Fri.Sep 15, 2023

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SparingVision shares trial updates for rare eye disease gene therapies

Pharmaceutical Technology

The company is also planning to expand its Phase I/II PRODYGY lead candidate trial in retinitis pigmentosa to three more US sites.

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FTC takes aim at pharma patent tactics used to block generics

Bio Pharma Dive

The antitrust regulator is examining what it describes as abuse of the FDA “Orange Book” — another step in its scrutiny of pharma business practices.

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Cure Genetics and Frametact seek gene cures for neurological ailments

Pharmaceutical Technology

Cure Genetics has entered a partnership and licensing deal with Frametact to develop gene therapy for familial neurological ailments.

Genetics 246
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J&J to phase out Janssen name in corporate rebrand

Bio Pharma Dive

Janssen will be recast as Johnson & Johnson Innovative Medicine, melding the drugs division’s identity more closely with its parent.

Medicine 161
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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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NICE recommends Idorsia’s chronic insomnia treatment for UK patients

Pharmaceutical Technology

The therapy will be available to patients who have insomnia multiple times a week, do not respond to CBTi, and whose wakeful day is severely impacted.

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J&J, GSK and other companies knowingly marketed ineffective decongestants, lawsuits claim

Fierce Pharma

Questions first circulated about decongestant pills containing phenylephrine in 2007. | Several companies, including Johnson & Johnson, GSK, Procter & Gamble and Walgreens, face class-action lawsuits that claim the drugmakers knew that over-the-counter cold and flu pills containing phenylephrine did not work as advertised.

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Advanced Therapies Europe: From bench to bedside and boardroom

Drug Discovery World

Advanced Therapies Europe took place from 9-12 September 2023 in Portugal. DDW’s Megan Thomas asked attendees: What is most important to scale from discovery to commercialisation of cell and gene therapies (CGTs)? Joel Eichmann, Co-Founder, Green Elephant Biotech It always comes down to time-to-market and risk minimisation. To cover these, it is critical to choose [.

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Charles River and Related Sciences partner for AI drug platform

Pharmaceutical Technology

Charles River has signed a multi-programme collaboration agreement with Related Sciences (RS) for the AI-powered drug platform, Logica.

Drugs 147
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Gilead-backed Lyndra Therapeutics cuts nearly a quarter of staff as ph. 3 data nears

Fierce Pharma

Lyndra Therapeutics is laying off roughly 23% of its staff, two months after the company swapped out longtime CEO Patricia Hurter, Ph.D., and as a pivotal trial for a long-acting, oral schizophreni | Lyndra Therapeutics is laying off staff two months after a CEO swap and as interim data from a pivotal trial for a schizophrenia drug nears. The company's lead asset is a long-acting, oral version of Johnson & Johnson's Uzedy.

Trials 111
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EMA CHMP recommends approval for Moderna’s updated Covid-19 vaccine

Pharmaceutical Technology

The EMA CHMP has recommended granting marketing authorisation for Moderna’s updated Covid-19 vaccine targetting XBB.1.5 sublineage.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Bayer CEO plots management cuts as first step in larger overhaul: Reuters

Fierce Pharma

Just a few months into Bill Anderson's tenure as Bayer's CEO, the helmsman is reportedly looking to trim the drugmaker's management ranks. | The CEO is eying some big changes, but he wants to show investors he's prepared to act swiftly, Reuters reports. The publication cited three people "familiar with the matter" in reporting the behind-the-scenes developments at Bayer.

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Remote Patient Monitoring market will reach $760m by 2030

Pharmaceutical Technology

A new report found that the Remote Patient Monitoring (RPM) sector will grow, since the pandemic revealed the benefits of remote healthcare.

Marketing 130
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Astellas to invest over €330m in a new facility in Ireland

Pharma Times

The site will contribute to the development and commercialisation of antibody drugs - News - PharmaTimes

Antibody 141
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Signal: Danaher’s $5.7bn acquisition of Abcam faces stand-off with founder

Pharmaceutical Technology

Abcam founder Jonathan Milner has declared his intention to vote against the acquisition of the company in which he holds a large stake.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Bristol Myers banks on 25-plus label expansions to help weather IRA, Revlimid generics and more

Fierce Pharma

With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of | With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of weighty patent losses.

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argenx wins EMA CHMP nod for subcutaneous Vyvgart in myasthenia gravis

Pharmaceutical Technology

The positive opinion relied on a comparator study that showed the subcutaneous version was non-inferior to the intravenous one.

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MIT’s new technique to remotely evaluate cerebral palsy patients

Pharma Times

The method could also be beneficial for Parkinson’s disease and strokes - News - PharmaTimes

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Market cap rebound by top 20 biopharmaceutical companies in Q2 2023

Pharmaceutical Technology

Market capitalisation increased by a total of 2.3% from $3.49tn in Q1 2023 to $3.56tn in Q2 2023, according to GlobalData.

Marketing 130
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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After FDA setback, PTC Therapeutics' DMD drug Translarna faces possible market withdrawal in Europe

Fierce Pharma

A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review. | A “surprised and extremely disappointed” PTC Therapeutics is scrambling to keep its Duchenne muscular dystrophy therapy Translarna on the European market after a detrimental review.

Marketing 106
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Generate:Biomedicines secures $273m to advance therapeutic portfolio 

Pharmaceutical Technology

Generate:Biomedicines has secured $273m in Series C financing round to expedite its generative AI therapeutics portfolio.

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FTC fires shot across pharma's bows over 'improper' patents

pharmaphorum

FTC fires shot across pharma's bows over 'improper' patents Phil.

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Iovance’s PDUFA date for lifileucel pushed due to FDA backlog

Pharmaceutical Technology

The FDA pushed lifileucel’s PDUFA date from November this year to 24 February 2024 citing resource constraints.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Scientists find elusive cause of cell death in Alzheimer's

pharmaphorum

Scientists find elusive cause of cell death in Alzheimer's Phil.

Scientist 129
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Pelican Appoints New CEO

Pharmaceutical Commerce

Protective case manufacturer hires James Curleigh, as company prepares to further innovation and expand.

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Driving data & analytics transformation in life sciences

pharmaphorum

Driving data & analytics transformation in life sciences Mike.

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How Payers Are Reacting to Insulin Price Changes

Drug Channels

Today’s guest post comes from Nicole Mayer, Senior Analyst at MMIT. Nicole summarizes MMIT’s research on payers’ views of two crucial market changes: (1) the Inflation Reduction Act of 2022’s requirement to cap insulin prices at $35 for Medicare beneficiaries, and (2) manufacturers’ reduction in list prices for certain insulin products. She also discusses MMIT’s research on such glucagon-like peptide 1 (GLP-1) drugs as Ozempic and Mounjaro.

Insulin 71
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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FDA capacity forces delay to Iovance's cell therapy

pharmaphorum

FDA capacity forces delay to Iovance's cell therapy Phil.

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HP&M’s Faraz Siddiqui to Speak at Informa’s Medicaid Drug Rebate Program (MDRP) Summit 2023 on Value Based Programs

FDA Law Blog

On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. This three-day summit will feature numerous presentations, workshops and networking opportunities featuring government officials, drug pricing and reimbursement lawyers and experts and industry leaders.

Drugs 64
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Double IPOs headline this week's biotech financings

pharmaphorum

Double IPOs headline this week's biotech financings Phil.

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New patent for Neurocrine drug INGREZZA

Drug Patent Watch

Annual Drug Patent Expirations for INGREZZA Ingrezza is a drug marketed by Neurocrine and is included in one NDA. It is available from one supplier. There are twenty patents protecting… The post New patent for Neurocrine drug INGREZZA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.