Bio Pharma Dive
FEBRUARY 14, 2023
Through social media, virtual meetings and mentorship programs, a growing group of entrepreneurs is looking for new ways to build drug companies.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Kidney disorder treatm
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Bio Pharma Dive
FEBRUARY 14, 2023
Syena will develop TCR-based natural killer cell therapies, building on research done by MD Anderson’s Katy Revzani and using technology from Replay.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Biosimilars in Pharmaceuticals: Neuro-degenerative re
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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
Bio Pharma Dive
FEBRUARY 14, 2023
The biotech company creator is deprioritizing work on a drug delivery technology called Orasome after what it described as a “key go/no go” experiment.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Kidney disorder treatm
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
FEBRUARY 14, 2023
The British drugmaker will retain an interest in COVID antibody drug sotrovimab, which was withdrawn from the U.S. market, and a second treatment still in early-stage trials.
Pharmaceutical Technology
FEBRUARY 14, 2023
The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373). Under the modified deal, Novavax will deliver up to 1.5 million additional doses of its Covid-19 vaccine. The company stated that the deal would maintain the access of the US public to its vaccine.
Bio Pharma Dive
FEBRUARY 14, 2023
Formed by the Yale scientist and Arvinas founder, Halda Therapeutics is developing a twist on targeted protein degradation, an area of research that’s recently caught drugmakers’ attention.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Key innovation: Leading companies in nanoparticles fo
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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
AuroBlog - Aurous Healthcare Clinical Trials blog
FEBRUARY 14, 2023
The workshop on ‘Quality Control in Ayurveda Industry’ organized by the Association of Ayurveda Drug Manufacturing Industries (ADMI) in Andhra Pradesh last week highlighted the importance of quality control (QC) and quality assurance (QA) which are needed in the Ayurveda drug manufacturing industry and it evoked good response from all the stakeholders.
Rethinking Clinical Trials
FEBRUARY 14, 2023
Dr. Fan Li Dr. Fan Li, a member of the NIH Pragmatic Trials Collaboratory’s Biostatistics and Study Design Core, will present “Methods for Designing Cluster Randomized Trials to Detect Treatment Effect Heterogeneity” during IMPACT Grand Rounds on Thursday, February 16, at 12:00 pm eastern. IMPACT Grand Rounds is hosted by the NIA IMPACT Collaboratory.
Pharmaceutical Technology
FEBRUARY 14, 2023
Precision oncology firm Corbus Pharmaceuticals and CSPC Megalith Biopharmaceutical have entered an exclusive licensing agreement for the latter’s new clinical stage antibody drug conjugate (ADC), CRB-701 (SYS6002). CSPC Megalith is a subsidiary of CSPC Pharmaceutical Group. Under the deal, Corbus Pharmaceuticals will have exclusive rights to develop and commercialise CRB-701 in Canada, Australia, the UK, the EU (including the European Free Trade Area), and the US, while CSPC will retain SYS6002’
STAT News
FEBRUARY 14, 2023
A Marburg fever outbreak in Equatorial Guinea is galvanizing efforts to test drugs and vaccines for a virus that currently has none. But every day counts, warned experts who gathered virtually on Tuesday to try to chart a course for the work. The outbreak is believed to have begun in early January, but the confirmation that the Marburg virus was responsible for the growing cluster of people sick with hemorrhagic-fever-like illness was only confirmed on Monday.
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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 14, 2023
Cullinan Oncology has signed an exclusive licence with Harbour BioMed for clinical-stage B7H4 x 4-1BB bispecific immune activator HBM7008’s (CLN-418) development and marketing in the US. HBM7008 has been developed from HBICE, a next-generation heavy chain-only antibody (HCAb)-based multi-specific antibody discovery platform. It is now in a Phase I clinical trial, conducted at Australian and US sites in advanced solid tumour patients.
NPR Health - Shots
FEBRUARY 14, 2023
Medicare suddenly stopped paying for the pricey drug that prolongs his life. As he waits for an appeal, this retired physician wonders if he should give up treatment to spare his family the cost.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Hepatitis B Virus (HBV
Fierce Pharma
FEBRUARY 14, 2023
Pfizer CEO's texts with European Commission chief trigger new NYT lawsuit kdunleavy Tue, 02/14/2023 - 10:29
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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 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on I nnovation in Pharmaceuticals: Isotropically modifie
STAT News
FEBRUARY 14, 2023
When we think of notable civil rights issues in medicine, the best-known cases might be Henrietta Lacks , whose cells were taken without consent for research, or the participants of the Tuskegee Syphilis Study who were subject to unethical experiments. These are important events that changed the course of medicine, but they’re also examples in which Black people were unknowingly harmed as patients.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Lactobacilli-based dru
NPR Health - Shots
FEBRUARY 14, 2023
For people with drug-resistant epilepsy, surgery used to be seen as a last resort. Now it's often the treatment of choice.
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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.
Pharmaceutical Technology
FEBRUARY 14, 2023
The pharmaceutical industry continues to be a hotbed of innovation, with activity driven by the evolution of new treatment paradigms, and the gravity of unmet needs, as well as the growing importance of technologies such as pharmacogenomics, digital therapeutics, and artificial intelligence. In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Mammalian expression v
Medical Xpress
FEBRUARY 14, 2023
A new comprehensive study of organ impairment in long COVID patients over 12 months shows organ damage persisted in 59% of patients a year after initial symptoms, even in those not severely affected when first diagnosed with the virus.
Pharmaceutical Technology
FEBRUARY 14, 2023
Pevonedistat hydrochloride is under clinical development by Millennium Pharmaceuticals and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Pevonedistat hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Medical Xpress
FEBRUARY 14, 2023
Even though the COVID-19 public health emergency classification will expire this spring, the lingering effects of the pandemic remain. A constant puzzle to solve since the first year of the pandemic has been "long COVID," a condition in which those infected with the virus have symptoms that linger months or even years after they have cleared the initial infection.
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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 14, 2023
Edoxaban tosylate is under clinical development by Daiichi Sankyo and currently in Phase II for Atrial Fibrillation. According to GlobalData, Phase II drugs for Atrial Fibrillation have a 43% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Edoxaban tosylate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
STAT News
FEBRUARY 14, 2023
To become more equitable and inclusive organizations, higher education and scientific institutions must go beyond increasing the number of people from underrepresented racial and ethnic groups in their ranks and change their cultures, a leading academic group said in a sweeping new report Tuesday. The report , from the National Academies of Sciences, Engineering, and Medicine, calls for such institutions to actively pursue antiracist initiatives to start overcoming the barriers and structural ra
Pharmaceutical Technology
FEBRUARY 14, 2023
Sirolimus is under clinical development by Rare Partners and currently in Phase II for Beta Thalassaemia. According to GlobalData, Phase II drugs for Beta Thalassaemia have a 39% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Sirolimus’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
STAT News
FEBRUARY 14, 2023
Greg Bowman, a University of Pennsylvania biophysicist, had the kind of idea biotech venture capitalists salivate over. His lab had been working on how to drug “cryptic sites” on proteins that were previously thought unreachable by drug molecules. Machine learning, he believed, would make new types of medicine possible. The idea seemed ready to be spun out of his lab and into a company.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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