Bio Pharma Dive
AUGUST 17, 2022
The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.
Pharmaceutical Technology
AUGUST 17, 2022
RANKINGS 2022 Excellence Innovation Commended Excellence Product Launch Commended Excellence Safety Commended. The Verdict. Northgate Technologies Inc. (NTI) is a Illinois based producer of medical devices and technologies for the healthcare sector, with a particular focus on surgical environments. The company is ranked in the 2022 Excellence Rankings in the INNOVATION , PRODUCT LAUNCH and SAFETY categories.
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Bio Pharma Dive
AUGUST 17, 2022
The federal government will begin the transition as early as this fall, clearing the way for drugmakers to control sales and distribution of their shots and therapeutics.
Pharmaceutical Technology
AUGUST 17, 2022
Merck (MSD outside North America) has entered a partnership agreement with Orna Therapeutics for discovering, developing and marketing various programmes based on next-generation RNA technology. These programmes will include therapies and vaccines in infectious disease and oncology areas. By self-circularisation, Orna’s oRNA technology makes circular ribonucleic acids (oRNAs) from linear RNAs. oRNA molecules have been demonstrated to possess increased stability in vivo compared to linear mRNA an
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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
AUGUST 17, 2022
The COVID-19 vaccine maker has appointed James Mock, currently PerkinElmer’s CFO, as its next finance head, three months after ousting Jorge Gomez from the role.
Pharmaceutical Technology
AUGUST 17, 2022
Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. The alliance will merge the cell and media products and process development services of RoosterBio with the worldwide cell and gene therapy manufacturing expertise of AGC. .
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
AUGUST 17, 2022
The US Food and Drug Administration (FDA) has accepted Roche ’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) plus Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to treat priorly untreated diffuse large B-cell lymphoma (DLBCL) patients. Roche expects a decision on the approval from the regulatory authority by 2 April next year.
Rethinking Clinical Trials
AUGUST 17, 2022
In this Friday’s PCT Grand Rounds, Dr. Gerald Bloomfield and Dr. Michelle Kelsey will present “Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change.” The Grand Rounds session will be held on Friday, August 19, 2022, at 1:00 pm eastern. Dr. Bloomfield is an associate professor of medicine and global health and Dr.
Bio Pharma Dive
AUGUST 17, 2022
The French drugmaker’s shares fell by more than 6% after the once promising treatment, called amcenestrant, failed its second major trial this year.
STAT News
AUGUST 17, 2022
Among the many worrying consequences of Covid-19, neuropsychiatric conditions rank high. A year ago researchers from Oxford University reported that 1 in 3 patients experienced mood disorders, strokes, or dementia six months after Covid infection. Now the same group is back with a longer-term analysis of 1.25 million Covid patient records, including what they believe is the first large-scale look at children and at new variants.
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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
NPR Health - Shots
AUGUST 17, 2022
A probe found troubling lapses in the country's organ transplant system. Blood types mismatched, diseased organs accidentally transplanted and donor organs lost or damaged in transit.
pharmaphorum
AUGUST 17, 2022
The clock is now ticking on the FDA’s review of GSK’s momelotinib for myelofibrosis patients with anaemia – the centrepiece of its $1.9 billion acquisition of Sierra Oncology which completed last month. The US regulator is due to make a decision on momelotinib by 16 June, 2023, on the basis of phase 3 results reported in January, said GSK.
NPR Health - Shots
AUGUST 17, 2022
Starting practice at the hottest time of year, football players face dangers from the heat. Georgia high school heat rules have turned the state into a national model.
STAT News
AUGUST 17, 2022
Covid-19 turned hospitals into battlefields. Wards burst at the seams, caregivers died in the thousands, staff burnout and compassion fatigue spiked as clinicians cared for critically ill patients — many of whom had declined vaccination. To one of us (A.D.), who has worked as a physician during the AIDS epidemic, in Nicaraguan war zones, at Ground Zero on 9/11, and during Hurricane Maria in Puerto Rico, Covid-19 has pulsed more fear than those scenarios combined.
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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.
NPR Health - Shots
AUGUST 17, 2022
The proposed changes at the Centers for Disease Control and Prevention come amid ongoing criticism of the agency's response to COVID-19, monkeypox and other public health threats.
STAT News
AUGUST 17, 2022
The Food and Drug Administration on Wednesday approved a new treatment that delivers a potentially permanent, genetic fix for patients with the inherited blood disorder beta thalassemia — and quite possibly a financial lifeline for its maker, the biotech company Bluebird Bio. Called Zynteglo, the one-time treatment works by replacing a defective gene with a normally functioning one, thereby allowing the body to produce healthy red blood cells.
Antidote
AUGUST 17, 2022
Clinical research studies around the United States are in need of participants to learn more about various conditions. For those interested in learning how to take part in research, finding clinical trials that might be a fit can be simple — by answering a few questions about your location and medical history, you can see all the active trials you may be eligible for.
STAT News
AUGUST 17, 2022
CLEVELAND — A federal judge in Cleveland awarded $650 million in damages Wednesday to two Ohio counties that won a landmark lawsuit against national pharmacy chains CVS, Walgreens and Walmart, claiming the way they distributed opioids to customers caused severe harm to communities and created a public nuisance. U.S. District Judge Dan Polster said in the ruling that the money will be used to abate a continuing opioid crisis in Lake and Trumbull counties, outside Cleveland.
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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.
XTalks
AUGUST 17, 2022
August is National Immunization Awareness Month (NIAM), which is marked to help raise awareness about the importance of vaccines in the protection of public health. One of the themes of this year’s National Immunization Awareness Month is “vaccines work.” This has been a particularly important message during the pandemic amid some segments of the public questioning the safety and efficacy of the COVID-19 vaccines, and vaccines in general.
STAT News
AUGUST 17, 2022
A drug made by Blueprint Medicines markedly improved symptoms of a rare immune system disorder called non-advanced systemic mastocytosis in a clinical trial that is being closely watched by investors, the company said Wednesday. Blueprint’s stock has risen 28% to $70 this month in anticipation of the results, and the data, though inarguably positive, will lead to more discussion about the drug’s safety and efficacy as well as Blueprint’s pricing strategy for it.
XTalks
AUGUST 17, 2022
Are you looking to host a webinar but struggling to come up with a title that will grab attention? Writing a good webinar title is essential if you want people to attend. In a world where we are overwhelmed with content, you need to make sure your webinar title stands out from the rest. Needless to say, a webinar title can have a profound impact on overall registration rates.
STAT News
AUGUST 17, 2022
The U.S. National Institutes of Health failed to ensure that results of roughly half of clinical trials funded by the agency — both those conducted by its own scientists and outside researchers — were reported to a federal database during a recent two-year period, a new government review has found. Of the 72 trials funded by the NIH, results for just 35 studies were reported in 2019 and 2020 to ClinicalTrials.gov, a federal repository for information on studies.
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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.
ACRP blog
AUGUST 17, 2022
While it’s obviously laudable to work to advance clinical trial diversity both in terms of patient population and workforce, it’s also important to widen the “aperture” to address a wide range of underserved populations, including the elderly, rural, people with disabilities, under/un-insured, and others, says Sarah White, executive director at the Multi-Regional Clinical Trials (MRCT) Center of Brigham & Women’s Hospital and Harvard.
STAT News
AUGUST 17, 2022
Covid-19 turned hospitals into battlefields. Wards burst at the seams, caregivers died in the thousands, staff burnout and compassion fatigue spiked as clinicians cared for critically ill patients — many of whom had declined vaccination. To one of us (A.D.), who has worked as a physician during the AIDS epidemic, in Nicaraguan war zones, at Ground Zero on 9/11, and during Hurricane Maria in Puerto Rico, Covid-19 has pulsed more fear than those scenarios combined.
BioPharma Reporter
AUGUST 17, 2022
AGC Biologics and RoosterBio have launched a strategic partnership to create an end-to-end solution for the development and production of hMSC and exosome therapeutics.
STAT News
AUGUST 17, 2022
Innovation Endeavors, the venture capital firm co-founded by former Google chairman and CEO Eric Schmidt, is bringing in one of the few researchers who saw through Theranos to help expand its biotech investing. The firm has hired Joel Dudley as a partner specializing in biotech. Until recently, Dudley served as the chief scientific officer at Tempus , a health tech unicorn that’s developing a system that can answer physicians’ cancer questions on the spot.
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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.
NPR Health - Shots
AUGUST 17, 2022
A new FDA rule is being praised for making hearing aids more affordable. But Medicare doesn't cover them, and neither do most insurance policies.
STAT News
AUGUST 17, 2022
On Target is a recurring feature from STAT that dives deep into the most promising drug targets in oncology. The hunt for cancer cures has, to a large degree, been a hunt for biomarkers — DNA, peptides, RNA, proteins or more — that might set tumor cells apart from healthy tissue. With the right biomarker, scientists can find cancers earlier, monitor a treatment’s progress, or predict if a certain therapy will work for a given patient.
pharmaphorum
AUGUST 17, 2022
Sanofi is tapping San Francisco-based Atomwise for a new AI-fuelled drug discovery deal, paying $20 million for five new drug targets — and possibly spending more than a billion in milestone payments and tiered royalties when all is said and done. The deal will see Atomwise identify, synthesize, and advance lead compounds for up to five drug targets that will then be exclusively Sanofi’s to develop.
STAT News
AUGUST 17, 2022
When the Smithsonian National Museum of Natural History opened its genomics exhibit in 2013, the field was just celebrating the 10th anniversary of the completed Human Genome Project. Sequencing that first genome cost over $500 million. The genomes since cost $10,000. In 2022, as the museum prepares to wrap up the landmark exhibit, much has changed.
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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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