Pharmaceutical Technology
JULY 17, 2024
In January, the US House Select Committee on the Strategic Competition between the US and the Chinese Communist Party introduced the Biosecure Act.
Bio Pharma Dive
JULY 17, 2024
Treatment led to "clinically meaningful" weight loss over four weeks, but longer studies will be needed to compare it to Wegovy and Zepbound.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 17, 2024
Can you pass me the whatchamacallit? It’s right over there next to the thingamajig. Many of us will experience “lethologica”, or difficulty finding words, in everyday life. And it usually becomes more prominent with age.
Bio Pharma Dive
JULY 17, 2024
Jefferies analyst Andrew Tsai views growing sales for J&J’s depression treatment as evidence that psychedelics like it can be commercially viable.
AuroBlog - Aurous Healthcare Clinical Trials blog
JULY 17, 2024
In a landmark injunction order, the Delhi High Court has banned Zydus’ biosimilar Sigrima. As per the Delhi HC order, Zydus and Dr Reddy’s launched ‘Sigrima/Womab,’ a biosimilar of Roche’s ‘Perjeta’ (pertuzumab), in a clear contempt of court.
Rethinking Clinical Trials
JULY 17, 2024
Dr. Brendan Everett and Dr. Deborah Wexler In this Friday’s PCT Grand Rounds, Brendan Everett and Deborah Wexler of Harvard Medical School will present “Lessons From PRECIDENTD: A Pragmatic Comparative Effectiveness Trial.” The Grand Rounds session will be held on Friday, July 19, 2024, at 1:00 pm eastern. The PRECIDENTD study (Prevention of Cardiovascular and Diabetic Kidney Disease in Type 2 Diabetes) is comparing SGLT2 inhibitors and a GLP-1 receptor agonist to treat type 2
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 17, 2024
AbbVie has maintained a strong position within the immunology space for the past few years, largely due to the success of its antitumour necrosis factor (TNF) agent, Humira (adalimumab).
Bio Pharma Dive
JULY 17, 2024
The Series A round was led by healthcare investor The Column Group, which made the 17-year-old biotechnology company private earlier this year.
Pharmaceutical Technology
JULY 17, 2024
As US China trade relations are set to be impacted by the BIOSECURE Act, pharma companies exploring CDMOs outside China may need to contend with increased drug development and manufacturing costs.
Bio Pharma Dive
JULY 17, 2024
Caribou is slashing its workforce by 12%. Elsewhere, a CDMO is investing in GLP-1 drug demand and Beam’s CFO is returning to J.P. Morgan.
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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 17, 2024
Upperton Pharma has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) approval for its facility in Nottingham.
Bio Pharma Dive
JULY 17, 2024
Diagnostics is the largest industry represented in the data, with more than 5,000 affected positions, according to an analysis by MedTech Dive.
Pharmaceutical Technology
JULY 17, 2024
The new funding is set to fund the expansion of the company’s Phase IIb studies into visugromab in combination with checkpoint inhibitors.
Fierce Pharma
JULY 17, 2024
Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer (mHSPC). | Bayer has claimed a second pivotal trial win for its blockbuster-to-be androgen receptor inhibitor Nubeqa, looking to reach the entire space of metastatic hormone-sensitive prostate cancer.
Pharmaceutical Technology
JULY 17, 2024
Scorpion Therapeutics has secured $150m in a Series C financing round to progress the development of its clinical-stage oncology pipeline.
Drug Patent Watch
JULY 17, 2024
The High Stakes of Pharmaceutical Patent Litigation In the fiercely competitive pharmaceutical industry, patent disputes can make or break a […] Source
Pharmaceutical Technology
JULY 17, 2024
China’s NMPA has granted approval for Zai Lab and argenx's efgartigimod SC for the treatment of generalised myasthenia gravis (gMG).
Fierce Pharma
JULY 17, 2024
As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations. | As myriad pharma industry attempts to challenge the Inflation Reduction Act (IRA) fall flat, Johnson & Johnson is settling into a reality of pricing rebates and Medicare drug cost negotiations.
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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
JULY 17, 2024
Biomanufacturers must tread carefully when seeking the optimum solution for their drug product's commercial supply chain.
Fierce Pharma
JULY 17, 2024
Sanofi is looking to bulk up its workforce at its global capacity center in Hyderabad, India, with a multi-year investment totaling 400 million euros ($437 million), according to reports. | The drugmaker plans to grow it its workforce at the site to 2,600, making it the largest of Sanofi's four global capacity centers, according to reports.
Pharmaceutical Technology
JULY 17, 2024
The US FDA has issued a complete response letter (CRL) to Orexo regarding its NDA for OX124 to counteract opioid overdoses.
BioSpace
JULY 17, 2024
Already approved for erosive gastroesophageal reflux disease, Phathom’s Voquenza is now authorized to treat patients with non-erosive GERD.
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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 17, 2024
The funds will finance late-stage trials of CRD-750, a PDE9 inhibitor for heart failure, and CRD-4730, a CaMKII inhibitor.
pharmaphorum
JULY 17, 2024
Get insights into Dr James Burt's leadership as CEO of Pharmanovia through a 12-question interview that covers his background, achievements, and vision for the company.
Pharmaceutical Technology
JULY 17, 2024
Gene therapy trials can often be held back by cost and complexity. New database software is helping optimise the process.
pharmaphorum
JULY 17, 2024
Vertex Pharma has teamed up with Orum Therapeutics to develop a conditioning regimen, used to prepare patients to receive gene-editing medicines, that it hopes will offer a more tolerable alternative to current chemotherapy options.Vertex is paying $15 million upfront to get the ball rolling on the collaboration, which could be worth up to $945 million if it exercises options to use the technology for three developmental programmes and all of them hit various milestones.
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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
JULY 17, 2024
Approval of tabelecleucel would mark the first available therapy for the treatment of EBV+PTLD in the US.
Pharma Times
JULY 17, 2024
The most globally prevalent cancers include breast, lung, bowel and prostate cancers
Outsourcing Pharma
JULY 17, 2024
JOGO Health, a leader in non-invasive digital therapeutics, has announced a pivotal collaboration with the Mayo Clinic to study tremors.
pharmaphorum
JULY 17, 2024
Huma raised $80m to support a cloud platform that can be used by digital health developers to create disease management tools
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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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