OctariusRx

AUGUST 19, 2024

The 2024 version of the OctariusRx medication safety quiz is about to be released. The quiz focuses on some of the most commonly encountered situations, including allergies, labeling medications and controlled substances. The post Medication Safety Quiz 2024 appeared first on OctariusRX. How are you assessing your staff?

Controlled Substances 93

Controlled Substances Labelling 93

Pharmaceutical Technology

NOVEMBER 18, 2024

At AHA 2024, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE, involving lerodalciep.

Labelling 52

Labelling 52

STAT

MAY 2, 2024

All are simply labeled with “USA” and “2024.” Like a large tranche of sequences that the USDA uploaded to a public database on April 21, this week’s data dump did not include information about where and when the sequenced samples were obtained from cows or other sequenced animals.

Labelling 145

Labelling 145

OctariusRx

MAY 13, 2024

Our 2024 nursing calculations quiz is now available. Read the medication label carefully: This is a critically important step and one that often leads to errors and potential patient harm. Label all syringes once drawn: Medications that are not for immediate use require proper labeling. Take the quiz and find out!

Long-Term Care Facilities 69

Long-Term Care Facilities Labelling Medication Labelling Documentation 69

OctariusRx

MARCH 11, 2024

During the week of March 10-16, 2024, we have the unique opportunity to come together with our clients and help spread the word about patient safety and how pharmacy consultants help make patients safer. Use warning labels for both drugs with confused names and High-Alert medications. The post It’s Patient Safety Awareness Week 2024!

Labelling 82

Labelling Patient Care 82

Pharmaceutical Technology

JANUARY 22, 2024

Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.

Labelling 69

Labelling 69

STAT

SEPTEMBER 13, 2023

The Boston-based company will continue offering its pediatric treatment, EndeavorRx, by prescription until it can convert it to over-the-counter labeling — it plans to submit data to FDA in 2024. In its second-quarter results reported in August, Akili said it earned just $114,000 on $15.3 million in expenses.

Labelling 137

Labelling FDA 137

STAT

JULY 26, 2024

On July 6, 2024, Sonya Massey, 36, called 911 to report a potential home intruder at her home in Springfield, Ill. After the shooting, Grayson labeled her as “crazy” and not deserving of first aid. “Don’t hurt me,” were her first words to the two officers who responded. You called us.”

Labelling 126

Labelling 126

European Pharmaceutical Review

JUNE 4, 2024

Meeting the Divisions at ACHEMA 2024 IMA Active The ideal partner for each solid dose processing phase: granulation, tableting, capsule filling and banding, weight checking, coating, handling and washing. customers will have the opportunity to experience first hand various digital solutions aimed at reducing maintenance costs and downtime.

Packaging 95

Packaging Customer Service Labelling Dosage 95

The FDA Law Blog

MARCH 5, 2024

Many individual states have pursued some type of legislation to restrict the use of traditional meat terminology for the labeling of APPs. Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims.

Labelling 59

Labelling FDA 59

IDStewardship

OCTOBER 14, 2024

BCPS, BCIDP Article Posted October 2024, First Released in the October 2024 IDstewardship Newsletter 1. Read all about this in the product label here. More information on ganciclovir in the label here. Authored By: Timothy P. Gauthier, Pharm.D., Well, maybe not. Products can impact stability.

Compounding 130

Compounding Labelling Packaging Hospitals 130

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. All medicines on the UK market must be labelled as for sale only within the UK, including in Northern Ireland.

Packaging 105

Packaging Labelling 105

Oswald's

OCTOBER 8, 2024

Foster in early October to discuss problems with the pharmacy industry in 2024. Think of the costs involved in your prescriptions: labels, vials, pharmacy overhead costs, the technicians, the clerks, the pharmacists’ time to consult, and so on—would you want to do all that and still lose money? Yang Rohr and Sen.

Independent Pharmacies 52

Independent Pharmacies Labelling Insurance Vaccines 52

The FDA Law Blog

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence.

Labelling 59

Labelling Adverse Reactions Dosage 59

Pharmaceutical Technology

JUNE 17, 2024

If Calquence receives FDA label expansion in MCL, it will achieve a unique position in the treatment-naive MCL market share.

Labelling 52

Labelling FDA 52

The FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Labelling 105

Labelling Compounding Payment Processing Vaccines 105

Pharmaceutical Commerce

SEPTEMBER 6, 2024

Bernstein, President of Bernstein Rx Solutions, LLC, comments on industry’s preparedness for DSCSA compliance and provides an update as to where pharma is in terms of RFID label adoption. In the final part of her interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G.

Labelling 52

Labelling 52

The FDA Law Blog

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. Comments to the revised draft guidance are due to the docket by June 25, 2024.

Labelling 59

Labelling Communication FDA 59

European Pharmaceutical Review

SEPTEMBER 26, 2023

Patients who experienced disease progression while having a placebo treatment were offered resminostat in an open label treatment arm. In terms of drug development , the company stated that filing for marketing approval of the oral small molecule treatment in the EU, Switzerland and UK is planned for Q1 2024.

Labelling 110

Labelling 110

European Pharmaceutical Review

NOVEMBER 28, 2023

“We are pleased with the broad label, which includes all progressing adult patients and specifically references improvement in pain, and believe Ogsiveo has the potential to become the new standard of care for people living with these devastating tumours,” Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics commented.

Labelling 104

Labelling FDA 104

European Pharmaceutical Review

MARCH 8, 2024

Novo Nordisk stated it expects to file for regulatory approvals of a label expansion for Ozempic ® in the US and EU this year. The company added that the detailed results from FLOW will be presented at a scientific conference in 2024.

Labelling 98

Labelling 98

The FDA Law Blog

JULY 23, 2024

The draft guidance (June 2024) defines an EDDO as the “design outputs necessary to ensure delivery of the intended drug dose to the intended delivery site. Comments may be submitted by September 30, 2024. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

FDA 105

FDA Labelling 105

Pharmaceutical Technology

OCTOBER 26, 2023

GSK plans to submit the data to regulatory agencies to support label expansion for Arexvy in the younger adult patient population in 2024.

Labelling 52

Labelling Vaccines 52

Pharmaceutical Technology

JULY 17, 2023

The complete data readouts of two-Phase II trials are expected in 2024, with an additional open-label extension study currently in the works.

Labelling 52

Labelling 52

Hospital Pharmacy Europe

OCTOBER 30, 2023

Immediate and short-term actions include the creation of a Union list of critical medicines, which will be available by the end of 2023, guidance on procurement and further regulatory flexibilities to follow in 2024.

Packaging 98

Packaging Labelling Hospitals 98

European Pharmaceutical Review

MAY 28, 2024

A higher incidence of chronic diseases will propel growth of the market between 2024 and 2033, according to the data. Other limitations include the small space available for labels on this type of packaging. A report by The Brainy Insights has predicted that the ampoules packaging market will value $9.83 billion by 2033.

Packaging 97

Packaging Labelling 97

European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. Identification threshold: 10 ppm Qualification threshold: 20 ppm The FDA’s deadline for submitting comments on its draft guidance is 26 February 2024.

FDA 98

FDA Documentation Method Validation Packaging 98

European Pharmaceutical Review

MARCH 4, 2024

Importance of the new data for the Novartis gene therapy This data is “the first Zolgensma open-label clinical study to include older and heavier, as well as previously treated patients,” according to Dr Sandra Reyna, Chief Scientific Advisor and Head of Global Medical Engagement for SMA at Novartis.

Labelling 97

Labelling 97

pharmaphorum

NOVEMBER 1, 2021

The full approval for T315I-positive CML came on the back of a non-randomised, open-label phase 1 trial involving 330 patients that is also looking at combinations of Scemblix with other TKIs. It hopes to show that early treatment with the STAMP inhibitor could lead to a treatment-free period for patients.

FDA 115

FDA Labelling 115

pharmaphorum

OCTOBER 19, 2020

Both Repatha and Praluent have that in hand, but Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. That said, Novartis is no stranger to building a slow-starting cardiovascular drug into a blockbuster franchise.

Labelling 98

Labelling FDA 98

The Checkup by Singlecare

APRIL 10, 2024

In fact, as recently as April 2, 2024, the FDA announced that shortages of certain Mounjaro dosages were expected to continue at least through the end of April. Mounjaro’s weight loss effects have led to an increased demand for off-label prescriptions of the drug. clinical pharmacist practitioner in Minneapolis, Minnesota.

Labelling 98

Labelling Dosage Insurance Coverage Health Insurance Companies 98

European Pharmaceutical Review

JANUARY 5, 2024

Although these data are derived from an open-label clinical trial, the increasing benefit over time from six-weeks to one-year suggests that the glutamate modulating effect of evenamide could lead to a progressive and long-standing alteration in brain processes synergising with the effect of antipsychotics to which the patient had become resistant.

Labelling 111

Labelling 111

European Pharmaceutical Review

JUNE 10, 2024

New five-year data from Genentech (a member of the Roche Group)’s open-label extension of the pivotal Phase II FIREFISH study confirm the sustained efficacy and safety of Evrysdi ® (risdiplam) in children with Type 1 spinal muscular atrophy (SMA). The data were presented at the 2024 Cure SMA Research & Clinical Care Meeting.

Labelling 98

Labelling Hospitals 98

The FDA Law Blog

AUGUST 7, 2024

But recently, a new challenge was filed in the District Court for the District of Columbia questioning whether modifications to labeling as a result of patent protections—beyond the mere omission of language—are permissible under the section viii carve-out requirements. FDA and intervenor MSN vehemently defend FDA’s approval here.

Labelling 59

Labelling FDA Hospitals 59

The FDA Law Blog

APRIL 21, 2024

In January 2024, FDA affirmed to the PTO in a letter that “NDA 214801 was approved on September 30, 2022, which makes the submission of the patent term extension application on November 29, 2022, not timely within the meaning of 35 U.S.C. It’s not terribly uncommon for FDA to issue corrected approval letters (and corrected labeling).

Labelling 59

Labelling FDA Controlled Substances 59

European Pharmaceutical Review

NOVEMBER 25, 2022

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6

FDA 105

FDA Dosage Labelling 105

The FDA Law Blog

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. Director Deborah L.

Labelling 59

Labelling FDA 59