STAT
JUNE 28, 2023
The Gates Foundation unveiled plans Wednesday to fund a long-awaited trial for what, if proven effective, would be the first new tuberculosis vaccine in over a century. The 26,000-person, Phase 3 study, set to begin next year, will test a vaccine known as M72/AS01 that showed promising results from a smaller trial in 2019. The findings stoked excitement at the time.
PharmaVoice
JUNE 28, 2023
Although DEI efforts have ramped up, the industry is still searching for proven ways to get results.
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STAT
JUNE 28, 2023
Until the early 20th century, America regularly experienced brutally destructive urban fires. Conflagrations like the 1871 Great Chicago Fire, which destroyed more than 17,000 buildings and left 100,000 people homeless, were thought to be unfortunate but inevitable: Large numbers of buildings in close proximity naturally led to large fires. But then, conscious changes to the built environment eliminated large urban fires.
Pharma Times
JUNE 28, 2023
Trial involved over 450 women across Europe, Turkey and Canada who were unsuitable for hormone therapy - News - PharmaTimes
Speaker: Chris Antypas and Josh Halladay
Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.
STAT
JUNE 28, 2023
Thanks to advances in treatments, children’s chances of surviving cancer are higher than ever before. But the trauma that patients experience as they deal with the disease can pose a lifelong risk to their mental health, according to a recent analysis published in JAMA Pediatrics. The meta-analysis of 52 clinical studies measured the prevalence and severity of psychological disorders in over 20,000 young cancer survivors.
The Pharmacist
JUNE 28, 2023
Virtual care platform Suvera has been contracted by NHS North East London Integrated Care Board for a remote hypertension programme involving pharmacist-led virtual care teams. The six-month hypertension outreach and patient management programme will be available in North East London boroughs with high deprivation levels, including Tower Hamlets, Newham and Waltham Forest.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
Express Pharma
JUNE 28, 2023
Chushul Suri, Founder and CEO, Medbikri highlights that the use of advanced digital technologies has improved inventory management in pharmacies by making it more secure and cost-effective Pharmacies have always been an integral part of the Indian healthcare system. It is the link between a doctor’s prescription and patients acquiring the medicines to recover from their illnesses.
STAT
JUNE 28, 2023
Drug shortages are a growing problem in the U.S., and a shortage of livesaving cancer drugs in particular has reached crisis levels. On the latest episode of the “First Opinion Podcast,” oncologist Kristen Rice explains that drug shortages have been happening for several years but have been progressively worsening in the past few months.
Pharmaceutical Commerce
JUNE 28, 2023
In an interview with Pharma Commerce Editor, Nicholas Saraceno, Courtney Granville, Director, Scientific Affairs, Drug Information Association, discusses issues impacting broader supply chains.
STAT
JUNE 28, 2023
For two days starting on Sunday, Moonlake Immunotherapeutics happily crunched numbers and shared results from a mid-stage clinical trial that depicted its experimental antibody in the most flattering terms possible. The drug, called sonelokimab, was “changing the game” for the treatment of a debilitating skin condition called hidradenitis suppurativa, or HS, said Moonlake CEO Jorge Santos da Silva, on a call for investors and analysts.
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Pharma Times
JUNE 28, 2023
GLORIA trial shows increased survival levels among newly diagnosed brain cancer patients - News - PharmaTimes
STAT
JUNE 28, 2023
In 20 states, people are once again breathing in hazardous smoke from Canadian wildfires. The return of the air quality warnings, just weeks after the first took much of the U.S. by surprise, are a reminder that we will keep experiencing these conditions in the absence of integrated and health-driven climate adaptation policies. As global temperatures continue to rise, we are likely to see more periods of extreme and prolonged heat as well as reduced rainfall and humidity, which in turn increase
Pharmaceutical Technology
JUNE 28, 2023
Research has shown that GLP-1RAs may have the potential to treat chronic metabolic diseases such as non-alcoholic steatohepatitis (NASH).
STAT
JUNE 28, 2023
WASHINGTON — Most of the medical community has acknowledged that racism is baked into many of its clinical tools: pulse oximeters and kidney function calculators are prime examples. But as presentations at a conference Tuesday showed, physicians remain divided on when to remove race from calculators and algorithms — and crucially, what characteristics should replace it.
Pharmaceutical Technology
JUNE 28, 2023
GSK has received a Fast Track designation for its Neisseria gonorrhoeae investigational vaccine from the US Food and Drug Administration.
STAT
JUNE 28, 2023
Good morning, everyone, and how are you today? We are doing just fine, thank you. Given that this is already the middle of the week and we have survived this far, no reason not to continue, yes? Just consider the alternatives. In fact, this modest accomplishment calls for celebration. So please join us in quaffing a ritual cup of needed stimulation.
European Pharmaceutical Review
JUNE 28, 2023
According to a report by Verified Market Research, the global high-performance liquid chromatography (HPLC) market is projected to reach a value of $8,084.56 million by 2030, growing at a compound annual growth rate (CAGR) of 5.57 percent from 2023 to 2030. What is driving the HPLC market? Growth of the pharmaceutical and biotechnology industries, plus the need for accurate and precise analytical tools in drug development and quality control are influencing factors.
World Pharma News
JUNE 28, 2023
This afternoon at 2 pm CET (8 am EDT), Bayer AG will host its Pharmaceuticals R&D Event 2023 for Investors. The company will present a deep dive on the innovation strategy in its four therapeutic core areas Oncology, Cardiovascular Diseases, Neurology & Rare Diseases and Immunology. The presentations will also include status updates on Bayer Pharmaceuticals' key assets in clinical and preclinical development as well as on its platform companies Asklepios BioPharmaceutical (AskBio), BlueR
European Pharmaceutical Review
JUNE 28, 2023
Obicetrapib as a treatment for reducing cholesterol levels has potential to be the first cholesteryl ester transfer protein (CETP) inhibitor to advance to clinical practice, data and analytics company GlobalData has reported. This forecast is based on positive data from NewAmsterdam Pharma’s Phase II ROSE2 trial evaluating obicetrapib in combination with ezetimibe as an adjunct to high-intensity statin therapy.
Pharmaceutical Technology
JUNE 28, 2023
Cellusion shares Phase I/II clinical development plans for its bullous keratopathy stem cell therapy CSL-001.
European Pharmaceutical Review
JUNE 28, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved a first-of-its-kind trial to run this year to test psychedelic drugs as a treatment for major depressive disorder (MDD). The clinical trial will combine dosages of a new psilocin-based drug with specialist therapy. The novel psilocin prodrug MSP-1014, the drug being used in the clinical trial is anticipated to exert similar efficacy to psilocybin in improving symptoms of depression. “This is an exciting milestone a
Outsourcing Pharma
JUNE 28, 2023
Dr. Theresa Heah is the CEO of Intergalactic Therapeutics, bringing over two decades of global leadership experience in ophthalmology drug development along with commercialization in early-stage, private-staged companies. We spoke to her about her background, overcoming adversity and unlocking the power of science. Losing her father at 5 years old due to a lack of medical advancement in her native Malaysia is what, she says, drove and determined her career.
The Pharmacist
JUNE 28, 2023
The government knew more about the pharmaceutical supply chain in the UK at the time the Covid-19 pandemic struck than at ‘any time in history’, the former health secretary Matt Hancock has claimed. While providing evidence to the ongoing UK Covid-19 Inquiry, Mr Hancock said that work done for a no-deal Brexit had meant that […] The post Ministers knew more about drug supply during Covid than ‘at any other time in history’ appeared first on The Pharmacist.
BioPharma Dive
JUNE 28, 2023
A manufacturing issue led the agency to turn back an application for a high-dose form of Eylea, surprising analysts and delaying a launch the company is relying on to answer a competitive threat from Roche.
pharmaphorum
JUNE 28, 2023
How social media is helping clinicians on the front line in the treatment of rare diseases Mike.
BioPharma Dive
JUNE 28, 2023
The companies aim to seek an FDA nod for their bispecific antibody, Epkinly, in follicular lymphoma, where it would compete with a recently approved Roche medicine.
pharmaphorum
JUNE 28, 2023
Nkarta tweaks regimen in bid to revive AML programme Phil.
Pharmacy Joe
JUNE 28, 2023
In this episode, I’ll discuss using heparin anti-Xa levels to evaluate apixaban, rivaroxaban, fondaparinux, and danaparoid levels. Episode 830: Using Heparin Anti-Xa Levels to Evaluate Apixaban, Rivaroxaban, Fondaparinux, or Danaparoid Levels Subscribe on iTunes , Android , or Stitcher Anti-Xa inhibitors such as apixaban, rivaroxaban, fondaparinux, and danaparoid do not have readily available assays, yet there is often a clinical need to determine their presence or absence.
pharmaphorum
JUNE 28, 2023
AbbVie, Genmab eye label expansion for Epkinly Phil.
Pharmaceutical Business Review
JUNE 28, 2023
The letter is based on a continuing assessment of inspection data at a third-party filler. No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical trial, labelling or production of drug substance were noted in the CRL. The regulatory agency also did not seek any further clinical findings or trials. Submissions to European and Japanese regulators for the product are being reviewed currently.
pharmaphorum
JUNE 28, 2023
Breaking down barriers: Data quality as a driver for pharma transformation Mike.
Pharma Leaders
JUNE 28, 2023
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals for its Biologics License Application (BLA) for aflibercept 8mg to treat wet diabetic macular oedema (DME), age-related macular degeneration (wAMD) and diabetic retinopathy (DR). The letter is based on a continuing assessment of inspection data at a third-party filler.
Drug Patent Watch
JUNE 28, 2023
Annual Drug Patent Expirations for KENGREAL Kengreal is a drug marketed by Chiesi and is included in one NDA. It is available from one supplier. There are eight patents protecting… The post New patent expiration for Chiesi drug KENGREAL appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog: Biosimilars
JUNE 28, 2023
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Philip Won — The Center for Devices and Radiological Health’s (CDRH) Standards and Conformity Assessment Program (S-CAP) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions. Use of voluntary consensus standards can reduce regulatory burden, streamline conformity assessment, harmonize requirements globally, and enhance the quality and safety of a device.
Drug Patent Watch
JUNE 28, 2023
Annual Drug Patent Expirations for BORTEZOMIB Bortezomib is a drug marketed by Accord Hlthcare, Apotex, Baxter Hlthcare Corp, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Jiangsu Hansoh Pharm, Meitheal,… The post New patent for Maia Pharms drug BORTEZOMIB appeared first on DrugPatentWatch - Make Better Decisions.
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