PM360

MAY 25, 2023

ChatGPT is poised to revolutionize the pharmaceutical industry by providing innovative communication and marketing strategies. With the assistance of AI tools, pharma marketers can develop personalized sales messages and educational content, improving their engagement with healthcare providers and equipping them to deliver better patient care. ChatGPT’s natural language processing (NLP) technology enables human-like conversations combined with the analysis of vast quantities of data, allowing ph

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PharmExec

MAY 22, 2023

The market for prescription medicines in the United States was subject to major shifts in use across therapeutic areas in 2022, reflecting changes in patient health needs, the development, and availability of novel medicines, and complex market dynamics.

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Fierce Pharma

MAY 26, 2023

Johnson & Johnson cites rebates and discounts for drug price increases kdunleavy Fri, 05/26/2023 - 07:36

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MedCity News

MAY 25, 2023

It’s clear that services like telehealth and remote patient monitoring have potential to provide value within the healthcare industry, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce in order to earn reimbursement, panelists argued during MedCity’s INVEST conference.

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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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Nixon Gwilt Law

MAY 26, 2023

As a law firm focused specifically on healthcare innovation, we get really excited about developing areas of the healthcare industry. One area we are particularly excited about? Virtual Reality. Providers are already integrating Virtual Reality ( VR ) into patient care in a variety of ways. For example, using VR to gamify physical therapy exercises for pediatric patients to keep them engaged in their treatment, or to provide targeted exposure therapy in a controlled environment for patients with

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Clarivate

MAY 22, 2023

From self-driving cars to ChatGPT and Amazon Bedrock, the world is quickly waking up to the enormous potential for artificial intelligence (AI) to change our world. Much discussion has focused on whether this will ultimately be for better or worse; but as with any seismic shift in technology, the answer will depend on how we choose to engage with and deploy the new tools.

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MedCity News

MAY 23, 2023

A panel during the MedCity News INVEST conference discussed what digital health technologies need to do to demonstrate return on investment for payers, providers, and other stakeholders.

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European Pharmaceutical Review

MAY 23, 2023

New research by IQVIA and recently published in the 2023 Swiss Biotech Report shows that 20 percent of European biotech companies are now headquartered in Switzerland. Sixty three out of a total of 265 companies settling in Switzerland were biotechs. This makes it the second most important sector after ICT, the research found. 2022 statistics by the Swiss federal government confirm that the trend to base here is continuing.

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Pharmaceutical Technology

MAY 22, 2023

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted an investigational new drug application (IND) for SinoMab BioScience’s SM17 to treat asthma. SM17 is a humanised IgG4-k monoclonal antibody that targets IL-17RB to treat asthma, idiopathic pulmonary fibrosis (IPF), atopic dermatitis (AD) and other immunological disorders.

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Fierce Pharma

MAY 22, 2023

Pfizer, Moderna among many biopharma giants to post Q1 sales declines, as Novo Nordisk led growth charge kdunleavy Mon, 05/22/2023 - 13:04

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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.

Safety

MedCity News

MAY 25, 2023

Paxlovid, a Pfizer antiviral awarded FDA emergency authorization in 2021 for treating Covid-19, is now approved for treating adults. Results from a pivotal clinical showed that Paxlovid led to an 86% reduction in Covid-19-related hospitalization or death from any cause compared to a placebo.

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PM360

MAY 25, 2023

The world is full of tradeoffs—it’s the way progress is made while proportionately managing risk. When it comes to decentralized clinical trials (DCTs), arguably the most transformative innovation clinical research has seen in decades, the same is true. The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption.

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Pharmaceutical Technology

MAY 26, 2023

The US Food and Drug Administration (FDA) has granted priority review for Takeda and HUTCHMED’s new drug application (NDA) for fruquintinib. Fruquintinib is a selective and potent oral VEGFR -1, -2 and -3 receptors inhibitor and is used for the treatment of adults with previously treated metastatic colorectal cancer. Fruquintinib will be the first and only highly selective inhibitor of these receptors approved in the US.

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Fierce Pharma

MAY 25, 2023

Johnson & Johnson takes another step in CAR-T race with Bristol Myers in multiple myeloma kdunleavy Thu, 05/25/2023 - 10:52

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Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

MedCity News

MAY 26, 2023

Although there is uncertainty and risk, the implementation of AI with the right compliance framework and infrastructure offers an exciting opportunity to transform healthcare into a new frontier with improved patient outcomes and increased efficiency.

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European Pharmaceutical Review

MAY 26, 2023

The UK Chancellor has announced a £650 million life sciences growth package (Life Sci for Growth) to help deliver the Science and Technology framework through reforming regulation, boosting investment and driving up talent and skills. Bringing together 10 different policies, the package includes: A total of £121 million to improve commercial clinical trials to bring new medicines to patients faster Up to £48 million of new money for scientific innovation to prepare for any future health emergenc

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Pharmaceutical Technology

MAY 26, 2023

The immuno-oncology market continues to evolve as treatments establish their presence across different types of cancer, having seen approvals in multiple indications in the past decade. While the market was worth over $6 billion in 2012, this has now grown to nearly $48 billion only a decade later, said Avigayil Chalk, PhD, GlobalData’s Senior Oncology and Haematology analyst, at an immuno-oncology webinar held on May 23.

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Fierce Pharma

MAY 22, 2023

Bayer's blockbuster hopeful Nubeqa, AstraZeneca's Forxiga pick up nods from England's NICE zbecker Mon, 05/22/2023 - 10:44

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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.

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MedCity News

MAY 22, 2023

NeuroFlow — a startup that provides behavioral health integration software — struck a new partnership with Atlantic Health System, which will be using the company’s technology across 16 ACO sites. The health system’s goals for the partnership are to expand access to behavioral health professionals, alleviate administrative burden among primary care practices and improve performance in its ACO’s value-based contracts.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older. The gene therapy is a topical gel that restores functional copies of the COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.

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Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. VYJUVEK is designed to address the underlying genetic cause of the disease. An excipient gel applied topically is a key component of the therapy, which is supplied by Krystal’s client, Berkshire Sterile Manufacturing (BSM).

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Fierce Pharma

MAY 24, 2023

Biopharma staffers exhausted and susceptible to burnout, report says kdunleavy Wed, 05/24/2023 - 16:52

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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.

Specialization

MedCity News

MAY 21, 2023

Krystal Biotech’s Vyjuvek is approved to treat recessive and dominant forms of dystrophic epidermolysis bullosa (DEB), a rare genetic skin disorder. The redosable gene therapy, applied to the skin, delivers a gene that gets cells to produce collagen that DEB patients lack.

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LEVO Health

MAY 23, 2023

In the dynamic world of healthcare marketing, understanding your audience and optimizing your strategies are key to staying ahead of the competition. Practices can use healthcare data analytics to gain insights that can transform their marketing efforts in the digital age. Data analytics is the process of collecting and analyzing data to make informed decisions.

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Pharmaceutical Technology

MAY 25, 2023

Appili Therapeutics has received a US patent for ATI-1501 , a liquid oral reformulation of metronidazole. The patent claims for ATI-1501 were published by the US patent and trademark office under US application no. 18/072,154, filed on 30 November 2022. It covers the composition and preparation methods for ATI-1501 until 2039. Metronidazole is a widely used frontline oral treatment for parasitic and anaerobic bacterial infections.

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Fierce Pharma

MAY 26, 2023

EU regulators recommend yanking authorization for Novartis' sickle cell med Adakveo after phase 3 miss zbecker Fri, 05/26/2023 - 10:48

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Safety

MedCity News

MAY 23, 2023

Yaniv Sneor, the co-founder of Mid Atlantic Bio Angels and part of the Ask the Investor sessions at MedCity INVEST this week, explained what his firm looks for in life science startups.

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PharmaTech

MAY 24, 2023

Process development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.

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Manufacturing 97

Pharmaceutical Technology

MAY 25, 2023

Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of its quadrivalent seasonal influenza vaccine, AdimFlu-S (QIS), in China. The China National Medical Products Administration approved AdimFlu-S (QIS) in January 2022 for individuals aged three years and above.

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Fierce Pharma

MAY 25, 2023

Apellis scraps pegcetacoplan development in ALS after phase 2 trial flop zbecker Thu, 05/25/2023 - 10:42

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Advertiser: ZoomInfo

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

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