Sat.Jul 02, 2022 - Fri.Jul 08, 2022

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10 clinical trials to watch in the second half of 2022

Bio Pharma Dive

The biotech industry's downturn accelerated in the first half of the year. Important study readouts for Eisai, Gilead, Merck and Seagen, among others, could determine whether the slump will endure.

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Is biotech facing a long bear market?

Pharmaceutical Technology

Talks of a bear market in the biotech sector do not seem to pass, with news of companies falling into administration and layoffs becoming a recurrence. Just last week, trading for 4D Pharma , a British biotech, was suspended on the London Stock Exchange’s Alternative Investment Market , and the company will be delisted from NASDAQ on July 7. Elsewhere, San Diego, California-based Heron Therapeutics announced restructuring and layoffs for 34% of its workforce.

Marketing 324
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Misjustice benefits pharma

World of DTC Marketing

Endpoint News reported “Three major drug distributors are off the hook for what may have been a $2.5 billion payment after a federal judge found them not liable for the opioid epidemic in parts of West Virginia, one of the hardest-hit areas of the country. This is beyond outrageous it’s a classic example of abuse of power. Despite distributing more than 51.3 million doses of oxycodone and hydrocodone to pharmacies in Cabell County and the city of Huntington over less than a decade, M

Pharmacy 238
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These Microbes Could Make You More Attractive to Mosquitoes, Mice Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

Mosquitoes are the world’s deadliest animal. Over 1 million deaths per year are attributed to mosquito-borne diseases, including malaria, yellow fever, dengue fever, Zika, and chikungunya fever. [link] How mosquitoes seek out and feed on their hosts are important factors in how a virus circulates in nature. Mosquitoes spread diseases by acting as carriers of […].

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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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Vertex, continuing its rebound, cleared to resume testing of diabetes cell therapy

Bio Pharma Dive

The decision by U.S. regulators is the latest boost for a company whose shares have climbed more than 30% during the biotech sector’s worst downswing in years.

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GSK acquires US-based Sierra Oncology for $1.9bn

Pharmaceutical Technology

GlaxoSmithKline (GSK) has completed the acquisition of all outstanding shares of US-based Sierra Oncology in a deal totalling $1.9bn (£1.6bn), in cash. In April this year, GSK entered an agreement for the acquisition of Sierra Oncology for $55 per share. The conclusion of the deal comes after the shareholders of Sierra Oncology approved the takeover on 29 June this year.

Vaccine 306

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Head Injuries Can Rewire Whole-Brain Networks in Mice, Important New Maps Reveal

AuroBlog - Aurous Healthcare Clinical Trials blog

We know the brain changes after traumatic injury, and now we have maps from mice showing what that change looks like. A team of scientists has traced connections between nerve cells throughout the entire brain of mice, showing that distant parts of the brain become disconnected after a head injury. The stunning visualizations of brain-wide […].

Scientist 226
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Two cancer biotechs merge, raise cash as sector-wide downturn continues

Bio Pharma Dive

Syros Pharmaceuticals and Tyme Technologies, shares of which trade near all-time lows, will combine and raise about $130 million from private investors to stay afloat.

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Brii Bio acquires Vir’s antibody rights for Hepatitis B in Greater China

Pharmaceutical Technology

Brii Biosciences (Brii Bio) has exercised an option for the acquisition of exclusive development and marketing rights for Vir Biotechnology’s investigational antibody, VIR-3434, for Hepatitis B in Greater China, under a partnership agreement. Following the option exercise, Vir will receive the option exercise fee, regulatory and commercial milestone payments as well as tiered royalties on net product sales from Brii Bio.

Antibody 279
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Pharma’s spend on AI in drug discovery ‘could top $3bn by 2025’

pharmaphorum

The pharmaceutical industry is increasingly relying on artificial intelligence to power its drug discovery and development efforts, and its spend in this area has created a multibillion-dollar market for AI technologies. That’s the conclusion of a GlobalData report , which notes that AI is being used to enhance computer-aided drug design (CADD) in a bid to reduce the time and costs involved in getting a new drug to market.

Drugs 131
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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NIMHANS to treat neuro & mental disorders through holistic care combining allopathy, Ayurveda and Yoga

AuroBlog - Aurous Healthcare Clinical Trials blog

The National Institute of Mental Health and Neuro Sciences (NIMHANS), Department of Integrative Medicine is propelling its efforts towards holistic care combining modern medicine, Ayurveda and Yoga to treat the neurological and mental diseases and disorders. Here three medical experts of allopathy, Ayurveda and Yoga disciplines sit together to formulate a tailor made approach for […].

Medicine 181
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With $100M AstraZeneca deal, a biotech and its investors engineer another buyout

Bio Pharma Dive

An entity originally known as Teneobio has now been the focus of three acquisition deals with large pharmaceutical companies since 2021, capitalizing on the industry’s growing interest in dual-acting antibody drugs.

Engineer 330
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Brii Bio introduces Covid-19 combination therapy in China

Pharmaceutical Technology

Brii Biosciences and TSB Therapeutics have commercially launched a long-acting neutralising antibody therapy combination, amubarvimab/romlusevimab, for Covid-19 in China. The two non-competing SARS-CoV-2 monoclonal neutralising antibodies, amubarvimab and romlusevimab are obtained from convalesced Covid-19 patients. The company developed these antibodies in partnership with Tsinghua University and the 3rd People’s Hospital of Shenzhen.

Antibody 264
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July 7, 2022: Patient-Centered Outcomes Core Values Cross-Core Collaboration and Real-World Knowledge

Rethinking Clinical Trials

Dr. Emily O’Brien. In connection with the NIH Pragmatic Trials Collaboratory’s annual Steering Committee meeting and 10th anniversary celebration, we asked Dr. Christy Zigler and Dr. Emily O’Brien to reflect on the role of the Patient-Centered Outcomes Core in helping the Demonstration Project teams plan and implement their trials, and to discuss their focus for the Core’s future contributions to pragmatic clinical trials.

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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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Health ministry releases 9th edition of IP containing 3,152 monographs

AuroBlog - Aurous Healthcare Clinical Trials blog

With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution specifications […].

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After a lengthy drought, could biotech M&A be on the upswing?

Bio Pharma Dive

With at least 14 buyouts worth $50 million or more, the second quarter was one of the busiest three-month periods for acquisitions in recent years. Some industry watchers expect that pace to continue.

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EC approves Novavax’s Covid-19 vaccine CMA expansion for adolescents

Pharmaceutical Technology

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain. The latest development comes after the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive recommendation in

Vaccine 264
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July 6, 2022: Article Offers Framework for Meeting Ethical Obligation of Respect for Persons in Pragmatic Trials

Rethinking Clinical Trials

Respect for persons is a central obligation for the ethical conduct of research with human subjects. Traditionally, clinical trials have primarily relied on informed consent practices to fulfill this ethical obligation. A new article in the Hastings Center Report proposes 8 dimensions for how researchers can meet the ethical obligation of respect for persons in pragmatic clinical trials.

Trials 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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AlzeCure’s Alzheimer’s candidate shows promise

Pharma Times

Treatment abstract focuses on results from a multiple ascending dose study in healthy volunteers

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Radius, fending off activists, outlines pitch for $890 million buyout

Bio Pharma Dive

The biotech detailed the process that led to its take-private offer last month, aiming to win the support of shareholders, including two firms that have pushed for change.

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Europe is seeing a hiring boom in pharmaceutical industry data analytics roles

Pharmaceutical Technology

Europe was the fastest growing region for data analytics hiring among pharmaceutical industry companies in the three months ending May. The number of roles in Europe made up 11.8% of total data analytics jobs - up from 11.1% in the same quarter last year. That was followed by North America, which saw a -0.4 year-on-year percentage point change in data analytics roles.

Marketing 246
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AstraZeneca agrees $1.3bn deal to buy oncology player TeneoTwo

pharmaphorum

AstraZeneca has signed a deal to buy US biotech TeneoTwo in a deal worth up to $1.27 billion that will boost its position therapies for haematological cancers. The big pharma is paying $100 million upfront for the company, and offering up to $805 million in milestone payments if TeneoTwo’s drug candidates meet development objectives, plus up to $360 million if they hit sales targets.

Antibody 124
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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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NICE recommends Opdivo as post-surgery treatment

Pharma Times

The therapy will be used for specific muscle invasive urothelial cancer patients

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FDA, under fire for Aduhelm approval, starts review of another Alzheimer's drug

Bio Pharma Dive

The regulator could clear Biogen and Eisai’s lecanemab by early January. A decision before Phase 3 results could amplify the criticism the agency already faces, however.

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Specialised Therapeutics’ breast cancer drug gets Philippines FDA approval

Pharmaceutical Technology

Specialised Therapeutics’ oral drug, Nerlynx (neratinib) has obtained the Philippines Food and Drug Administration approval to lower the recurrence or mortality risk in early-stage HER2-positive (HER2+) breast cancer patients. The treatment is indicated as extended adjuvant treatment for adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

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Sanofi makes low-cost medicines pledge for low-income countries

pharmaphorum

Sanofi has said it will make 30 of its most commonly prescribed medicines available at non-profit prices to 40 lower-income countries, as part of a global health initiative launched by the company last year. The medicines – which include insulin, oral diabetes agent glibenclamide and cancer chemotherapy oxaliplatin – will be sold under a new Impact brand and are all classed as essential medicines by the World Health Organisation (WHO).

Medicine 119
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Bloom’s smart CRP test gets green light

Pharma Times

C-Reactive protein test gets go-ahead for professional use across Europe

Protein 119
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CureVac sues rival COVID-19 vaccine maker BioNTech for patent infringement

Bio Pharma Dive

The biotech, whose own efforts to develop a COVID-19 vaccine have faltered, claims its inventions were crucial to the development of BioNTech’s top-selling coronavirus shot.

Vaccine 299
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Cell and gene therapies: why advanced medicines call for specialised logistics

Pharmaceutical Technology

Genetic mutations, both germline and acquired, are behind a large proportion of the most debilitating and sometimes life-threatening human diseases. But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. For many decades, investigators have been working on innovative therapeutic modalities known as cell and gene therapies, which use modified versions of the body’s own cellular and genetic material to treat and potentially cure the

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Partners come on board GSK’s plan for Stevenage life science hub

pharmaphorum

GSK’s recently-unveiled plan to develop a bioscience cluster close to its main R&D site in Stevenage, UK, has moved closer to fruition, now that the first partners have joined the initiative. The asset management arm of Swiss back UBS has formed a joint venture with property developer Reef Group that will develop the 33-acre campus in Stevenage, Hertfordshire.

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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.