Bio Pharma Dive
AUGUST 29, 2023
A broadened clearance for Reblozyl in myelodysplastic syndromes should help Bristol Myers offset the looming loss of revenue from top-selling medicines set to soon lose market exclusivity.
Pharmaceutical Technology
AUGUST 29, 2023
The clinical trials industry is facing a number of hurdles, but AI and digitalisation are being heralded as key to overcoming them, particularly when it comes to preparing for inspections and audits
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Bio Pharma Dive
AUGUST 29, 2023
The list includes the top-selling blood thinners Eliquis and Xarelto, as well as the arthritis drug Enbrel and heart failure medicine Entresto.
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 29, 2023
Analysis of human brain tissue reveals differences in how immune cells behave in the brains with Alzheimer’s disease compared to healthy brains, indicating a potential new treatment target.
Pharmaceutical Technology
AUGUST 29, 2023
On 21 August, the US Food and Drug Administration (FDA) announced that it had granted an orphan drug designation (ODD) to Redx’s zelasudil (RXC007), which is an oral, selective rho-associated coiled-coil containing a protein kinase 2 (ROCK2) inhibitor for the potential treatment of idiopathic pulmonary fibrosis (IPF).
AuroBlog - Aurous Healthcare Clinical Trials blog
AUGUST 29, 2023
India’s mental healthcare landscape paints a complex picture, rife with challenges. The persistence of age-old societal stigma surrounding mental health leads to underreporting and inadequate awareness, hindering effective intervention.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
AUGUST 29, 2023
The CDMO is adding four new independent directors to its board, and has set up a committee to review its business and capital allocation priorities.
Pharmaceutical Technology
AUGUST 29, 2023
Ipilimumab is under clinical development by Bristol-Myers Squibb and currently in Phase I for Metastatic Transitional (Urothelial) Tract Cancer.
Drug Discovery World
AUGUST 29, 2023
The pharmaceutical industry continues to maintain strong levels of public trust and favourability in the UK, according to data from the Association of the British Pharmaceutical Industry (ABPI). Opinions showed consistent recognition of the sector’s support for the NHS, with 67% of respondents saying the industry is committed to developing new medicines to meet patient needs.
Pharmaceutical Technology
AUGUST 29, 2023
Ipilimumab is under clinical development by Bristol-Myers Squibb and currently in Phase I for Metastatic Transitional (Urothelial) Tract Cancer.
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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
BioPharma Reporter
AUGUST 29, 2023
Lytix Biopharma, a clinical stage immuno-oncology company, has completed recruitment of 20 patients in its trial evaluating LTX-315, the companyâs lead drug candidate.
Pharmaceutical Technology
AUGUST 29, 2023
Despite Big Pharma's pushback, plans for Medicare to negotiate prices for blockbuster drugs are going ahead with the release of a new list.
Pharma Times
AUGUST 29, 2023
The ODD will offer clinical development and commercialisation benefits that will strengthen the drug programme - News - PharmaTimes
Pharmaceutical Technology
AUGUST 29, 2023
The European PFAS ban would come into force in 2025 and would apply to pharmaceutical excipients, raw materials and packaging materials
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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
AUGUST 29, 2023
GLP-1 agonists such as Novo Nordisk’s semaglutide and SGLT2 inhibitors like AstraZeneca’s Farxiga are already butting heads in the treatment of diabetes. | GLP-1 agonists such as Novo Nordisk’s semaglutide and SGLT2 inhibitors like AstraZeneca’s Farxiga are already bumping heads in diabetes treatment. AstraZeneca’s biopharma business president, Ruud Dobber, said he’s not concerned about a potential upcoming clash between the two classes in heart failure.
Pharmaceutical Technology
AUGUST 29, 2023
Bioethicist Robert Klitzman talks about the Henrietta Lacks lawsuits and the consequences such cases can have for the biotech industry.
Fierce Pharma
AUGUST 29, 2023
As Moderna’s COVID vaccine patent lawsuits wind their way through courts around the globe, Pfizer and BioNTech contend their rival is trying to monopolize the entire mRNA field. | Pfizer and BioNTech have filed a pair of petitions seeking to invalidate two Moderna patents at the heart of the legal proceedings between the mRNA juggernauts.
Pharmaceutical Technology
AUGUST 29, 2023
The Centers for Medicare and Medicaid Services will soon release a list of 10 drugs that will be subject to drug price negotiations.
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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.
BioSpace
AUGUST 29, 2023
Warning signs that preceded the current economic squeeze in the biopharma sector were not heeded by investors seeking rapid profits. Now, biotechs interested in making the leap to the public markets must get creative.
Pharmaceutical Technology
AUGUST 29, 2023
The announcement follows the release of safety data from a Phase III trial in adolescents, which will be used in other submissions.
BioSpace
AUGUST 29, 2023
This is the Danish company’s second obesity-focused acquisition in three weeks. Under the deal, Novo Nordisk receives the full rights to develop and commercialize Embark’s lead metabolic platform.
Pharmaceutical Technology
AUGUST 29, 2023
Data from the open-label Phase III extension study showed LDL-C levels reduced by half in 80% of the patients receiving Leqvio.
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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.
Fierce Pharma
AUGUST 29, 2023
The day drugmakers have been dreading has arrived: Tuesday, the Centers for Medicare & Medicaid Services (CMS) unveiled its list of 10 drugs up for the first price negotiations under the Inflat | The drugs that made the cut for the first price negotiations are Johnson & Johnson’s Imbruvica, Stelara and Xarelto plus Bristol Myers Squibb’s Eliquis, Merck & Co.’s Januvia, Novartis’ Entresto, Eli Lilly’s Jardiance, AstraZeneca’s Farxiga, Novo Nordisk’s Fiasp and Amgen’s Enbrel.
Pharmaceutical Technology
AUGUST 29, 2023
The approval from the European Commission builds on the FDA's approval for usage in patients aged two months and younger.
Pharma Times
AUGUST 29, 2023
ImmunoGen is expected to receive an upfront payment from Takeda plus additional payment - News - PharmaTimes
Pharmaceutical Technology
AUGUST 29, 2023
Bristol Myers Squibb has received FDA approval for Reblozyl (luspatercept-aamt) as a first-line treatment for anaemia.
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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.
BioSpace
AUGUST 29, 2023
Lupin Pharmaceuticals' recall of Tydemy birth control is the latest in a string of problems with India-based generic drug manufacturers.
Pharmaceutical Technology
AUGUST 29, 2023
AbbVie has submitted applications to the FDA and European Medicines Agency for a new indication of risankizumab.
BioSpace
AUGUST 29, 2023
In the latest salvo, Pfizer and BioNTech fired back at Moderna and asked the U.S. Patent and Trademark Office to invalidate patent claims over the COVID-19 vaccines they say are overly broad.
Pharmaceutical Technology
AUGUST 29, 2023
Danaher has signed a definitive agreement to acquire all the outstanding stakes in UK-based Abcam for $5.7bn.
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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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