Pharmaceutical Technology

SEPTEMBER 15, 2023

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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Gene Therapy Trials Gene 264

Bio Pharma Dive

SEPTEMBER 15, 2023

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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Regulation 176

Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Genetics Gene Gene Therapy Licensing 246

Bio Pharma Dive

SEPTEMBER 15, 2023

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

Medicine 167

Medicine Drugs 167

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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.

Clinical Trials

Pharmaceutical Technology

SEPTEMBER 15, 2023

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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Fierce Pharma

SEPTEMBER 15, 2023

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.

Containment 117

Containment Marketing 117

Drug Discovery World

SEPTEMBER 15, 2023

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 [.

Gene Therapy 115

Gene Therapy Gene Drugs Marketing 115

Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Drugs 147

Fierce Pharma

SEPTEMBER 15, 2023

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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Development 107

Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Vaccination Vaccine Marketing 147

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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.

Trials

Fierce Pharma

SEPTEMBER 15, 2023

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.

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Trials Drugs 106

Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Marketing 130

Pharma Times

SEPTEMBER 15, 2023

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

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Antibody Drugs Development 129

Pharmaceutical Technology

SEPTEMBER 15, 2023

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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Clinical Trials

Fierce Pharma

SEPTEMBER 15, 2023

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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Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Pharma Times

SEPTEMBER 15, 2023

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

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125

Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Marketing 130

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

Clinical Research

Fierce Pharma

SEPTEMBER 15, 2023

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.

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Marketing Drugs 93

Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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pharmaphorum

SEPTEMBER 15, 2023

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

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Pharmaceutical Technology

SEPTEMBER 15, 2023

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

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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

Clinical Trials

pharmaphorum

SEPTEMBER 15, 2023

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

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Scientist 129

Pharmaceutical Commerce

SEPTEMBER 15, 2023

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

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Manufacturing 105

Drug Channels

SEPTEMBER 15, 2023

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.

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Insulin Drugs Manufacturing Research 74

pharmaphorum

SEPTEMBER 15, 2023

Driving data & analytics transformation in life sciences Mike.

Life Science 122

Life Science 122

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

FDA Law Blog

SEPTEMBER 15, 2023

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.

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Drugs Regulation 64

pharmaphorum

SEPTEMBER 15, 2023

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

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Drug Patent Watch

SEPTEMBER 15, 2023

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

Drugs Marketing 59

pharmaphorum

SEPTEMBER 15, 2023

Double IPOs headline this week's biotech financings Phil.

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Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

Sales