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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Bio Pharma Dive

MAY 26, 2023

Investors struck deals worth $1.8 billion over the first three months of the year, down from $3.0 billion across the start of 2022.

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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 26, 2023

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

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Drugs 139

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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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Gene Therapy Gene FDA Approval Manufacturing 264

Pharma Times

MAY 26, 2023

Life Sciences Council meeting hosted by chancellor Jeremy Hunt has unfolded in Downing Street

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Life Science 129

Outsourcing Pharma

MAY 26, 2023

A drug that has the ability to âtransform the landscapeâ for people living with metastatic colorectal cancer (CRC) has been granted priority review by the US Food and Drug Administration (FDA).

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Pharmaceutical Technology

MAY 26, 2023

After earning multimillion dollar revenues while being an authorised preferred treatment for Covid-19, the US Food and Drug Administration (FDA) has granted a full approval to Pfizer’s oral antiviral Paxlovid (nirmatrelvir + ritonavir). The label is specified for the treatment of “mild-to-moderate Covid-19 in adults who are at high risk for progression to severe COVID-19, including hospitalisation or death.

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Intouch Solutions

MAY 26, 2023

Even as some of the effects of COVID-19 have begun to wane, it’s a challenging time to be a life-sciences sales representative. Survey after survey indicates that rep access remains a challenge. “No-see” policies, live-meeting reluctance from healthcare professionals (HCPs) and the time crunch HCPs face all represent barriers that reps must overcome.

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Sales Life Science Marketing Production 98

Pharmaceutical Technology

MAY 26, 2023

Daiichi Sankyo has received approval from Japan’s ministry of health, labour and welfare (MHLW) for VANFLYTA (quizartinib) to treat acute myeloid leukaemia (AML) patients who are positive for the FLT3-ITD mutation. The approval is based on the results of the placebo-controlled, randomised, double-blind, global Phase III QuANTUM-First trial of VANFLYTA in combination with standard cytarabine and anthracycline induction.

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

Clinical Trials

XTalks

MAY 26, 2023

Krystal Biotech’s Vyjuvek has been awarded US Food and Drug Administration (FDA) approval to make it the first topical gene therapy for the treatment of wounds in patients with the rare, often debilitating skin disease dystrophic epidermolysis bullosa (DEB). Vyjuvek is also the first drug approved to treat the disease and is Krystal’s first approved product.

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Gene Therapy Gene FDA Approval Dermatology 97

Pharmaceutical Technology

MAY 26, 2023

On 18 May 2023, the FDA announced the approval of Rinvoq (upadacitinib), AbbVie’s Janus kinase inhibitor (JAKi), to treat adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) blockers. The decision was based on data from two randomised induction trials, U-EXCEED (NCT03345836) and U-EXCEL (NCT03345849), and the subsequent maintenance study, U-ENDURE (NCT03345823).

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Pharma Times

MAY 26, 2023

Therapy has been developed for use among children and adolescents with growth hormone deficiency

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Pharmaceutical Technology

MAY 26, 2023

Pharma company merger and acquisition (M&A) activity in the first half of 2023 has remained relatively low, consistent with the second half of last year, but investors predict deals will increase later in 2023. Experts at PWC, Goldman Sachs, and Morgan Stanley agree that pharma-related M&A is expected to pick up in 2023. PWC predicts deal volumes to resemble prior years with the effect of the US Inflation Reduction Act on pricing better understood and less uncertainty surrounding busines

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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

Clinical Research

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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Pharmaceutical Technology

MAY 26, 2023

The European Medicines Agency (EMA) has accepted two marketing authorisation applications (MAA) from Sandoz for the proposed biosimilar denosumab. The MAAs include all indications covered by the Xgeva (denosumab) and Prolia (denosumab) reference medicines to treat conditions such as osteoporosis in postmenopausal women. Other conditions include the prevention of skeletal-related complications in cancer that has spread to the bones, as well as treatment-induced bone loss.

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Fierce Pharma

MAY 26, 2023

While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China kdunleavy Fri, 05/26/2023 - 10:03

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Vaccination Vaccine 90

Pharmaceutical Technology

MAY 26, 2023

Applied Therapeutics has received orphan medicinal product designation from the European Medicines Agency (EMA) for AT-007 (govorestat) to treat sorbitol dehydrogenase (SORD) deficiency, which is caused by a lack of the sorbitol dehydrogenase enzyme. The central nervous system (CNS) penetrant aldose reductase inhibitor (ARI) govorestat is being developed to treat many rare neurological diseases, including PMM2-CDG, galactosemia, and SORD deficiency.

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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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pharmaphorum

MAY 26, 2023

Elon Musk’s Neuralink says FDA has cleared human trial Phil.

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Pharmaceutical Technology

MAY 26, 2023

HanAll Biopharma and Daewoong Pharmaceutical have entered into a co-development deal with NurrOn Pharmaceuticals to develop therapy for Parkinson’s disease (PD) and other neurodegenerative disorders. HanAll Biopharma and Daewoong Pharmaceutical will combine their resources and knowledge to develop NurrOn’s ATH-399A and other compounds targeting Nurr1 [nuclear receptor-related 1 protein] to treat neurodegenerative disorders.

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Fierce Pharma

MAY 26, 2023

Gilead, Teva reach 11th-hour settlements with some groups in HIV antitrust case zbecker Fri, 05/26/2023 - 09:09

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pharmaphorum

MAY 26, 2023

Primary care a weak link in trials, says O’Shaughnessy Phil.

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Trials 93

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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.

Clinical Supply

Fierce Pharma

MAY 26, 2023

Fierce Pharma Asia—Carvykti's EU filing; Thermo Fisher's Singapore expansion; Celltrion's Humira biosim nod aliu Fri, 05/26/2023 - 08:43

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Crucial Data Soutions

MAY 26, 2023

If you are working in clinical trials in any capacity, you know the way we do studies has changed dramatically. The post The Power of One Unified and Comprehensive Data Platform for Clinical Trials appeared first on Crucial Data Solutions.

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Clinical Trials Clinical Trials Trials 52

The Pharma Data

MAY 26, 2023

Bolivia conducts a simulation exercise to strengthen the National Deployment and Vaccination Plan for influenza and other respiratory viruses As part of a series of twelve workshops to identify lessons learned from COVID-19 and to develop a pandemic preparedness plan for influenza and other respiratory viruses (ORVs), a simulation exercise in Bolivia was carried out using a board game to strengthen the deployment of pandemic products.

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Vaccination Vaccine Development Medicine 52

Crucial Data Soutions

MAY 26, 2023

Researchers know that we must all do more to make clinical trials more inclusive. Yes, legislators in the United States. The post Collecting Trial Data from Patients in Remote Areas – Choosing the Right Technologies appeared first on Crucial Data Solutions.

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Trials Clinical Trials Clinical Trials Research 52

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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

The Pharma Data

MAY 26, 2023

WHO urges governments to stop subsidizing life-threatening tobacco crops On World No Tobacco Day , WHO urges governments to stop subsidizing tobacco farming and support more sustainable crops that could feed millions. “Tobacco is responsible for 8 million deaths a year, yet governments across the world spend millions supporting tobacco farms,” said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.

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Protein 52

Drug Discovery World

MAY 26, 2023

News round-up for 22-26 May by DDW Digital Content Editor Diana Spencer. The theme of our news review this week is money. Although Clarivate has reported a recent drop in investment in the industry, it is good to see companies raising money through funding rounds and investing in new facilities, as well as government support coming through to boost research in areas of urgent need.

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The Pharma Data

MAY 26, 2023

More ways, to save more lives, for less money: World Health Assembly adopts more Best Buys to tackle noncommunicable diseases The World Health Organization has expanded the list of ‘NCD best buys’. The updated list was approved at the 76 th World Health Assembly, a move that will support governments to select lifesaving interventions and policies for the world’s biggest killers, noncommunicable diseases.

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Advarra

MAY 26, 2023

The Association of American Cancer Institutes (AACI) recently published a white paper titled Collaboration to Develop Recommendations to Improve Trial Activation Timelines. The paper highlighted findings from a 33-member task force made up of representatives from cancer centers, industry sponsors, and the National Cancer Institute (NCI). The task force focused on three main areas of study activation: contract negotiation, budget development, and trial start up committee reviews.

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Clinical Research Trials Research Development 52

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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.

Clinical Supply