Medicare names first 10 drugs for price negotiations
Bio Pharma Dive
AUGUST 29, 2023
The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.
Sat.Aug 26, 2023 - Fri.Sep 01, 2023
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Signal: Novo Nordisk market cap higher than Danish GDP due to obesity drugs
Pharmaceutical Technology
SEPTEMBER 1, 2023
Novo Nordisk's obesity drugs are driving Danish growth as well as record profits as the company becomes second-most valuable in Europe.
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Does Drinking Lots of Water Help You Lose Weight? An Expert Explains.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 31, 2023
It’s often claimed that if you’re trying to lose weight, one of the things you should do each day is drink plenty of water – with some internet advice even suggesting this should be as much as a gallon (about 4.5 liters).
August 31, 2023: FDA’s Robert Califf and Coauthors Assert More Is Needed to Achieve Learning Health Care
Rethinking Clinical Trials
AUGUST 31, 2023
In an article published this month in the American Journal of Bioethics , FDA Commissioner Robert Califf and coauthors suggest that—despite the potential of embedded pragmatic research to generate information to improve clinical practice and public health policy—it is still relatively uncommon in US healthcare. “Simply stated, what we are currently doing does not work, and in the face of declining health status we lack answers to critical questions about what we should be doing in health care an
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
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
Sanofi appoints a venture investor to R&D head as executive team expands
Bio Pharma Dive
AUGUST 31, 2023
Houman Ashrafian, currently a scientific advisor at SV Health Investors, will fill the role left by John Reed, who oversaw the transformation of research and development during his five years at Sanofi.
Novo Nordisk acquires Embark and lead asset metabolic programme
Pharmaceutical Technology
AUGUST 31, 2023
Novo Nordisk has acquired Embark Biotech and its lead asset targeting obesity and other cardiometabolic diseases.
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Intelligent OMICS partners with Janssen on AI-driven research
Pharma Times
SEPTEMBER 1, 2023
The AI platform and expertise will be combined to discover novel targets for haematological cancers - News - PharmaTimes
Bristol Myers gets key FDA approval for bone marrow disease drug
Bio Pharma Dive
AUGUST 29, 2023
A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.
Otsuka Pharmaceutical agrees to buy Mindset Pharma
Pharmaceutical Technology
SEPTEMBER 1, 2023
Otsuka Pharmaceutical has signed a definitive arrangement agreement to acquire Mindset Pharma, in an all-cash deal worth C$80m ($59.1m).
Amazing Brain Implant Gives a Voice to People Who Couldn’t Speak For Years
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 27, 2023
There’s new hope for people who have lost their ability to speak. In two separate cases, scientists have successfully used brain implants and machine learning to give patients back their voice after theirs was taken; one by a stroke, the other a result of amyotrophic lateral sclerosis (ALS).
Twist Bioscience and Ono Pharmaceutical collaborate
Pharma Times
SEPTEMBER 1, 2023
Partnership will discover and develop novel antibodies for a range of autoimmune diseases - News - PharmaTimes
FTC allows Amgen’s $28B deal for Horizon to go through, with conditions
Bio Pharma Dive
SEPTEMBER 1, 2023
The settlement between Amgen and the FTC may reassure those in the industry who feared a more activist regulator would gum up dealmaking.
Clinical trials: How AI can help providers stay TMF inspection-ready
Pharmaceutical Technology
AUGUST 29, 2023
The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits
Groundbreaking Stem Cell Therapy Can Repair Vision After Eye Injury
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 30, 2023
Four patients with severe chemical burns to one eye have shown early positive results in a phase 1 clinical trial of a therapy based on their own stem cells. Even without further treatment, two of the patients reported significant improvements in their vision after a year of follow-up, according to a team of US researchers.
The New Age of Decentralized Clinical Trials
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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
UCB announces approval of Bimzelx
Pharma Times
AUGUST 31, 2023
The therapy is used to treat patients with psoriatic arthritis and axial spondyloarthritis - News - PharmaTimes
Sage, reeling from depression drug decision, to lay off 40% of workforce
Bio Pharma Dive
AUGUST 31, 2023
Two founding executives are leaving Sage alongside a major restructuring announced weeks after the FDA approved the medicine, Zurzuvae, for much narrower use than the company had hoped.
The changing of the guard is expected in the Crohn’s disease marketplace
Pharmaceutical Technology
SEPTEMBER 1, 2023
As per GlobalData, AbbVie has remained the Crohn’s disease market leader over the last five years, with Humira sales of $2.7bn in 2022 in 8MM.
A Mediterranean Lifestyle Really Can Help You Live Longer, Study Shows
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 28, 2023
Rich in fruits, vegetables, whole grains, and fish, the Mediterranean diet has long been linked with improving health. In fact, living a Mediterranean lifestyle in general could be the ticket to a longer, healthier life.
How Machine Learning Drives Clinical Trial Efficiency
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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.
BenevolentAI doses participants in BEN-8744 study
Pharma Times
AUGUST 31, 2023
The candidate is a peripherally restricted small-molecule PDE10 inhibitor to treat ulcerative colitis - News - PharmaTimes
Roche claims study success for targeted drug in early lung cancer
Bio Pharma Dive
SEPTEMBER 1, 2023
The Swiss pharma said, without details, that it observed “unprecedented” results that could make Alecensa the first treatment specifically available after surgery for ALK-positive lung tumors.
EC grants approval to Merck’s Keytruda for gastric cancer
Pharmaceutical Technology
AUGUST 30, 2023
The EC has granted approval for Merck’s Keytruda regimen for gastric or gastroesophageal junction (GEJ) adenocarcinoma.
CDSCO declares three drug samples as spurious, 51 as NSQ during July
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 31, 2023
The Central Drugs Standard Control Organisation (CDSCO) has declared three drug samples it tested in the month of July as spurious and another 51 samples as Not of Standard Quality (NSQ). It added that two drug samples tested as not of standard quality during June were also alerted by the manufacturer as spurious.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
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.
Amid shortage, FDA clears several generics of Takeda's popular ADHD drug Vyvanse
Fierce Pharma
AUGUST 30, 2023
After 16 years on the market, Takeda's blockbuster attention-deficit/hyperactivity disorder (ADHD) med Vyvanse has finally reached its patent cliff. | After 16 years on the market, Takeda's blockbuster ADHD med Vyvanse has finally reached its patent cliff. And the FDA's approval of several generics comes amid a U.S. shortage of the drug.
Novo, continuing deal streak, buys another obesity drug startup
Bio Pharma Dive
AUGUST 30, 2023
The acquisition of Embark Biotech, which Novo helped found, gives the company another prospect to add to its arsenal of weight-loss medicines.
FDA shuns Outlook Therapeutics with wet AMD drug BLA rejection
Pharmaceutical Technology
AUGUST 30, 2023
Shares in the company tanked 80% following the FDA issued a CRL for its bevacizumab formulation.
India’s success story in pediatric vaccination program should be further replicated in adult vaccination: Experts
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 28, 2023
India’s success story in pediatric vaccination programme should be further replicated in the form of adult vaccination programme, experts recommended on the occasion of the 2nd edition of the India Vaccine Leaders Conclave (IVLC) held between August 22 and August 23, 2023 under the theme “Building Resilient Vaccine Ecosystems” in Mumbai.
Johnson & Johnson's spinoff of Kenvue provides $13.2B in potential M&A firepower
Fierce Pharma
AUGUST 30, 2023
Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the compan | Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.
Artificial intelligence: The prime mover in drug discovery
Bio Pharma Dive
AUGUST 28, 2023
With its ability to process vast amounts of data and identify patterns, AI can significantly reduce the time and cost involved in developing new drugs.
Specialised Therapeutics partners with Treeway to license ALS drug
Pharmaceutical Technology
AUGUST 28, 2023
Specialised Therapeutics has entered into a licensing agreement with Treeway for TW001, designed for treating amyotrophic lateral sclerosis.
Industry sees push for Ayurveda signals shift towards scientifically validated nutraceuticals
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 30, 2023
The push for Ayurveda, herbal remedies, and nutraceuticals to bridge nutritional gaps reflects a growing interest in holistic health and natural approaches to wellness. In India, healthcare sector has evolved considerably post Covid-19 and there is an increased emphasis on nutraceuticals which have emerged as the way forward.
The New Age of Decentralized Clinical Trials
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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.
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