceutical Technology
OCTOBER 17, 2022
Recent reports show that influenza cases are rising in the US and the UK. The intensity of the flu season in North America and Europe can be predicted by Australia’s flu season, having occurred months before the northern hemisphere’s winter period. This year, Australia experienced its worst flu season in five years. At its height, more than 30,000 cases were reported each week, according to the Australian Government Department of Health and Aged Care.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2022
In 1906, Alois Alzheimer, a psychiatrist and neuroanatomist, reported “a peculiar severe disease process of the cerebral cortex” to a gathering of psychiatrists in Tübingen, Germany. The case was a 50-year-old woman who suffered from memory loss, delusions, hallucinations, aggression, and confusion – all of which worsened until her untimely death five years later.
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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
OCTOBER 16, 2022
In an unusual step, the European Public Prosecutor’s Office (EPPO) confirmed it has opened an investigation into the Covid-19 contracts signed by the European Union, a move that comes shortly after numerous members of the European Parliament harshly criticized a lack of transparency surrounding an agreement with Pfizer. The EPPO is an independent public prosecution office that is responsible for investigating, prosecuting, and bringing to judgment crimes such as fraud, money laundering an
Bio Pharma Dive
OCTOBER 17, 2022
The newly enacted drug pricing law, along with Eisai and Biogen’s Alzheimer’s study success, will bring questions for many of the industry’s top companies.
Pharmaceutical Technology
OCTOBER 21, 2022
Of late, it seemed that all the stars had aligned well for Roche in the wet age-related macular degeneration (wAMD) space. With Susvimo (ranibizumab sustained release) winning US FDA approval last year, followed by an FDA approval for Vabysmo (faricimab) this year, Roche had all the right assets to take the game to the current market leader, Regeneron and Bayer’s Eylea (aflibercept), at an accelerated pace.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 16, 2022
The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade. “Yes, we feel that a cure for cancer, or to changing cancer patients’ lives, is in our grasp,” said […].
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.
STAT News
OCTOBER 17, 2022
Before the Covid-19 pandemic emerged, influenza trackers would begin reading tea leaves around this time of the year, looking for signs of whether there would be an early start to the flu season in the northern hemisphere and which of the various flu viruses might be responsible for the most cases over the coming winter. Flu transmission has been low since the start of the pandemic , but an odd spurt of activity in April, May, and even early June of 2022 — which coincided with the onset o
Bio Pharma Dive
OCTOBER 20, 2022
The deal gives AbbVie an experimental medicine for idiopathic pulmonary fibrosis, as well as a platform for designing antibody drugs that can target proteins known as GPCRs.
Pharmaceutical Technology
OCTOBER 19, 2022
The European Union (EU) is on the cusp of approving clearer rules governing the joint procurement of medicines and medical devices by member states at the EU level. The imminent rule changes will apply to crisis-relevant supplies of medical countermeasures, including both vaccines and therapeutics, where the threshold of a 'serious cross-border threat to health' is met.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 21, 2022
The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, 1945.
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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
OCTOBER 21, 2022
More than half of these deaths occur well after the mom leaves the hospital. To save lives, mothers need more support in the "fourth trimester, that time after the baby is born," one researcher says.
Bio Pharma Dive
OCTOBER 19, 2022
Acrivon Therapeutics is looking to fund a development approach it claims could improve the prospects of a cancer drug Lilly scrapped after testing it in clinical trials.
Pharmaceutical Technology
OCTOBER 18, 2022
Oculis has signed a definitive business combination agreement with special purpose acquisition company (SPAC) European Biotech Acquisition (EBAC). The merged business is anticipated to have an enterprise value of nearly $220m following the closing of the transaction. The deal is also expected to offer proceeds comprising nearly $127.5m held in the trust of EBAC and nearly $80m in upsized private investment in public equity (PIPE) and private investment.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 18, 2022
With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority. In a relief to the Centre, 12 out of […].
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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
OCTOBER 20, 2022
While the U.S. considers finally banning the carcinogen, a group of men have come forward, saying they were exposed repeatedly while working at a chemical plant in New York.
Bio Pharma Dive
OCTOBER 17, 2022
The agency has requested more information about tofersen, a closely watched medicine that Biogen is seeking approval of despite a failed Phase 3 trial.
Pharmaceutical Technology
OCTOBER 20, 2022
RANKINGS 2022 Excellence Social Commended. Pharmaceutical Technology Excellence Rankings - The Verdict. Pharmacy, health and beauty company Walgreens is ranked in our SOCIAL category in the 2022 Pharmaceutical Technology Excellence Rankings. The company is ranked in large part due to its work during the COVID-19 pandemic improving access to vaccines and key medical information for vulnerable communities through its COVID-19 Vaccine Equity Initiative.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2022
Animal rights organisation People for Ethical Treatment of Animals (PETA) India has urged the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) to withdraw its recent recommendations for using stray dogs for vaccine testing in favour of superior, human-relevant, animal-free research methods, which are more effective and don’t cause suffering […].
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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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