Bio Pharma Dive
JUNE 22, 2023
The conditional clearance for Sarepta’s Elevidys in 4- and 5-year-olds is a milestone for research into the deadly disease, and raises the stakes of an ongoing trial that could prove how well it works.
Pharmaceutical Technology
JUNE 22, 2023
The European Commission’s (EC) plan to test a novel scheme to incentivise antimicrobial drug development companies remains beset by questions amidst the bloc’s drive to tackle the growing threat of antimicrobial resistance (AMR). Presented as part of the EC’s long-awaited pharmaceutical reform in late April, the scheme aims to encourage the research of novel antimicrobials by creating a system of transferable exclusivity vouchers.
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AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 21, 2023
A large study covering 37 years from start to finish has revealed something about those who tend to stay up late: These night owls are more likely to die at a younger age, but due to smoking and drinking-related causes rather than how late they go to bed.
Fierce Pharma
JUNE 20, 2023
Used by Egyptians 35 centuries ago as a remedy for inflammation, colchicine was found over the ages to be effective against a variety of maladies including gout, dropsy and familial Mediterranean f | Agepha Pharma, a family-owned company based in Slovakia, has gained an FDA approval for Lodoco, which becomes the first drug to target cardiovascular inflammation.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
Pharmaceutical Technology
JUNE 21, 2023
CSL announced the first patient with haemophilia B has been treated with its recently approved gene therapy Hemgenix (etranacogene dezaparvovec). Hemgenix is the first and only gene therapy approved for haemophilia B. At $3.5m per dose, it is the most expensive single-use gene therapy in the US. The high price tag may be hard to defend , but with lifetime treatment costs for haemophilia B reaching as high as $23m for some, the single-dose treatment could prove far more cost-effective.
Bio Pharma Dive
JUNE 20, 2023
The company said limitations on "bridging treatment" used to hold cancer in check could be to blame, and is working with the FDA to change the study's protocol.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharma Times
JUNE 22, 2023
ATLX-1088 is regarded as a possible first-in-class human antibody targeting CD33 – a cell surface protein - News - PharmaTimes
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 18, 2023
A type of bacteria commonly found in human oral and gut flora could play a major role in the development of endometriosis, scientists have discovered – potentially giving us crucial insight into the development of the painful condition, and opening up new ways to treat it.
Bio Pharma Dive
JUNE 21, 2023
While treated patients appear to be doing better than history suggests they would, mixed findings involving a key surrogate marker perplexed Wall Street analysts and sent shares falling 38%.
Pharmaceutical Technology
JUNE 20, 2023
The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator. Developed using pharmaceutical company GSK’s pandemic adjuvant, the vaccine targets the receptor-binding domain of the SARS-CoV-2 spike protein.
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
Pharma Times
JUNE 21, 2023
Candidate is a cancer therapy that has been chemically modified with Avacta’s pre|CISION platform - News - PharmaTimes
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 19, 2023
In a major scientific first, synthetic human embryo models have been grown in the lab, without any need for the usual natural ingredients of eggs and sperm. The research – first brought to wider attention by The Guardian – has prompted excitement about the potential for new breakthroughs in health, genetics, and treating disease.
Bio Pharma Dive
JUNE 22, 2023
The cost makes Sarepta’s treatment, called Elevidys, among the most expensive medicines in the world. But company executives said they don’t expect significant insurer pushback.
Pharmaceutical Technology
JUNE 23, 2023
Psylo and Daiichi Sankyo have signed a sponsored research deal to advance the development of non-hallucinogenic psychiatric therapies.
Pharma Times
JUNE 23, 2023
Companies’ precision medicine approach has potential to increase clinical trial success rates - News - PharmaTimes
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 22, 2023
Scientists have demonstrated how nasal drops containing a particular molecule can help mice recover from the damaging biological consequences of a stroke – and the hope is that the treatment could eventually be transferred to humans. [link] Crucially, the treatment isn’t applied straight away but is initiated seven days after the stroke.
Bio Pharma Dive
JUNE 21, 2023
Empress Therapeutics claims its technology allows it to identify chemical drug candidates faster and more reliably. It has $50 million from Flagship to prove it can.
Pharmaceutical Technology
JUNE 22, 2023
Eli Lilly and Boehringer Ingelheim have received approval from the US FDA for Jardiance to treat type 2 diabetes in children
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Pharma Times
JUNE 23, 2023
The organisations will focus on the delivery of clinical trials which concentrate on rare cancers - News - PharmaTimes
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 20, 2023
Scientists have discovered cannabidiol, a compound in cannabis known as CBD, in a common Brazilian plant, opening potential new avenues to produce the increasingly popular substance, a lead researcher said Thursday.
Bio Pharma Dive
JUNE 20, 2023
Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.
Pharmaceutical Technology
JUNE 22, 2023
The SFDA of the KSA has granted approval to Amarin’s VASCEPA (icosapent ethyl) capsules for reducing cardiovascular risk.
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pharmaphorum
JUNE 23, 2023
Generative Health: A new standard of care Mike.
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 22, 2023
The Central Drugs Standard Control Organisation (CDSCO) has said that a joint investigation team of its East Zone office and the State Licensing Authority (SLA) of Sikkim have declared the samples of Glenmark Pharmaceuticals’ blood pressure-lowering drug Telma 40 failed in the quality tests in February, 2023, as spurious.
Bio Pharma Dive
JUNE 23, 2023
In a memo made public Friday, Peter Marks, head of the agency office that oversees gene therapies, wrote that he disagreed with other reviewers and saw “compelling” evidence to clear Elevidys.
Pharmaceutical Technology
JUNE 21, 2023
AGEPHA Pharma has received approval from the US Food and Drug Administration (FDA) for LODOCO (colchicine, 0.5 mg tablet) to treat cardiovascular disease. LODOCO is indicated for reducing the risk of stroke, myocardial infarction and cardiovascular death in adults with established atherosclerotic cardiovascular disease (ASCVD) or with multiple risk factors for the disease.
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.
Pharma Times
JUNE 20, 2023
The treatment is administered intravenously prior to surgery, lighting up cancer during surgery - News - PharmaTimes
AuroBlog - Aurous Healthcare Clinical Trials blog
JUNE 21, 2023
The Central Drugs Standard Control Organisation (CDSCO) has started carrying daily updates of the number of batches of cough syrup samples submitted with each of the laboratories prior to exports in its website, in order to enable time bound testing and release of reports.
Bio Pharma Dive
JUNE 23, 2023
Ahead of Leqembi’s possible full approval next month, the agency released details emphasizing how the required registry to track patient outcomes will be free and easy to use.
Pharmaceutical Technology
JUNE 19, 2023
UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The FDA will make an approval decision by the new Prescription Drug User Fee Act (PDUFA) target action date of 16 September 2023. The reason for this review extension was undisclosed in the announcement.
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