Pharmaceutical Technology

NOVEMBER 18, 2024

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

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Labelling 52

Hospital Pharmacy Europe

FEBRUARY 8, 2024

Tiene Bauters, PharmD PhD, Pharmacy Department , Ghent University Hospital in Belgium, offers her take on what’s hot on the horizon for hospital pharmacy in 2024. In conclusion, we can see that pharmacy in 2024 will be filled with opportunities that we should embrace to help us continue to shape the future of our profession.

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Hospitals Health and Personal Care Stores Medical Records Compounding 111

IDStewardship

FEBRUARY 12, 2025

BCPS, BCIDP Article posted12 February 2024 An antibiotic’s minimum inhibitory concentrations (MIC) is the lowest drugconcentration that prevents visible growth of a standard inoculum of a microorganism after ~24 hours of incubation. coli labeled as susceptible in 2010 may be labeled as resistant in 2025. Gauthier, Pharm.D.,

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Labelling 130

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.

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Labelling 145

Fierce Pharma

JANUARY 10, 2024

With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. | In AZ's push to reach industry-leading growth by 2030, confidence is key, chief financial officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference.

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Labelling 98

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.

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Packaging Customer Service Labelling Dosage 95

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.

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Labelling FDA 127

The Checkup by Singlecare

APRIL 9, 2025

For instance, in 2024, Ozempic was covered under Aetna s Advanced Control Plan and Standard Plan. Though some healthcare providers prescribe it off-label for obesity, Ozempic is not FDA -approved for weight loss. … In my experience, it is not covered for off-label use. And if so, how much does Aetna cover the drugs cost?

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Insurance Coverage Insurance Pharmacy Program Director Labelling 76

Pharmaceutical Technology

JANUARY 22, 2024

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

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Labelling 69

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.

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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.

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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.

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Packaging Labelling 105

European Pharmaceutical Review

NOVEMBER 1, 2024

percent between 2024 and 2033. Otherwise, advanced technological features such as “Advanced Recycling PET or Carbon Capture PET” as well as “labelling and sensory tracking systems” offer opportunities too, Towards Packaging asserted. The worldwide pharmaceutical container packaging market is expected to rise in revenue from $104.12

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Packaging Dosage Pharmaceutical Companies Pharmaceutical Companies 52

The Checkup by Singlecare

APRIL 15, 2025

It is also commonly used off-label for weight loss because, as a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist, tirzepatide helps control appetite (and thereby facilitates weight loss) in addition to lowering blood sugar. So, why is compounded tirzepatide even available?

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Compounding Dosage Compounding Pharmacies FDA 85

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.

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Labelling Adverse Reactions Dosage 59

The FDA Law Blog

MARCH 23, 2025

We wrote about the December 26, 2024 publication of the final rule (89 FR 105288) here. Livornese On Friday, March 21, 2025, FDA announced that it was further delaying the effective date for the ACNU final rule until May 27, 2025.

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FDA Labelling 59

The Checkup by Singlecare

NOVEMBER 4, 2024

If you prefer to take cinnamon capsules instead of adding ground cinnamon to your foods and drinks, Dr. Sapola says it’s important to read the supplement label so you know how much cinnamon is in each capsule. In September 2024, Consumer Reports tested 36 popular brands of ground cinnamon.

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Compounding People Management Dosage Labelling 95

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.

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Labelling FDA 52

The Checkup by Singlecare

DECEMBER 30, 2024

According to a 2024 study in Animals, gabapentin is also safe and well-tolerated for dogs with behavior disorders. Additionally, gabapentin is typically used as a human medicine; its prescribed off-label for dogs since it doesnt have FDA approval for them yet. It can help treat seizures and relieve anxiety.

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Dosage Compounding Compounding Pharmacies Labelling 59

The Checkup by Singlecare

AUGUST 14, 2024

Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use. While healthcare providers can prescribe Ozempic for off-label uses like weight loss, there are pros and cons to consider when taking it if you don’t have Type 2 diabetes. That is what happened with Ozempic, according to Dr. Shutze.

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Labelling FDA Insurance Insurance Coverage 88

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.

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Labelling 52

The Checkup by Singlecare

MARCH 11, 2025

In a 2024 KFF survey, one out of every eight Americans said they had taken a GLP-1 drug like semaglutide. Some healthcare providers might prescribe it off-label for weight management as well. Additionally, a 2024 study in Diabetes Epidemiology and Management found that oral semaglutide reduced hemoglobin A1C by an average of 3.1%.

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Compounding Compounding Pharmacies FDA Dosage 52

European Pharmaceutical Review

MARCH 27, 2025

Meanwhile, immigration costs continue to skyrocket, with the 2024 Royal Society report finding that the UKs upfront visa costs are 17 times higher than those of other leading science nations. Equalise: making UK immigration costs competitive The UKs visa fees have been labelled as national self-harm by the House of Lords. References 1.

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Pharmaceutical Companies Pharmaceutical Companies Labelling 52

The FDA Law Blog

NOVEMBER 10, 2024

In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2 Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. million over the next four years.

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FDA Labelling 69

European Pharmaceutical Review

DECEMBER 13, 2024

This authorises a novel CE-labelled needle for intravitreal injection. Subsequently, Vabysmo PFS was granted first approval for the conditions by the US Food and Drug Administration (FDA) in July 2024, Roche shared.

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Labelling Hospitals FDA 97

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.

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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.

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Labelling FDA 104

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.

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FDA Labelling 105

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.

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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.

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Packaging Labelling Hospitals 98

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.

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Labelling Communication FDA 59

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.

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Packaging Labelling 97

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.

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Labelling FDA 98

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.

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FDA Labelling 115

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.

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Labelling Hospitals 98

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.

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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.

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Labelling 97