Fri.Jan 27, 2023

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FDA pulls AZ’s Evusheld for COVID, citing lack of efficacy

Pharma Phorum

AstraZeneca’s revenue boost from COVID-19 therapy Evusheld looks set to be curbed early, as the FDA withdraws authorisation for the antibody on the grounds that it is ineffective against most subvariants now circulating in the US.

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SDOH startup Spatially Health partners with Florida ACO amid new CMS rules on equity

Fierce Healthcare

SDOH startup Spatially Health partners with Florida ACO amid new CMS rules on equity agliadkovskaya Fri, 01/27/2023 - 13:40

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Patient centricity and the changing pharmaceutical vista

Pharma Phorum

Late last year, pharmaphorum caught up with Dr Karen Mullen, chief medical officer and VP of clinical & medical affairs at global drug development consultancy Boyds.

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FDA refuses to regulate CBD, calling on Congress to take charge

Pharmafile

The FDA is calling on the US Congress to work with them on a new regulatory pathway for cannabidiol (CBD). CBD is the non-psychoactive ingredient from the cannabis plant generally considered to have wellness properties.

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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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J&J copay lawsuit against drug benefit firm gets green light

Pharma Phorum

Johnson & Johnson has been cleared to continue a lawsuit filed last year against drug benefit programme SaveOnSP, which claims it defrauded a payment assistance programme for patients out of “at least $100 million.”

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FDA Approves Elacestrant for ER+/HER2–, ESR1-Mutated Advanced or Metastatic Breast Cancer

Pharmacy Times

The FDA has approved elacestrant (Orserdu) for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least 1 line of endocrine therapy.

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FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Pharmacy Times

The FDA has approved pirtobrutinib (Jaypirca) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma following at least 2 lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

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Breaking through the forecasting fog – 3 trends that will impact critical medicine supply in 2023

Pharma Phorum

As the legendary investor Warren Buffett once said, forecasts about the future usually tell you more about the forecaster than they do about the future.

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Majority of patients repeatedly provide duplicate health information, Carta Healthcare survey finds

Fierce Healthcare

Majority of patients repeatedly provide duplicate health information, Carta Healthcare survey finds aburky Fri, 01/27/2023 - 16:21

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Ipsen’s rare disease drug palovarotene knocked back in EU

Pharma Phorum

Ipsen has suffered rather a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended against approval.

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Cigna sues CVS, former exec Amy Bricker over noncompete agreement

Fierce Healthcare

Cigna sues CVS, former exec Amy Bricker over noncompete agreement pminemyer Fri, 01/27/2023 - 12:20

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With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug

Fierce Pharma

With FDA approval for Jaypirca, Eli Lilly introduces new BTK blood cancer drug aliu Fri, 01/27/2023 - 15:29

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FDA panel approves path toward one-shot yearly COVID vaccine

Fierce Healthcare

FDA panel approves path toward one-shot yearly COVID vaccine fdiamond Fri, 01/27/2023 - 09:17

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Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira

Fierce Pharma

Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira zbecker Fri, 01/27/2023 - 11:50

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Senators introduced bills to reform PBMs after stalling out in last Congress

Fierce Healthcare

Senators introduced bills to reform PBMs after stalling out in last Congress rking Fri, 01/27/2023 - 15:23

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EU approves Daiichi Sankyo-AstraZeneca’s breast cancer therapy

Pharmaceutical Technology

The European Union (EU) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) as monotherapy to treat unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer adult patients.

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HCA Healthcare closes out 2022 with revenue gains, lingering capacity constraints

Fierce Healthcare

HCA Healthcare closes out 2022 with revenue gains, lingering capacity constraints dmuoio Fri, 01/27/2023 - 12:42

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J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma

Fierce Pharma

J&J, Legend's Carvykti hits goal in earlier myeloma, escalates CAR-T showdown with Bristol Myers' Abecma aliu Fri, 01/27/2023 - 11:02

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'I cry and no one cares': Medscape survey shows doctor burnout, depression is getting worse

Fierce Healthcare

I cry and no one cares': Medscape survey shows doctor burnout, depression is getting worse agliadkovskaya Fri, 01/27/2023 - 15:35

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FDA advisors vote to standardize COVID vaccines as bivalent, stump for more data

Fierce Pharma

FDA advisors vote to standardize COVID vaccines as bivalent, stump for more data kdunleavy Fri, 01/27/2023 - 10:01

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CVS Health launches initiative with Meharry Medical College, Sinai Chicago aiming to reduce disparities in marginalized communities

Fierce Healthcare

CVS Health launches initiative with Meharry Medical College, Sinai Chicago aiming to reduce disparities in marginalized communities agliadkovskaya Fri, 01/27/2023 - 12:25

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JP Morgan 2023 – Adi Hoess

Pharma Phorum

pharmaphorum editor-in-chief Jonah Comstock joins Adi Hoess, CEO of Affimed Therapeutics, at their JPM2023 headquarters at the Zeppelin Hotel, to learn about Affimed’s work and their plans for the year to come.

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Pearl Health clinches $75M backed by a16z to scale up value-based care tech

Fierce Healthcare

Pearl Health clinches $75M backed by a16z to scale up value-based care tech hlandi Fri, 01/27/2023 - 17:00

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New UK point of care manufacturing regulatory framework

European Pharmaceutical Review

The UK will be the first country to introduce a tailored framework for the regulation of innovative medicines manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

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Kaiser Permanente earmarks $25M for gun violence prevention research, collaboration

Fierce Healthcare

Kaiser Permanente earmarks $25M for gun violence prevention research, collaboration dmuoio Fri, 01/27/2023 - 09:34

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Eli Lilly to help fund cold chain initiative

European Pharmaceutical Review

To help expand access to medicines in low- and middle-income countries (LICs) Eli Lilly and Company has announced it will provide $1.15m to a new cold chain capacity initiative.

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The last to fall: FDA nixes emergency nod on AstraZeneca's COVID-19 antibody Evusheld

Fierce Pharma

The last to fall: FDA nixes emergency nod on AstraZeneca's COVID-19 antibody Evusheld fkansteiner Fri, 01/27/2023 - 09:38

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Catalent Completes Belgium Manufacturing Facility

Pharmaceutical Commerce

Complex to develop cGMP-compliant, commercial-scale plasmid DNA.

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Chiesi fills CEO post with Baxter veteran Accogli after acquiring Amryt in $1.5B deal

Fierce Pharma

Chiesi fills CEO post with Baxter veteran Accogli after acquiring Amryt in $1.5B deal kdunleavy Fri, 01/27/2023 - 15:07

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Strengthening the Cold Chain: Insights Gained from COVID-19

Pharmaceutical Commerce

A breakdown of how the industry is using these lessons to move full steam ahead.

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Measuring the cost-effectiveness of vaccines targeting infectious diseases

Pharma Phorum

Cost-effectiveness modelling is a powerful tool in understanding the value health interventions can bring to populations.

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Ipsen reports CHMP negative review for use of palovarotene in EU

Pharmafile

Ipsen, a biopharmaceutical company focused on medicines in oncology, rare diseases and neuroscience, have been denied marketing authorisation by the Committee for Medicinal Products for Human Use (CHMP) of the EMA for their drug palovarotene. read more Research and Development

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Could your loyalty card help spot cancer? Study says yes

Pharma Phorum

A study by UK researchers has found that buying patterns for over-the-counter (OTC) medicines for pain and indigestion, recorded using a store loyalty card, could be used to pick up early symptoms of ovarian cancer.

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FDA pulls approval of COVID-19 antibody treatment due to inefficacy against variants

Pharmafile

The FDA has revoked its approval of AstraZeneca’s Evusheld due to the fact that it is not effective against more than 90% of COVID-19 variants currently in circulation in the US.

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UK biotech sees worst funding downturn since 2012

Pharma Phorum

The UK BioIndustry Association (BIA) and data and insights company Clarivate have released their annual UK Biotech Financing report – and, on the whole, the findings are not positive.

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Monoclonal antibody could prevent malaria, study shows

European Pharmaceutical Review

A single dose of monoclonal antibody (mAb) CIS43LS provided high levels of protection against malaria in a challenge study , according to new research.

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