Drug Topics

APRIL 13, 2023

As more adalimumab biosimilars are poised to enter the market, manufacturers, payers, and patient advocates are preparing to navigate potentially turbulent waters.

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Drug Topics

APRIL 12, 2023

Autofill programs and metrics reporting can help pharmacists streamline their inventory management.

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Pharmacy Times

APRIL 13, 2023

Pharmacy professionals can bring in the right people at the right time to identify needed changes and develop an action plan.

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PhRMA

APRIL 12, 2023

Recent district court rulings set an alarming precedent that calls into question the authority of the U.S. Food and Drug Administration (FDA) to determine the safety and effectiveness of new medicines.

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FDA 249

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.

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. Gauthier, Pharm.D., BCPS, BCIDP Article Posted 14 April 2023 In 2014 CDC released the Core Elements of Hospital Antibiotic Stewardship Programs (Core Elements) to help hospitals increase infection cure rates while reducing treatment failures, C. difficile infection, adverse effects, antibiotic resistance, ho

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Hospitals Documentation Communication Patient Care 241

Drug Topics

APRIL 14, 2023

Over 400 pharmaceutical employees and executives signed an open letter in a show of solidarity with the FDA, but some say that big pharma’s actions helped lead to this moment in the first place.

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FDA 187

PhRMA

APRIL 13, 2023

At the direction of the U.S. Trade Representative, the U.S. International Trade Commission (USTIC) is investigating the impact of a proposed waiver of intellectual property (IP) protections for COVID-19 diagnostics and therapeutics under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Public submissions to the USITC from experts across patient groups, academia, public health, labor and the private sector make clear that, much like the orig

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Vaccines 208

STAT

APRIL 14, 2023

Black people in counties with more Black primary care physicians live longer, according to a new national analysis that provides the strongest evidence yet that increasing the diversity of the medical workforce may be key to ending deeply entrenched racial health disparities. The study , published Friday in JAMA Network Open, is the first to link a higher prevalence of Black doctors to longer life expectancy and lower mortality in Black populations.

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Drug Topics

APRIL 10, 2023

The FDA granted the EUA based on the phase 3 trial results that demonstrated vilobelimab's efficacy compared to placebo, with a 23.9% relative reduction in all-cause mortality from COVID-19 at 28 days.

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FDA 187

Pharmacy Times

APRIL 14, 2023

Based on the study results, investigators concluded that there is justification for a randomized clinical trial.

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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

PhRMA

APRIL 14, 2023

As part of the implementation of the Inflation Reduction Act (IRA), the Centers for Medicare & Medicaid Services (CMS) issued draft guidance on the process for setting the price of medicines. The process is in no way a “negotiation,” and CMS chose to go beyond what was outlined in the statute, taking the most extreme stance to sweep in as many medicines as possible and be as punitive as possible.

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STAT

APRIL 14, 2023

On most days around 2pm, home health aide Duane Crichlow can be found in an apartment in Sunset Park, Brooklyn, playing catch with his client — a man in his 30s with a developmental disability who is quick to give Crichlow hugs and kisses. If it’s nice outside, Crichlow will walk his client, who is nonverbal and in a wheelchair half the time, down three flights of stairs, hauling the wheelchair back and forth separately.

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Drug Topics

APRIL 13, 2023

Vaccine hesitancy exists on a spectrum, but with the right tools, pharmacists can provide education and reassurance to parents and caregivers.

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Vaccines 186

Pharmacy Times

APRIL 12, 2023

Pharmacists serve as advocates to optimize patient pharmaceutical care, advance the profession, and positively influence the community.

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PhRMA

APRIL 12, 2023

Today PhRMA released a new report that analyzes the share of new medicines that are available in over 70 countries and how long patients wait to receive them. The Global Access to New Medicines Report includes comprehensive comparisons across countries in the G20, Organization for Economic Co-operation and Development (OECD) and several geographic regions.

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STAT

APRIL 14, 2023

WASHINGTON — Even though the Biden administration is ending its highest-profile Covid-19 emergency declaration next month, it’s still going to hold on to some pandemic-era powers. The Department of Health and Human Services gave governors a heads-up on Friday that it is planning to keep pharmacists’ ability to administer Covid-19 and flu vaccines past the end of the public health emergency.

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Vaccines 138

Drug Topics

APRIL 14, 2023

As more and more states legalize recreational marijuana, caregivers need to be vigilant about keeping products out of the reach of children.

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Pharmacy Times

APRIL 14, 2023

The Aquilino Cancer Center established the Bill Richards Center for Healing inside the same building, so patients with cancer can receive psychedelic-assisted therapy in the same location as their cancer care.

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PhRMA

APRIL 13, 2023

Today, the Medicare Payment Advisory Commission (MedPAC), an independent congressional agency that advises Congress on issues related to the Medicare program, will vote on draft recommendations related to Part B. Unfortunately, these recommendations include proposals that could give the Centers for Medicare and Medicaid Services (CMS) new authority to make one-size-fits-all value judgments based on flawed cost-effectiveness standards, and to come between doctors and patients in deciding which tr

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STAT

APRIL 12, 2023

Prior to the early 20th century, America had no regulation of medications or food additives. Formaldehyde was used to preserve meat, morphine was included in infant “soothing syrups,” and marketing, not science, drove the promotion of tonics and medications. The 1906 Food and Drug Act was the first in a series of consumer protection laws focused on setting standards for safe and effective medications and food additives.

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FDA 132

Drug Topics

APRIL 8, 2023

The FDA, state governors, and OB/GYN groups around the country are fighting back against Judge Matthew Kacsmaryk’s ruling.

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FDA 185

Pharmacy Times

APRIL 13, 2023

Patients administered anakinra did not meet a study’s primary endpoint of proportion of patients who did not need mechanical ventilation 15 days after starting treatment for severe COVID-19 pneumonia.

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Pharmafile

APRIL 14, 2023

Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine. Mirikizumab was hoped to become a new drug treatment for ulcerative colitis (UC), a condition where abnormal reactions in the immune system cause inflammation in the inner lining of the colon.

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STAT

APRIL 13, 2023

Like many cardiologists, Manuela Thienel spends most days in the chlorinated, temperature-controlled halls of a large hospital. But one week in February 2019, her work brought her to a snowy Swedish forest, where she stood shuddering in a winter coat, looking on as veterinarians and rangers walked into a bear den to drug a hibernating bear and retrieve its blood.

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Hospitals 118

Drug Topics

APRIL 14, 2023

HHS Secretary Xavier Becerra will release an amendment to the declaration in the coming weeks.

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Pharmacy Times

APRIL 10, 2023

The overall survival hazard ratio numerically favored niraparib in the germline BRCA mutation cohort and favored placebo in the non-germline BRCA mutation cohort in patients with platinum-sensitive recurrent ovarian cancer.

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European Pharmaceutical Review

APRIL 13, 2023

Psychedelics are a class of psychoactive substances that produce temporary changes in perception, mood and cognitive processes. 1 Some psychedelics are found in nature, including psilocybin, a naturally occurring molecule found in almost 150 species of mushrooms which turns into psilocin once ingested, causing psychedelic effects. Other psychedelics are man-made, such as lysergic diethylamide (LSD), which was first synthesised in 1938 by Albert Hofmann at a laboratory in Switzerland. 2 LSD is wi

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Pharmaceutical Companies Pharmaceutical Companies FDA 122

Pharmaceutical Technology

APRIL 14, 2023

Ghana’s Food and Drug Authority (FDA) has approved R21/Matrix-M malaria vaccine in children aged 5 to 36 months, marking the first regulatory clearance for the University of Oxford-developed vaccine in any country in the world. Serum Institute of India (SIIPL), manufacturer and licence holder of the vaccine, has been notified of the registration by Ghana’s FDA.

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Vaccines FDA Immunization 111

Drug Topics

APRIL 11, 2023

Antimicrobial stewardship remains important in tropical diseases such as malaria and dengue.

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Pharmacy Times

APRIL 12, 2023

During the 12-month trial period, Hyqvia was shown to be efficacious treating the occurrence of acute serious bacterial infections in children aged 2 through 16 years with primary immunodeficiency.

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FDA 123

European Pharmaceutical Review

APRIL 10, 2023

The high reliability of matrix-assisted laser desorption/ionization (MALDI) time-of-flight (TOF) mass spectrometry (MS) systems for microbiological identification offer an alternative to serological-based methods, according to a review by researchers. “New technologies for the accurate and rapid identification of bacteria are essential in various fields of applied microbiology.

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Pharmaceutical Technology

APRIL 13, 2023

Dyadic International has announced expansion of a licence agreement for its C1-cell protein expression platform with South African consortium Rubic One Health. The expanded licence will include the development of vaccines and therapeutic proteins beyond Covid-19 for human and animal health markets in Africa. During the Covid-19 pandemic, vaccination rates of many countries in Africa were significantly trailing the rest of the world.

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Vaccines 111

Drug Topics

APRIL 14, 2023

Despite a massive COVID-19 vaccination campaign, many still fear a return to normal.

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Vaccines 186

Pharmacy Times

APRIL 11, 2023

It is important for pharmacists to educate patients, especially those with cardiovascular risks, about the differences between fish oil supplements and prescription n3-FAs products.

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