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The agency will extend its review of Sarepta’s treatment by roughly one month as it weighs limiting an initial OK only to children with Duchenne aged 4 to 5 years old.
By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases. The ability to modify or introduce genetic material in human cells in such a precise and patient-centered manner clearly constitutes a breakthrough in personalized medicine.
The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.
Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. The BGTC is part of the accelerating medicines partnership (AMP) programme and is managed by the Foundation for the National Institutes of Health (FNIH).
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
The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.
An estimated 2.8 million people around the world have multiple sclerosis (MS), an autoimmune disease in which the immune system damages the brain and spinal cord. Symptoms include fatigue, vision disturbance, problems with mobility and balance, and cognitive dysfunction.
The US Food and Drug Administration (FDA) has approved Braeburn’s Brixadi (buprenorphine) – a subcutaneous extended-release injection available in weekly or monthly treatments. Patients with opioid use disorder (OUD) who have started treatment with a single dose of a transmucosal buprenorphine product or those who are already being treated with buprenorphine will be eligible to take the newly approved treatment option.
The US Food and Drug Administration (FDA) has approved Braeburn’s Brixadi (buprenorphine) – a subcutaneous extended-release injection available in weekly or monthly treatments. Patients with opioid use disorder (OUD) who have started treatment with a single dose of a transmucosal buprenorphine product or those who are already being treated with buprenorphine will be eligible to take the newly approved treatment option.
With an intention to bring both the administrations of the food safety department and the drug control under one controller, the Government of Tamil Nadu has given the charge of director of drugs control administration (DCA) to the commissioner of food safety, R Lalvena, an IAS officer.
HBM’s wholly owned subsidiary Nona Biosciences has entered an agreement with OPKO Health’s ModeX Therapeutics for the discovery of antibodies. ModeX Therapeutics will gain access to the fully human Harbour Mice platforms of Nona Bioscience for integration into its MSTAR platform to expedite the monoclonal antibodies’ discovery. This is expected to significantly shorten the preclinical antibody therapeutics development process.
Y-mAbs Therapeutics has received marketing authorisation for Danyelza (naxitamab-gqgk) 40mg/10mL injection from the Brazilian Health Regulatory Agency, Agência Nacional de Vigilância Sanitária, to treat high-risk neuroblastoma. Danyelza is a recombinant humanised monoclonal antibody that acts on the ganglioside GD2 that is highly expressed in several neuroectoderm-derived tumours and sarcomas.
Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). The investigational DNA medicine candidate INO-3107 has been designed for eliciting a targeted T cell response against HPV[human papillomavirus]-6 and HPV-11, the types of HPV that cause RRP and other related diseases.
CohBar has entered into a definitive merger deal with Morphogenesis to advance a late-stage clinical immuno-oncology pipeline of therapies to overcome resistance to cancer immunotherapy. Expected to operate under the name TuHURA Biosciences, the combined company will focus on advancing two technologies of Morphogenesis that seek to overcome the major hurdles which limit existing immunotherapies’ effectiveness in treating cancer.
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: Recombinant viral vect
In The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies , I shared Drug Channels Institute's analysis showing that three pharmacy benefit managers (PBMs)—the Caremark business of CVS Health, the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group—accounted for about 80% of total equivalent prescription claims in 2022.
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: Tetrapeptide derivativ
Rocket Pharmaceuticals has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for its gene therapy RP-L301 to treat pyruvate kinase deficiency (PKD), The investigational lentiviral-based gene therapy comprises autologous (patient-derived) hematopoietic stem cells (HSCs) genetically modified with a lentiviral vector containing a functional copy of the PKLR [pyruvate kinase-encoding] gene.
China’s National Medical Products Administration (NMPA) has accepted Shanghai Junshi Biosciences ’ supplemental new drug application (sNDA) for toripalimab in combination with chemotherapy to treat advanced triple-negative breast cancer (TNBC). The anti-PD-1 monoclonal antibody toripalimab will be used along with albumin-bound paclitaxel to treat PD-L1 positive (CPS ≥ [greater than or equal to] 1) untreated metastatic or recurrent metastatic TNBC.
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.
Earlier this month, Novo Nordisk revealed that they would be limiting starter doses of their obesity pharmacotherapy, Wegovy (semaglutide), in the US until September, in an effort to avoid running into supply shortages. It is an issue that the company faced in March 2022, which resulted in halted sales of Wegovy and a delay in launching in the EU. The demand for Wegovy currently outweighs supply capacity, as it is the first therapy to be approved in the obesity space that is administered on a we
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
Leading health solutions company CVS Health recently disclosed that its clinical trial business will shut down just two years after its initiation in May 2021. The company will gradually wind down its CVS Health Clinical Trial Services unit with full exit by December 31, 2024. According to the company, it is an attempt to focus on its core businesses which include retail pharmacy, health insurance, prescription drug coverage and health care and wellness. “We continually evaluate our portfo
Manuka honey, a natural product renowned for its antibacterial and potential health benefits, has been at the center of a prolonged legal dispute between Australia and New Zealand. The conflict involves the naming rights to “Manuka honey,” a product whose potential health benefits and significant price markup have made it a highly sought-after commodity in the international market.
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.
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