Fierce Pharma
JUNE 14, 2023
Sanofi is jumping on the artificial intelligence boat with a new app and a pledge to become “the first pharma company powered by artificial intelligence at scale.” | Sanofi's new app, plai, provides teams with a “360° view" to aid decision-making. The platform is one step in the company's digital transformation and goal to become the "first pharma powered by AI at scale.
MedCity News
JUNE 14, 2023
Hospitals’ digital health adoption exploded during the pandemic, leading to many vendor contracts spanning three to five years. As these contracts reach their expiration dates over this year and next, a new report predicts that telemedicine platforms and remote patient monitoring tools face the highest risk of being turned over by hospitals.
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Fierce Pharma
JUNE 14, 2023
An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout o | An FTC lawsuit aimed at blocking Amgen’s $27.8 billion buyout of Horizon Therapeutics has raised concerns that the United States’ antitrust watchdog is tightening the screws on major M&A moves in the biopharma industry. A month later, according to an SEC filing, Pfizer has withdrawn its notification for its proposed $43 billion acquisition of cancer drug specialist Seagen and will submit another later in the day.
Pharmaceutical Commerce
JUNE 14, 2023
In this latest Harvard Business School Healthcare Alumni Association Q&A, Susan Wilner Golden, DSC, lecturer at the Stanford Graduate School of Business, reveals an untapped $22 trillion global opportunity for all companies and others supporting healthy aging and longer life spans.
MedCity News
JUNE 14, 2023
While the U.S. did very well on the scientific front of Covid-19 with the production of vaccines, it needs to improve on the public health front, said Dr. Anthony Fauci, former director of the National Institute of Allergy and Infectious Diseases. He made these comments Tuesday at the AHIP 2023 conference in Portland.
Pharmaceutical Technology
JUNE 14, 2023
The US Food and Drug Administration (FDA) has granted fast track designation for CellCentric’s inobrodib (CCS1477) to treat relapsed or refractory multiple myeloma patients. Inobrodib is an oral first-in-class cancer drug, indicated for patients who have previously received four or more lines of therapy, including an anti-CD38 monoclonal antibody, an immunomodulatory agent and a proteasome inhibitor.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
PharmaTimes
JUNE 14, 2023
Find out more about the PharmaTimes Communications Awards 2023 – key dates, categories and which charity we have partnered with this year!
MedCity News
JUNE 14, 2023
2seventy Bio reported that an acute myeloid leukemia patient treated with its experimental cell therapy has died, prompting research partner Seattle Children’s Research Institute to pause the Phase 1 study. The FDA has been notified and an investigation is underway.
Pharmaceutical Commerce
JUNE 14, 2023
Changes to 3PL’s facility feature newly-converted controlled room temperature pallets.
MedCity News
JUNE 14, 2023
Cala Health recently launched its kIQ system — which it calls the first noninvasive wearable device cleared by the FDA to temporarily relieve tremors in people with essential tremor and Parkinson’s disease.
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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.
PharmaTimes
JUNE 14, 2023
Preliminary data has shown excellent safety, while also demonstrating proof of mechanism - News - PharmaTimes
PharmaVoice
JUNE 14, 2023
The big pharma patent cliff is almost here — and could change the face of the industry. Here’s a look at the key stats behind the coming wave of blockbuster losses.
PharmaTimes
JUNE 14, 2023
Gilead will present real-world data on its efforts to advance WHO’s aim of eliminating viral hepatitis - News - PharmaTimes
Scott’s Directories
JUNE 14, 2023
In the world of healthcare professionals, access to accurate and comprehensive information is crucial for both individuals seeking medical assistance and professionals looking to connect with their peers. Canada’s healthcare landscape is vast, and navigating through it can be a daunting task. However, with the advent of MD Select’s Canadian Medical Directory, finding a list of doctors in New Brunswick has become easier than ever.
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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
PharmExec
JUNE 14, 2023
Christon Hill, chief innovation officer, SERB Pharmaceuticals, reveals the demand for antidotes, the process of financial backing, administration needs, as well as antidotes the company is working on, including antidotes for toxins, infectious diseases, biological agents, and drug toxicities.
European Pharmaceutical Review
JUNE 14, 2023
To be a superpower globally, the UK life sciences sector must not only discover and develop medicines of the future domestically, but also manufacture a significant share in the country too, according to a new report from the Medicines Manufacturing Industry Partnership (MMIP). The “UK’s life sciences sector has tremendous potential to drive significant growth.
Pharmaceutical Technology
JUNE 14, 2023
The European Patent Office (EPO) has issued an intention to grant a patent for Vistagen’s new PH80 nasal spray to treat migraine. The patent’s claims also include treatment given at the onset of migraine symptoms as well as the treatment of migraines associated with traumatic brain injury. The patent will remain active until at least 2040. PH80 is a first-in-class, rapid-onset nasal spray designed to be used in a similar way to a rescue asthma inhaler.
European Pharmaceutical Review
JUNE 14, 2023
A report has stated that the pharmaceutical sterility testing market is expected to grow in value from $0.636 billion in 2023 to $1.0223 billion by 2032. The rising importance of quality and sterility in the pharmaceutical sterility testing market is anticipated as a main driving factor, in addition to government investment and new drugs entering the market.
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Pharmaceutical Technology
JUNE 14, 2023
The US Food and Drug Administration (FDA) has granted qualified infectious disease product (QIDP) and fast track designations for Eagle Pharmaceuticals’ CAL02. The QIDP designation has been granted under the Generating Antibiotic Incentives Now (GAIN) Act. Eagle expects to obtain eight to ten years of regulatory exclusivity for the therapy with QIDP, upon receipt of its new drug application approval.
Pharma Leaders
JUNE 14, 2023
Eupraxia Pharmaceuticals has received Fast Track designation from the US Food and Drug Administration (FDA) for EP-104IAR to treat osteoarthritis of the knee in adult patients. EP-104IAR has been designed for meeting the market demand for long-lasting disease relief in many indications and gain benefit from highly localised and longer delivery of corticosteroids.
Pharmaceutical Technology
JUNE 14, 2023
The Council of the EU has adopted recommendations proposed by the European Commission (EC) to combat antimicrobial resistance (AMR), setting targets for reduced antimicrobial use and increased surveillance. The recommendations to combat AMR propose that there should be a 20% reduction in the total human consumption of antibiotics by 2030 alongside an even larger pushback against their use in animals, per the 13 June announcement.
Legacy MEDSearch
JUNE 14, 2023
Surmodics, Inc. (Nasdaq: SRDX), a leading provider of medical device and in vitro diagnostic technologies, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (Low Profile) Thrombectomy System. Introduced in 2021, the Pounce Thrombectomy System is intended for the non-surgical removal of thrombi and emboli from the peripheral arterial vasculature in vessels 3.5 mm to 6 mm in diameter.
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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.
Pharmaceutical Technology
JUNE 14, 2023
Blue Water Biotech has expanded its commercial portfolio with the purchase agreement of six assets from WraSer. The agreement includes an $8.5m cash payment and the offering of one million restricted shares. Blue Water’s deal includes treatments across cardiology, otic infections, and pain management indications and will see Zontivity (vorapaxar), Trezix (acetaminophen-caffeine-dihydrocodeine), Nalfon (fenoprofen calcium), Conjupri (levamlodipine), Otovel (ciprofloxacin and fluocinolone acetonid
PharmExec
JUNE 14, 2023
Expansion expected to create additional production capacity, company says.
Pharmaceutical Technology
JUNE 14, 2023
Senju Pharmaceutical and Novaliq have closed a licence agreement for NOV03 (perfluorohexyloctane ophthalmic solution) to treat dry eye disease in Japan. The agreement covers rights for the development, manufacture and commercialisation of NOV03 in the country. NOV03 is the first and only water-free and preservative-free prescription treatment for dry eye disease, and targets the evaporation of tears by forming a monolayer at the tear film’s air-liquid interface.
PharmaVoice
JUNE 14, 2023
The first-time CEO discusses the lessons she has learned since taking the role last year and how she’s pivoting the company into a commercial entity.
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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
Pharmaceutical Technology
JUNE 14, 2023
China’s National Medical Products Administration (NMPA) has granted approval for AstraZeneca’s Soliris (eculizumab) to treat refractory generalised myasthenia gravis (gMG) in adult patients. Soliris is a first-in-class C5 complement inhibitor indicated for patients who are anti-acetylcholine receptor (AChR) antibody-positive. It inhibits the C5 protein in the terminal complement cascade, part of the body’s immune system.
PharmaTech
JUNE 14, 2023
The deal, valued at more than $2 billion dollars, will see Quell Therapeutics develop various T-regulatory cell therapies for AstraZeneca.
Pharmaceutical Technology
JUNE 14, 2023
Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS). Bylvay is a once-a-day, non-systemic ileal bile acid transport inhibitor (IBATi) that acts locally in the small intestine and has minimal systemic exposure.
Pharmacy Times
JUNE 14, 2023
Pharmacogenomics is gaining support in mental health and polypharmacy, where the data make a strong case for improvements in clinical and economic outcomes.
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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.
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