Bio Pharma Dive
JULY 6, 2023
Five years after helping launch Allogene Therapeutics, Pfizer is backing another developer of “off-the-shelf” cell therapies in a deal that gives the drugmaker the chance to acquire a multiple myeloma treatment.
Pharmaceutical Technology
JULY 6, 2023
Lifera, Arabio and Sanofi have signed a memorandum of understanding (MOU) to bolster manufacturing of vaccines in Saudi Arabia.
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Bio Pharma Dive
JULY 6, 2023
The broader approval is expected to push insurers, namely Medicare, to increase coverage of so-called amyloid-targeting therapies.
Pharmaceutical Technology
JULY 6, 2023
The ICMRA says evidence from more than 13 billion global vaccine doses shows good safety amid “dangerous” false information.
Rethinking Clinical Trials
JULY 6, 2023
Dr. Michele Balas and Dr. Eduard Vasilevskis The NIH Pragmatic Trials Collaboratory is excited to add 2 new Demonstration Projects to its portfolio of innovative pragmatic clinical trials embedded in healthcare systems. BEST-ICU (or Behavioral Economic and Staffing Strategies to Increase Adoption of the ABCDEF Bundle in the ICU) is supported by the National Heart, Lung, and Blood Institute (NHLBI).
Pharmaceutical Technology
JULY 6, 2023
SK bioscience and Thailand's GPO have entered a memorandum of understanding (MoU) to bolster vaccine infrastructure in Thailand.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 6, 2023
VBI Vaccines has announced the expansion of its HBV partnership with Brii Bio to address prevention and treatment of the disease.
Bio Pharma Dive
JULY 6, 2023
The deal comes three months after VBI cut costs and laid off staff in a restructuring meant to prioritize the two medicines Brii is interested in.
Pharmaceutical Technology
JULY 6, 2023
Atopic dermatitis (AD) manifests differently across White, Brown, Asian, and Black skin and this impacts how these patients are treated.
Bio Pharma Dive
JULY 6, 2023
The eye care company has become an active acquirer under new CEO Brent Saunders, buying an eye drop product line one week after purchasing several medicines from Novartis.
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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
JULY 6, 2023
F-star Therapeutics and Takeda have signed a strategic discovery partnership and licence deal to develop multi-specific immunotherapies.
Bio Pharma Dive
JULY 6, 2023
Industry lawsuits have taken a ‘multi-pronged’ approach to challenge the Inflation Reduction Act’s price negotiation program on constitutional grounds.
Fierce Pharma
JULY 6, 2023
After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. | After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices.
Bio Pharma Dive
JULY 6, 2023
The contract services provider, which secured the deal through a reportedly competitive process, expects CorEvitas to expand its drug research business.
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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
JULY 6, 2023
The US Department of Defense (DOD) has granted a contract of up to $74m to Evotec subsidiary, Just – Evotec Biologics.
Fierce Pharma
JULY 6, 2023
Less than two months into its "Pivot to Growth" strategy under a new CEO, Israeli-American generics giant Teva Pharmaceutical could be weighing a major shake-up of its key drug ingredients business | Teva is looking at strategic options for its active pharmaceutical ingredient unit, with a potential sale on the table, BNN Bloomberg and Benzinga have reported.
Pharmaceutical Technology
JULY 6, 2023
The company aims to file an IND for the therapy in 2023, with a Phase I trial set to start later this year.
Rethinking Clinical Trials
JULY 6, 2023
Speaker Adrian Hernandez, MD, MHS Director, Duke Clinical Research Institute Pamela Tenaerts, MD, MPH Chief Scientific Officer, Medable Craig Lipset, MPH Co-Chair, Decentralized Trials & Research Alliance Slides Keywords Decentralized; Guidance; FDA; Clinical trials Key Points Decentralized clinical trials (DCTs) are regular clinical trials in which all activities take place at locations other than trad
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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.
Fierce Pharma
JULY 6, 2023
It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fl | With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s disease under the FDA's traditional approval pathway.
Outsourcing Pharma
JULY 6, 2023
This yearâs CPHI South East Asia is expecting a surge in international partnering with organizers expecting a record attendance of 8,000 visitors including a significant number from overseas â doubling last yearâs figures.
ProRelix Research
JULY 6, 2023
Biosimilar clinical trials and study designs’ Considerations The rising prevalence and large market share of biological products emphasize their importance as treatment options for several cancers and autoimmune diseases. In […] The post Biosimilar clinical trials and study designs’ considerations appeared first on ProRelix Research.
XTalks
JULY 6, 2023
Pfizer has been going strong on the approval front, having secured its fifth US Food and Drug Administration (FDA) approval in the past five weeks, with the most recent being for the company’s once-weekly human growth hormone analog Ngenla (somatrogon-ghla). The treatment is indicated for pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
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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.
Outsourcing Pharma
JULY 6, 2023
With the FDA issuing guidance on more diversity within clinical trials, it is a subject many companies are being encouraged to focus on, each with their own approach.
XTalks
JULY 6, 2023
Mars Inc., the family-owned food conglomerate, recently announced its acquisition of Kevin’s Natural Foods , a renowned brand known for its high-quality sous-vide meals, sauces and side dishes. The deal, which values Kevin’s at approximately $800 million, was pursued after Kevin’s explored various options, including a potential sale earlier this year.
Fierce Pharma
JULY 6, 2023
GSK’s Cabenuva made history in 2020 as the world’s firs | GSK's long-acting Cabenuva is currently approved only as a switch therapy for patients who already have undetectable HIV levels in the blood. Trying to reach some tough populations who have difficulty adhering to existing daily oral therapies, GSK is getting creative.
Pharma Times
JULY 6, 2023
European Innovation Council Accelerator finances treatment development drive for condition - News - PharmaTimes
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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.
pharmaphorum
JULY 6, 2023
In our penultimate video from ASCO 2023, Editor in Chief Jonah Comstock touches base with Biofourmis Chief Operating Officer Jaydev Thakkar. Biofourmis works with pharma on accelerating drug development and with post-market monitoring of approved drugs.
Outsourcing Pharma
JULY 6, 2023
Toenail fungus is an embarrassing problem to have but Scottish health tech firm, Emblation is hopeful its treatment could prove effective.
Pharma Times
JULY 6, 2023
Patients treated with Kesimpta experienced considerable decreases in relapse rates - News - PharmaTimes
Fierce Pharma
JULY 6, 2023
In this episode of "The Top Line," we talk with ViiV’s head of R&D, Dr. Kimberly Smith, about new HIV therapies. | This week on "The Top Line," we discuss new HIV therapies, plus Humira's new biosimilar, foreign pharmaceutical investments, and the rest of the week's headlines.
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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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