February, 2023

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Disruptive Factors Shape RA Landscape

Pharmaceutical Commerce

As the range of treatment options for rheumatoid arthritis (RA) continues to grow and biosimilars are poised to enter the arena, the need for expert strategies to improve therapy selection and address the access, affordability, and adherence challenges patients face is coming into sharper focus.

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A new generation of biotech leaders is emerging. Can they change how drug startups are built?

Bio Pharma Dive

Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies

Drugs 363
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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.

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He Slimed Me: FTC Hits GoodRx Over Unauthorized Use of Consumer Data

FDA Law Blog

By Jeffrey N. Wasserstein — GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace.

Radiology 105
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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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Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license

Fierce Pharma

Moderna pays US government $400M 'catch-up payment' under new COVID-19 vaccine license esagonowsky Fri, 02/24/2023 - 09:18

Licensing 145
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Digital natives: are pharma companies ready?

Pharma Phorum

Engaging digitally native healthcare professionals requires companies to challenge existing business ethos and commit to the customer experience in an increasingly digital world. Life Sciences" HCP Digital

More Trending

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Pfizer begins plan to challenge Shingrix with an mRNA vaccine

Bio Pharma Dive

The pharma and partner BioNTech have kicked off the first human trial of a messenger RNA shot for shingles, believing there’s room to clear the high bar set by GSK’s rival vaccine

RNA 358
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The one-shot cervical cancer vaccine paradigm

Pharmaceutical Technology

On December 20, 2022, the World Health Organization (WHO) updated its recommendations for cervical cancer vaccines in a bid to boost vaccination coverage.

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Celebrating Black History Month 

Intouch Solutions

EVERSANA INTOUCH is once again celebrating Black History Month this February!

Nurses 98
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Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit

Fierce Pharma

Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29

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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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Pharma Marketers Need AI Now: How to deliver a truly personalized, omnichannel experience for your patients, with William Grambley, CEO of Allazo Health

Pharma Marketing Network

Marketing in the era of consumer-driven healthcare requires new tools and techniques. If you want patients to initiate therapy, you need to connect across more channels, more personally, and in the ways consumers prefer to be engaged.

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So Much More than Just Paperwork – The Importance of Design Controls for Device Start-ups

FDA Law Blog

By Adrienne R. Lenz, Principal Medical Device Regulation Expert — For medical device start-up companies, understanding and successfully navigating applicable FDA regulations and requirements is an important part of the path to market.

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Biotech startup Structure pulls off rare IPO, raising $161M

Bio Pharma Dive

The company’s lead drug could be an oral alternative to marketed diabetes and obesity drugs from Novo Nordisk and Eli Lilly

Drugs 360
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Is the microbiome therapy hype up for a reckoning?

Pharmaceutical Technology

In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream.

Bacteria 278
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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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CSL’s first gene therapy for haemophilia B approved

Pharma Times

Boost for effected patients as HEMGENIX receives green light from European Commission

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FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv

Fierce Pharma

FDA turns down Cytokinetics’ once-promising heart failure drug omecamtiv kdunleavy Tue, 02/28/2023 - 18:55

Drugs 139
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Hemab raises $135m in Series B cash to treat genetic bleeding disorders

BioPharma Reporter

The Danish-US biotech Hemab Therapeutics bags $135m to finance the clinical development of prophylactic treatments for genetic bleeding disorders including Glanzmann thrombasthenia and von Willebrand disease. Bio Developments

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Eight essential steps for patient engagement, recruitment and retention

Outsourcing Pharma

Patient engagement, recruitment and retention are critical to achieving a successful clinical trial. Patient centricity

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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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FDA to convene advisers on review of RSV vaccines from GSK, Pfizer

Bio Pharma Dive

The agency is currently assessing applications filed by the two companies for what they hope will become the first vaccines against the virus in older adults

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Biohacking is a response to societal problems, but is not the answer

Pharmaceutical Technology

Biohacking is a do-it-yourself biology movement that aims to improve the hacker’s health, appearance, performance, and overall well-being.

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Sangamo’s ST-920 demonstrates evidence of clinical benefit

Pharma Times

Phase 1/2 research shows that treatment could be very effective against Fabry disease

Research 131
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J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries

Fierce Pharma

J&J's pharma group quietly works through global overhaul, with layoffs expected to reach multiple countries mbayer Fri, 02/03/2023 - 09:29

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Forxiga approved in the EU for the treatment of symptomatic chronic heart failure

The Pharma Data

First and only heart failure therapy with proven mortality benefit across the full ejection fraction range Forxiga (dapagliflozin) has been approved in the European Union to extend the indication for heart failure (HF) with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF), including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).

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After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS

BioSpace

After Historic Hemophilia B Approval, uniQure Targets Huntington’s and ALS 2/27/2023

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New cancer cell therapy biotech emerges, backed by MD Anderson and Replay

Bio Pharma Dive

Syena will develop TCR-based natural killer cell therapies, building on research done by MD Anderson’s Katy Revzani and using technology from Replay

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GenScript ProBio and RVAC partner for Covid-19 vaccine pDNA

Pharmaceutical Technology

GenScript ProBio has announced a strategic collaboration with RVAC Medicines to manufacture GMP-grade plasmid DNA (pDNA) for the latter’s RVM-V001, an mRNA Covid-19 vaccine candidate. Under the agreement, GenScript ProBio will offer GMP plasmid manufacturing service for the RVM-V001 programme.

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Pfizer update Lyme disease vaccine candidate

Pharma Times

Research concerning candidate VLA15 has been discontinued across certain trial sites

Trials 133
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GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg

Fierce Pharma

GSK was warned repeatedly about Zantac impurity but played down risks: Bloomberg esagonowsky Wed, 02/15/2023 - 09:02

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New machine-learning tech 'reads and interpret data like a PhD scientist'

Outsourcing Pharma

Scientists can now dramatically reduce trial-and-error experimentation and uncover risks early thanks to an artificial intelligence solutions company. Clinical Development

Trials 111
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BioSpace Layoff Tracker 2023: Grifols, Frequency, Eliem and More Cut Staff

BioSpace

BioSpace Layoff Tracker 2023: Grifols, Frequency, Eliem and More Cut Staff 2/16/2023

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Apellis wins FDA approval of first drug for type of vision loss

Bio Pharma Dive

Apellis’ Syfovre is the first marketed treatment for geographic atrophy, a common and irreversible eye condition. But questions linger about its benefit and safety

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HIV vaccines suffer setbacks but new approaches could turn the tide

Pharmaceutical Technology

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

Antibody 284
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Hope for Parkinson’s disease and Lewy body dementia patients

Pharma Times

Research into modified RNA messages could help treat diseases and develop new therapies

RNA 129