Sat.Jan 21, 2023 - Fri.Jan 27, 2023

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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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Three VCs launch Dimension, a new firm with plans to fuel biotech’s ‘digitization’

Bio Pharma Dive

The veteran investors see the marriage of tech and life sciences as the “largest opportunity in venture today,” said co-founder and former Lux Capital general partner Adam Goulburn

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Pharma Mirror Q&A with Jane Myles, Vice President of Clinical Trial Innovation at Curebase

Pharma Mirror

The White House Office of Science & Technology Policy (OSTP) convened a listening session January 11.

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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.

Antibody 135
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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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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases.

Hormones 317
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Roivant’s Matt Gline on the hub-and-spoke biotech model and lessons learned from Axovant

Bio Pharma Dive

This year could stay turbulent for the biotech sector as investors look for what the Roivant CEO described in an interview with BioPharma Dive as “safe harbors in a storm &rdquo

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A new dawn of the genomic age: five areas set to be transformed in 2023

Pharma Phorum

2022 was a banner year for genomics. In March, the collaborative T2T consortium published the first complete telomere-to-telomere sequence of the human genome, filling in the last 8% of the 3 billion base pairs that make up our DNA.

Genome 129
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Current and future players in the lupus market

Pharmaceutical Technology

Systemic lupus erythematosus (SLE) is a systemic, inflammatory, chronic autoimmune disease that can affect multiple organs simultaneously or sequentially, with a relapsing and remitting nature.

Marketing 278
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Pliant shares jump on new data for lung disease drug

Bio Pharma Dive

A high dose of the company’s experimental medicine appeared potent in patients with idiopathic pulmonary fibrosis, an elusive target for drugmakers. The results are from a small and short clinical trial, however

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Neuraxpharm completes its presence in Benelux

Pharma Mirror

Branding 130
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2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

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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 accepts Lilly-Boehringer Ingelheim’ sNDA for Jardiance

Pharmaceutical Technology

Eli Lilly and Company and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets for chronic kidney disease (CKD) in adult patients.

Drugs 264
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FDA weighs shift in COVID vaccination strategy

Bio Pharma Dive

Agency scientists are proposing to update COVID shots once a year to match circulating coronavirus strains, as well as simplifying current vaccination regimens

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Modernizing Therapeutic Cell Production

Pharma Mirror

Science-based innovation for manufacturing high quality cells challenges dogma and terminology Cell and gene therapies are dominating the world of drug development.

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An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space

Speaker: Steve Goldstein, Sales Leader

Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.

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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.”

Pharmacy 105
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Health Canada accepts Veru’s Covid-19 therapy NDS-CV for review

Pharmaceutical Technology

Health Canada has accepted for review Valeo Pharma partner Veru’s new drug submission (NDS-CV) for Covid-19 therapy sabizabulin.

Antibody 246
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FDA to seek outside advice on Biogen’s ALS drug

Bio Pharma Dive

The agency plans to convene a panel of experts on March 22 to discuss the approval application for tofersen, a closely watched medicine Biogen submitted to the FDA despite its failure in a key clinical trial

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BMS settles lawsuit with two fired employees who refused COVID vaccines

Fierce Pharma

BMS settles lawsuit with two fired employees who refused COVID vaccines kdunleavy Thu, 01/26/2023 - 14:30

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

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Tackling ongoing staffing burnout rates through AI-enabled precision oncology

Pharma Phorum

The emergence of COVID-19 resulted in staffing challenges that have continued to have a sustained, negative impact on clinical trial workflows.

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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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J&J puts focus on cancer drugs in push to reach 2025 sales target

Bio Pharma Dive

The drugmaker reported fourth quarter revenue that fell short of forecasts, but reiterated confidence in reaching a $60 billion pharmaceutical sales goal

Sales 297
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A Day in the Life of a Senior Art Director

Intouch Solutions

M eet Meg Bradley, Senior Art Director at EVERSANA INTOUCH. Meg has been with EVERSANA INTOUCH for more than 5 years and has held a variety of positions.

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How Moderna kept diversity in mind amid vaccine development

Pharma Phorum

In the newest episode of the pharmaphorum podcast, editor-in-chief Jonah Comstock speaks with Jameka Hill, senior director of clinical trial health equity at Moderna.

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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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Merck gets a ‘surprise’ win for Keytruda in early lung cancer

Bio Pharma Dive

The FDA gave the top-selling immunotherapy a broad label in adjuvant lung cancer despite mixed results in the main study supporting its application, taking one Wall Street analyst by surprise

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Can machine learning accelerate drug formulation?

Outsourcing Pharma

Research emerging from the University of Toronto found that using machine learning models was able to guide the design of long-acting drug formulations. Clinical Development

Research 130
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ABPI code updated with first social media guidance

Pharma Phorum

Guidance on the way pharma companies communicate about prescription medicines has been updated in the UK to cover use of social media channels for the first time.

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US FDA clears Transcenta’s IND for Rett syndrome treatment

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted clearance for Neurogene’s investigational new drug (IND) application for NGN-401 to treat Rett syndrome.

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Finch to lay off 95% of staff, scrap microbiome drug study

Bio Pharma Dive

The company blamed a range of factors in its decision, including limited funding, slower-than-anticipated trial enrollment and “broader sector trends &rdquo

Trials 272
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NICE recommends Alexion’s asfotase alfa across England

Pharma Times

Therapy involves patients with paediatric-onset hypophosphatasia – a rare bone disease

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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.

Medicine 105
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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.

Marketing 173
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Veteran biotech leader George Scangos to step down as Vir CEO

Bio Pharma Dive

The former Biogen head is retiring after taking Vir from a small startup to a publicly traded developer of infectious disease drugs. Bayer executive Marianne De Backer will succeed him

Drugs 266