Thu.Jul 14, 2022

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Case Study: Insulin Sensitizers as Enhancers in Diabetes Management

Pharmacy Times

The objective of this study is to evaluate the use of low-dose pioglitazone, without relying on high doses of insulin, by enhancing sensitivity as a suitable, cost-effective strategy compared to larger insulin doses in patients with limited access to care.

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NICE backs two new breast cancer drugs for NHS use

pharmaphorum

Cost-effectiveness watchdog NICE has recommended routine NHS use of two new therapies for women with advanced breast cancer – Gilead’s Trodelvy and Novartis’ Piqray – in England. . In a statement , the health technology assessment (HTA) organisation said that the two drugs were backed after an agreement with the two developers on pricing that will make them an option for around 3,450 NHS patients.

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Role of Pharmacy Technicians Continues to Grow in Post-COVID-19 Era

Pharmacy Times

Donald Klepser, PhD, MBA, professor and dean of academic affairs at the College of Pharmacy in the University of Nebraska Medical Center, discusses how the COVID-19 pandemic has changed the role of pharmacy technicians and what is expected as we move forward.

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Janssen extends LGBTQ mental health outreach beyond Pride Month

PharmaVoice

The pharma giant’s ‘Depression looks like me’ campaign assembles a ‘one stop shop’ of resources to help combat high rates of severe depression in the LGBTQ community.

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Position Your Pharmacy for Expansion

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.

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FDA Accepts Biologics License Application for [Vic-]Trastuzumab Duocarmazine, an Antibody Drug Conjugate for HER2-Positive Metastatic Breast Cancer

Pharmacy Times

Dutch biopharmaceutical company Byondis submitted the BLA for [vic-]trastuzumab duocarmazine (SYD985) in the treatment of patients with HER2-positive metastatic breast cancer with the goal of improving patient outcomes.

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Bayer sells testosterone drug rights to Grünenthal for €500m

pharmaphorum

Bayer’s venerable testosterone replacement product for men with hypogonadism – Nebido – is being sold to Grünenthal as the group continues a revamp of its healthcare business. Grünenthal is paying up to €500 million ($501 million) for rights to Nebido (testosterone undecanoate), which is sold in around 80 countries worldwide for testosterone deficiency and made sales of €117 million last year.

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Pilot scheme to analyse raw trial data launched by EMA

European Pharmaceutical Review

A new pilot project by the European Medicines Agency (EMA) will assess whether the analysis of ‘raw data’ from clinical trials improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications. The project will also evaluate the practicality of such submissions and analyses. Raw data constitutes individual patient data from clinical studies in electronic structured format that is directly accessible for analysis and visualisation.

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FDA Grants EUA to Novavax COVID-19 Vaccine for Individuals 18 Years of Age and Older.

Pharmacy Times

NVX-CoV2373, a protein-based COVID-19 vaccine, may increase the country's vaccination rate for those hesitant to receive other vaccines.

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Alkermes looks to fill cancer treatment gaps with new immune pathways

PharmaVoice

The company’s chief medical officer discusses its lead candidate and how it fits into wider oncology trends.

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Pharmacists Can Help Slow the Opioid Crisis

Pharmacy Times

Patient education, naloxone training, and monitoring programs make a difference.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Novavax receives FDA emergency use authorization for Covid-19 vaccine

Pharmaceutical Technology

Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above. Novavax president and CEO Stanley Erck said: “Today's FDA emergency use authorization of our Covid-19 vaccine provides the US with access to the first protei

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Controlling Blood Sugar Benefits Heart Health

Pharmacy Times

Women, in particular, suffer more severe cardiovascular and other complications related to diabetes.

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Orphan drugs and where to launch them: The keys to Europe’s forgotten territories

Pharmaceutical Technology

It is estimated that there are currently more than 7,000 orphan diseases, many of which are considered life-threatening and most of which have a genetic basis. Despite this high number, orphan diseases are rare by definition, affecting around one in 2,000 people as defined by the European Union. Historically, the pharmaceutical industry has failed to meet the needs of this patient population.

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CDC: HIV Testing, Diagnoses Dropped Significantly During the COVID-19 Pandemic

Pharmacy Times

In 2020, there was a 17% decrease in new HIV diagnoses and significant reductions in HIV testing in health care and non-health care settings, impeding the Ending the HIV Epidemic initiative to increase testing and reduce infections.

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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Innoviva agrees to sell stake in Theravance Respiratory Company

Pharmaceutical Technology

Innoviva has signed an agreement for the sale of its 15% economic stake in Theravance Respiratory Company (TRC) to Royalty Pharma for nearly $282m in upfront cash payments and a potential contingent sales-based milestone payment of $50m. TRC receives royalties generating from sales of TRELEGY ELLIPTA (the combination FF/UMEC/VI). According to the agreement, TRC also transferred all of its ownership stakes and investments in InCarda Therapeutics, ImaginAb, Gate Neurosciences, and Nanolive to Inno

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The Role of the Ambulatory Care Pharmacist in Promoting Vaccine Confidence

Pharmacy Times

A pharmacist’s role in the ambulatory care setting has traditionally included a review of medications for potential drug-drug interactions and adverse events, medication reconciliation, and the provision of counseling services.

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Watchdog reprimands EU executive for failing to share Von der Leyen texts

The Guardian - Pharmaceutical Industry

European Commission ‘gave no good reason’ why its president’s messages with Pfizer were not released The EU’s official watchdog has issued a formal reprimand to the European Commission over its president Ursula von der Leyen’s failure to release text messages exchanged with the boss of Pfizer during the pandemic. The EU ombudsman, Emily O’Reilly, on Thursday upheld her verdict of maladministration by the commission, saying it had failed “to answer the basic question of whether the text messages

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Patients with Suspicion of Systemic Disease Require Ongoing Follow-Up for Diagnosis

Pharmacy Times

A recent case report detailing multiple procedures and inconclusive biopsies underwent by a patient with unusual presentation of immunoglobulin G4-related disease before conclusive diagnosis emphasizes the importance of follow-up with patients with suspicion of systemic disease.

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Female Providers, A Unique Perspective: Part 2

InCrowd

As much as I and my fellow colleagues try to separate work and home life, being a female provider is unique in that we face the same challenges as other professional women when it comes to having children. We are more likely to lose time from work both during maternity leave, and when children are sick, and are more likely to be the ones responsible with managing coordination of family tasks, schedules, and chores (Gold, 2020).

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Daily Medication Pearl: Liraglutide (Saxenda)

Pharmacy Times

Liraglutide (Saxenda) is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with type 2 diabetes.

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Meet the 2022 BoardVitals Nursing School Scholarship Winners 

Board Vitals - Pharmacist

What principles inspire nurses in their care of patients? According to the Code of Ethics for Nurses , the four main principles nurses are expected to act with are Non-maleficence, Beneficence, Justice, and Autonomy. But each individual nurse brings a unique outlook to healthcare. As a part of BoardVitals’s commitment to supporting the nurses of the future, we awarded our second annual Nursing School Scholarship.

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Pharmacy Focus: Independent Rx Forum- NCPA's Upcoming Month of Action

Pharmacy Times

This year's events are intended to invite members of Congress to visit the pharmacy to help solidify conversations surrounding pharmacy issues.

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UK approved fewer new drugs than EU and US in year after Brexit transition

The Guardian - Pharmaceutical Industry

Fears extra expense and paperwork caused by Brexit will make Britain unattractive to global drugmakers The UK approved fewer new medicines than the EU and the US in 2021, the first year after the end of the Brexit transition period, researchers at Imperial College London have found. Their analysis shows that only 35 new drugs were approved for use in the UK by the country’s medicines regulator last year, compared with 40 approvals in the EU and 52 in the US.

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The influence of roller compactor process parameters on granule properties

Pharmaceutical Technology

Processing powder blends can present a number of challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. Granulation is used in a range of industries and applications to combine multiple components of a blend into a more free-flowing, homogeneous intermediate product for downstream processing.

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Pharma’s post-COVID opportunity to improve patient outcomes

pharmaphorum

The immediate threat to patient care from COVID-19 has diminished with the passing of the acute phase of the pandemic, but its impact continues to be stubbornly significant. After placing unprecedented pressure on health systems for two years and more, patient backlogs in Europe could take six years to clear and there’s still much unknown about ‘ long COVID ’ or even the virus’ links with other conditions like diabetes.

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Avrobio receives orphan drug designation for Hunter syndrome gene therapy

Pharmaceutical Technology

Avrobio has received orphan drug designation for its gene therapy, AVR-RD-05, from the US Food and Drug Administration (FDA) to treat mucopolysaccharidosis type II (MPSII) or Hunter syndrome. The rare and seriously debilitating lysosomal disorder, Hunter syndrome primarily affects young boys and is caused by a deficiency in the lysosomal enzyme iduronate-2-sulfatase (IDS).

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EMA pilot will see if clinical trial data should be digested ‘raw’

pharmaphorum

A pilot study has been launched by the EMA to see whether it is helpful for regulators to look at the ‘raw data’ from clinical trials submitted in support of new marketing application along with the usual structured analyses from sponsors. The pilot will focus on individual patient data from clinical studies in electronic structured formats that are “accessible for analysis and visualisation,” said the EU regulator.

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CMO Moves: Regulatory catalysts for drug manufacturing-April

Pharmaceutical Technology

Regulatory decisions have a ripple effect, first affecting the pharma sponsors, and then the companies tasked to manufacture the drug. Pharmaceutical Technology looks at drugs and biologics with recent regulatory verdicts that will likely impact manufacturing volumes. In this ongoing series , we put a spotlight on contracts between pharma companies and contract manufacturing organizations (CMOs).

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EU watchdog formally reprimands Commission over Pfizer texts

pharmaphorum

The European Commission’s failure to reveal text messages between president Ursula von der Leyen and Pfizer chief executive Albert Bourla on COVID-19 vaccine procurement has earned it a formal rebuke from the EU Ombudsman. Emily O’Reilly today upheld her earlier preliminary verdict of “maladministration” by the Commission, saying the judgment is a “wake up call for all EU institutions about ensuring accountability in an era of instant messaging” The messages w

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DeepIntent Adds More Leading Data Providers to its Audience Marketplace

PharmExec

Over two dozen pharma brands and agencies have embraced the industry’s first and only healthcare-specific data marketplace with hundreds of ready-to-activate custom segments.

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Treatment Options in Patients With PIK3CA Mutation

Pharmacy Times

Susan Faye Dent, MD, FRCPC, FICQS, provides an overview of the BYLieve study and the impact on treatment options in patients with HR+, HER2- breast cancer.

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FDA Regulation of Nonprescription Drugs in Spotlight

PharmExec

Application for OTC contraceptive highlights efforts to broaden access to medicines.

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Daily OTC Pearl: Calmoseptine

Pharmacy Times

Calmoseptine is used to treat irritation caused by skin rashes.

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Knox Lane–Backed Fingerpaint Acquires Emcay, Expanding Company’s Multicultural Capabilities

PharmExec

The specialty offering will leverage Pharmacultural®, a proprietary approach to multicultural marketing in the pharmaceutical space.

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