Bio Pharma Dive
FEBRUARY 8, 2024
The German biotech will invest $200 million in Autolus — funds that, along with a $50 million fee, will give it licensing opportunities and access to supply infrastructure.
Pharmaceutical Technology
FEBRUARY 8, 2024
AFFINITY data has spurred RegenxBio towards a pivotal study for DMD while pivotal CAMPSIITE data has the company moving towards an FDA BLA.
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AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 8, 2024
A report by the US Centers for Disease Control and Prevention claims antifungal creams and combinations of antifungal treatments with corticosteroids are likely to be contributing to the rise and spread of severe skin, scalp, and nail fungal infections.
Pharmaceutical Technology
FEBRUARY 8, 2024
Despite several ground-breaking developments, pharmaceutical and biotech companies are often reluctant to invest in cell and gene therapy.
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 8, 2024
The healthcare industry has welcomed the interim budget presented by Union Finance Minister Nirmala Sitharaman, while adding that the government needs to prioritise spending towards healthcare sector and long standing demands like rationalisation of Goods and Services Tax (GST) and increased investments in the healthcare sector are yet to be addressed.
Bio Pharma Dive
FEBRUARY 8, 2024
The company is one of three preclinical biotechs to successfully go public since last summer, but it pulled in significantly less than others who’ve debuted with more advanced medicines.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 8, 2024
The company’s haul is the latest sign brain drugs are recapturing the interest of investors after years of being passed over for other areas of research.
Pharmaceutical Technology
FEBRUARY 8, 2024
Anvatabart opadotin is under clinical development by Ambrx Biopharma and currently in Phase I for Adenocarcinoma Of The Gastroesophageal Junction.
Bio Pharma Dive
FEBRUARY 8, 2024
Forced into testifying by Senate HELP chair Bernie Sanders, the heads of Bristol Myers Squibb, J&J and Merck largely avoided major missteps.
Rethinking Clinical Trials
FEBRUARY 8, 2024
The Health Care Systems Research Network (HCSRN) continued early-bird registration and announced the opening plenary speaker for its 2024 Annual Conference , which be held from April 9 to 11 in Milwaukee, Wisconsin. This year's opening plenary session will feature keynote speaker David Kent, director of the Tufts Predictive Analytics and Comparative Effectiveness Center and a professor of medicine, neurology, and clinical and translational science at Tufts Medical Center and Tufts University Sch
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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
FEBRUARY 8, 2024
Anvatabart opadotin is under clinical development by Ambrx Biopharma and currently in Phase I for Gastric Cancer.
Fierce Pharma
FEBRUARY 8, 2024
Thursday, when senators questioned three Big Pharma CEOs about the high price of drugs in the U.S., Health, Education, Labor and Pensions (HELP) committee chairman Bernie Sanders, I-Vermont, put th | CEOs from Bristol Myers Squibb, Johnson & Johnson and Merck faced tough questions from senators on why prices for drugs in the U.S. exceed those in other countries.
Pharmaceutical Technology
FEBRUARY 8, 2024
GEN-3014 is under clinical development by Genmab and currently in Phase II for Relapsed Multiple Myeloma.
pharmaphorum
FEBRUARY 8, 2024
Explore the commercial research landscape in the UK and the evolution of the National Institute for Health Research (NIHR) through an informative webinar.
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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
FEBRUARY 8, 2024
In recognition of its 30th anniversary, the International Gaucher Alliance (IGA) unveiled a visionary five-year strategic plan extending to 2029.
pharmaphorum
FEBRUARY 8, 2024
Gilead Sciences has said it will no longer develop its CD47-targeting antibody magrolimab in blood cancers after data suggested that patients taking the drug in clinical trials were more likely to die than those in control groups.
Pharmaceutical Technology
FEBRUARY 8, 2024
Isuzinaxib is under clinical development by AptaBio Therapeutics and currently in Phase II for Acute Renal Failure (ARF) (Acute Kidney Injury).
Fierce Pharma
FEBRUARY 8, 2024
With $45.8 billion in 2023 revenues, AstraZeneca has met the $45 billion-by-2023 goal CEO Pascal Soriot established in 2014 when he was fending off a takeover bid from Pfizer. | AstraZeneca has met the $45 billion-by-2023 revenue goal that CEO Pascal Soriot established in 2014. But questions have emerged for one of the company's key growth drivers.
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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
FEBRUARY 8, 2024
This initiative builds on the original parallel scientific advice programme launched by the FDA and EMA in 2021.
Outsourcing Pharma
FEBRUARY 8, 2024
With independent pharmacies now facing significant challenges, healthcare SaaS provider Charac was pleased to announce more investment so it can accelerate a digitization drive.
Pharmaceutical Technology
FEBRUARY 8, 2024
Abilify Maintena is approaching a significant market shift with the loss of market exclusivity in Europe and the US in October 2024.
BioPharma Reporter
FEBRUARY 8, 2024
Outsourcing Pharma and BioPharma Reporter breaks down the key people on the move in the pharma industry. Enhanc3D Genomics, Cytomos and Cellular Origins are among the companies welcoming new faces to top jobs.
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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
FEBRUARY 8, 2024
BridgeBio Pharma has entered a partnership with Kyowa Kirin, granting the latter an exclusive licence for infigratinib in Japan.
XTalks
FEBRUARY 8, 2024
As we commemorate the International Day of Women and Girls in Science 2024, it’s a moment to reflect on and celebrate the vital contributions of women and girls in the spheres of science and technology. This day, observed globally on February 11, underscores the critical role of gender equality in science, spotlighting the achievements of women pioneers in the field while also emphasizing the need to encourage and support the next generation of female scientists.
Pharmaceutical Technology
FEBRUARY 8, 2024
The US FDA has accepted the sBLA for Bristol Myers Squibb’s Opdivo (nivolumab) regimen for non-small cell lung cancer (NSCLC).
XTalks
FEBRUARY 8, 2024
The countdown to Super Bowl LVIII 2024 has begun and businesses across a variety of sectors, including pharma, have snapped up some of the most coveted advertising airtime of the year. Pharma commercials at Super Bowl 2024 will include ones for newly approved menopause drug Veozah and a unique partnership between antacid giant TUMS and sports betting company Draft Kings.
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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
FEBRUARY 8, 2024
Kowa will pay €3m upfront and up to €27.5m in milestone-based payment to gain rights for Nicox’s IOP reduction drug in Japan.
pharmaphorum
FEBRUARY 8, 2024
China has become the first country in the world to approve Roche’s anti-complement C5 antibody crovalimab, the only treatment for the rare disorder paroxysmal nocturnal haemoglobinuria (PNH) that can be given by subcutaneous injection.
Pharmaceutical Technology
FEBRUARY 8, 2024
Novo Holdings will acquire Catalent in an all-cash transaction that values Catalent at $16.5bn on an enterprise value basis.
BioPharma Reporter
FEBRUARY 8, 2024
A collaboration to expand autologous CAR-T programs into trials for multiple cancers in a cost-efficient way, has been formed by BioNTech SE and Autolus Therapeutics plc.
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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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