Bio Pharma Dive
AUGUST 16, 2023
The decision stands in contrast to the agency’s plans for a would-be rival gene editing treatment from Vertex Pharmaceuticals and CRISPR Therapeutics that is also under a regulatory review.
Pharmaceutical Technology
AUGUST 16, 2023
The proportion of cases found in migrants to Florida has decreased significantly since 2002 while cases in US residents has risen.
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Bio Pharma Dive
AUGUST 16, 2023
The struggling biotech also plans to offload other cell therapy assets, including a multiple myeloma therapy, and focus exclusively on gene editing medicines.
Pharmaceutical Technology
AUGUST 16, 2023
Bluebird bio eyes hattrick of gene therapy approvals, with a PDUFA date for sickle cell disease therapy lovo-cel set in December.
Rethinking Clinical Trials
AUGUST 16, 2023
From left: Martin Landray, Khair ElZarrad, and Adrian Hernandez In this Friday’s PCT Grand Rounds, Martin Landray of the University of Oxford, Khair ElZarrad of the US Food and Drug Administration, and Adrian Hernandez of Duke University will present “Opportunities to Improve Clinical Trials: Draft Revision of the ICH Good Clinical Practice Guideline (E6[R3]).” The Grand Rounds session will be held on Friday, August 18, 2023, at 1:00 pm eastern.
Pharmaceutical Technology
AUGUST 16, 2023
Several companies are developing robotics to automate cell and gene therapy manufacturing, but some challenges persist.
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
AUGUST 16, 2023
A Parliamentary Panel that looked into the mental healthcare and management policies in the country has observed that even though the Mental Healthcare Act (MHCA), 2017 was implemented five years back, there is still much work to be done to implement the provisions of the Act effectively.
Bio Pharma Dive
AUGUST 16, 2023
Investors known for funding the final private financing round before a biotech company goes public have pulled back as the IPO window remains shut.
Pharmaceutical Technology
AUGUST 16, 2023
The US FDA has approved Artiva's IND application for the combination of AlloNK (AB-101) and rituximab to treat systemic lupus erythematosus
Bio Pharma Dive
AUGUST 16, 2023
The new coupons include some of the most commonly prescribed diabetes drugs from Eli Lilly, Novo Nordisk and Sanofi.
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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 16, 2023
Precision BioSciences and Imugene have concluded a strategic transaction for worldwide rights to the former’s allogeneic CAR T candidate
Antidote
AUGUST 16, 2023
Primary sclerosing cholangitis (PSC) is a condition that impacts the bile ducts of the liver, causing them to become inflamed and ultimately scar. It primarily affects young and middle-aged men, and 80% of patients with PBC also have inflammatory bowel disease (IBD).
Pharmaceutical Technology
AUGUST 16, 2023
Gilead Sciences has entered into partnerships with Tentarix for the development of new therapies for oncology and inflammatory diseases.
Drug Patent Watch
AUGUST 16, 2023
Annual Drug Patent Expirations for REMODULIN Remodulin is a drug marketed by United Therap and is included in two NDAs. It is available from one supplier. There are nine patents… The post New patent for United Therap drug REMODULIN appeared first on DrugPatentWatch - Make Better Decisions.
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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 16, 2023
AGC has entered into an agreement with Asahi Kasei to produce clinical drug substance for antibody-based therapies at its Seattle site.
FDA Law Blog
AUGUST 16, 2023
By Douglas B. Farquhar — Francis Godwin, Director of the Office of Manufacturing Quality of the Office of Compliance at FDA’s Center for Drug Evaluation and Research provided useful information (presentation attached here ) Tuesday at the GMP by the Sea Conference. He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of
Pharmaceutical Technology
AUGUST 16, 2023
Avidity Biosciences has obtained orphan drug designation from the US FDA for its AOC 1044 to treat Duchenne Muscular Dystrophy (DMD)
Pharma Times
AUGUST 16, 2023
The collaboration will focus on multiple enzyme cargoes modified using Aliada's modular delivery platform - News - PharmaTimes
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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 16, 2023
The Phase IIb trial in idiopathic pulmonary fibrosis for GB0139 did not meet its endpoint, leading Galecto to abandon development.
Fierce Pharma
AUGUST 16, 2023
With plasma collection as its stock-in-trade, the struggles of | With plasma collection as its stock-in-trade, the struggles of CSL during the coronavirus lockdown were understandable. But a surge in post-pandemic collections—and an $11.7B acquisition of Swiss blood specialist Vifor—has rekindled the growth of Australia’s largest biotech. With plasma collections up 31% and to a record level for the company, CSL reported revenue of $13.3 billion for fiscal year 2023.
Pharmaceutical Technology
AUGUST 16, 2023
Illumina has faced a series of legal challenges to its 2021 acquisition of Grail; regulators allege willful ignorance.
Fierce Pharma
AUGUST 16, 2023
Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines. | Concern over the cost of prescription drugs is becoming less of a policy issue and more of a “core value” for voters across party lines, a pollster found. Two pollsters presented results from their recent survey on Tuesday.
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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 16, 2023
Amicus’ Pombiliti and Opfolda received approval from the UK MHRA through the Innovative Licensing and Access Pathway.
Eye on FDA
AUGUST 16, 2023
In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June FDA posted an Untitled Letter , the first regulatory action letter in a year, reported on here regarding a website communication.
Pharmaceutical Technology
AUGUST 16, 2023
Eyenovia hopes for near-term revenue from the licencing deal, with APP13007’s PDUFA date set for 4 March 2024.
Outsourcing Pharma
AUGUST 16, 2023
OSP discussed going beyond industry sponsors and how to support both patients and centers through clincal trial design with Erin Leckrone, senior director, clinical trials and Kathleen Kane, senior manager, clinical operations, at Be The Match BioTherapies.
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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
AUGUST 16, 2023
Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option. | Johnson & Johnson and Legend Biotech’s Carvykti continues to grow in multiple myeloma despite the introduction of a more convenient option.
BioSpace
AUGUST 16, 2023
Biotech startups often struggle with hiring decisions. Incubators can help through mentorship opportunities and by bringing in potential talent.
Fierce Pharma
AUGUST 16, 2023
For three years, Teva has been defending against claims from the | The trial was previously set to begin in September but is now on hold as the company appeals a key ruling from July.
BioSpace
AUGUST 16, 2023
Mifepristone’s legal saga continues as the U.S. 5th Circuit Court of Appeals ruled for steep restrictions on the drug’s access, though its effectivity is pending the Supreme Court’s review.
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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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