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
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.
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There’s been a rapid shift towards decentralization in clinical trials & it’s clear why. The potential for reaching a larger pool of recruits is possible when sponsors can bring more trial activities to the patient. Tele visits, digital consent, new monitoring sensors, & direct-to-patient supply are virtual tools that existed before the pandemic, but now there’s swift adoption of these methods because they’ve been proven to help launch & complete trials more effectively.
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.
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.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
MAY 23, 2023
The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. SerpinPC causes the inhibition of coagulation factor XIV, which leads to an increase in thrombin production, speeding up the clot formation process. Centessa is exploring Serpin PC in a registrational program consisting of several trials, including the observational Phase II PRESent-5 clinical trial (NCT05605678).
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
ReNAgade Therapeutics has burst onto the RNA technology scene by announcing a $300m financing round. As per the company, the round, led by MPM BioImpact and F2 Ventures, is the largest Series A funding round of 2023. Founded by MPM BioImpact, ReNAgade’s portfolio includes novel lipid nanoparticles (LNPs). With its delivery system, Cambridge, Massachusetts-based biotech says it aims to “address major limitations in RNA therapeutics by enabling the delivery of RNA medicines to previously inaccessi
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.
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.
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.
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 behind the recent takeover of Jounce Therapeutics is looking to buy a second drug developer to potentially sell for parts.
Advertiser: FourKites
A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.
Pharmaceutical Technology
MAY 23, 2023
The war in Ukraine has had a significant impact on clinical trials in Europe, exacerbating supply chain delays that were already causing multiple problems even before the Covid-19 pandemic intensified the situation. When war broke out in Ukraine in early 2022, many clinical trial patients had to flee the country or relocate, presenting considerable disruption to existing clinical trials and risking data collection on medical products.
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
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
Pharma Times
MAY 23, 2023
Receptor antagonist AM1476 developed as an anti-fibrotic treatment for lung and skin disorders
Speaker: Steve Goldstein, Sales Leader
Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g
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.
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
Pharmaceutical Technology
MAY 23, 2023
The recent legislative reform proposals put forward by the European Commission (EC) have sparked significant discontent among pharmaceutical companies. The proposed changes aim to reduce the time between new drug launches in the 27 EU markets and the entry of generic competitors into the market. While a handful of incentives are offered by the reform package, they are overshadowed by the potential drawbacks for the innovative sector.
Pharma Times
MAY 23, 2023
Vital financing will allow the company to build a pipeline of novel therapies targeting serious conditions
Advertiser: Aggregage
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Pharmaceutical Technology
MAY 23, 2023
In April, the pilot-level Nordic Pharmaceutical Forum (NPF) initiative, representing Finland, Iceland, Norway, Sweden, and Denmark, released an updated strategy document outlining the region’s plans to establish a joint procurement mechanism for medicines, with a declared focus on advanced therapy medicinal products (ATMPs) such as gene therapies. According to the NPF, the function of its joint tender agreement is not limited to ensuring lower prices and security of supply.
BioSpace
MAY 23, 2023
PTC Cuts Early-Stage Pipeline but Pushes Forward on FA Drug After Phase III Flop 5/24/2023
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.
BioSpace
MAY 23, 2023
Merck’s Gardasil Under Legal Scrutiny Despite Lack of Evidence to Support Suits 5/24/2023
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.
BioSpace
MAY 23, 2023
ElevateBio Takes Title of Largest 2023 Funding with $401M Series D 5/24/2023
pharmaphorum
MAY 23, 2023
The continued questions over new Alzheimer’s treatments Mike.
BioSpace
MAY 23, 2023
Amyloid-Beta Structure Revelation Sheds Light on Leqembi’s Function 5/24/2023
pharmaphorum
MAY 23, 2023
Relevance and impact: Connecting with HCPs in the digital age Mike.
BioSpace
MAY 23, 2023
Moving From the Bench to Management: How to Become an Effective Leader 5/24/2023
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