Bio Pharma Dive
FEBRUARY 27, 2023
Celgene veteran Scott Smith will take over for Michael Goettler on April 1 as the generic drugmaker prepares for a return to growth after divestitures and the addition of a new eye care division.
Pharmaceutical Technology
FEBRUARY 27, 2023
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the refusal of the marketing authorisation for Me rck and Ridgeback Biotherapeutics’ Lagevrio (molnupiravir). After evaluating the data provided by the companies, CHMP concluded that Lagevrio’s clinical benefit in treating Covid-19 could not be demonstrated in adult subjects.
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Bio Pharma Dive
FEBRUARY 27, 2023
Citing people familiar with the talks, The Wall Street Journal reported over the weekend that Pfizer is trying to acquire Seagen and its suite of cancer therapies in a deal that could be worth more than $30 billion.
Pharmaceutical Technology
FEBRUARY 27, 2023
China’s National Medical Products Administration (NMPA) has granted approval for Daiichi Sankyo and AstraZeneca ’s Enhertu (trastuzumab deruxtecan) to treat HER2-positive metastatic breast cancer. Enhertu has received approval as a monotherapy to treat unresectable or metastatic HER2-positive breast cancer in adult patients who have previously received one or more anti-HER2-based regimens.
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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 27, 2023
Digital transformation has much to offer life sciences as well as healthcare — and the synergies between the two can further optimize the power of digital health, clinical trials and patient outcomes.
Pharmaceutical Technology
FEBRUARY 27, 2023
Finnish pharmaceutical firm Orion has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for darolutamide plus androgen deprivation therapy (ADT) along with docetaxel to treat metastatic prostate cancer. The oral androgen receptor inhibitor (ARi) darolutamide has a distinct chemical structure that attaches to the receptor with high affinity and shows strong antagonistic activity and inhibits the receptor function as well as prostate cancer cells growth.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
FEBRUARY 27, 2023
Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Multiple Myeloma. According to GlobalData, Phase I drugs for Relapsed Multiple Myeloma have an 80% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Enzalutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Bio Pharma Dive
FEBRUARY 27, 2023
Dunn had become a controversial figure after his role in the FDA's review and approval of Biogen's Alzheimer's drug Aduhelm.
NPR Health - Shots
FEBRUARY 27, 2023
The federal agency that oversees Medicaid suggested Idaho wasn't trying hard enough to reach beneficiaries before letting their coverage lapse. Consumer advocates fear that could happen again.
Bio Pharma Dive
FEBRUARY 27, 2023
The test’s maker, Lucira, said the agency’s “protracted” authorization process caused it to miss out on test sales in the 2022 to 2023 flu season.
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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 27, 2023
Hydrocortisone is under clinical development by Antares Pharma and currently in Phase I for Adrenal Insufficiency. According to GlobalData, Phase I drugs for Adrenal Insufficiency have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Hydrocortisone’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Bio Pharma Dive
FEBRUARY 27, 2023
Tips to Modernize Patient Experience
Pharmaceutical Technology
FEBRUARY 27, 2023
Givinostat is under clinical development by Italfarmaco and currently in Phase II for Myelofibrosis. According to GlobalData, Phase II drugs for Myelofibrosis have a 43% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Givinostat’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Medical Xpress
FEBRUARY 27, 2023
Engineers from UNSW Sydney have developed a miniature and flexible soft robotic arm that could be used to 3D-print biomaterial directly onto organs inside a person's body.
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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 27, 2023
HY-0102 is under clinical development by Shanghai HyaMab Biotech and currently in Phase I for Head And Neck Cancer. According to GlobalData, Phase I drugs for Head And Neck Cancer have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how HY-0102’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
NPR Health - Shots
FEBRUARY 27, 2023
That's the view of Joseph Glauber of the International Food Policy Research Institute. He considers the fear the war would lead to a surge in food prices – and a dramatic worsening of world hunger.
Pharmaceutical Technology
FEBRUARY 27, 2023
Givinostat is under clinical development by Italfarmaco and currently in Phase II for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF). According to GlobalData, Phase II drugs for Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF) have a 74% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Givinostat’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmark
STAT News
FEBRUARY 27, 2023
The sweetener erythritol, which is becoming increasingly popular in snack bars and low-sugar ice cream substitutes, may increase the risk of heart attacks and strokes, according to a paper published Monday in the journal Nature Medicine. Outside experts who reviewed the findings emphasized that more evidence is needed, with some raising concerns that the results of the study could be due to other factors that make it appear the sweetener causes risks when it does not.
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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 27, 2023
Enzalutamide is under clinical development by Pfizer and currently in Phase I for Myelofibrosis. According to GlobalData, Phase I drugs for Myelofibrosis have an 85% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Enzalutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
BioPharma Reporter
FEBRUARY 27, 2023
The Boston-based messenger RNA (mRNA) specialist Moderna revealed $19.3bn in revenues last year, but rising costs and falling demand for its COVID-19 vaccine cut into its earnings in the fourth quarter of 2022.
Pharmaceutical Technology
FEBRUARY 27, 2023
GI-XBI-302 is under clinical development by Xbiome and currently in Phase I for Graft Versus Host Disease (GVHD). According to GlobalData, Phase I drugs for Graft Versus Host Disease (GVHD) have an 89% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how GI-XBI-302’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Medical Xpress
FEBRUARY 27, 2023
A tumor's necrotic core contains factors that appear to promote metastasis, or the seeding of tumors cells throughout the body, according to a new study in rats by researchers at Fred Hutchinson Cancer Center.
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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 27, 2023
Enzalutamide is under clinical development by Pfizer and currently in Phase I for Relapsed Chronic Lymphocytic Leukemia (CLL). According to GlobalData, Phase I drugs for Relapsed Chronic Lymphocytic Leukemia (CLL) have a 75% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Enzalutamide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Antidote
FEBRUARY 27, 2023
Participating in a clinical trial has many benefits, including working with condition specialists, getting access to personalized medical care, and helping science move forward — but did you know that some clinical trials offer compensation, as well?
Pharmaceutical Technology
FEBRUARY 27, 2023
Givinostat is under clinical development by Italfarmaco and currently in Phase II for Myelofibrosis. According to GlobalData, Phase II drugs for Myelofibrosis have a 43% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Givinostat’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks.
Medical Xpress
FEBRUARY 27, 2023
Neuroscientists know that what makes a memory really stick is reconsolidation, when a new memory is reactivated by identical or similar experiences, stimulating the creation of additional and stronger neural connections.
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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.
STAT News
FEBRUARY 27, 2023
Entries for this year’s STAT Madness, our annual, bracket-style competition in biomedical research, include some of 2022’s biggest discoveries, in areas ranging from Covid-19 and cancer treatment to medical imaging and surgery. Popular voting begins on Wednesday, March 1, when first-round pairings will be revealed, along with descriptions of all the entrants’ research.
NPR Health - Shots
FEBRUARY 27, 2023
Rep. Joaquin Castro, who represents the 20th Congressional District in Texas, said doctors discovered tumors in his gastrointestinal tract last summer, and he had them removed Monday.
STAT News
FEBRUARY 27, 2023
It looked like the perfect collaboration. The Massachusetts Institute of Technology was preparing to roll out a new introductory course in biology, the first time the subject would be required for all undergraduates. It was 1991, and the university turned to two scientists who already were standouts.
Medical Xpress
FEBRUARY 27, 2023
Tapping into the dark side and using anxiety and anger can spark more success than fun and relaxation—but at the cost of your health. The multi-national research led by The University of Essex has uncovered how the mind processes "achievement emotions.
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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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