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 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. .
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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.
AuroBlog - Aurous Healthcare Clinical Trials blog
OCTOBER 17, 2022
Studies in mammals have shown that the ‘memories’ of various environmental effects – such as diet, weight, and stress – can be passed on from fathers to offspring, despite these effects not being coded for in the DNA sequences carried by sperm. Thanks to a 2021 study, we have an explanation for how it’s possible. […].
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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 17, 2022
Collaborating with an experienced partner, such as a Contract Development & Manufacturing Organization (CDMO), could prove to be invaluable in developing nano-based systems.
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.
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
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 […].
Bio Pharma Dive
OCTOBER 17, 2022
Executives said the biotech could search for a new partner for the geographic atrophy drug if Merck decides not to license it under an existing deal.
Pharma Mirror
OCTOBER 17, 2022
What is AI? Artificial intelligence (AI) is intelligence demonstrated by machines, as opposed to the natural intelligence displayed by animals including humans. AI research has been defined as the field of study of intelligent agents, which refers to any system that perceives its environment and takes actions that maximize its chance of achieving its goals.
Bio Pharma Dive
OCTOBER 17, 2022
Learn how to attract and retain top talent, in an ultra-competitive labor market.
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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
Pharma Mirror
OCTOBER 17, 2022
BRISBANE, AUS, AcuraBio (formerly Luina Bio), a leading Australian biopharmaceutical CDMO, recently acquired by biotech investor Dr. Glenn Haifer and Ampersand Capital Partners, announced today new senior executive hires to support global growth plans. International biopharma executive Guillaume Herry has been appointed as CEO, while HR executive Joanne Reichardt has been appointed Head of People & Culture.
Bio Pharma Dive
OCTOBER 17, 2022
Led by former Loxo and Novartis executives, Treeline has divulged few details about its research, even as it’s raised nearly half a billion dollars and grown to over 130 employees.
Pharmaceutical Technology
OCTOBER 17, 2022
Asset finance companies play an essential role in greasing the wheels of commerce. Despite economic headwinds – high energy costs are driving inflation, a serious concern for firms’ balance sheets – the UK’s Finance and Leasing Association (FLA) reports asset finance new business grew 2% year-on-year in July 2022. Construction equipment, heavy commercial vehicles and used commercial vehicles all reported double digit growth.
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.
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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.
Pharmaceutical Technology
OCTOBER 17, 2022
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicine Agency (EMA) has recommended granting conditional marketing authorization (CMA) for Boehringer Ingelheim’s spesolimab as a therapy option in adults with generalised pustular psoriasis (GPP) flares. Based on the data from the Phase II EFFISAYIL 1 clinical trial of spesolimab in patients with GPP flares, the committee provided a positive opinion.
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
Pharmaceutical Technology
OCTOBER 17, 2022
The UK Government has announced funding worth more than $894.6m (£800m) to back research into ground-breaking, experimental therapies and progress the response of the country to patient safety challenges. The funds will be allocated by the National Institute for Health and Care Research (NIHR) to expert research facilities for developing an environment where such therapies and patient safety research can flourish.
STAT News
OCTOBER 17, 2022
The next big Alzheimer’s disease study readout is almost here. Roche is nearing the completion of a pair of clinical trials involving its experimental treatment called gantenerumab. The Swiss pharma giant will announce results from the studies within the next six weeks.
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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.
Worldwide Clinical Trials
OCTOBER 17, 2022
BioPharma Dive sat down with our Gary Fishbein for a conversation on how to de-risk trials without sacrificing cost or speed. Phase 3 oncology studies have approximately a 35% likelihood of leading to regulatory approval. There are particular challenges for oncology studies, in view of the fact that the overall likelihood of non-oncology Phase 3 studies leading to approval averages 65%.
STAT News
OCTOBER 17, 2022
The University of Pennsylvania’s Division of Renal-Electrolyte and Hypertension recently made a quiet update to its history web page : it removed all references to its former co-chief, Dr. Stanley Goldfarb. For several years, Goldfarb has been a vocal critic of considering social determinants of health, racism, and anything else he considers too “woke” in medical education or health care at large.
Rethinking Clinical Trials
OCTOBER 17, 2022
The National Institute of Nursing Research (NINR) will host a webinar for its recent request for applications, “ RFA-NR-23-001 , HEAL Initiative: Prevention and Management of Chronic Pain in Rural Populations (UG3/UH3 Clinical Trial Required).” The webinar will describe key features of the funding opportunity, review the interests of participating Institutes and Centers, and address questions from potential applicants.
STAT News
OCTOBER 17, 2022
Milestone Pharmaceuticals said Monday that an experimental nasal-spray medicine acted quickly to treat people experiencing episodes of a rapid but non-fatal heart rate — more than doubling the conversion to normal heart rhythm and achieving the primary goal of a late-stage clinical trial. The medicine, called etripamil , is meant to treat people with paroxysmal supraventricular tachycardia, or PSVT, a condition characterized by episodes of rapid heartbeat that suddenly start and stop.
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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.
pharmaphorum
OCTOBER 17, 2022
When James P Allison and Tasuku Honjo were awarded the Nobel Prize for Medicine in 2018 for their discovery of cancer therapy through inhibition of negative immune regulation, it shone a light on decades of research into recruiting the immune system to fight cancer. Their success led to the discovery of an entirely new principle for cancer therapy – the field of immuno-oncology – one that is now a mainstay of cancer treatment, changing the way these diseases can be managed.
STAT News
OCTOBER 17, 2022
The Department of Justice filed a new lawsuit against Cigna Monday, alleging the health insurance company overcharged the federal government by purposefully inflating how sick its Medicare Advantage members were. The decision is a change of heart from federal prosecutors, who originally declined to intervene in the whistleblower case back in 2020.
pharmaphorum
OCTOBER 17, 2022
Bayer has added another clinical trial to its extensive phase 3 programme for oral neurokinin antagonist elinzanetant, hoping to show that it can treat vasomotor symptoms (VMS) in breast cancer patients. Elinzanetant is already being tested in the OASIS trials for VMS associated with menopause – an indication in which Bayer is in a head-to-head race with Astellas and its fezolinetant drug candidate – and breast cancer could represent a sizeable additional patient population for the drug.
STAT News
OCTOBER 17, 2022
Josh Bilenker’s last company, Loxo Oncology, was purchased by Eli Lilly for $8 billion. No surprise, then, that his next effort has already raised at least $473 million in funding from private investors even before telling the public what, exactly, it is working on. Treeline Biosciences, the new venture by Bilenker and Jeffrey Engelman, formerly Novartis’s top cancer researcher, has hired more than 130 people across three research sites in little more than a year, according to a co
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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.
Pharma Times
OCTOBER 17, 2022
Demonstrators will demand hundreds of millions of pounds ‘missing’ from ME research
STAT News
OCTOBER 17, 2022
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that all-too-predictable routine of online meetings, calls, and deadlines has returned. But what can you do? The world, such as it is, keeps spinning. So time to give it a nudge in a better direction by firing up the coffee kettle to brew another cup of stimulation.
NPR Health - Shots
OCTOBER 17, 2022
Two scientists were surprised to see goats and sheep hanging out above the tree line. Turns out they were fighting over patchy salt deposits. They saw 106 "interactions." Guess who almost always won? (Image credit: Forest P.
BioSpace
OCTOBER 17, 2022
Between top-notch academic institutions, solid venture capital funding, expanding lab space and governmental support, Chicago is emerging as a true hotbed for biotech growth.
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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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