Sat.Sep 18, 2021 - Fri.Sep 24, 2021

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CDC panel clears way for Pfizer booster shots, but divided on broader use

Bio Pharma Dive

Agency advisers supported giving a third Pfizer vaccine dose to older adults and those with medical conditions. But in a break with the FDA, they voted against recommending it for younger people in high-risk jobs.

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World Pharmacists Day 2021 Celebration

Pharma Mirror

25th September is celebrated as world pharmacists day, and it brings a new theme every year. The main motive behind this celebration is to give an excellent message to improve people’s health worldwide. And also, create an acceptance and encourage the role of a pharmacist in health. The pharmacist community from all over the world arranges different campaigns, exhibitions, lectures, etc., for serving this purpose.

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What is Biogen and can they repair their reputation?

World of DTC Marketing

SUMMARY: If I were to ask you, “what type of company is Biogen?” what would be your response? I tried asking that of several colleagues in the industry, and they couldn’t come up with an answer. Biogen has lost its way and is in desperate need of a corporate rebranding. This week two colleagues, who worked at Biogen, left the company because they knew that the ax was coming after the failure of Aduhelm.

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UK trial to evaluate existing drugs for secondary breast cancer

Pharma Times

Trial will test if radium-223 plus avelumab can improve outcomes for metastatic breast cancer patients

Trials 137
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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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Novartis pushes further into gene therapy for the eye with deal for Swiss startup

Bio Pharma Dive

The large drugmaker has acquired Arctos Medical and its preclinical research into optogenetics, an area Novartis already showed interest in with its buyout of Vedere Bio last year.

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Scientific study finds music can ‘tune out pain’

pharmaphorum

A study has found that listening to a specially composed music track can achieve “clinically significant” reductions in pain intensity and unpleasantness, according to the researchers behind the work. The All of Us track – composed by musician Anatole with the help of psychologist Dr Claire Howlin of University College Dublin and available via Spotify – reportedly showed a benefit in 286 people suffering from various types of acute pain, including headache, backache or period pain in

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NHS patients gain access to COVID-19 treatment Ronapreve

Pharma Times

Ronapreve will be targeted at hospitalised patients who have not mounted an antibody response against COVID-19

Antibody 136
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Chinese drugmaker Clover says vaccine prevents COVID-19 in large trial

Bio Pharma Dive

Positive results from Clover's Phase 3 study could mean another coronavirus vaccine option for the many countries still grappling with short supplies.

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Olympus Strengthens Surgical Portfolio with the Launch of POWERSEAL Advanced Bipolar Surgical Energy Devices

Pharma Mirror

TOKYO, Sept 21, 2021 – (ACN Newswire) – Olympus Corporation (Representative Executive Officer, President and CEO: Yasuo Takeuchi) announced the launch of the first devices in the new POWERSEAL™ family of advanced bipolar surgical energy products. The POWERSEAL 5mm Curved Jaw Tissue Sealer and Divider, Double-Action devices meet the highest standards of clinical performance for advanced bipolar surgical energy devices by delivering consistent sealing reliability in an ergonomic, multi

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The hypocrisy of big pharma

World of DTC Marketing

SUMMARY: Pfizer will earn over 26 billion dollars from their COVID vaccine, while Moderna and J&J also look to their vaccines for more profit dollars. The suggestion by Pfizer’s CEO that drug pricing negotiations with the government would slow innovation is PR doubletalk. Recently Pfizer’s CEO sent a video message to company employees urging them to fight proposed government drug price negotiations and expressing frustration with Congress, considering using the projected savings

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

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Enhertu reduces breast cancer disease progression or death by 72%

Pharma Times

'Groundbreaking results' for the treatment of HER2-positive metastatic breast cancer

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AstraZeneca strikes deal with university spinoff to turn RNA into drugs

Bio Pharma Dive

The British drugmaker is investing in VaxEquity, a biotech founded last year to explore a twist on the mRNA technology that Moderna and BioNTech have made famous.

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Galileo Research and InSilicoTrials partner up to reduce time and cost of drug development

Pharma Mirror

Milan, Italy, Innovation and cutting-edge technology to reduce Research and Development time and costs: InSilicoTrials, a company with broad expertise in Computational Modeling and Simulation, IT and cloud solutions for the healthcare sector, and Galileo Research established a partnership to apply in silico services for drug repurposing activities and provide mutual support in modeling and simulation activities.

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Study finds 10% of medicines in England are overprescribed

pharmaphorum

An alarming number of people in England are being prescribed medicines unnecessarily, which could harm their health, according to a UK government review. The study , led by the Chief Pharmaceutical Officer for England Dr Keith Ridge, estimates that 10% of items dispensed in primary care are inappropriate or could be better served with alternative treatments.

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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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Telling it how it is: The need for plain language summaries in medical journals

BioPharma Reporter

Open Pharma wants to see articles in peer-reviewed medical journals provide plain language summaries: those written in everyday language that is easy to understand by anyone from patients to policymakers. It's now set out its recommendations on how to write a good plain language summary.

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Pfizer says coronavirus vaccine is safe and spurs immune response in children

Bio Pharma Dive

The results position Pfizer and BioNTech to seek clearance in children as young as five years old. But the companies haven't yet shared data on a rare heart inflammation associated with their shot that's a concern for regulators.

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Naobios manufactures FluGen Inc’s M2SR influenza vaccine candidate for upcoming clinical trials

Pharma Mirror

Nantes, France, Naobios, a CDMO (Contract Development and Manufacturing Organization) providing bioprocess development and GMP production of clinical batches of viral vaccines BSL2/BSL3, oncolytic viruses and viral vectors, today announces the next phase in its partnership with FluGen, Inc., a clinical-stage vaccine company transforming vaccine efficacy in infectious respiratory diseases.

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Early detection of cancers will require blood sweat and tears

pharmaphorum

An NHS study of a new cancer blood test holds huge promise, but will not be without its challenges, says Snedden Campbell’s Ivor Campbell. The announcement that the NHS is taking part in a major new clinical trial for a blood test that could detect more than 50 cancers early has been welcomed as a potential, once-in-a-generation breakthrough. The UK health service partner with Silicon Valley-based healthcare company Grail in a randomised control trial involving up to 140,000 volunteers.

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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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New data demonstrates long-term benefit of Crysvita for XLH patients

Pharma Times

Results showed treatment with Crysvita reduces disease burden for patients

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'This is the time to double down': Top Vertex executives defend research plan as pressure builds

Bio Pharma Dive

A series of setbacks has led to criticism of the storied biotech's bid to diversify. But Vertex intends to stay the course, its CEO and top scientist say.

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BMG Pharma and HTL sign a development agreement to manufacture BMG’s new biopolymer

Pharma Mirror

Milan, BMG Pharma – a biotech and B2B company headquartered in Milan with its chemical plant in Torviscosa (Italy) that exports its medical products to more than 80 countries – has signed a development and commercial agreement with HTL, a leading biotech and industrial player in the development and production of innovative, pharmaceutical-grade biopolymers.

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Novavax files its COVID jab to WHO for emergency use listing

pharmaphorum

Novavax and its partner Serum Institute of India have applied to the World Health Organization for an emergency use listing for their COVID-19 vaccine, based on a conventional recombinant protein technology. Getting a WHO emergency use listing (EUL) is a requirement for approvals by many national regulatory authorities, as well as for participation in the COVAX mechanism, which has been set up to procure COVID-19 vaccines for lower-income countries.

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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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Mirati’s adagrasib scores encouraging results in KRAS-mutated lung cancer

Pharma Times

Adagrasib is an investigational oral small-molecule inhibitor of KRAS G12C

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Insurers sue Merck for 'monopolistic scheme' to delay generics of blockbuster cholesterol drug

Bio Pharma Dive

The suits allege an agreement between Merck and a generic manufacturer kept low-cost versions of the drugmaker's widely used Zetia off the market for years.

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Portuguese initiative wins FIP Pharmacy Practice Improvement Award

Pharma Mirror

The Hague, A freephone service created by a pharmacy COVID-19 “crisis cabinet” to maintain care and help ensure safety of citizens and pharmacy teams following a declaration of a state of emergency is the winner of the International Pharmaceutical Federation (FIP) Pharmacy Practice Improvement Award 2021. The award to the National Association of Pharmacies (ANF), Portugal, was announced today at an online awards ceremony.

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RwHealth, the Artificial Intelligence provider for the NHS, promises to transform healthcare

pharmaphorum

RwHealth , the leading provider of Artificial Intelligence to the healthcare industry, has today reported 160 per cent year-on-year growth as its data-led solutions are increasingly embraced by NHS trusts, private healthcare providers and major pharmaceutical companies. RwHealth’s unique Data Science Platform combines Artificial Intelligence (AI), Machine Learning and Data Science to give healthcare providers access to the best and most in-depth data available, helping them to make better decisi

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CHMP recommends Nucala for three new indications

Pharma Times

Positive opinions recommend approval for mAb in three additional eosinophil-driven diseases

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Seagen, Genmab win speedy FDA approval for cervical cancer drug

Bio Pharma Dive

Tivdak, a type of drug known as an antibody-drug conjugate, is the fourth approved medicine for Seagen and its third to reach market since December 2019.

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Catalent Signs Commercial Supply Agreement with Phathom

Pharma Mirror

SOMERSET, N.J. Catalent, the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and gene therapies; and consumer health products, today announced that it had signed a commercial supply agreement with Phathom Pharmaceuticals, a late clinical-stage biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases, for its lead compound, vonoprazan, which is a novel, orally acti

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EU panel rejects Pfizer’s tanezumab for osteoarthritis pain

pharmaphorum

Any lingering hope that Pfizer’s may finally get a regulatory approval for its nerve growth factor (NGF) inhibitor tanezumab looks to have been dashed after the EMA’s human medicines committee rejected the drug. A positive recommendation was already looking like a long shot for after FDA advisors voted 15 to one against approval of the drug in March.

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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.