Pharmaceutical Technology
MAY 23, 2023
Avrobio has announced a deal to sell its investigational haematopoietic stem cell (HSC) gene therapy programme , designed to treat cystinosis, to Novartis in an all-cash deal valued at $87.5m. Novartis will receive an exclusive licence for intellectual property related to the gene therapy platform of Avrobio for use in cystinosis and for other assets.
Bio Pharma Dive
MAY 23, 2023
The clearance of Ayvakit in indolent systemic mastocytosis is important to the biotech’s future. But the drug’s sales potential isn’t clear, and a top competitor is close behind.
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Pharmaceutical Technology
MAY 23, 2023
The US Food and Drug Administration (FDA) has granted approval for Blueprint Medicines’ Ayvakit (avapritinib) as the first and only treatment for indolent systemic mastocytosis (ISM) in adult patients. The precision therapy has been designed for potently and selectively inhibiting KIT D816V, which is the main underlying driver of the disease. It received FDA approval to treat ISM, advanced SM, including SM with an associated haematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and aggr
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2023
Long COVID has more than 200 potential symptoms and can affect almost every organ in the body. With more than 65 million people now estimated to live with this often-disabling condition worldwide, and numbers growing daily, there is a desperate need to understand the underlying biology driving it.
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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
Pharmaceutical Technology
MAY 23, 2023
Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade vaccine adjuvant QS-21. QS-21 is a potent component of adjuvant systems used in vaccines for diseases such as RSV, malaria and shingles, as well as in new vaccines and immunotherapy treatments such as cancer.
Bio Pharma Dive
MAY 23, 2023
Staffed by many former Alnylam and Moderna employees, the startup is developing technologies that could be useful in a variety of RNA drugmaking methods.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Bio Pharma Dive
MAY 23, 2023
A small study found patients on the experimental therapy fared no better than those receiving a placebo, dealing yet another blow to Wave’s research efforts.
AuroBlog - Aurous Healthcare Clinical Trials blog
MAY 23, 2023
Teleconsultation is seen as a viable alternative with low doctor-to-population ratio and shortage of specialists doctors. In fact, teleconsultation is seen to bridge this gap by allowing patients in remote areas to receive earlier diagnosis and treatment with low cost and faster follow-up check-ups. We have seen teleconsultation has become an essential solution in India.
Pharmaceutical Technology
MAY 23, 2023
The global pharmaceutical industry experienced a 23% decline in the number of environmental sustainability-related patent applications in Q1 2023 compared with the previous quarter. The total number of environmental sustainability-related grants dropped by 24% in Q1 2023, according to GlobalData’s Patent Analytics. With an increasing focus on ESG, Pharmaceutical companies are under pressure to incorporate sustainability with suppliers playing a crucial role in the process.
Pharma Mirror
MAY 23, 2023
Davis, California – Croda Pharma and BSI announced that they have entered into a strategic collaboration agreement to support the sustainable sourcing of pharmaceutical grade adjuvant QS-21, a potent component of adjuvant systems. QS-21 is used in several innovative vaccines against diseases such as shingles, malaria and RSV, plus promising new vaccine and immunotherapy treatments such as cancer.
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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
MAY 23, 2023
Quanta Therapeutics has raised $50.7 million in a Series D round that will be used to fund the development of two of its allosteric KRAS inhibitors in 2024. Last month, the South San Francisco, California-headquartered company presented preclinical data on its KRAS inhibitor pipeline, which includes QTX3034 and QTX3046 at the Annual Meeting of the American Association for Cancer Research in Orlando, Florida.
Bio Pharma Dive
MAY 23, 2023
The company plans to seek approvals of the drug, a more convenient form of the popular injectable medicine Wegovy, later this year.
Pharmaceutical Technology
MAY 23, 2023
The US Food and Drug Administration (FDA) has granted approval for Indivior’s Opvee (nalmefene) nasal spray to reverse opioid overdose. Opvee is indicated for the emergency treatment of known or suspected opioid overdose in adults and paediatric patients aged 12 years and above. It comprises the opioid receptor antagonist nalmefene, which offers quick onset and long-duration reversal of the opioid-induced respiratory depression that is said to be the main cause of opioid overdose injury and deat
Bio Pharma Dive
MAY 23, 2023
The company behind the recent takeover of Jounce Therapeutics is looking to buy a second drug developer to potentially sell for parts.
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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
MAY 23, 2023
The UK’s medicines and healthcare products regulatory agency (MHRA) has granted marketing authorisation for Akebia Therapeutics’ Vafseo (vadadustat) to treat symptomatic anaemia associated with chronic kidney disease (CKD) in adult patients on chronic maintenance dialysis. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat has been designed for imitating the physiologic effect of altitude on oxygen availability.
Drug Channels
MAY 23, 2023
In 2022, the PBM market remained highly consolidated—although there were some intriguing share shifts among the largest players. Below, you’ll find Drug Channels Institute's latest estimates of pharmacy benefit manager (PBM) market share based on equivalent prescription claims. I also provide commentary on recent market developments and offer some helpful tips for interpreting the figures.
Pharmaceutical Technology
MAY 23, 2023
BioCryst Pharmaceuticals has secured marketing authorisation from the Public Health Institute (ISP) of Chile for oral, once-daily ORLADEYO (berotralstat) for the prophylactic treatment of hereditary angioedema (HAE) attacks in patients aged 12 years and above. ORLADEYO is an oral therapy that has been primarily developed to prevent HAE attacks by inhibiting plasma kallikrein activity.
Pharma Times
MAY 23, 2023
Receptor antagonist AM1476 developed as an anti-fibrotic treatment for lung and skin disorders
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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
MAY 23, 2023
AlzeCure Pharma has secured a patent from the European Patent Office (EPO) covering its drug candidate, ACD856. The patent has been granted in Europe and is expected to offer protection until 2039. A significant drug candidate in the NeuroRestore platform, ACD856 is being developed to treat Alzheimer’s disease and other disorders associated with cognitive impairment.
Fierce Pharma
MAY 23, 2023
Amid high-profile injectable launch, Novo Nordisk scores with its pill version of obesity drug Wegovy kdunleavy Tue, 05/23/2023 - 10:34
Pharma Times
MAY 23, 2023
Vital financing will allow the company to build a pipeline of novel therapies targeting serious conditions
BioSpace
MAY 23, 2023
PTC Cuts Early-Stage Pipeline but Pushes Forward on FA Drug After Phase III Flop 5/24/2023
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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.
pharmaphorum
MAY 23, 2023
The continued questions over new Alzheimer’s treatments Mike.
BioSpace
MAY 23, 2023
Merck’s Gardasil Under Legal Scrutiny Despite Lack of Evidence to Support Suits 5/24/2023
Drug Patent Watch
MAY 23, 2023
Annual Drug Patent Expirations for MYDAYIS Mydayis is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are three… The post New patent expiration for Takeda Pharms drug MYDAYIS appeared first on DrugPatentWatch - Make Better Decisions.
BioSpace
MAY 23, 2023
Moving From the Bench to Management: How to Become an Effective Leader 5/24/2023
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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.
Antidote
MAY 23, 2023
Chronic kidney disease (CKD) is a medical condition that occurs when the kidneys experience a gradual loss of functioning that inhibits their ability to filter blood. It is estimated to impact over 37 million Americans, and millions more are at an increased risk.
BioSpace
MAY 23, 2023
Amyloid-Beta Structure Revelation Sheds Light on Leqembi’s Function 5/24/2023
Drug Discovery World
MAY 23, 2023
New Phase IIa data indicates that Vicore Pharma’s C21 has the potential to transform the treatment of idiopathic pulmonary fibrosis (IPF) and restore lung function. In data from the AIR trial, C21 has demonstrated long-term efficacy. At 36 weeks, the average forced vital capacity (FVC) had increased to +350ml over baseline, which is +530ml over the expected trajectory of untreated patients.
BioSpace
MAY 23, 2023
ElevateBio Takes Title of Largest 2023 Funding with $401M Series D 5/24/2023
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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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