Drug Discovery World
MARCH 23, 2023
iOnctura, a clinical stage biotechnology company developing cancer therapies, has published non-clinical research on roginolisib in the AACR journal Cancer Research Communications. Roginolisib is a first-in-class, non-ATP-competitive, allosteric modulator of PI3Kd which prevents tumour proliferation and breaks immune tolerance in patients with solid and haematological tumours.
FDA Law Blog: Biosimilars
MARCH 29, 2023
By Kalie E. Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a n
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Antidote
MARCH 29, 2023
The annual Kidney Action Week is a virtual event put on by the American Kidney Fund designed to bring the entire kidney health community together for a week of amazing and informative content on all things related to kidney health. The event is filled with discussions, Q&As, webinars, and more — and this year, Antidote was thrilled to be involved!
Drug Channels
MARCH 28, 2023
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Click here to see the original post and comments from January 2023. For 2023, the three largest pharmacy benefit managers (PBMs)—Caremark (CVS Health), Express Scripts (Cigna), and OptumRx (United Health Group)—have again increased the number of drugs they exclude from their standard formularies.
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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.
FDA Law Blog: Drug Discovery
MARCH 13, 2023
By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab
Advarra
MARCH 10, 2023
Having a one in four chance of developing sickle cell disease (SCD) is uniquely, and overwhelmingly, familiar to the African American population. Considered a rare disease, research in finding better therapies – and possibly even a cure – for SCD may be competing for funding with conditions impacting broader populations. SCD’s significant impact on African Americans also means it predominantly impacts a minority community historically underserved by clinical research.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
FDA Law Blog: Biosimilars
MARCH 12, 2023
The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. When the public health emergency ends on May 11, 2023 , so do these exemptions.
Antidote
MARCH 24, 2023
The rare, inherited blood disorder hemophilia is estimated to impact approximately 20,000 individuals in the United States , and over 400,000 worldwide. Currently, there is no cure for hemophilia — but through ongoing research, medical experts are continually learning more about the disease.
Drug Channels
MARCH 14, 2023
I am pleased to announce our new 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers , available for purchase and immediate download. Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study Analyzes Impact of Inflation Reduction Act on U.S.
Drug Patent Watch
MARCH 3, 2023
Annual Drug Patent Expirations for NORMOCARB+HF+25 Normocarb Hf 25 is a drug marketed by Dialysis Sups and is included in one NDA. There is one patent protecting this drug. This… The post New patent expiration for Dialysis Sups drug NORMOCARB HF 25 appeared first on DrugPatentWatch - Make Better Decisions.
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NIOSH Science Blog: Drugs
MARCH 15, 2023
Employers can play a vital role in suicide prevention. Historically, suicide, mental health, and well-being have been underrepresented in workplace health and safety efforts, but this is changing. In some European countries, there are workplace standards for workplace psychosocial hazards that put workers at risk for suicide. Additionally, in France, employers have been made accountable for toxic workplaces and management practices that contributed to worker suicides.[1] Some of the latest workp
Drug Discovery World
MARCH 10, 2023
Cancer Research UK and UCB have agreed a clinical development collaboration to advance two of UCB’s investigational oncology antibody candidates through clinical trials. The collaboration focuses on the development of two investigational antibody candidates, UCB6114 and UCB4594, by bringing together the oncology-focused translational research and clinical development capabilities of Cancer Research UK, and UCB’s antibody discovery expertise.
Eye on FDA
MARCH 5, 2023
In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the outcomes were increasingly negative. Just to recap, for the entire year of 2022 there were only 14 meetings held to consider whether new medicines should be recommended for approval, a slight increase over the 10 the year before, but considerably lower fewer than 2018
Antidote
MARCH 20, 2023
Hepatitis B , sometimes abbreviated to HBV, is a liver infection that is one of the most serious in the world. If left untreated, hepatitis B can cause fibrosis, cirrhosis, hepatocellular carcinoma, and end-stage liver disease.
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Drug Channels
MARCH 17, 2023
Today’s guest post comes from Rhiannon Naslund, Chief Marketing Officer at Kalderos. Rhiannon discusses the growing collaboration between manufacturers and covered entities regarding 340B discount claims. She goes on to describe the Kalderos Discount Hub solution that reviews claims that have a high likelihood of being a duplicate discount. To stay up-to-date with the latest drug discount developments, sign up for the Kalderos newsletter.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for ORKAMBI Orkambi is a drug marketed by Vertex Pharms Inc and is included in two NDAs. It is available from one supplier. There are twenty… The post New patent for Vertex Pharms drug ORKAMBI appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
MARCH 31, 2023
If subsequently approved, Entresto will be the first and only approved therapy for the treatment of symptomatic chronic heart failure patients aged 1 to <18 years in the European Union Pediatric heart failure is an important cause of childhood morbidity and mortality – up to a third of all pediatric cardiac admissions are due to heart failure; these hospitalizations are associated with a 20-fold increase in the risk of death 1, 2 The positive opinion is based on final data from the 52-week P
Drug Discovery World
MARCH 14, 2023
Scientists have discovered why breast cancer cells that have spread to the lungs may ‘wake up’ following years of sleep – forming incurable secondary tumours. Patients with oestrogen receptor positive (ER+) breast cancer – the most common type – have a continued risk of their cancer recurring in another part of their body for many years or even decades after their original diagnosis and treatment.
NIOSH Science Blog: Drugs
MARCH 6, 2023
The construction sector includes a diverse population of workers exposed to many different types of hazards. An important way to prevent occupational illness and injury related to these hazards is by implementing the hierarchy of controls. Personal protective equipment (PPE) is the last control in the hierarchy, but PPE is particularly important when the other controls cannot sufficiently reduce or eliminate hazards.
Antidote
MARCH 15, 2023
Idiopathic pulmonary fibrosis , or IPF, can be a frightening diagnosis. IPF is a rare, progressive lung disease that develops differently for everyone, and managing its development can be difficult. However, some individuals are able to live with the disease and stay active for many years.
Drug Channels
MARCH 8, 2023
Next week, Drug Channels Institute will release our 2023 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. It’s the 14th edition of our popular and comprehensive examination of the entire U.S. drug pricing, reimbursement, and dispensing system. The exhibit below—one of 241 in our new report—provides a first look at the 15 largest organizations, ranked by total U.S. prescription dispensing revenues for calendar year 2022.
Drug Patent Watch
MARCH 4, 2023
Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier. There are… The post New patent for Vertex Pharms drug SYMDEKO (COPACKAGED) appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog: Biosimilars
MARCH 30, 2023
By Larry K. Houck — Perhaps you obtain controlled substance quotas or submit ARCOS reports? Maybe you identify and report suspicious orders or thefts/losses. Or you obtain import or export permits, submit import or export declarations or listed chemical DEA-486s. Do you want to learn more? You have your chance. DEA’s Diversion Control Division is hosting a Supply Chain Conference for registered manufacturers, distributors, importers and exporters on controlled substance and listed chemical r
Drug Discovery World
MARCH 7, 2023
For International Women’s Day, DDW’s Diana Spencer celebrates some of the women in leadership making an impact on the drug discovery and life sciences sector. The life sciences sector has traditionally outperformed others when it comes to attracting women to its workforce. In its ‘Women in Business 2022’ report, Grant Thornton reported that at 39%, the healthcare industry had the highest proportion of women in senior management out of the 15 industries surveyed. 1 However, this progress seems t
BenchSci
MARCH 31, 2023
As Women’s History Month comes to a close, I wanted to share some of the events and takeaways we learned on behalf of the BenchShe+ leadership team. We had the honor of putting together programming not just for members of the BenchShe+ employee resource group (ERG), but also hosting events company-wide to help educate and inspire our team throughout the month.
Antidote
MARCH 14, 2023
Lung cancer, the leading cause of cancer deaths in the United States , occurs when cells within the lung begin growing in an uncontrolled way, forming tumors or lesions. It typically begins in the cells lining the bronchi, and can eventually spread throughout the lung and to other parts of the body.
Drug Channels
MARCH 27, 2023
This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Discount Cards, Cost-Plus Pharmacies, and PBMs: Trends, Controversies, and Outlook. Friday's webinar will include my latest thoughts on a key trend discussed in todays rerun: how plan sponsors are incorporating patient-paid prescriptions—cash-pay prescriptions and discount cards—within pharmacy benefits.
Drug Patent Watch
MARCH 21, 2023
Annual Drug Patent Expirations for NUZYRA Nuzyra is a drug marketed by Paratek Pharms Inc and is included in two NDAs. It is available from one supplier. There are ten… The post New patent for Paratek Pharms drug NUZYRA appeared first on DrugPatentWatch - Make Better Decisions.
FDA Law Blog: Biosimilars
MARCH 15, 2023
By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). The MQSA was passed to ensure, among other things, that nationwide, patients have access to quality mammography services.
Drug Discovery World
MARCH 16, 2023
There was some good news for the UK life sciences sector in the government’s Spring Budget, but did it go far enough? DDW’s Diana Spencer takes a look at the industry’s reaction. There wasn’t much to write home about in the UK government’s Spring Budget, described by Bloomberg UK’s Marcus Ashworth as a “minimalist masterclass”. However, there was some positive news for what the Chancellor Jeremy Hunt referred to as the “largest life sciences sector in Europe”, and some measures that could assist
Advarra
MARCH 31, 2023
The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. This trend came to the forefront during the COVID-19 pandemic, as the three most popular vaccines developed in response to the coronavirus contained engineered genetic materials in the form of mRNA or a genetically engineered virus.
Antidote
MARCH 27, 2023
Each year in March, the National Institute of Diabetes and Digestive and Kidney Diseases puts on National Kidney Month , a month dedicated to raising awareness about kidney health and conditions. Chronic kidney disease, a grouping of conditions that damage the kidneys , impacts around 37 million Americans, and millions of others are considered to be at an increased risk.
Drug Channels
MARCH 6, 2023
Informa Connect’s Drug Pricing Transparency Congress May 16-17, 2023 in Washington, DC Drug Channels readers can save 10% with code 23DRCH10 www.informaconnect.com/drug-pricing-transparency Join Informa Connect on May 16-17, 2023 in Washington, DC at the Drug Pricing Transparency Congress to stay on the pulse of federal and state reporting requirements, policy initiatives and strategic best practices for compliance.
Drug Patent Watch
MARCH 31, 2023
Annual Drug Patent Expirations for VANCOMYCIN Vancomycin is a drug marketed by Xellia Pharms Aps, Akorn, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Strides Pharma, Watson Labs, Alkem… The post New patent for Xellia Pharms drug VANCOMYCIN appeared first on DrugPatentWatch - Make Better Decisions.
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