Bio Pharma Dive
AUGUST 21, 2023
Analysts expect the approval of Ingrezza in Huntington’s patients with a movement disorder known as chorea to intensify a commercial battle between Neurocrine and Teva.
Pharmaceutical Technology
AUGUST 21, 2023
The EC approved Janssen's Type II variation application for reduced dosing frequency of bispecific antibody TECVAYLI for multiple myeloma.
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Bio Pharma Dive
AUGUST 21, 2023
The Series B round brings the total funding for Genesis, a California startup backed by Andreessen Horowitz and Nvidia’s VC arm, to over $280 million.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 21, 2023
There is no denying the importance of sleep. Everyone feels better after a good night of sleep, and lack of sleep can have profoundly negative effects on both the body and the brain. So what can be done to substitute for a lack of sleep?
Bio Pharma Dive
AUGUST 21, 2023
The agency cleared high-dose Eylea less than two months after rejecting it, and approved a separate Regeneron drug for an ultra-rare disease as well.
Pharmaceutical Technology
AUGUST 21, 2023
The US Food and Drug Administration (FDA) has granted approval to Regeneron Pharmaceuticals’ EYLEA HD injection 8 mg.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 21, 2023
The company’s generative and predictive AI-powered drug discovery platform is already being used by Eli Lilly.
Bio Pharma Dive
AUGUST 21, 2023
The expanded approval follows the FDA’s May clearance of the shot, called Abrysvo, in older adults.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 21, 2023
In a move to strengthen the research and development (R&D) and innovation efforts of Indian pharma industry and academia, the Cabinet has approved the National Policy on Research & Development and Innovation in the Pharma-MedTech Sector and the Scheme for Promotion of Research and Innovation in Pharma-MedTech (PRIP).
Bio Pharma Dive
AUGUST 21, 2023
By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.
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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
Pharmaceutical Technology
AUGUST 21, 2023
AstraZeneca received China’s NMPA approval for Forxiga to cut the risk of cardiovascular mortality and hospital admission for heart failure.
Bio Pharma Dive
AUGUST 21, 2023
Uncover how PhilRx helped a women’s health brand achieve 91% patient enrollment and 5x refill adherence.
Pharmaceutical Technology
AUGUST 21, 2023
The FDA granted Calliditas a December priority review date for its IgA nephropathy drug Tarpeyo, which already has an accelerated approval.
Antidote
AUGUST 21, 2023
Before any new treatment is able to be approved, it is required to go through the vigorous testing process known as clinical trials. These trials are aimed at determining whether or not a drug, medical device, therapy, or other type of intervention is safe and effective for the public.
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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
Pharmaceutical Technology
AUGUST 21, 2023
The Phase III trial for Cabometyx and Tecentriq combination treatment met progression-free survival endpoint in metastatic prostate cancer.
Drug Patent Watch
AUGUST 21, 2023
Loss of exclusivity (LOE) doesn’t have to spell doom for branded drug revenue streams. In the face of impending patent expirations, pharmaceutical companies can adopt key approaches to preserve meaningful… The post Strategies to Maximize Product Value Amid Loss of Exclusivity in the Pharmaceutical Industry appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Technology
AUGUST 21, 2023
The European Medicines Agency granted orphan designation for Alligator Bioscience’s mitazalimab to treat patients with pancreatic cancer.
XTalks
AUGUST 21, 2023
The US Food and Drug Administration (FDA) has approved Ipsen’s groundbreaking Sohonos (palovarotene) capsules for the treatment of fibrodysplasia ossificans progressive (FOP), an ultra-rare bone disease. This approval marks a significant milestone as Sohonos becomes the singular treatment for individuals afflicted by FOP, which causes abnormal bone growth.
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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.
Pharmaceutical Technology
AUGUST 21, 2023
The medical device manufacturer has returned to pre-pandemic levels of M&A spend, reflecting a trend in the broader market.
Drug Discovery World
AUGUST 21, 2023
Talus Bio has received $4.3 million in new grants from the National Institutes for Health (NIH) and the Washington State Andy Hill CARE Fund to advance its paediatric cancer therapeutics. The Seattle-based company received two grants totalling $2.3M from the CARE Fund to fuel the discovery of new transcription factor inhibitors for rhabdomyosarcoma and neuroblastoma, two childhood cancers.
Pharmaceutical Technology
AUGUST 21, 2023
The medical device manufacturer has returned to pre-pandemic levels of M&A spend, reflecting a trend in the broader market.
XTalks
AUGUST 21, 2023
Tebra, a frontrunner in the medical practice management industry and a provider of practice automation solutions for autonomous healthcare providers, has unveiled its latest initiative: The Intake. This comprehensive, free online platform is meticulously designed to empower and fortify independent healthcare practices, facilitating their prosperity.
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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
AUGUST 21, 2023
Experts in Europe detail the challenge with current cancer drug shortages and how regulators are trying to abate the scarcity.
Outsourcing Pharma
AUGUST 21, 2023
The US Food and Drug Administration (FDA) has given orphan drug designation (ODD) to Redxâs Zelasudil for the potential treatment of idiopathic pulmonary fibrosis (IPF).
Pharmaceutical Technology
AUGUST 21, 2023
With probiotics gaining popularity, the ability to process dried, concentrated cultures into a powder is essential.
Fierce Pharma
AUGUST 21, 2023
Regeneron pulled off a rare double play on Friday afternoon as it scored two FDA approvals—one under the radar and the other highly anticipated. | With the FDA signing off on Regeneron and Bayer’s high-dose Eylea, the companies are set to take on Roche’s Vabysmo in a high-stakes battle for the massive eye disease 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.
Pharmaceutical Technology
AUGUST 21, 2023
The monoclonal antibody is the first to be approved for both adult and paediatric patients with CHAPLE disease.
BioPharma Reporter
AUGUST 21, 2023
Throughout 2023, the life sciences industry has been faced with many operational issues, including supply-chain uncertainty, inflation, and talent shortages.
BioSpace
AUGUST 21, 2023
The FDA on Monday gave the greenlight to Pfizer’s RSV vaccine for expectant mothers, given during the third trimester of pregnancy, designed to protect newborn babies through the first six months of life.
Fierce Pharma
AUGUST 21, 2023
First came doubts about the combinability of Amgen’s Lumakras with a standard PD-1 inhibitor. | The FDA will hold an advisory committee meeting to discuss confirmatory trial data for Amgen's Lumakras in KRAS-mutated lung cancer. This comes after a bumpy stretch for the medicine since its debut in 2021.
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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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