Sat.Oct 01, 2022 - Fri.Oct 07, 2022

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Tackling Specialty Conditions and Side Effects Simultaneously

Pharmaceutical Commerce

Ways to combat these ailments alongside worsening mental health.

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A Versant-backed biotech emerges to take on ‘overlooked’ cancer targets

Bio Pharma Dive

Nested Therapeutics touts a deep bench of scientific leaders and advisers, including Kevan Shokat, whose work drugging KRAS — a cancer-related gene once thought to be undruggable — helped lead to the development of Amgen’s Lumakras.

Gene 358
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Provention and Sanofi enter deal to launch teplizumab for type 1 diabetes

Pharmaceutical Technology

Provention Bio and Sanofi US have signed a co-promotion agreement to launch the former’s lead investigational drug candidate, teplizumab for the delay in the onset of clinical type 1 diabetes (T1D). The agreement aids Provention in leveraging the capabilities and commercial resources of Sanofi to back teplizumab’s launch. The US Food and Drug Administration (FDA) is presently reviewing teplizumab for the delay of clinical T1D in people who are at risk.

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Do You Sleep on Your Back or Side? Here’s The Research on ‘Optimal’ Sleep Positions

AuroBlog - Aurous Healthcare Clinical Trials blog

After 50 years of research, eminent Stanford University sleep researcher William Dement reportedly said the only solid explanation he knows for why we sleep is “because we get sleepy” Even though sleep may be, as one researcher put it, “the only major behavior in search of a function”, it clearly does matter for our health […].

Research 198
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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

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Eli Lilly receives marketing authorisation for baricitinib

Pharma Times

Treatment involves adult patients with severe alopecia areata

Marketing 174
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AstraZeneca to acquire gene editing biotech LogicBio

Bio Pharma Dive

Shares in LogicBio had lost nearly all their value since a 2018 IPO, bringing the company to the brink of Nasdaq delisting. The buyout deal represents a premium of over 600%.

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B Pharm Ayurveda should be redesigned with syllabus of all Ayush streams to create multiple opportunities

AuroBlog - Aurous Healthcare Clinical Trials blog

Multiple job opportunities can be created for the pharmacy graduates in Ayurveda provided the degree course in Ayurveda pharmacy (B Pharm Ayurveda) is redesigned as a combined pharmacy degree course for all the Ayush streams such as Ayurveda, Unani, Siddha and Homoeopathy which involve drugs for therapies. If the programme is reconfigured to a common […].

Pharmacy 166
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Positive in vitro results for Imutex’s FLU-v

Pharma Times

Data further supports the continued development of FLU-v as a broad-spectrum influenza vaccine

In-Vitro 159
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BioMarin resubmits its hemophilia gene therapy to the FDA

Bio Pharma Dive

The resubmission has been long awaited after BioMarin’s original application was unexpectedly rejected by the FDA two years ago. The company expects a decision around the middle of next year.

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High risk, high reward – the future of CAR-T therapy in CLL

Pharmaceutical Technology

In 2010, two patients with end-stage refractory chronic lymphocytic leukaemia (CLL) were administered Novartis’ autologous anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, Kymriah (tisagenlecleucel), as part of a Phase I trial. In March this year, it was reported that these two patients were still in remission, making this the longest known CLL remission after CAR-T therapy and demonstrating to the industry that long-term remission is indeed possible.

In-Vitro 279
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Meet Florence, WHO’s AI-powered digital health worker

pharmaphorum

An artificial intelligence-powered digital health worker has been unveiled by the World Health Organisation (WHO) as its latest tool for disseminating reliable health information to the public. Originally developed by New Zealand tech company Soul Machines with support of the Qatar Ministry of Health, the first version of the virtual health worker was used to combat misinformation about the pandemic.

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‘Junk’ DNA may hold the key to neurological disorders

Pharma Times

University of Lincoln and the University of Sheffield are researching how DNA could be repaired

DNA 158
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Lilly looks to speed FDA review of new diabetes drug in obesity

Bio Pharma Dive

A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.

Drugs 337
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Pfizer acquires biopharma firm Biohaven for $11.6bn

Pharmaceutical Technology

Pfizer has acquired commercial-stage biopharmaceutical firm Biohaven Pharmaceutical for $148.50 for each share or a total consideration of nearly $11.6bn in cash. In May, Pfizer entered a definitive agreement to acquire all outstanding shares of Biohaven which were not previously held by the former. . With the takeover, Biohaven became a wholly-owned Pfizer subsidiary.

Medicine 266
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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Opinion: Messaging — the unrecognized coefficient in pandemic control — matters

STAT News

A little over a century ago, scientists working in laboratories discovered that microbes were the cause of many epidemics. Once they understood that, they began to put their faith more and more in laboratory science. This major transformation, called the bacteriological revolution, began in the 1880s. During this period, diphtheria was one of the leading causes of death among mostly poor children in New York City.

Scientist 145
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OPTIMA announce AstraZeneca and Mutabor as official partners

Pharma Times

The companies will aim to improve treatment for patients with prostate, breast and lung cancer

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Biogen, Denali begin late-stage testing of Parkinson’s drug

Bio Pharma Dive

Part of a $1 billion alliance the companies formed in 2020, the drug will be tested in a large study of patients who test positive for mutations in a gene called LRRK2.

Drugs 333
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European Commission’s approval of Mounjaro provides hope within obesity space

Pharmaceutical Technology

The type 2 diabetes (T2D) space recently witnessed a new approval: on 15 September, the European Commission (EC) authorised Eli Lilly’s Mounjaro (tirzepatide) for T2D patients. Mounjaro is a dual gastric inhibitory polypeptide (GIP)/glucagon-like peptide 1 (GLP-1) receptor agonist. This event is of paramount interest, and not only for T2D patients, as it could address vital unmet needs for other GIP/GLP-1 receptor agonist–treated diseases, including obesity.

Marketing 264
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How Machine Learning Drives Clinical Trial Efficiency

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.

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The hidden faces of hunger in America

NPR Health - Shots

More than 1.2 million people struggled to put food on the table at some point last year in the Washington, D.C. region. Tens of millions more are struggling across the country.

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Ziphius vaccines and UZ Ghent establish vaccine collaboration

Pharma Times

First EU public-private collaboration for production of saRNA-based vaccines

Vaccine 143
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Allogene starts first pivotal trials of an ‘off-the-shelf’ cell therapy for cancer

Bio Pharma Dive

The biotech believes the two Phase 2 trials initiated Thursday can support approval applications for what could be the first so-called allogeneic cancer cell therapy.

Trials 331
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UK NICE recommends zanubrutinib for Waldenstrom’s macroglobulinaemia

Pharmaceutical Technology

The UK National Institute for Health and Care Excellence (NICE) has recommended zanubrutinib (Brukinsa) as an option to treat Waldenstrom’s macroglobulinaemia (WM) patients. With the latest development, zanubrutinib became the first WM drug to receive the recommendation for routine National Health Service (NHS) usage in England. The recommendation will also be applicable in Wales and Northern Ireland.

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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.

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The Ice Bucket Challenge wasn't just for social media. It helped fund a new ALS drug

NPR Health - Shots

In 2014, it was hard to miss the ALS Ice Bucket Challenge that set out to raise money to fund research for the disease. And it paid off. A new treatment was funded by $2.2 million of the funds raised.

Drugs 145
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Nobel Prize in medicine awarded for research into the evolutionary history of humankind

STAT News

A Swedish scientist won the 2022 Nobel Prize in medicine or physiology on Monday for his groundbreaking research into the evolutionary history of humankind. Svante Pääbo, of the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany, accomplished something widely believed to be impossible: recovering and reading DNA from 40,000-year-old bones.

Medicine 142
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A Flagship cell therapy startup secures $121M in new funding

Bio Pharma Dive

Cellarity is the second Flagship company in as many months to raise a Series C round instead of filing to go public.

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US FDA grants Fast Track status for Lilly’s tirzepatide to treat obesity

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for Eli Lilly and Company ’s tirzepatide to treat adults with obesity or overweight with weight-associated comorbidities. . On holding talks with the regulatory agency, the company intends to commence a rolling submission of a new drug application (NDA) for tirzepatide in adults for this indication this year.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Early signs a new U.S. COVID surge could be on its way

NPR Health - Shots

Here we go again. The virus is starting to surge in many European countries and there are early signs a wave may be starting in the U.S. too.

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FlyPharma: airea

Pharma Times

The Airport Region in Central Germany’ presents itself as an attractive location for the international pharmaceutical industry

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5 FDA decisions to watch in the fourth quarter

Bio Pharma Dive

The regulator could soon approve medicines from Apellis, Gilead and GSK, as well as decide on whether to pull a controversial preterm birth drug from the market.

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BioLink receives funds to develop Covid-19 pneumonia treatment

Pharmaceutical Technology

BioLink Life Sciences has received a contract worth $750,000 from the US Biomedical Advanced Research and Development Authority (BARDA) to develop Ramatroban for treating Covid-19 pneumonia patients in the hospital setting. A dual blocker of thromboxane and prostanoid receptors, Ramatroban showed efficacy in animal models of atherosclerosis, respiratory dysfunction, thrombosis and sepsis.

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The New Age of Decentralized Clinical Trials

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.