FDA Law Blog
DECEMBER 7, 2022
By Mark A. Tobolowsky & James E. Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
Bio Pharma Dive
DECEMBER 6, 2022
In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups.
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Pharmaceutical Technology
DECEMBER 8, 2022
Kite Pharma and Daiichi Sankyo have updated a partnership agreement signed in 2017 for the former’s CAR T-cell therapy, Yescarta (axicabtagene ciloleucel). Under the prior deal, Daiichi Sankyo acquired exclusive rights for the development, manufacturing and commercialisation of Yescarta in Japan. Subsequently, in the same year, Gilead Sciences acquired Kite.
STAT News
DECEMBER 9, 2022
There’s been significant investment in companies creating artificial intelligence (AI) applications for health and health care over the last decade. But while there have been successes, notably in the area of medical imaging, the industry is known more for not yet living up to its potential — think IBM Watson. The slow pace of AI adoption in health care stems from the fact that health AI sits on the border between two large industries, health care and tech.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
NPR Health - Shots
DECEMBER 8, 2022
The experimental drug lecanemab was able to slow down Alzheimer's in a large study. Many researchers think the drug will become the first to help large numbers of patients.
Bio Pharma Dive
DECEMBER 8, 2022
As the success of drugs like Enhertu catalyzes new investment in antibody-drug conjugates, the California startup is launching with plans to develop more potent versions of the targeted cancer medicines.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
STAT News
DECEMBER 6, 2022
Two vastly different experiences — serving as a “guest coach” on the sidelines for a Division I football team and volunteering in a busy emergency department — showed me just how unequal and damaging the lack of care provided for women who are victims of domestic violence can be. In the first decade of the 2000s, one of the benefits of being a professor at Wake Forest University was the opportunity I received nearly every year to serve as a guest coach.
NPR Health - Shots
DECEMBER 3, 2022
Makers of products like Children's Tylenol say they're trying to keep up with big demand as RSV, flu, and COVID spread. But medical experts note that kids' fevers don't always call for medicine.
Bio Pharma Dive
DECEMBER 5, 2022
After a private equity takeover unraveled this summer, the women’s health company is selling its drug portfolio to Mayne Pharma in a $153 million deal.
Pharmaceutical Technology
DECEMBER 8, 2022
The US Food and Drug Administration (FDA) has granted an amendment to the Emergency Use Authorization (EUA) for Pfi z er and BioNTech’s Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for usage in children aged six months to four years. The vaccine is indicated for use as a third 3µg dose in the three-dose initial regimen for children of this age group.
STAT News
DECEMBER 8, 2022
Doctors across the country, especially those in primary care, have been up in arms about Medicare’s proposed cuts in reimbursement that are scheduled to go into effect on January 1. They are concerned — rightfully so — that these cuts will be ruinous to their practices and compromise the care they can provide to their patients. As an emergency physician, I worry about the cuts for a different reason: emergency departments might soon be filled with more and more people who ca
NPR Health - Shots
DECEMBER 6, 2022
China doles out much cash for infrastructure. It must be repaid. Is that frustrating for recipients? A new survey has a surprising answer. But skeptics wonder: How honest were the participants?
Bio Pharma Dive
DECEMBER 8, 2022
The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result.
Pharmaceutical Technology
DECEMBER 5, 2022
Sanofi has signed an agreement with the Queensland Government in Australia to establish a $190m (A$280m) research facility in Brisbane. With the establishment of this Translational Science Hub, Queensland is set to become an international messenger ribonucleic acid (mRNA) vaccine hub. According to the latest deal, the University of Queensland (UQ) and Griffith University will serve as foundational partners.
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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
Pharma Times
DECEMBER 7, 2022
Data reinforces potential to deliver new standards across HER2-targetable breast cancer
NPR Health - Shots
DECEMBER 4, 2022
For decades birth control research focused on women. Now there's a new push to develop gels, pills or other products that could keep men from getting their partners pregnant.
Bio Pharma Dive
DECEMBER 9, 2022
Cell therapy Instil Bio will cut 60% of its staff and Sensei Bio will reduce its headcount by 40%. TherapeuticsMD, meanwhile, is laying off all its employees days after announcing a deal to sell off its drug portfolio.
Pharmaceutical Technology
DECEMBER 5, 2022
Cannabinoid receptors are a popular therapeutic target for cannabinoid-based drugs in the treatment of pain, neurological disorders and inflammation, according to GlobalData’s Pharma Intelligence Centre Drugs database. In 2022, a surge in the pipeline has led to cannabinoid receptors becoming the most popular target in preclinical development. Despite this, the medical use of cannabinoid drugs is heavily restricted, including being banned in 137 countries, according to the United Nations.
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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.
Medical Xpress
DECEMBER 8, 2022
Florida State University College of Medicine researchers have linked aspartame, an artificial sweetener found in nearly 5,000 diet foods and drinks, to anxiety-like behavior in mice.
NPR Health - Shots
DECEMBER 9, 2022
The reluctance of many citizens — especially the elderly — to get vaccinated is a problem for a government facing intense pressure to roll back strict COVID policies.
Bio Pharma Dive
DECEMBER 7, 2022
The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.
Pharmaceutical Technology
DECEMBER 7, 2022
On 29 November, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) warned of some new and potentially serious eye-related side effects associated with Dupixent, an interleukin (IL)-4/13 inhibitor drug used in the treatment of numerous allergic indications such as atopic dermatitis, asthma and nasal polyps. GlobalData anticipates that this safety update will likely raise physician and regulator vigilance regarding long-term Dupixent use but is unlikely to impact overall prescribi
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.
STAT News
DECEMBER 7, 2022
For many patients, one of the most antagonizing parts of a hospital visit is paying for parking. Those parking fees aren’t just an annoyance for the sick and injured, according to a new paper in the Journal of Medical Imaging and Radiation Sciences. The charges are actually eating into their financial well-being, particularly for people who have cancer and have to make frequent visits to the hospital for treatments like radiation and chemotherapy.
Medical Xpress
DECEMBER 9, 2022
A new study in the journal Nature Communications reveals how a viral toxin produced by the SARS-CoV-2 virus may contribute to severe COVID-19 infections.
Bio Pharma Dive
DECEMBER 6, 2022
The second startup to emerge from Star’s “hub-and-spoke” model aims to develop a Hemlibra-like antibody drug for the blood clotting disorder von Willebrand disease.
Pharmaceutical Technology
DECEMBER 9, 2022
The European Commission (EC) has granted marketing authorisation for Takeda ’s Qdenga (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) to prevent dengue in people aged four years and above. This development comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency provided a positive recommendation in October this year.
Pharma Times
DECEMBER 8, 2022
Implantable ARC therapy demonstrates potential to improve blood pressure regulation
NPR Health - Shots
DECEMBER 4, 2022
Sangeeta Siwan lost her job and wasn't able to pay rent or feed her family. Her neighbors helped her survive. A study of giving in India during the pandemic shows she wasn't alone.
Bio Pharma Dive
DECEMBER 5, 2022
The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.
Pharmaceutical Technology
DECEMBER 8, 2022
Touchlight and Odimma Therapeutics have entered an agreement for the development and supply of clinical material for usage in the latter’s neoantigen programme for cancer. According to the agreement, Odimma will obtain access to the doggybone deoxyribonucleic acid (dbDNA) vector technology of Touchlight. . This will back and strengthen their immunotherapy cancer treatment candidate’s 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.
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