Wed.Jan 25, 2023

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DTx for women’s mental health – Woebot and postpartum depression

Pharma Phorum

Digital therapeutics company Woebot Health has announced enrolment of the first patient in a pivotal clinical trial to evaluate the safety and efficacy of WB001, an investigational therapeutic for postpartum depression (PPD), granted Breakthrough Device designation by the US Food and Drug Administration (FDA) in 2021.

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Wave of leading medical schools pull out of U.S. News' annual rankings

Fierce Healthcare

Wave of leading medical schools pull out of U.S. News' annual rankings dmuoio Wed, 01/25/2023 - 17:13

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Trending Sources

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Automating – and optimising – HCP engagement to maximise commercial success

Pharma Phorum

Life sciences marketing has rapidly evolved to mirror that of consumer retail.

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COVID-19 caused surge in heart disease deaths in first year of pandemic: report

Fierce Healthcare

COVID-19 caused surge in heart disease deaths in first year of pandemic: report fdiamond Wed, 01/25/2023 - 08:44

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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

This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.

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Ovarian cancer, Olivia, and the OCC – part one

Pharma Phorum

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Major study on DMT shows promise for depression

European Pharmaceutical Review

The first major study on the efficacy of DMT in treating any mental health condition showed a remission rate of 57 percent following a single dose, in a Phase IIa trial for major depressive disorder (MDD).

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More Trending

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Moderna now in the crosshairs of Sens. Warren, Welch over price tag for COVID vaccine

Fierce Pharma

Moderna now in the crosshairs of Sens. Warren, Welch over price tag for COVID vaccine kdunleavy Wed, 01/25/2023 - 13:16

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Payer startup Angle Health scores $58M to scale operations, expand to new markets

Fierce Healthcare

Payer startup Angle Health scores $58M to scale operations, expand to new markets agliadkovskaya Wed, 01/25/2023 - 09:42

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Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi

Fierce Pharma

Merck's Keytruda dealt another blow in prostate cancer but readies new challenge to AZ's Imfinzi aliu Wed, 01/25/2023 - 10:17

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State-by-state licensure is anachronistic in the age of teletherapy, providers say

Fierce Healthcare

State-by-state licensure is anachronistic in the age of teletherapy, providers say aburky Wed, 01/25/2023 - 14:52

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EMA validates first regulatory submission for CRISPR-based medicine

European Pharmaceutical Review

The European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for exagamglogene autotemcel (exa-cel), the first regulatory submission for a CRISPR-based medicine.

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Health system hospitals, physicians deliver 'marginally' better care at higher cost than independent peers: study

Fierce Healthcare

Health system hospitals, physicians deliver 'marginally' better care at higher cost than independent peers: study dmuoio Wed, 01/25/2023 - 13:52

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UTSA researchers to develop compounds for GBM tumours

Pharmaceutical Technology

A researchers’ team from the University of Texas at San Antonio’s (UTSA) Department of Chemistry and its partners are developing compounds to treat Glioblastoma multiforme (GBM) tumours. UTSA’s partners include UT Health San Antonio’s Department of Obstetrics and Gynecology and Mays Cancer Center.

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After years of back-and-forth, Gilead's CAR-T Yescarta sways England's cost watchdog NICE

Fierce Pharma

After years of back-and-forth, Gilead's CAR-T Yescarta sways England's cost watchdog NICE fkansteiner Wed, 01/25/2023 - 18:51

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Poxel given EC’s Orphan Drug Designation for rare metabolic disorders

Pharmafile

Clinical stage biopharmaceutical company Poxel, who focus on developing innovative treatments for chronic, serious diseases with metabolic pathophysiology, has been awarded Orphan Drug Designation (ODD) for two drugs for the treatment of adrenoleukodystrophy (ALD).

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WHO urges supply chain to take action on contaminated medicines

European Pharmaceutical Review

Regulators, medicine manufacturers and suppliers have been urged by the World Health Organization (WHO) to take action against contaminated medicines in the supply chain.

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Automated insulin dosing app Tidepool Loop FDA-cleared

Pharma Phorum

The 501(c)3 non-profit Tidepool, which seeks to empower the next generation of innovations in diabetes management, has announced that the US Food and Drug Administration (FDA) has cleared Tidepool Loop, an automated insulin dosing app intended for the management of type 1 diabetes (T1D) in those six years old and above.

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As Scangos bids adieu, Vir taps Bayer dealmaker De Backer as its next CEO

Fierce Pharma

As Scangos bids adieu, Vir taps Bayer dealmaker De Backer as its next CEO fkansteiner Wed, 01/25/2023 - 11:09

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Medicare officials call for gradual shift in calculation of Medicare Advantage benchmarks to reflect growing popularity

Fierce Healthcare

Medicare officials call for gradual shift in calculation of Medicare Advantage benchmarks to reflect growing popularity rking Wed, 01/25/2023 - 17:10

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Lilly Financially Commits Additional $450M toward Research Triangle Park Facility

Pharmaceutical Commerce

Expansion expected to help tackle health issues at a faster rate, company says us

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FDA advisors back Cidara antifungal rezafungin

Pharma Phorum

An FDA advisory committee has recommended approval of Cidara Therapeutics’ once-weekly antifungal therapy rezafungin, setting it up to become the first new option for severe infections caused by Candida species in a decade.

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Global Medicines Market to Grow 3-6% Annually to $1.9 Trillion through 2027, Says IQVIA

Pharmaceutical Commerce

Annual report finds continuing impact of COVID-19 on global markets us

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Woman of the Week: Dr. Lauren Lazar

PharmaVoice

As Calcium’s medical director, Lazar is leveraging next-generation innovation to create strategic connections between science and marketing for healthcare brands

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Pliant seeks $250m offering on lung fibrosis data

Pharma Phorum

Buoyed by encouraging mid-stage clinical results for its idiopathic pulmonary fibrosis therapy bexotegrast, Pliant Therapeutics filed a $175million public offering, and then swiftly raised its target to $250million on strong early interest.

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Economic crisis? J&J execs say that won’t stop them from hitting $60B target

PharmaVoice

The pharma giant's CEO Joaquin Duato and CFO Joseph Wolk showed that they're optimistic about reaching lofty goals despite hard economic times

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BMS lawsuit claims AZ’s Imjudo infringes Yervoy patents

Pharma Phorum

AstraZeneca followed a long and arduous road to bring its CTLA4 inhibitor Imjudo to market, and will now have to defend its new product from a patent infringement complaint brought by Bristol-Myers Squibb in the US.

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Thermo Fisher Scientific announces launch of CE-IVD marked assay to detect treatment-resistant strains of HIV-1

Pharmafile

US-based Thermo Fisher Scientific has announced the launch of its CE-IVD marked Applied Biosystems Taqpath Seq HIV-1 Genotyping kit.

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A record 16.3M people signed up for coverage on ACA exchanges during open enrollment, CMS says

Fierce Healthcare

A record 16.3M people signed up for coverage on ACA exchanges during open enrollment, CMS says pminemyer Wed, 01/25/2023 - 16:40

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Eli Lilly plans to invest $450m at production site in Research Triangle Park

Pharmafile

US-based pharmaceutical company, Eli Lilly and Company, has announced plans to invest $450m in its manufacturing facilities at Research Triangle Park in North Carolina, US.

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Money moves: How the biotech market is weathering inflationary storms

Pharmaceutical Technology

After a tumultuous year that weathered the continued impact of a bear market , many in biotech are looking for signs of improvement in 2023. However, industry experts have buckled up in anticipation of continued challenges this year.

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Data Analysis Finds Threshold for Lifting/Reinstating Masking to Combat Respiratory Illness

Pharmacy Times

Research showed that 600 hospital beds filled with patients with severe illness would be enough to reimplement (mask mandates to stop the spread of infection.

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The impact of clinical trial decentralisation on the pharma supply chain

Pharmaceutical Technology

Clinical trials require precision and faultless execution for hypotheses to become therapies. For most of pharmaceutical history, this has made the potential benefits from outsourcing elements of these trials elusive.

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An Overview of Pharmacist Involvement, Management in Treatment With Inclisiran

Pharmacy Times

Luke Gormley, PharmD, BCPS, discusses how pharmacists are involved in the management of inclisiran.

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Moderna’s Covid-19 vaccine sales forecast slashed amidst strong competition

Pharmaceutical Technology

It was an exceptional year for Moderna’s vaccine Spikevax, with forecast sales of $19.5bn in 2022.

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US Center for Disease Control (CDC) and two major medical journals cite the importance of decolonization in preventing surgical site infections

Pharmafile

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Alvotech-Bioventure’s AVT02 approved in Saudi Arabia for manufacturing

Pharmaceutical Technology

The Saudi Food & Drug Authority (SFDA) has approved the manufacturing and distribution of Alvotech and Bioventure’s AVT02 (adalimumab). The monoclonal antibody AVT02 is the approved biosimilar for AbbVie ’s Humira (adalimumab).

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