Bio Pharma Dive
SEPTEMBER 23, 2024
The companies now plan on starting this year another large study of their drug, dapirolizumab pegol, in the hopes that they can confirm its safety and effectiveness to drug regulators.
Pharmaceutical Technology
SEPTEMBER 23, 2024
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Bio Pharma Dive
SEPTEMBER 23, 2024
With fresh, positive data in hand, Biohaven now believes its medicine could be the first to receive FDA approval for spinocerebellar ataxia.
Pharmaceutical Technology
SEPTEMBER 23, 2024
The US FDA has granted approval for AstraZeneca's FluMist, a needle-free nasal spray influenza vaccine for self-administration.
Bio Pharma Dive
SEPTEMBER 23, 2024
Regulatory and strategic challenges can delay the delivery of life-changing cell and gene therapies.
Pharmaceutical Technology
SEPTEMBER 23, 2024
View the top artificial intelligence (AI) companies in the pharmaceutical industry and download your free guide to AI in pharma here.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 23, 2024
(Tanja Ivanova/Getty Images) The world is in the midst of an antibiotic resistance crisis that contributes to the death of nearly 5 million people a year. But bacteria aren’t the only mutating pathogens we need to worry about.
Bio Pharma Dive
SEPTEMBER 23, 2024
The partners said their antibody-drug conjugate datopotomab deruxtecan didn’t extend survival in a breast cancer study, fueling additional doubts about its approval prospects.
Pharmaceutical Technology
SEPTEMBER 23, 2024
Discover Lyell Immunopharma's groundbreaking patent for EGFR-derived polypeptides, enhancing cancer treatment through innovative nucleic acid technologies and engineered T cells.
AuroBlog - Aurous Healthcare Clinical Trials blog
SEPTEMBER 23, 2024
The Central Drugs Standard Control Organisation (CDSCO) has revised the guidance document for functions and responsibilities of its zonal, sub-zonal and port offices after almost 13 years, updating the adding procedures including for Risk Based Inspection (RBI) of drug manufacturing sites.
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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
SEPTEMBER 23, 2024
Discover Telesis Bio Inc.'s groundbreaking patent for synthesizing specific DNA sequences. Learn how their innovative method enhances genetic engineering and biotechnology.
Bio Pharma Dive
SEPTEMBER 23, 2024
GLP-1 drugs went from helping with blood sugar management to supporting weight loss. What’s next?
Pharmaceutical Technology
SEPTEMBER 23, 2024
Pancreatic cancer is resistant to conventional therapies, but cutting-edge research may improve survival rates and patient quality of life.
Bio Pharma Dive
SEPTEMBER 23, 2024
Dr. Meg Richards from Panalgo discusses how real-world data is unlocking advancements in drug safety during pregnancy.
Pharmaceutical Technology
SEPTEMBER 23, 2024
Under the terms of the agreement, Sanofi will gain an exclusive right to first negotiation for the CNS-penetrant, VTX3232.
Drug Patent Watch
SEPTEMBER 23, 2024
The generic drug market has experienced significant growth over the past few decades, driven by the expiration of patents on branded drugs and the increasing demand for affordable healthcare solutions. However, the industry faces several challenges, including commoditization, regulatory hurdles, and intense competition.
Pharmaceutical Technology
SEPTEMBER 23, 2024
Takeda UK has announced the UK's MHRA approval of fruquintinib for adults with metastatic colorectal cancer (CRC).
Fierce Pharma
SEPTEMBER 23, 2024
Despite being thrown off its rhythm twice already, Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the compan | Johnson & Johnson is making another go of its “Texas two-step” strategy to wash its hands of tens of thousands of lawsuits claiming the company’s talc products caused users to develop cancer.
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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
SEPTEMBER 23, 2024
New safety data shows an absence of post-injection syndrome, a rare and serious side effect of long-acting olanzapine.
pharmaphorum
SEPTEMBER 23, 2024
RHYTHM AI has FDA approval for a new version of its algorithm for mapping areas of the heart that are affected by atrial fibrillation
Pharmaceutical Technology
SEPTEMBER 23, 2024
The EMA CHMP has recommended approval of MSD’s KEYTRUDA for two gynaecological cancers: endometrial and cervical.
pharmaphorum
SEPTEMBER 23, 2024
Zevra Therapeutics' Miplyffa is first drug approved by the FDA for ultra-rare disease Niemann-Pick type C.
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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
SEPTEMBER 23, 2024
Zevra Therapeutics has gained FDA approval for Miplyffa (arimoclomol) to treat Niemann-Pick disease type C (NPC).
Fierce Pharma
SEPTEMBER 23, 2024
For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet. | Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February, punting the complaint back to a lower Texas court.
Pharmaceutical Technology
SEPTEMBER 23, 2024
The company has initiated a Phase I trial of its bivalent RSV and hMPV-targeting vaccine called VXB-241.
pharmaphorum
SEPTEMBER 23, 2024
Johnson & Johnson's long-running effort to put litigation claiming its talc products caused cancer has continued with a third attempt to place a subsidiary company into bankruptcy. Red River Talc LLC was set up specifically to resolve the thousands of claims related to ovarian cancer arising from cosmetic talc litigation, separated from the group's core business and armed with billions of dollars in settlement money to provide compensation to alleged victims.
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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
SEPTEMBER 23, 2024
The approval sets up a showdown between Iqirvo and Intercept’s PBC treatment Ocaliva.
Fierce Pharma
SEPTEMBER 23, 2024
Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease trea | Along with psoriasis, the biologic is now FDA approved to treat psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis.
pharmaphorum
SEPTEMBER 23, 2024
Sanofi's Sarclisa has been an also-ran in the anti-CD38 antibody class behind Johnson & Johnson and Genmab's blockbuster Darzalex, but now has a chance to steal some of the spotlight. The FDA has approved Sarclisa (isatuximab) as a first-line therapy for blood cancer multiple myeloma as a combination regimen alongside bortezomib, lenalidomide, and dexamethasone (VRd), for people who are not eligible for an autologous stem cell transplant (ASCT).
Fierce Pharma
SEPTEMBER 23, 2024
Ahead of a Senate hearing centered on high prices for Novo Nordisk’s in-demand semaglutide medications, lawmakers are pressing the government to use its “march-in” rights and allow generic versions | In a letter to HHS secretary Xavier Becerra, several lawmakers urged the government to allow generic licenses for Novo's GLP-1 medicines Ozempic and Wegovy.
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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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