Sat.Sep 10, 2022 - Fri.Sep 16, 2022

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FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

Bio Pharma Dive

The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments.

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Novo Nordisk partners with Microsoft for AI-driven drug discovery

Pharmaceutical Technology

Novo Nordisk has signed a new strategic partnership with Microsoft to expedite the discovery and development of drugs leveraging big data and artificial intelligence (AI). Under the deal, Microsoft's computational services, Cloud and artificial intelligence (AI) will be merged with the drug discovery, development and data science expertise of Novo Nordisk.

Drugs 348
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IPO refuses patent to Mitsubishi for diabetes drug teneligliptin following pre-grant opposition by Glenmark Pharma

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Patent Office (IPO) has refused the patent application of Japanese drug maker Mitsubishi Tanabe Pharma Corporation for exclusive rights for its innovation related to type 2 diabetes drug teneligliptin, in favour of a pre-grant opposition filed by Mumbai-based pharma major Glenmark Pharmaceuticals Ltd. The company filed the patent application on July 11, 2012 […].

Drugs 189
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Is Apple that naive when it comes to compliance?

World of DTC Marketing

Apple’s Health app gets new capabilities with iOS 16. The Health app adds Medications, allowing users to conveniently build and manage a medications list, create schedules and reminders, and track their medications, vitamins, or supplements. Will it matter? The health app will also tell users about potential interactions between medications, and it’s possible to connect with healthcare providers to see a list of past medications, get future updates, or add items to your schedule.

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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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Third Harmonic boosts biotech with sector’s top IPO in four months

Bio Pharma Dive

The startup’s $185 million initial public offering is the largest for the sector since early May and potentially a sign of renewed investor interest in young biotechs.

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Gilead’s Veklury receives WHO recommendation to treat severe Covid-19

Pharmaceutical Technology

Gilead Sciences has received expanded recommendation under the World Health Organization’s (WHO) Therapeutics and COVID-19: living guideline for the use of Veklury (remdesivir) to treat severe Covid-19 patients. The guideline update comes after the treatment received recommendation from the health agency for treating non-severe Covid-19 in patients at increased risk of hospitalisation.

Allergies 277

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Scientists debate how lethal COVID is. Some say it's now less risky than flu

NPR Health - Shots

They argue the threat posed by COVID has lessened because of preexisting immunity and access to treatment. Plus, some deaths may be incorrectly blamed on COVID. Others caution it's too soon to tell.

Scientist 145
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AstraZeneca claims positive results for its “add-on” drug for rare blood disease

Bio Pharma Dive

The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019.

Drugs 325
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Top biopharmaceutical Covid-19 vaccine companies boosted with over 80% revenue growth

Pharmaceutical Technology

Last year was a positive year for biopharmaceutical companies, particularly those with Covid-19 vaccines. The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database.

Vaccine 272
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Medical devices industry asks govt to define and bring clarity on online sale of devices in New Drugs Bill, 2022

AuroBlog - Aurous Healthcare Clinical Trials blog

The medical devices industry in the country has sought the Centre to define online and offline mode of sale, provide more clarity on the regulations that are binding the online sales and suggested inclusion of online medical devices players under the Uniform Code for Medical Devices Marketing Practices (UCMDMP). The Association of Indian Medical Device […].

Sales 166
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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STAT+: USDA starts cracking down on companies that ship animals without timely inspections

STAT News

Earlier this year, a leading animal rights group asked U.S. authorities to investigate medical research labs for allegedly violating federal law after finding numerous instances where nearly 2,000 monkeys were shipped between facilities without required veterinary inspections. Now, the federal government appears to be acting.

Research 145
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Alnylam, Regeneron to advance NASH drug after early signs of potential

Bio Pharma Dive

A gene discovery four years ago led to a partnership between the companies, which plan to start a Phase 2 study later this year after encouraging early data.

Gene 320
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US FDA grants approval for BMS’ Sotyktu to treat plaque psoriasis

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb ’s (BMS) Sotyktu (deucravacitinib) to treat adult patients with moderate-to-severe plaque psoriasis. The oral treatment is indicated for such patients who are candidates for systemic therapy or phototherapy. It should not be used along with other immunosuppressants.

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How a Texas court decision threatens Affordable Care Act protections

NPR Health - Shots

The ACA has required health insurers to provide many medical screenings and other preventive services with no out-of-pocket cost to health plan members. But a recent court decision could upend that.

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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: 6 tactics to make artificial intelligence work on the frontlines

STAT News

Artificial intelligence is a transformative tool in the workplace — except when it isn’t. For top managers, state-of-the art AI tools are a no-brainer: in theory, they increase revenues, decrease costs, and improve the quality of products and services. But in the wild, it’s often just the opposite for frontline employees who actually need to integrate these tools into their daily work.

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Intellia offers first look at CRISPR drug for rare swelling disorder

Bio Pharma Dive

Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited.

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ESMO 2022: the evolution of TIL therapy – a highly promising approach

Pharmaceutical Technology

Tumour-infiltrating lymphocyte (TIL) therapy has been investigated as a treatment modality for melanoma for almost 20 years. As an autologous cell therapy, manufacturing the infusion product is a highly specialised process involving tumour harvest and the extraction and large-scale ex vivo expansion of TILs. Before TIL infusion, the patient undergoes lymphodepletion, which reduces the proportion of myeloid immune suppressive cells and creates space for the incoming lymphocytes.

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HeartBeat.bio and Molecular Devices link up to automate cardiac organoids

Pharma Times

Collaboration will involve sophisticated screening for cardiac-based drug discovery

Drugs 141
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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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STAT+: Akero treatment for NASH reduces liver scarring, achieves goals of mid-stage study

STAT News

Akero Therapeutics said Tuesday that an experimental medicine improved liver scarring at twice the rate of a placebo without worsening other symptoms — achieving the main goal of a mid-stage clinical trial involving patients with the fatty liver disease known as NASH. If the encouraging study results are confirmed in later Phase 3 clinical trials, the Akero drug, called efruxifermin, could become an effective treatment for a chronic disease that has grown into one of the leading causes of

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Bristol Myers gets FDA approval for new type of psoriasis drug

Bio Pharma Dive

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company.

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ESMO 2022: neoadjuvant or adjuvant immunotherapy for locally advanced cancers?

Pharmaceutical Technology

The advent of immune checkpoint inhibition has arguably been the greatest breakthrough for the treatment of metastatic solid tumours, with durable complete responses observed across multiple cancer types. With success in the metastatic setting, pharma companies, researchers and physicians have invested heavily in exploring the use of immune checkpoint inhibitors (ICIs) for the treatment of locally advanced disease, hoping to increase response rates and prevent disease progression.

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So you haven't caught COVID yet. Does that mean you're a superdodger?

NPR Health - Shots

A new study suggests that. yes, there are superdodgers. But explaining why they've been able to avoid the virus is a bit complicated.

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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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With increased virus activity, providers urged to be alert for signs of rare polio-like syndrome in kids

STAT News

Pediatricians and top health officials are warning about an uptick in activity of a common virus that in rare cases can cause a polio-like syndrome in young children. The virus, an enterovirus known as EV-D68, is one of the bugs that regularly circulates and infects us from time to time, typically just causing colds. But occasionally, children infected with it will develop limb weakness and a progressive form of paralysis, what’s called acute flaccid myelitis , or AFM.

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Acelyrin sets hopes high for arthritis drug with $300M fundraise

Bio Pharma Dive

The well-funded startup is planning Phase 3 trials for a drug it claims could be superior to top-selling medicines from Novartis and others.

Drugs 294
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ESMO 2022: shrinking market for Trodelvy, with fierce ADC competition

Pharmaceutical Technology

Hormone receptor-positive/human epidermal growth factor negative (HR+/HER2-) breast cancer accounts for approximately 70% of all breast cancers, with close to 40,000 new cases diagnosed each year worldwide. Although many patients are diagnosed with early-stage disease, almost a third progress to metastatic disease, with a five-year survival rate of just 30%.

HR 162
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ONWARD reports positive results from a pivotal spinal cord injury study

Pharma Times

Up-LIFT research achieves primary endpoint with improvement in arm and hand function

Research 139
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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STAT+: Intellia says CRISPR treatment safely corrects DNA of six patients with rare disease

STAT News

Intellia Therapeutics said Friday the first six patients to receive its CRISPR-based treatment for a genetic swelling disorder have safely had small, corrective changes made to dysfunctional DNA inside their liver cells. Preliminary results from the study — just the second to show that CRISPR-based gene editing can be delivered systemically and performed in vivo, or inside the body — found that the treatment, NTLA-2002, reduced levels of the disease-causing protein, kallikrein, by

DNA 142
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Pfizer brings mRNA flu vaccine into Phase 3 testing

Bio Pharma Dive

The trial, expected to enroll 25,000 adults, is the second late-stage test of an mRNA flu shot to begin this year, following the June start of a Moderna study.

Vaccine 279
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ESMO 2022: data updates push immunotherapy’s scope in cervical cancer

Pharmaceutical Technology

This week, at the European Society of Medical Oncology (ESMO) Congress 2022 researchers presented encouraging updates on immunotherapies in the field of cervical cancer. Positive data with checkpoint inhibitor combinations in particular garnered attention for their potential in broader patient groups. September marks Gynaecological Cancer awareness month, and cervical cancer ranks as the fourth most prevalent cancer for women worldwide.

Vaccine 147
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CHMP recommends Sanofi and AstraZeneca’s Beyfortus to treat respiratory syncytial virus

Pharma Times

Therapy has been developed for the prevention of disease in infants

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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.