Bio Pharma Dive
DECEMBER 12, 2023
Based on the work of MIT scientists, the well-funded startup is developing ways to insert large sizes of genetic material anywhere in the genome without damaging or breaking DNA.
Rethinking Clinical Trials
DECEMBER 12, 2023
Investigators from the NIH Pragmatic Trials Collaboratory in 2023 shared study results, generated new knowledge, and developed innovative methods in the design, conduct, and analysis of pragmatic clinical trials. Their work included insights from the Coordinating Center and Core Working Groups , analyses from the Distributed Research Network , and study designs and results from the NIH Collaboratory Trials.
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Bio Pharma Dive
DECEMBER 12, 2023
Just before clearing Pfizer’s buyout of Seagen, the regulator threatened to block Sanofi’s licensing deal with Maze Therapeutics, a challenge the biotech called ‘‘unprecedented.
Pharmaceutical Technology
DECEMBER 12, 2023
The funding will advance Bicara’s lead candidate BCA101, with the EGFR/TGF-β inhibitor currently being evaluated in Phase II clinical trials.
Bio Pharma Dive
DECEMBER 12, 2023
The deal signals the pharma company’s continuing interest in vaccine development and hands it a combination shot aimed at two respiratory viruses.
Pharmaceutical Technology
DECEMBER 12, 2023
The license of Maze’s GYS1 program, including MZE-001, was the subject of FTC opposition, leading to Sanofi terminating the agreement
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Fierce Pharma
DECEMBER 12, 2023
Over the past several years, drug shortages have vexed doctors and patients on both sides of the Atlantic, prompting lawmakers and government agencies to take action in both Europe and the U.S. | Tuesday, the European Medicines Agency laid out a list of more than 300 critical generic drugs that could fall prey to future shortages. Inclusion in the list doesn’t mean a particular drug is likely to experience a shortage anytime soon, the EMA said.
Pharmaceutical Technology
DECEMBER 12, 2023
Access and buy GlobalData’s databook on the latest filings and grants activity for Imeik Technology Development here.
Rethinking Clinical Trials
DECEMBER 12, 2023
Speakers Ruth Engelberg, PhD Research Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Erin Kross, MD Associate Professor of Medicine, Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Robert Lee, MD, MS Assistant Professor of Medicine Division of Pulmonary, Critical Care and Sleep Medicine University of Washington Slides Keywords Jumpstart, Advanced Planning, Goals of Care Key Points Researche
Fierce Pharma
DECEMBER 12, 2023
To complete its acquisition of Seagen, what did Pfizer need to do to satisfy antitrust concerns of the Federal Trade Commission? | By agreeing to donate royalties on its U.S. sales of bladder cancer drug Bavencio, Pfizer has received the go-ahead to finalize its $43 billion buyout of Seagen, the company said on Tuesday. Pfizer expects to close the merger on Thursday.
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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
Antidote
DECEMBER 12, 2023
Achondroplasia, a term meaning “without cartilage formation,” is a genetic disorder leading to disproportionate short stature. Sometimes called achondroplastic dwarfism or ACH , this condition has few treatment options and no known cure. However, individuals diagnosed with this condition can typically lead fulfilling, healthy lives with proper management.
Fierce Pharma
DECEMBER 12, 2023
Genentech’s brief leadership interregnum is coming to an end as the company’s interim chief executive, Ashley Magargee, prepares to take a permanent place on the throne. | Genentech veteran Ashley Magargee, who was tapped to temporarily steer the Roche subsidiary in November, will don the mantle of full-time CEO on Jan. 1, 2024. The executive move comes amid a period of C-suite fluidity for Roche and its large pharma group.
BioSpace
DECEMBER 12, 2023
Ahead of an expected surge in regulatory filings, the FDA is establishing the Genetic Metabolic Diseases Advisory Committee to provide advice on treatments for these complex and challenging conditions.
XTalks
DECEMBER 12, 2023
Plasma medicine is a critical and specialized field within healthcare, centering on the use of human plasma for the development and administration of life-saving treatments. Human plasma, the clear, liquid portion of blood, is composed of water, electrolytes, nutrients and crucial proteins such as antibodies, clotting factors and albumin. These components make plasma an invaluable resource for treating various medical conditions, especially those that are rare and chronic.
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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
BioSpace
DECEMBER 12, 2023
Even before its billionaire owner made recent headlines by endorsing an antisemitic post and hurling an expletive at advertisers, biopharma companies had begun to find different uses for their advertisement budgets.
Outsourcing Pharma
DECEMBER 12, 2023
The AIDS and Cancer Specimen (ACSR), a biorepository of specimens collected from persons living with HIV (PLWH) has today (December 12) announced it is using software from Proscia that can provide near real-time access to pathology data to investigators around the world.
BioSpace
DECEMBER 12, 2023
Medicines on the list can still be prescribed but will be under tight monitoring by a regulatory network, which can implement measures to prevent shortages and ensure supply chain continuity.
BioPharma Reporter
DECEMBER 12, 2023
ViroCell Biologics, a London-based viral vector CDMO for cell and gene therapy clinical trials, has partnered with University College London (UCL) to advance its pediatric cancer treatment.
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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
DECEMBER 12, 2023
This week, we discuss the two major FDA approvals for sickle cell from Vertex/CRISPR and bluebird bio; Axcella and the future of long-covid treatments, Vanda's $100m purchase and AI regulatory developments in Europe.
XTalks
DECEMBER 12, 2023
White Claw is entering the non-alcoholic beverage space with its latest innovation, the White Claw 0% Alcohol seltzers. Offering a new twist on traditional flavors, these drinks come in black cherry cranberry, mango passionfruit, peach orange blossom and lime yuzu. Designed to mirror the taste of the original White Claw Hard Seltzers, these 12-ounce beverages contain only 15 calories per can and are infused with electrolytes for added hydration benefits.
BioSpace
DECEMBER 12, 2023
If approved by the FDA, the MDMA-assisted treatment for individuals with post-traumatic stress disorder would be the first U.S. psychedelic-assisted therapy.
Fierce Pharma
DECEMBER 12, 2023
As waves of layoffs continue to hit the biopharma industry, Ferring Pharmaceuticals is trimming its headcount by 134 across its two U.S. locations. | The drugmaker will lay off 79 at its New Jersey headquarters and 55 at its microbiome subsidiary Rebiotix in Minnesota as a result of a "revised business strategy.
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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
DECEMBER 12, 2023
Access and buy GlobalData’s databook on the latest filings and grants activity for Guangzhou Kingmed Diagnostics Group here.
Fierce Pharma
DECEMBER 12, 2023
After multiple expansion forays overseas this year, biomanufacturing outfit National Resilience is returning to its American roots with plans to beef up production and add hundreds of new jobs at a | Resilience is expanding operations at the West Chester, Ohio, facility it bought from AstraZeneca in January, the technology-focused contract manufacturer said Monday.
Pharmaceutical Technology
DECEMBER 12, 2023
Access and buy GlobalData’s databook on the latest filings and grants activity for China Traditional Chinese Medicine here.
Fierce Pharma
DECEMBER 12, 2023
Evofem has struggled to gain commercial traction with Phexxi. Now, it's selling itself after shares crashed dramatically over the last few years.
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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
DECEMBER 12, 2023
Access and buy GlobalData’s databook on the latest filings and grants activity for Zhejiang Jiuzhou Pharmaceutical here.
Fierce Pharma
DECEMBER 12, 2023
With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to sta | With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to stage a comeback in mantle cell lymphoma.
Outsourcing Pharma
DECEMBER 12, 2023
Clinical-stage pharma company, PharmaKure which develops precision medicine for Alzheimerâs Disease and other neurological diseases has announced a collaboration agreement with one of the largest comprehensive universities in Malaysia.
Fierce Pharma
DECEMBER 12, 2023
Another data face-off between the two anti-CD38 multiple myeloma drugs—Johnson & Johnson’s Darzalex and Sanofi’s Sarclisa—took place at the 65th American Society of Hematology meeting. | Another data face-off between the two anti-CD38 multiple myeloma drugs—J&J's Darzalex and Sanofi's Sarclisa—took place at the ASH conference. Both regimens showed strong efficacy in newly diagnosed patients, but only one result is considered practice-changing right now.
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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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