Bio Pharma Dive
JUNE 26, 2024
The findings provide early proof that multiple doses of a gene editing medicine can be safely administered with additive effects, overcoming a key constraint of the complex therapies.
Pharmaceutical Technology
JUNE 26, 2024
AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).
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Bio Pharma Dive
JUNE 26, 2024
Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2024
Moods and emotions play an important role in our day-to-day life. They even influence how we experience things – for instance, whether we start the day feeling hopeful and energised or grumpy and lethargic. This can affect whether we interpret events in a positive or negative light.
Bio Pharma Dive
JUNE 26, 2024
The failure of a Phase 3 trial led the Wegovy maker to take an accounting charge that will hit its operating profit growth this year.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 26, 2024
The Tamil Nadu government has appointed the incumbent controlling authority (CA) of the drugs control administration, M N Sridhar, as state licensing and controlling authority (SLA and CA) for the department of drugs control from June 18 onwards.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
JUNE 26, 2024
Zealand capitalized on a stock surge following the release of early study results. Elsewhere, U.S. regulators rejected an AbbVie medicine and another well-funded AI drug discovery startup emerged.
Pharmaceutical Technology
JUNE 26, 2024
The collaboration is intended to leverage OpenAI's generative AI-based platform to invent novel antimicrobials to treat drug-resistant pathogens.
Fierce Pharma
JUNE 26, 2024
In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.
Pharmaceutical Technology
JUNE 26, 2024
The China National Medical Products Administration (NMPA) has granted marketing approval for Simcere Zaiming’s Enlituo for the treatment of metastatic colorectal cancer (mCRC).
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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
Bio Pharma Dive
JUNE 26, 2024
The decades-long story of how a novel type of blood cancer drug went from a scientific idea to an approved product.
Pharmaceutical Technology
JUNE 26, 2024
The US Food and Drug Administration (FDA) has granted Fast Track designation for Carisma Therapeutics’ CT-0525 for the treatment of solid tumours overexpressing human epidermal growth factor receptor 2 (HER2).
pharmaphorum
JUNE 26, 2024
Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.
Pharmaceutical Technology
JUNE 26, 2024
In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.
Fierce Pharma
JUNE 26, 2024
Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.
Pharmaceutical Technology
JUNE 26, 2024
From Pfizer’s Seagen acquisition to Sanofi’s deal with Provention Bio, Pharmaceutical Technology lists the highest value pharma deals that were completed in 2023.
pharmaphorum
JUNE 26, 2024
Take part in the pharmaphorum reader survey 2024 and share your views on the latest trends and developments in the pharmaceutical industry. Your input helps us tailor our publication to meet your needs.
Pharmaceutical Technology
JUNE 26, 2024
The US FDA has issued a complete response letter (CRL) for AbbVie’s NDA for ABBV-951 in adult patients with advanced Parkinson's disease.
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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.
Drug Patent Watch
JUNE 26, 2024
This is an example from the DrugPatentWatch AI Research Assistant, which is available with DrugPatentWatch subscriptions. The DrugPatentWatch AI Research Assistantuses sophisticated AI algorithms to understand and process your questions, delivering precise answers. It goes beyond simple keyword matching, comprehending the intent and context of questions to provide meaningful and relevant responses.
Pharmaceutical Technology
JUNE 26, 2024
In the US, an initiative to cap the monthly cost of asthma inhalers at $35 marks a development in healthcare affordability and accessibility.
Drug Patent Watch
JUNE 26, 2024
Introduction In the rapidly evolving landscape of pharmaceutical patent disputes in China, injunctive relief has emerged as a critical tool for patent holders. This legal remedy, which aims to halt infringement activities swiftly, plays a pivotal role in protecting intellectual property (IP) rights and fostering innovation.
Pharmaceutical Technology
JUNE 26, 2024
Electronic clinical outcome assessment (eCOA) solutions are vital for sponsors to capture, manage, and utilize growing volumes of data.
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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
Fierce Pharma
JUNE 26, 2024
The respiratory syncytial virus (RSV) vaccine showdown already saw a shakeup last month with a new competitor in Moderna’s mRESVIA. | The vaccines are now recommended for adults aged 75 years and older and those aged 60 to 74 with a higher risk of severe disease. Previously, all adults aged 60 and older were advised for vaccination.
Pharmaceutical Technology
JUNE 26, 2024
The EU regulatory agency states that the shortages are due to higher demand and off-label use of GLP-1 receptor agonists.
FDA Law Blog
JUNE 26, 2024
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.
Pharmaceutical Technology
JUNE 26, 2024
Sharp Services announces expansion in Pennsylvania to facilitate growth in sterile injectable market
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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.
Fierce Pharma
JUNE 26, 2024
The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years. | Amarin is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish oil-derived heart med in the lower courts. But the legal development comes after a patent loss on Vascepa eviscerated its U.S. business.
XTalks
JUNE 26, 2024
In this episode, Ayesha spoke with Alessio Travaglia, PhD, Director Neuroscience at the Foundation for the National Institutes of Health (FNIH) who also manages FNIH’s new Accelerating Medicines Partnership in Amyotrophic Lateral Sclerosis (AMP ALS) program, and Nadia Sethi, DDS, an ALS patient advocate who formerly served as Director of Community Outreach and Engagement at the ALS Therapy Development Institute.
pharmaphorum
JUNE 26, 2024
AI in drug discovery start-up EvolutionaryScale raises $142m in seed financing for its LLM-powered platform for designing protein structures.
XTalks
JUNE 26, 2024
The US Food and Drug Administration (FDA) recently approved Botanix Pharmaceuticals’ New Drug Application (NDA) for Sofdra (sofpironium) topical gel, 12.45 percent. This marks a significant milestone as Sofdra is the first and only new chemical entity approved for the treatment of primary axillary hyperhidrosis, a condition characterized by excessive underarm sweating.
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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.
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