Outsourcing Pharma
SEPTEMBER 27, 2024
Joaquima Guix Salichs is the director of engineering and extraction technology at Bioiberica, where she leads a team of scientists focused on advancing extraction methods and solving large-scale industrial challenges.
Bio Pharma Dive
SEPTEMBER 27, 2024
Dupixent is the first biologic medicine approved in the U.S. for the lung condition, though competitors from GSK, AstraZeneca and Roche could follow.
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Pharmaceutical Technology
SEPTEMBER 27, 2024
The FDA has approved the first treatment for schizophrenia that targets cholinergic receptors rather than dopamine receptors.
Bio Pharma Dive
SEPTEMBER 27, 2024
New data show Talvey’s potential in multiple myeloma drug combinations. Elsewhere, AbbVie got more positive Parkinson’s drug data and Biogen ended a Sage collaboration.
Pharmaceutical Technology
SEPTEMBER 27, 2024
Bavarian Nordic has already said it would prioritise mpox vaccine production to fulfil orders this year.
pharmaphorum
SEPTEMBER 27, 2024
Stay up to date on cutting edge healthcare news, from PDURS to D2C, with Frontiers Health. Explore the latest in digital health trends and innovations.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
pharmaphorum
SEPTEMBER 27, 2024
Discover how GenAI leverages cutting-edge technology to automate the generation of regulatory dossiers, saving time and resources for your organization. Explore how GenAI can streamline the process and enhance efficiency.
Pharmaceutical Technology
SEPTEMBER 27, 2024
Biocon has entered a partnership with Tabuk for the commercialisation of glucagon-like peptide-1 (GLP-1) products in the Middle East.
XTalks
SEPTEMBER 27, 2024
In a news release published yesterday, Pfizer announced it will voluntarily withdraw its sickle cell disease (SCD) therapy Oxbryta (voxelotor) from all markets worldwide. The company said it is also discontinuing all active clinical trials for voxelotor and expanded access programs around the world. Pfizer explained that it made its decision based on a full review of clinical data that indicates the “overall benefit of Oxbryta no longer outweighs the risk in the approved sickle cell patient popu
Pharmaceutical Technology
SEPTEMBER 27, 2024
Direct-to-patient communication is emerging as a powerful solution to the challenges of non-adherence to medication. By leveraging innovative technology, patients can receive personalised reminders, educational content, and support.
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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
pharmaphorum
SEPTEMBER 27, 2024
Cassava Sciences will pay $40m to settle SEC charges that it made misleading claims about a phase 2b study of Alzheimer's candidate simufilam.
Pharmaceutical Technology
SEPTEMBER 27, 2024
Opioid use disorder (OUD) is a chronic neurological disorder characterised by the compulsive, repeated use of opioids, leading to prolonged self-administration.
pharmaphorum
SEPTEMBER 27, 2024
Pruritus, or itching, is a common symptom of Primary Biliary Cholangitis (PBC). Learn more about its impact and the importance of raising awareness about this condition.
Pharmaceutical Technology
SEPTEMBER 27, 2024
Phare Bio has received up to $27m from the Advanced Research Projects Agency for Health (ARPA-H) to advance its drug discovery platform
pharmaphorum
SEPTEMBER 27, 2024
BMS' acquisition of Karuna looks set to pay off after it gets FDA approval for the schizophrenia drug at the heart of the $14bn takeover
Pharmaceutical Technology
SEPTEMBER 27, 2024
Customised medication providers come under scrutiny as weight management copycat drugs raise safety concerns.
Fierce Pharma
SEPTEMBER 27, 2024
In the latest of several recent mpox vaccine supply deals, Bavarian Nordic plans to provide 1 million doses of its shot, Jynneos, to affected African countries through an agreement with UNICEF. | The agreement is the latest in a string of mpox vaccine supply deals that have come in response to the ongoing outbreak in Africa.
Pharmaceutical Technology
SEPTEMBER 27, 2024
Tempus AI has announced an expanded collaboration with Takeda to enhance oncology research and development.
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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
SEPTEMBER 27, 2024
Shortly after winning full FDA approval for its rare kidney disease drug Filspari, San Diego’s Travere Therapeutics has run into trouble with its enzyme replacement candidate pegtibatinase. | Travere is pausing enrollment in its Harmony study evaluating pegtibatinase in classic homocystinuria to make improvements on manufacturing scale-up for commercial production and to fully enroll the phase 3 trial.
Pharmaceutical Technology
SEPTEMBER 27, 2024
The FDA has approved AstraZeneca's Tagrisso (osimertinib) to treat adults with unresectable stage III EGFR-mutated NSCLC.
pharmaphorum
SEPTEMBER 27, 2024
NICE backs Roche's PiaSky for NHS treatment of paroxysmal nocturnal haemoglobinuria, the first drug that can be self-administered by patients.
Pharmaceutical Technology
SEPTEMBER 27, 2024
With an approval based on two pivotal Phase III studies, Dupixent is now the first-ever biologic indicated for treating COPD.
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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
Fierce Pharma
SEPTEMBER 27, 2024
AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead Sciences' Kite will bow out of its China joint venture with Fosun Pharma. | AstraZeneca and Daiichi Sankyo's Dato-DXd failed to improve survival in a breast cancer study. Gilead's Kite will bow out of its China joint venture with Fosun Pharma.
Pharmaceutical Technology
SEPTEMBER 27, 2024
The US FDA placed a full clinical hold on two diabetes trials for Biomea’s menin inhibitor after reports of liver toxicity.
pharmaphorum
SEPTEMBER 27, 2024
World leaders seek 10% cut in antibiotic resistance deaths Phil.
Fierce Pharma
SEPTEMBER 27, 2024
Following the FDA's green light for a combo regimen of Sanofi’s Sarclisa in patients with newly diagnosed multiple myeloma last week, J&J has wasted little time hitting back with new data on it | Following the FDA's green light for a combo regimen of Sanofi’s Sarclisa in patients with newly diagnosed multiple myeloma last week, J&J has wasted little time hitting back with new data on its own cancer quartet leveraging the company’s subcutaneous oncology stalwart Darzalex Faspro.
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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
SEPTEMBER 27, 2024
Sanofi's Dupixent scores double COPD win in US, China Jonah.
Crucial Data Soutions
SEPTEMBER 27, 2024
Clinical trial delays cost everyone. They cost sponsors in the traditional, dollars-and-cents way. However, they also cost patients and their. The post The Benefits of Real-Time ePRO/eCOA in Clinical Trials: Stay Ahead with Instant Insights appeared first on Crucial Data Solutions.
XTalks
SEPTEMBER 27, 2024
Syncromune, a privately held, clinical-stage biopharmaceutical company headquartered in Fort Lauderdale, Florida, is innovating immunotherapy for cancer treatment. The company’s mission is to develop groundbreaking therapies that significantly enhance response rates and potentially improve survival outcomes for patients with metastatic solid tumor cancers.
Drug Discovery World
SEPTEMBER 27, 2024
Nxera Pharma Japan has received approval from the Ministry of Health, Labour and Welfare of Japan (MHLW) of its New Drug Application (NDA) for ACT-541468 (daridorexant or Quviviq) in 25 and 50mg doses for the treatment of adult patients with insomnia. The approval of Quviviq, a novel dual orexin receptor antagonist, is based on robust clinical efficacy and safety data including from a dedicated Japanese Phase III trial.
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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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