Sat.Sep 25, 2021 - Fri.Oct 01, 2021

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After long wait, Editas reveals first data for CRISPR gene editing treatment

Bio Pharma Dive

Early study results offer some hopeful signs of efficacy, but the small number of patients treated and short follow-up limit firmer conclusions.

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Quality of life in patients with chronic health conditions

World of DTC Marketing

SUMMARY : Six in ten Americans live with at least one chronic disease, like heart disease and stroke , cancer , or diabetes. These and other chronic diseases are the leading causes of death and disability in America, and they are also a top driver of health care costs. But what we most often overlook is the effect of chronic health conditions on the quality of life leading to depression and suicide.

Doctor 199
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New report sheds light on medicine shortages in Northern Ireland following Brexit

Pharma Times

Informa Pharma Intelligence (IPI) has found that some drug firms may withdraw up to 90% of their products from Northern Ireland, once the Brexit grace period has passed.

Medicine 158
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Merck Says Its Antiviral Pill Is Effective Against Covid

NY Times

The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.

Drugs 144
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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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Acceleron provides biggest biopharma deal this year, with $11.5B sale to Merck

Bio Pharma Dive

The acquisition is notable for Merck, which is under pressure to diversify its business beyond the cancer drug Keytruda and has typically favored smaller buyouts.

Sales 347
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Amazon names 10 finalists in its first digital health accelerator

pharmaphorum

Amazon’s push into healthcare takes many forms, and one is decidedly biotech-like – running an accelerator to identify and support startups with promising technology platforms. The online commerce giant’s first accelerator kicked off in June, focusing on digital health companies, and 427 applications from 31 countries around the world have now been winnowed down to 10 finalists.

More Trending

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How Has COVID-19 Changed the Way We Work in the Life Sciences?

XTalks

The world as we know it has changed because of the COVID-19 pandemic. We’ve adopted and embraced new technologies at a much faster pace in order to conform to these changes. Simple examples include the increased popularity of food delivery apps and at-home meal kits, but in the larger picture, the nature of working has changed entirely for many companies and people.

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Worrisome side effects lead Pfizer to narrow Duchenne gene therapy trial

Bio Pharma Dive

Outside trial data reviewers have attributed three cases of severe muscle weakness to Pfizer’s treatment, causing the company to change the design of its closely watched Phase 3 study.

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Bayer teams up with Huma to apply AI to lung cancer diagnosis

pharmaphorum

A research project between Bayer and digital health company Huma will use artificial intelligence to detect lung cancer in CT scans – and determine which type a patient has, in order to direct treatment. AI is already being applied by a number of groups, with some studies indicating it can even be more effective than trained radiologists in detecting subtle patterns that indicate the presence of tumours.

Genomics 133
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A*STAR and Local SME Work with Vaccination Centres to Deploy Automated Systems for Filling Syringes

Pharma Mirror

SINGAPORE; The Agency for Science, Technology and Research (A*STAR) has developed an Automated Vaccine Inoculation Dispenser (AVID) system, which replaces the manual step of filling injection syringes with vaccine liquid. AVID is customised for the vaccination centres which are set up by the Ministry of Health and operated by private healthcare providers AVID was designed to address the labour-intensive steps of the vaccination process to reduce the workload of healthcare providers, increase acc

Vaccine 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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BioNTech Doses First Patient with Personalized mRNA Cancer Vaccine

BioSpace

First COVID-19, now cancer. BioNTech made history when its COVID-19 mRNA vaccine with partner Pfizer became the first ever approved.

Vaccine 115
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Merck says antiviral pill effective against COVID-19, lifting hopes for first oral drug

Bio Pharma Dive

The drugmaker, along with partner Ridgeback Biotherapeutics, plan to ask the FDA for emergency authorization "as soon as possible.

Drugs 338
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Barts Health NHS Trust launches app for cognitively impaired

pharmaphorum

An app to support people with cognitive disabilities, developed with clinicians at Barts Health NHS Trust, has started to be made available more widely to patients. The Hear Me Now app developed with UCLPartners and software company Maldaba is designed to improve quality of care for people with cognitive impairment, specifically adults with a learning disability.

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Utrace Offers A Single Solution to Serialization Challenges

Pharma Mirror

Unfair competition arising in the pharmaceutical markets and the presence of a shadow sector require the protection of the brand’s interests and confirmation of quality for the end customer. In recent years, the reaction to this has been the emergence of intercorporate methods of protecting goods from counterfeiting. The regulators of specific countries of national projects have started to control counterfeit and falsification by creating complex systems that verify each unit of goods.

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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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CyanVac starts Phase 1 clinical trial for intranasal COVID-19 vaccine

BioPharma Reporter

CyanVac LLC and its subsidiary, Blue Lake Biotechnology, Inc., have enrolled the first participant in a Phase 1 clinical trial of their intranasal COVID-19 vaccine in Rochester, NY.

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5 FDA approval decisions to watch in the fourth quarter

Bio Pharma Dive

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

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Treatment for all: the key steps to better representation in pharma

pharmaphorum

As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most. This already significant industry is growing – it is estimated to be worth $1.27 trillion by end of 2020.

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Which Medical Supplies Should You Have at Home?

Pharma Mirror

With the COVID-19 coronavirus outbreak, emergency preparedness has become an increasing concern. In extreme pandemics, overburdened healthcare systems can delay critical medical services or a shortage of essential supplies, but these supplies serve an important purpose. Our list of essentials for a survival medical kit is vital for every home, so we have compiled it for you.

Doctor 130
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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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UK headquartered N4 Pharma granted European patent for cancer treatment and vaccine delivery system

Pharma Times

The European Patent Office (EPO) has granted a patent to specialist pharmaceutical company, N4 Pharma, for its Nuvec cancer treatment and vaccine delivery system.

Vaccine 110
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Eisai, Biogen to test FDA by asking for approval of second Alzheimer's drug

Bio Pharma Dive

The Japanese pharma and Biogen partner is filing an application for accelerated OK of lecanemab, which works similarly to the companies' controversially cleared Aduhelm.

Drugs 312
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Takeda bags Japanese approval for Crohn’s cell therapy Alofisel

pharmaphorum

Takeda has chalked up another milestone for its Alofisel cell therapy for a complication of Crohn’s disease, becoming the first allogeneic stem cell therapy to be approved in Japan. Alofisel (darvadstrocel) has been cleared by the Ministry of Health, Labour and Welfare (MHLW) for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease who have not responded to conventional therapies.

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Syntegon to showcase new laboratory and small batch solutions for solid and liquid pharmaceuticals

Pharma Mirror

New York/USA, At Interphex 2021 in New York, Syntegon (formerly Bosch Packaging Technology) presents new solutions for lab-scale and small batch filling of solid and liquid pharmaceuticals. “The need for smaller quantities of highly potent drugs is rising continuously. We have put these solutions in the focus of our current development activities and are proud to offer our customers a number of exciting new technologies”, says Thomas Mauritzen, General Manager at Syntegon Minneapolis.

Packaging 130
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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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TDP-43 DNA methylation may contribute to the mystery of age-dependent motor cortex involvement in ALS

Scienmag

Niigata, Japan – Amyotrophic lateral sclerosis (ALS) is an intractable neurological disease. Aging is a risk factor for the accumulation of TDP-43 (transduction responsive region DNA-binding protein of 43kDa) in the motor cortex. TDP-43 is a protein that tends to accumulate in increasing amounts, and the amount is strictly controlled by the splicing of TDP-43. […].

DNA 108
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Amicus, looking for a boost, sells its gene therapy work to a SPAC

Bio Pharma Dive

The value of the biotech's growing gene therapy portfolio has been "unrecognized" by investors, said CEO John Crowley, leading to a sudden shift for an initiative that began just three years ago.

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Top email calamities to avoid … and how to make an impact instead

pharmaphorum

Oliver Stohlmann’s Corporate Survival Hacks series draws on his experiences of working in local, regional and global life science communications to offer some little tips for enjoying a big business career. In this column he addresses the appropriate use of email and how to avoid nightmares in electronic communication. “My fiancée had bought me a string tanga birthday present.

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Researchers Present Key Research Results on Diabetes Remission of Dorzagliatin

Pharma Mirror

SHANGHAI, Hua Medicine (“Hua Medicine”; SEHK: 2552) today announced that at the 6th China BioMed Innovation and Investment Conference held September 25-27 in Suzhou, China (the “CBIIC”), Professor Jianhua MA, Director of the Department of Endocrinology, Nanjing First Hospital, Standing Member of the Chinese Diabetes Society, as one of the principal researchers, presented the results from a clinical study called DREAM, which showed that dorzagliatin, a glucokinase activato

Research 130
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Merck Says It Has First Effective Antiviral Pill for Covid

NY Times

The drug maker will seek authorization for molnupiravir, the first drug of its kind for Covid. Experts said such pills could be a powerful tool against the virus.

Drugs 105
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FDA lifts hold on GeneTx, Ultragenyx study of Angelman therapy

Bio Pharma Dive

The hold, which was put in place by the FDA during the fourth quarter last year, came after five patients in an early trial experienced muscle weakness following treatment.

Trials 293
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Merck confirms $11.5bn Acceleron takeover deal

pharmaphorum

After days of speculation, Merck & Co confirmed today that it has agreed to acquire Acceleron Pharma $1.5 billion, setting up what could be one of the largest biopharma acquisitions of 2021 so far. The $180-per-share deal – if completed – will give Merck a pair of blockbuster drug candidates, one of which is already on the market, and help to reduce its reliance on $14.4 billion immuno-oncology blockbuster Keytruda (pembrolizumab).

Sales 117
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UCLA bioengineers develop new class of human-powered bioelectronics

Scienmag

A team of bioengineers at the UCLA Samueli School of Engineering has invented a novel soft and flexible self-powered bioelectronic device. The technology converts human body motions — from bending an elbow to subtle movements such as a pulse on one’s wrist — into electricity that could be used to power wearable and implantable diagnostic […].

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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.