STAT
FEBRUARY 19, 2024
Six years ago, the National Institutes of Health placed its biggest ever bet on precision medicine, launching a study to enroll over 1 million participants in an ambitious data-gathering gambit unmatched in its scope and diversity. Since then, Americans from all walks of life have been showing up and handing over their blood, spit, and pee to the project, dubbed “All of Us.
pharmaphorum
FEBRUARY 19, 2024
Fast approaching the end of its patent life, Roche and Novartis’ Xolair is going out with a bang, picking up a new approval as the first and only drug therapy for people with food allergies in the US.
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STAT
FEBRUARY 19, 2024
Niacin, or vitamin B3, has long been a U.S. public health darling to the point that it is added, by law, to cereal products. But a new study published Monday in Nature Medicine points to a potentially concerning effect of an excess of the vitamin: It may increase the risk of cardiovascular disease. The study looked into two cohorts of patients without active heart disease, 60% of whom were treated with statins, and found a strong association between a metabolic product of excess niacin and an in
The Pharmacist
FEBRUARY 19, 2024
NHS England (NHSE) has launched its awaited Pharmacy First campaign to encourage patients to visit their local community pharmacy for the seven conditions covered under the service. The multimedia campaign features ‘temporarily rebranded’ pharmacy signs, bearing names such as ‘It Burns When I Pee Pharmacy’, ‘He’s Got An Itchy Rash Pharmacy’, ‘I’m So Bunged Up […] The post NHSE launches public-facing Pharmacy First campaign appeared first on The Pharmacist.
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
FEBRUARY 19, 2024
Mental illness can cause or worsen obesity, and obesity can cause or worsen mental illness. As an endocrinologist (Jody) and a psychiatrist (Karen), we know this connection better than most people, so we have long checked in with each other to help our mutual patients. Until recently, a quick curbside chat would do, asking, “Can I add bupropion if this patient is taking another antidepressant?
pharmaphorum
FEBRUARY 19, 2024
Learn how biotechnology trials are transforming clinical data management systems, leveraging machine learning and advanced protocols to enhance efficiency and accuracy in data collection and analysis.
Pharmacist Digest brings together the best content for pharmacists from the widest variety of industry thought leaders.
pharmaphorum
FEBRUARY 19, 2024
This case study explores the collaborative efforts of MGI and Alacris Theranostics in utilising molecular tumour profiling technology for advanced research. Discover the impact of this innovative approach on personalised medicine and treatment strategies.
The Pharmacist
FEBRUARY 19, 2024
Guidance for pharmacists across all sectors to support the prevention and management of iron deficiency anaemia has been published by the International Pharmaceutical Federation (FIP). Its new handbook, ‘Iron deficiency anaemia: Managing symptoms and supporting self-care’, provides a comprehensive guide for pharmacists to manage iron deficiency anaemia (IDA) effectively and patient education.
pharmaphorum
FEBRUARY 19, 2024
AstraZeneca’s Tagrisso is cleared by FDA for use alongside chemotherapy as a frontline therapy for EGFR-positive lung cancer (NSCLC)
Drug Patent Watch
FEBRUARY 19, 2024
Annual Drug Patent Expirations for LATUDA Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. It is available from one supplier. There are nine… The post New patent expiration for Sunovion Pharms drug LATUDA appeared first on DrugPatentWatch - Make Better Decisions.
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Express Pharma
FEBRUARY 19, 2024
The prevalence of colorectal cancer (CRC) is surging across the eight major markets (8MM*) due to an aging population and increased mutation testing. With a projected market expansion from $15.8 billion in 2021 to $21.8 billion in 2031, at a CAGR of 3.3 per cent, CRC presents a significant growth opportunity. This uptrend is primarily driven by rising diagnosis rates, notably in key markets like the US and China and approvals of 13 pipeline agents, according to GlobalData.
Pharma Times
FEBRUARY 19, 2024
Participants who received COMPASS showed a clinically significant improvement after 12 weeks
The Pharmacist
FEBRUARY 19, 2024
EXCLUSIVE The hurried preparations for Pharmacy First within an already overstretched sector will come at a ‘human cost’ to pharmacy teams, National Pharmacy Association (NPA) chief executive Paul Rees has warned. And he said that community pharmacies need a guarantee that the service is ‘here to stay’, given the investment that the sector has been […] The post Government must consider ‘human cost’ of delivering Pharmacy First appeared first on The Pharmacist.
World Pharma News
FEBRUARY 19, 2024
AstraZeneca announced today the successful completion of the acquisition of Icosavax, Inc., a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform. As a result of the acquisition, Icosavax has become a subsidiary of AstraZeneca, with operations in Seattle, US.
Outsourcing Pharma
FEBRUARY 19, 2024
February will see the 16th annual Rare Disease Day which raises awareness of the more than 7,000 identified rare diseases worldwide.
Pharma Times
FEBRUARY 19, 2024
The study aims to improve the representation of ethnic diversity within Parkinson’s research
Outsourcing Pharma
FEBRUARY 19, 2024
The father of a boy diagnosed with acute lymphoblastic leukemia at the age of nine, inspired by his son's love of collecting, has created patches of positivity for children going through cancer treatment to collect.
Pharmaceutical Technology
FEBRUARY 19, 2024
Almirall has signed a licensing agreement for the acquisition of worldwide rights to Novo Nordisk’s IL21-hindering antibody NN-8828.
Outsourcing Pharma
FEBRUARY 19, 2024
Patients in the US with epidermal growth factor receptor mutated (EGFRm) advanced lung cancer can now receive an important new treatment option delaying disease progression by nearly nine additional months.
pharmaphorum
FEBRUARY 19, 2024
Ahead of landmark SCOTUS hearing, study finds telehealth access to abortion pill mifepristone is as safe and effective as in-clinic access
European Pharmaceutical Review
FEBRUARY 19, 2024
The World Health Organization (WHO) has launched a new Biomanufacturing Workforce Training Initiative to help overcome challenges within the biomanufacturing sector in low- and middle-income countries’ (LMICs). The programme aims to support the limited capacity within the industry in LMICs. Another goal of the initiative is to manage the shortage of a qualified workforce in the production of biological products, such as vaccines, and monoclonal antibodies (mAbs).
Express Pharma
FEBRUARY 19, 2024
Iovance Biotherapeutics has received US Food and Drug Administration (FDA) approval for AMTAGVI (lifileucel) suspension for intravenous infusion. AMTAGVI is a tumour-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
European Pharmaceutical Review
FEBRUARY 19, 2024
Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the US Food and Drug Administration (FDA) for certain adults with unresectable or metastatic melanoma” Amtagvi (lifileucel) is the first tumour-derived autologous T cell immunotherapy therapy to be approved by the US Food and Drug Administration (FDA) for certain adults with unresectable or metastatic melanoma.
Pharmaceutical Technology
FEBRUARY 19, 2024
DYNE-251 is an antisense oligonucleotide commercialized by Dyne Therapeutics, with a leading Phase II program in Duchenne Muscular Dystrophy.
Drug Patent Watch
FEBRUARY 19, 2024
Annual Drug Patent Expirations for KYNMOBI Kynmobi is a drug marketed by Sumitomo Pharma Am and is included in one NDA. There are fifteen patents protecting this drug. Drug patent… The post New patent expiration for Sumitomo Pharma drug KYNMOBI appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog: Biosimilars
FEBRUARY 19, 2024
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Ana Loloei has joined the firm as Counsel. Ms. Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. While at FDA, Ms. Loloei also served as a Senior Policy Advisor in CDRH and as a Special Advisor in the Office of the Commissioner.
Drug Patent Watch
FEBRUARY 19, 2024
Annual Drug Patent Expirations for SYMPAZAN Sympazan is a drug marketed by Otter Pharms and is included in one NDA. It is available from one supplier. There are three patents… The post New patent expiration for Otter Pharms drug SYMPAZAN appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Business Review
FEBRUARY 19, 2024
A humanised IgG2 monoclonal antibody, sibeprenlimab acts on the B-cell growth factor dubbed APRIL, a critical player in IgAN’s development and progression. By neutralising APRIL, the drug aims to lower Gd-IgA1 production, a molecule implicated in the disease, potentially preventing further kidney damage and the progression to end-stage kidney disease.
Drug Patent Watch
FEBRUARY 19, 2024
Annual Drug Patent Expirations for EXSERVAN Exservan is a drug marketed by Aquestive and is included in one NDA. It is available from one supplier. There are two patents protecting… The post New patent expiration for Aquestive drug EXSERVAN appeared first on DrugPatentWatch - Make Better Decisions.
Pharmafile
FEBRUARY 19, 2024
Iovance Biotherapeutics has announced that the US Food and Drug Administration (FDA) has approved Amtagvi (lifileucel) suspension for intravenous infusion for the treatment of adult patients with unresectable or metastatic melanoma, previously treated with a PD-1 blocking antibody and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Pharmaceutical Technology
FEBRUARY 19, 2024
PDS-01ADC is under clinical development by PDS Biotechnology and currently in Phase II for Bile Duct Cancer (Cholangiocarcinoma).
Pharmafile
FEBRUARY 19, 2024
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Tagrisso for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The approval followed a Priority Review by the FDA and was based on results from the FLAURA2 phase 3 trial, […] The post AstraZeneca’s Tagrisso approved by FDA for lung cancer treatment appeared first on Pharmafile.
pharmaphorum
FEBRUARY 19, 2024
FDA sets December date for decision on AstraZeneca and Daiichi Sankyo’s TROP2-directed ADC Dato-DXd as a therapy for lung cancer (NSCLC)
PharmaState Academy
FEBRUARY 19, 2024
CASE STUDY Implementing a Communication Protocol for Multinational Product Launch Table of Contents Case Study ABCgenix Pharma, a leading multinational pharmaceutical company, is on the brink of launching a groundbreaking new medication called “XYzyme,” designed to treat a rare neurological disorder that affects. The product represents a significant breakthrough in medical science, offering hope to patients and their families who have long awaited an effective treatment.
Express Pharma
FEBRUARY 19, 2024
Heterozygous familial hypercholesterolemia (HeFH) is an autosomal dominant disorder characterised by elevated levels of low-density lipoprotein cholesterol (LDL-C), leading to an increased risk of cardiovascular disease. Praluent (alirocumab) is a monoclonal antibody against proprotein convertase subtilisin kexin type 9 (PCSK9), an enzyme that promotes degradation of the low-density lipoprotein (LDL) receptor, which is responsible for clearing excess LDL-C from the blood.
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