European Pharmaceutical Review

MARCH 27, 2023

Adults with treatment-resistant major depressive disorder (TRD) treated with SPRAVATO ® ▼ (esketamine nasal spray [NS]) achieved significantly higher remission rates compared to those given quetiapine extended-release (XR), long-term Phase III study data has shown. The results from Janssen’s ESCAPE-TRD Phase IIIb trial presented at the European Congress of Psychiatry (EPA) 2023 indicated that esketamine NS achieved significantly higher remission rates from Week 6 and response rates as early as D

Pharmaceutical Companies 82

Pharmaceutical Companies Pharmaceutical Companies 82

PhRMA

MARCH 29, 2023

The Patient Experience Survey (PES) series continues to reveal how health insurance is not working as it should for too many Americans — especially vulnerable groups. This series – including surveys of 5,000 Americans conducted with Ipsos, a leading research company in the United States — documents a consistent trend in reports of insurer- and middlemen-imposed practices that can keep patients from the medicines and treatments that they need.

Insurance 288

Insurance Documentation 288

Drug Topics

MARCH 30, 2023

The suit alleges that Express Scripts, Prime and Prime customer Humana Pharmacy Solutions are able to share drug pricing and rebate information to increase prices for insulins, biologics and cancer drugs.

187

187

STAT

MARCH 30, 2023

New evidence of the spillover of the avian flu virus, known as H5N1, to some mammals is again raising alarm bells, though for experts familiar with the virus, “ none of them ever stopped worrying about H5N1.” The recent death of a Cambodian girl from bird flu is a reminder that much is at stake. If H5N1 were to cross over to humans and ignite another pandemic, could the United States do it all over again?

Vaccines 145

Vaccines FDA 145

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.

Fierce Healthcare

MARCH 30, 2023

Uber Health rolls out same-day prescription delivery with plans to ship healthy food, OTC meds hlandi Thu, 03/30/2023 - 12:54

133

133

PhRMA

MARCH 30, 2023

At the request of the U.S. Trade Representative, the U.S. International Trade Commission (USITC) is conducting an investigation and will issue an accompanying report concerning the TRIPS Agreement and a variety of issues related to COVID-19 diagnostics and therapeutics. According to USTR, the USITC report will inform future discussions within the United States and at the World Trade Organization (WTO) concerning potential TRIPS waiver expansion.

Vaccines 250

Vaccines 250

STAT

MARCH 29, 2023

The Marburg outbreak in Equatorial Guinea continues to grow, the World Health Organization said Wednesday, as the global health agency stated that it knows of confirmed cases that the country has not yet reported. To date Equatorial Guinea has acknowledged nine laboratory-confirmed cases, seven of whom have died. In addition, 20 other people with links to the confirmed cases died without being tested; they are considered probable cases.

145

145

Pharmaceutical Technology

MARCH 31, 2023

The European Medicines Agency (EMA) has recommended HIPRA’s Covid-19 vaccine , Bimervax, as a Covid-19 booster. Available to people ages 16 years and above who have been vaccinated with a Covid-19 mRNA vaccine, EMA’s Human Medicines Committee concluded the vaccine is ready for marketing authorization in the EU, on 30 March. Bimervax is a recombinant protein subunit vaccine, marketed by the Girona, Spain-based Hipra.

Vaccines 110

Vaccines Immunization 110

PhRMA

MARCH 28, 2023

It’s that time of year again when the president releases his budget and questions arise about the solvency of the Medicare trust fund and Medicare spending more generally. Too often, critics point to spending on Medicare Part B medicines as a key driver of Medicare spending, but the data tells a different story. For example, next month the Medicare Payment Advisory Comission plans to vote on policy proposals that ignore the facts around Medicare Part B, and could harm patient access to both curr

234

234

Drug Topics

MARCH 28, 2023

According to a recent study, the diabetes medication semaglutide is more effective as a 25 mg or 50 mg dose on its own, rather than a 14 mg add-on dose with other medications.

181

181

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.

FDA

STAT

MARCH 28, 2023

A panel of experts that advises the World Health Organization on vaccine use suggested Tuesday that countries no longer need to consider offering additional Covid-19 boosters to people at medium or low risk of becoming seriously ill if they contract the SARS-CoV-2 virus. The Strategic Advisory Group of Experts on Immunization — which is known as the SAGE — said some countries may continue to offer boosters to people at medium and low risk, but those decisions should be made ba

Vaccines 129

Vaccines Immunization 129

Pharmaceutical Technology

MARCH 28, 2023

Following on from its Covid-19 vaccine programmes, BioNTech has set its sights on a range of infectious diseases for vaccine development. In its FY 2022 report, BioNTech has identified herpes simplex virus (HSV), malaria, and shingles as disease targets. The company saw major successes with its Covid-19 vaccine, developed in collaboration with Pfizer.

Vaccines 110

Vaccines 110

PhRMA

MARCH 28, 2023

Chronic diseases like Alzheimer’s disease, diabetes and kidney disease disproportionately affect older adults. In the United States, nearly 95% of older adults have at least one chronic condition and almost 80% have two or more. Chronic diseases can often limit an older adult’s ability to work, perform daily activities, cause them to lose their independence and lead to the need for long-term care.

226

226

Drug Topics

MARCH 29, 2023

Though unlikely to pass this year, opponents say the proposal is nonetheless amplifying the spread of false claims and sowing distrust of medical professionals.

Vaccines 186

Vaccines 186

Advertisement

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.

Pharmacy Management Software

STAT

MARCH 28, 2023

In the doctor’s offices of the future, artificial intelligence will be a fly on the wall, listening in and logging the sensitive conversations that happen every day between patients and their doctors. Gone will be the distracted doctor hunched over a keyboard, tapping, clicking, constantly playing catch-up with hours of extra work. That’s the vision pitched by a spate of new startups and major tech companies like Microsoft, which one year ago spent over $19 billion to acquire Nuanc

Documentation 128

Documentation Communication Hospitals 128

Fierce Healthcare

MARCH 26, 2023

Live at ViVE 2023—Trilliant Health unveils payer price transparency tool; AWS unveils 23 startups for workforce development accelerator hlandi Sun, 03/26/2023 - 21:28

110

110

PhRMA

MARCH 27, 2023

It’s been over three years since I saw my first COVID-19 patient in the emergency department. The image of that x-ray is burned into my memory: clusters of white spots spread out across both sides of the patient’s lung. A dramatic, and not all that common, clinical finding. The patient in front of me already had a fever and was breathing quickly, in need of extra oxygen support.

Vaccines 214

Vaccines 214

Drug Topics

MARCH 27, 2023

The drug Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. Its annual list price will be $547,500.

Immunization 187

Immunization FDA 187

STAT

MARCH 29, 2023

A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many companies will soon face costly delays starting clinical trials — leading to a slowdown in drug development. In recent weeks, the U.S Fish & Wildlife Service began denying company requests to import long-tailed macaques from Cambodia in the wake of a federal investigation into a smuggling ring.

127

127

Pharmaceutical Technology

MARCH 31, 2023

Moderna has finalised an agreement with the government of the Republic of Kenya to establish an mRNA manufacturing facility in the country. The company will construct the new advanced mRNA facility, which is claimed to be Moderna’s first mRNA manufacturing facility in Africa and is expected to have the capacity to produce up to 500 million vaccine doses annually.

Vaccines 105

Vaccines 105

PhRMA

MARCH 30, 2023

Between Congress, the Medicare Payment Advisory Commission (MedPAC) and the Center for Medicare & Medicaid Innovation (CMMI), there have been a number of policy proposals of late that would change reimbursement for medicines covered by Medicare Part B, some of which may harm patient access to important treatments. As we debate these proposals, it’s important to levelset on how reimbursement works in the program today.

202

202

Drug Topics

MARCH 28, 2023

The drug, called Leniolisib, is the first and only treatment approved in the United States for APDS, a rare primary immunodeficiency.

FDA 187

FDA 187

STAT

MARCH 29, 2023

Hidden in this year’s federal spending bill, among major changes to Medicare payments to doctors and post-pandemic Medicaid , lies a little-noticed change with big implications: a mandate to protect medical devices connected to the internet from hacks or ransomware attacks. The law, which goes into effect Wednesday, explicitly states that companies cannot sell their connected medical devices without first showing the Food and Drug Administration a solid cybersecurity plan.

FDA 125

FDA 125

The Thyroid Pharmacist

MARCH 31, 2023

Anxiety was one of the most challenging and disempowering symptoms I experienced when I was first diagnosed with Hashimoto’s. It changed my life dramatically and made me feel like a shell of my former self. I had always been an outspoken, level-headed and calm person, but sometime in 2005, something called “new-onset anxiety” rocked my world. I was scared.

Immunization 105

Immunization Dosage Documentation 105

The FDA Law Blog

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

Insurance 105

Insurance FDA Labelling 105

Drug Topics

MARCH 29, 2023

Naloxone hydrochloride nasal spray (Narcan) 4 mg is expected to be available over the counter in late summer 2023.

FDA 184

FDA 184

STAT

MARCH 28, 2023

As the U.S. drug crisis has accelerated, the pharmaceutical industry has jumped into action — particularly when it comes to naloxone, the drug used to reverse opioid overdoses. In recent years, companies have introduced a dizzying array of ambitious new naloxone products. They include a mechanized injector that gives robotic voice commands , a prefilled syringe pen, an ultra-high-dose nasal spray, and an autoinjector that the Pentagon has purchased for use in the event of a terrorist atta

125

125

Pharmaceutical Technology

MARCH 29, 2023

Viking Therapeutics has announced the start of a Phase I clinical study to evaluate its dual glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonist VK2735. The trial, which is investigating healthy adults with a minimum body mass index of 30 kg/m2, will see VK2735 administered as an oral tablet once daily for 28 days.

Dosage 105

Dosage Labelling FDA 105

European Pharmaceutical Review

MARCH 27, 2023

A report has predicted the rapid microbiology testing market size is estimated to grow at a compound annual growth rate (CAGR) of 9.31 percent between 2022 and 2027. According to the data, the market is forecasted to increase by $2,487.91 million. The research includes historic market data from 2017 to 2021, using 2022 as the base year. It covers various testing methods such as growth-based, nucleic-acid-based and viability-based.

Compounding 107

Compounding Vaccines 107

Drug Topics

MARCH 31, 2023

The theme of the upcoming Summit is the Expansion of Services Within Independent Pharmacy.

Independent Pharmacies 187

Independent Pharmacies 187

STAT

MARCH 31, 2023

Clinicians know the odds tend to be stacked against Black breast cancer patients. They get more dangerous and aggressive subtypes of breast cancer more frequently than white patients. Within breast cancer subtypes, Black patients tend to have worse outcomes compared to white negative patients, too. But what biological factors contribute to these disparities – and how much – is an open question.

Chemotherapy 109

Chemotherapy 109

Fierce Healthcare

MARCH 28, 2023

ViVE 2023: Amazon Pharmacy integrates coupons in latest bid to target affordability of branded drugs hlandi Tue, 03/28/2023 - 15:24

120

120

European Pharmaceutical Review

MARCH 31, 2023

The Medicines Patent Pool (MPP) has signed sublicence agreements with three generics manufacturers to produce generic versions of cabotegravir long-acting (LA) injectable for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP). First sublicence agreement signed by MPP for a long-acting medicine Through the sublicences, the selected generic manufacturers will be able to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP, in 90 countries, subject to requir

FDA 104

FDA 104

Drug Topics

MARCH 29, 2023

Pharmacists can provide support and guidance to patients during their month of fasting.

186

186