Bio Pharma Dive
MAY 24, 2023
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.
Pharmaceutical Technology
MAY 24, 2023
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).
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Bio Pharma Dive
MAY 24, 2023
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 24, 2023
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.
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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
MAY 24, 2023
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.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 24, 2023
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
XTalks
MAY 24, 2023
Eyecare giant Bausch + Lomb received its first prescription drug approval from the US Food and Drug Administration (FDA) for its dry eye disease med Miebo (perfluorohexyloctane ophthalmic solution). The eye drops are the first and only FDA-approved treatment that directly target tear evaporation at the ocular surface to treat the signs and symptoms of dry eye disease.
Pharmaceutical Technology
MAY 24, 2023
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.
XTalks
MAY 24, 2023
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
Pharmaceutical Technology
MAY 24, 2023
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.
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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
XTalks
MAY 24, 2023
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.
Pharmaceutical Technology
MAY 24, 2023
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.
Fierce Pharma
MAY 24, 2023
Biopharma staffers exhausted and susceptible to burnout, report says kdunleavy Wed, 05/24/2023 - 16:52
Pharmaceutical Technology
MAY 24, 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: Recombinant viral vect
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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.
Drug Channels
MAY 24, 2023
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.
Pharmaceutical Technology
MAY 24, 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: Tetrapeptide derivativ
Fierce Pharma
MAY 24, 2023
Innoviva subsidiary Entasis scores FDA nod for bacterial pneumonia combo drug Xacduro kdunleavy Wed, 05/24/2023 - 09:46
Pharmaceutical Technology
MAY 24, 2023
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.
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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.
Pharma Times
MAY 24, 2023
Vital data supports early intervention in order to treat chronic obstructive pulmonary disease
Pharmaceutical Technology
MAY 24, 2023
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.
Fierce Pharma
MAY 24, 2023
After years of litigation, Gilead and Teva's HIV antitrust trial kicks off in California zbecker Wed, 05/24/2023 - 17:17
Pharmaceutical Technology
MAY 24, 2023
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
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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.
Pharma Times
MAY 24, 2023
Celadon will sell a minimum of £3m worth of the high-THC product over the next three years
Fierce Pharma
MAY 24, 2023
FDA clears Braeburn's long-acting Braxadi to treat opioid use disorder zbecker Wed, 05/24/2023 - 09:15
pharmaphorum
MAY 24, 2023
A new ABPI president; a new take on health, productivity, and partnerships – ABPI Conference part two Mike.
BioSpace
MAY 24, 2023
Annexon Sets Sights on Phase III Geographic Atrophy Trial Despite Missing Mid-Stage Mark 5/25/2023
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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.
pharmaphorum
MAY 24, 2023
AI-based infectious disease detector gets UK funding Phil.
BioSpace
MAY 24, 2023
Braeburn’s Long-Acting Brixadi Receives FDA Clearance to Treat Opioid Use Disorder 5/25/2023
BioPharma Reporter
MAY 24, 2023
Cartherics, a biotechnology company developing immune cell therapies for the treatment of cancer, will be presenting at the upcoming 2023 BIO International Convention in Boston.
BioSpace
MAY 24, 2023
Mirati’s Sitravatinib Fails in Phase III Lung Cancer Trial, Nixes Development 5/25/2023
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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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