Sat.Mar 04, 2023 - Fri.Mar 10, 2023

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Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret

Fierce Pharma

Pfizer hopes to nose out competition with approval for new migraine nasal spray Zavzpret kdunleavy Fri, 03/10/2023 - 10:22

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First nasal monoclonal antibody COVID-19 treatment shows potential

European Pharmaceutical Review

A pilot study has demonstrated that a nasal version of the drug Foralumab, an anti-CD3 monoclonal antibody suppressed the inflammatory T cell response and decreased lung inflammation in patients with COVID-19. “This is the first nasal monoclonal antibody—other monoclonal antibody treatments were delivered intravenously and are no longer given as treatment because they are not effective against currently circulating viral variants,” explained Dr Howard Weiner, founder and Director of the Brigham

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Dawn of a new indication: how to study drugs for aging 

Pharmaceutical Technology

For a long time, aging biology and research have been enigmatic areas that biotechs hoped to capitalise on due to their market potential. Whether one refers to such research as “longevity”, “anti-aging” or “extending healthspan”, it is clear this area has evolved massively over the last few years with more scientists now eager to get drugs in this area from bench to bedside.

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Mapping the path to future changes in the Journal Citation Reports

Clarivate

In July 2022, I shared our plans to extend the Journal Impact Factor (JIF) to all journals in the Web of Science Core Collection from June 2023. This means that this year, journals from the Arts and Humanities Citation Index (AHCI) and the multidisciplinary Emerging Sources Citation Index (ESCI) in the Journal Citation Reports (JCR) will receive a JIF for the first time.

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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 Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines

Fierce Pharma

'The Top Line': Why pharma needs to ramp up its use of AI and machine learning, plus this week's headlines tcarey Thu, 03/09/2023 - 15:25

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New NHS cell and gene therapy centre opens

European Pharmaceutical Review

Today marks the opening the NHS Blood and Transplant (NHSBT)’s new Clinical Biotechnology Centre (CBC) in Bristol. The state-of-the-art facility was part-funded by a £9.43 million Government grant and is designed to expand the UK’s ability to manufacture new gene and cell therapies. The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international market.” “The CBC will help the UK grow its cell and gene therapy industry in a rapidly growing international

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Smartphone Photos to Detect Anemia

Medgadget

Researchers at University College London and at the University of Ghana have developed a smartphone-based system that can detect anemia through simple photos taken using the phone’s camera. The technology is intended for use in low- and middle-income countries where access to routine medical diagnostics may be unreliable. The process involves obtaining images of areas of the body which are least pigmented, including the white of the eye, the lower eyelid, and the lip.

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Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy

Fierce Pharma

Bucking FDA, independent panel backs Roche's lucrative lymphoma expansion bid for Polivy aliu Thu, 03/09/2023 - 17:22

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3 Keys to Better Cybersecurity

MedCity News

As companies review their processes, below are three approaches they can keep top of mind — namely, increasing employee training and utilizing technology as safeguards, making a point to learn and change processes following attacks, and prioritizing vetting partners’ security.

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New facility boosts UK’s cell and gene therapy manufacturing capacity

Pharmaceutical Technology

On 10 March, the National Health Service Blood and Transplant (NHSBT) opened a new Clinical Biotechnology Centre (CBC) with the aim of improving the UK’s ability to develop and manufacture cell and gene therapies. A £9.3 million ($11 million) grant is being used to build the facility in Bristol where therapies for currently incurable diseases, such as some forms of cancer, sickle cell disease, and cystic fibrosis can be manufactured.

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Ultrasound Catheter to Treat Hypertension

Medgadget

Researchers at Columbia University Irving Medical Center and the Université de Paris, France, have tested an ultrasound denervation catheter in its potential to treat hypertension. The technology is called the Paradise ultrasound denervation device and it has been developed by ReCor Medical , a medtech company with offices in California and the UK. The concept is based on the phenomenon whereby overactive neural activity in the kidney can lead to increases in sodium and water retention, underlyi

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FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva

Fierce Pharma

FDA calls expert hearing for Intercept’s high-profile NASH application for Ocaliva aliu Fri, 03/10/2023 - 10:49

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Consumerism, Customer Experience at Healthcare’s Forefront

MedCity News

Healthcare consumerism and prioritizing the customer experience to boost loyalty are key focus areas for providers and payers in the months and years ahead.

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Eli Lilly places price cap of $35 on out-of-pocket insulin cost

Pharmaceutical Technology

Eli Lilly has announced that it will reduce the price of its most commonly used insulin, Humalog, in the US, by 70% and cap the out-of-pocket cost for those on commercial insurance at $35. This follows on from recent US federal action, the Inflation Reduction Act, that legislated reducing the Medicare beneficiary insulin out-of-pocket costs at $35 a month.

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New cell therapy company will treat solid tumours

European Pharmaceutical Review

The joining of Adaptimmune Therapeutics and TCR² Therapeutics will form a new cell therapy company focused on treating solid tumours. Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer asserted that the combined companies will work to gain “approval for the first engineered T-cell receptor (TCR) T-cell therapy for a solid tumour – afami-cel for the treatment of synovial sarcoma.

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Sanofi's site modernization spree rolls on with plan to shift 2,000 staffers to new flexible workspace in New Jersey

Fierce Pharma

Sanofi's site modernization spree rolls on with plan to shift 2,000 staffers to new flexible workspace in New Jersey fkansteiner Tue, 03/07/2023 - 10:50

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Elevance Health: Long Covid Patients Are at Increased Risk for Cardiovascular Problems, Mortality

MedCity News

A recent Elevance Health study found that long Covid patients are 2.35 times more likely to experience cardiac arrhythmia and 3.64 times more likely to experience pulmonary embolism. The study also discovered higher mortality rates among long Covid patients.

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Teijin Pharma and Novartis sign licence deal for kidney disease candidate

Pharmaceutical Technology

Teijin Pharma and Novartis have signed an exclusive global licence agreement for an investigational preclinical small molecule candidate for proteinuric kidney diseases. Under the licence deal, Novartis will gain exclusive global rights for the research, development, manufacturing, and commercialisation of the candidate for all potential indications.

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An Inside Look at Pharma Revenue Management

PharmExec

According to the 2023 State of Revenue Report, pharma companies are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

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In SCOTUS filing, Amgen claps back at Sanofi and Regeneron in long-running patent feud

Fierce Pharma

In SCOTUS filing, Amgen claps back at Sanofi and Regeneron in long-running patent feud fkansteiner Thu, 03/09/2023 - 08:45

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Gen Z-Focused Mental Health Platform Founded by Stanford Psychologist Raises $6M

MedCity News

Wave Life — a mental health platform designed for Gen Z — recently closed a $6 million seed investment led by Santé Ventures. The company — which was founded by Sarah Adler, a clinical psychologist and clinical associate professor at Stanford’s psychiatry department — will use the funding to move further into the employer market and conduct research on its care model’s outcomes.

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Incannex partners with Catalent to manufacture psilocybin

Pharmaceutical Technology

Incannex Healthcare has collaborated with New Jersey-based pharma company Catalent for the development and manufacturing of a cGMP-grade psilocybin drug product for clinical trials and potential commercial use. The drug product is designed for use in the psilocybin-assisted psychotherapy drug development programme of Incannex for generalised anxiety disorder.

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Congress Probes PBM Link to Higher Drug Prices

PharmExec

Latest investigation signals more scrutiny of pharmacy benefit managers and their role in treatment cost and coverage.

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Sarissa's overhaul of Amarin's board is complete with resignation of 7 holdover members

Fierce Pharma

Sarissa's overhaul of Amarin's board is complete with resignation of 7 holdover members kdunleavy Tue, 03/07/2023 - 09:41

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Lawmakers Are Cracking Down on Companies Using Health Data for Advertising

MedCity News

Three senators recently introduced legislation that would ban the use of health data for advertising and marketing purposes. The proposed legislation comes amid media reports claiming that data brokers are selling social media companies patients’ location data, as well as reports that hospitals and digital health startups are collecting patients’ online data and sharing it with tech giants such as Facebook and Google.

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CNM-Au8 could address vision problems in multiple sclerosis

Pharmaceutical Technology

Clene has presented updated trial results for its Visionary MS Phase II clinical trial for its lead pipeline candidate, CNM-Au8. The trial is investigating CNM-Au8 as a treatment for patients with relapsing forms of multiple sclerosis (MS) with chronic optic neuropathy. The agent has a first-in-class mechanism of action within the MS portfolio, as it is a first drinkable treatment based on a nanocrystalline gold suspension that has reached late-stage development for MS.

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2023 Greatest Creators Cover Competition Winner

PM360

This industry is brimming with creative talent—both in what they do for their jobs and for themselves. To highlight the latter, every year PM360 asks for submissions of original artwork from those who work in the industry, and we pick our favorite piece to serve as the cover of our Greatest Creators section. We spoke to this year’s winner Phil Winn, Lead Art Director, Evoke MicroMass , about his piece “AI – Portrait Study #8.

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ACC23: Bayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery

Fierce Pharma

ACC23: Bayer and J&J's Xarelto reduces ischemia risk for PAD patients after revascularization surgery kdunleavy Mon, 03/06/2023 - 07:09

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Zocdoc Partners With Zaya Care for Pregnancy, Postpartum Services

MedCity News

Through the partnership, patients can find and book appointments with Zaya’s providers via Zocdoc’s website or app. The partnership represents the first time Zocdoc will have lactation consultants available on its marketplace, said Dr. Oliver Kharraz, Zocdoc founder and CEO.

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US FDA approves Pfizer’s migraine nasal spray Zavzpret

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Pfizer ’s Zavzpret (zavegepant) for the acute treatment of migraine in adult patients with or without aura. Zavzpret is claimed to be the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray approved to treat migraine. It is a third-generation, selective and structurally unique, small molecule CGRP receptor antagonist and is currently under clinical development with oral and intranasal formulation

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PM360’s Masterclass of Storytelling 2023 Marinus Pharmaceuticals and Heartbeat

PM360

Raising Lina: A CDKL5 Deficiency Disorder Story Marinus Pharmaceuticals and Heartbeat CDKL5 Deficiency Disorder (CDD) is a rare disease that occurs in approximately 1 in 40,000 births in the U.S. Among the hallmarks of the condition are seizures that begin in infancy and continue through life. Seizures can occur daily and are often severe. CDD patients can experience extreme delays in their physical and mental abilities, and the disease’s impact on patients and their families are significant, so

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Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing

Fierce Pharma

Eisai, Biogen's high-stakes Leqembi filing nets FDA priority review—and an AdComm hearing zbecker Mon, 03/06/2023 - 11:08

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The Healthcare Interoperability Policies Driving the Conversation at ViVE [Sponsored]

MedCity News

Sandy Vance, HLTH’s senior adviser, Interoperability, offered a preview of the interoperability pavilion at ViVE and what she hopes to achieve at the conference this year.