pharmaphorum

MARCH 1, 2021

European regulators have refused to back GlaxoSmithKline’s daily triple therapy Trelegy Ellipta for asthma, denying a label extension because there was no evidence to show a reduction of flare-ups.

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Labelling FDA 105

The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

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Labelling FDA Vaccines Communication 40

pharmaphorum

JANUARY 3, 2023

The Italian biopharma said it had decided to press ahead with the new study after assessing results from 100 patients with TRS in open-label studies who received the glutamate modulator drug as an add-on to their current therapy for more than six months. in the evenamide group. .

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Labelling 105

European Pharmaceutical Review

APRIL 8, 2024

The expanded label of CARVYKTI has the potential to transform the treatment paradigm for multiple myeloma by providing patients and physicians with a personalised immunotherapy that can be used earlier in the treatment regimen,” commented Ying Huang, PhD, Chief Executive Officer of Legend Biotech.

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FDA Labelling 98

The FDA Law Blog

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. So, while the skinny label may not actually be dead, there will certainly be a reluctance to use it.

Labelling 40

Labelling FDA 40

European Pharmaceutical Review

JULY 27, 2023

Soliris was first approved the EU in 2017 as a treatment for gMG. Patients who completed the randomised control period were eligible to continue into an open-label extension period evaluating the safety and efficacy of Soliris, which is ongoing.

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Labelling Hospitals 98

pharmaphorum

MARCH 23, 2021

The companies had been working on tominersen since December 2017, when Roche licensed it in from Ionis. Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study.

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Labelling 98

pharmaphorum

DECEMBER 18, 2020

The US regulator has cleared both intravenous and subcutaneous formulations of Benlysta (belimumab) for the new indication, extending the use of the drug beyond its earlier label covering the treatment of active systemic lupus erythematosus (SLE) in combination with other medicines.

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FDA Labelling 99

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. The post Novartis’ ‘wild card’ drug Scemblix gets FDA nod for leukaemia appeared first on.

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FDA Labelling 115

The Checkup by Singlecare

FEBRUARY 19, 2024

Rybelsus is the first oral form of semaglutide, approved in 2017. The drug label for Ozempic specifically states it can be used to help reduce the risk of cardiovascular events like heart attacks and stroke in people with Type 2 diabetes and heart disease. This indication is not found on the label for Rybelsus.

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Dosage Insurance Coverage Labelling Insurance 96

The Checkup by Singlecare

DECEMBER 21, 2023

Though metformin isn’t technically approved for use in treating anything other than diabetes, many healthcare providers prescribe it off-label because of the growing body of evidence supporting these added benefits. What is metformin approved to treat?

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Health and Personal Care Stores Labelling Dosage FDA 105

pharmaphorum

SEPTEMBER 11, 2020

Ocrevus (ocrelizumab) was approved in 2017 for relapsing and primary progressive forms of MS and is seen as one of the most successful drug launches in pharma history, generating sales of $3.79 Roche has hit back at Novartis’ newly-approved multiple sclerosis drug Kesimpta, with new data from its already-marketed blockbuster Ocrevus.

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Labelling FDA 86

pharmaphorum

MARCH 8, 2021

The new indication for the Merck & Co/MSD-partnered drug – which is also used to treat ovarian, breast and pancreatic cancer – was approved by the EMA last year with a slightly more restricted label than was previous cleared by the FDA.

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Chemotherapy Labelling FDA 98

pharmaphorum

FEBRUARY 8, 2021

Breyanzi has however been cleared with a similar black box warning on its label for neurotoxicity and cytokine release syndrome (CRS) as Novartis and Gilead/Kite’s therapies. At the moment there are limited fallback options for patients whose lymphoma progresses despite first line chemotherapy and anti-CD20 treatment.

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FDA Chemotherapy Labelling 111

Hospital Pharmacy Europe

APRIL 4, 2024

Cladribine tablets (brand name Mavenclad) have been granted a label extension by the Medicines and Healthcare products Regulatory Agency (MHRA) to expand access for additional patient populations with multiple sclerosis (MS), its manufacturer Merck has announced.

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Labelling Hospitals 52

The Checkup by Singlecare

JANUARY 26, 2024

Approved by the Food and Drug Administration (FDA) in 2017 for blood sugar management, Ozempic has recently gained attention for its weight loss effects. Healthcare professionals prescribe Ozempic off-label for weight management for patients with obesity.

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Labelling FDA 111

pharmaphorum

JUNE 7, 2021

Kymriah (tisagenlecleucel) was approved for relapsed/refractory ALL in 2017, but its label covers use in children and young adults aged up to 25, who account for the bulk of cases of the blood cancer. The median response duration was 12.8

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FDA Labelling Immunization 105

The Checkup by Singlecare

NOVEMBER 11, 2024

Although trazodone is FDA -approved for depression, it’s primarily known for its off-label use as a sleep aid due to its sedative effects. In a 2017 systematic review , researchers concluded that low-dose trazodone is effective for insomnia in people with or without depression.

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FDA Labelling 93

pharmaphorum

MARCH 9, 2022

The launch of Hemlibra (emicizumab) in 2017, with a label expansion in 2018 to broaden its use – had a speedy impact on Eloctate, which also came from Bioverativ’s stable. Sanofi recorded a $2 billion charge in 2019 that it said was largely down to pressure on its drug.

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Labelling FDA 98

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. Clinical practice guidelines for Clostridium difficile infection in adults and children: 2017 update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA).

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Documentation Labelling Hospitals 111

The Checkup by Singlecare

OCTOBER 30, 2023

According to a 2017 database review , no evidence of drug interactions between hormonal contraception and non-rifamycin antibiotics was found. Amoxicillin food interactions According to the amoxicillin product labeling , there are no drug-food interactions of concern.

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Vaccines Labelling FDA Dosage 105

pharmaphorum

NOVEMBER 6, 2022

The antibody-based drug has been cleared by the European Commission with a broad label, covering both full-term and pre-term babies and those with a range of health conditions that could make the vulnerable to RSV, said the two pharma groups in a statement. It is the first approval for Beyfortus (nirsevimab) by any regulatory authority.

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Vaccines Labelling 64

The Checkup by Singlecare

NOVEMBER 13, 2023

Always tell your pharmacist or provider all of the medications and supplements you are taking and read all the labels and pharmacy instructions before taking ibuprofen with any other medications. However, gastrointestinal issues may be reduced when ibuprofen is taken with food, milk, or antacids. What is the standard ibuprofen dosage?

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Dosage Labelling 105

The Checkup by Singlecare

AUGUST 14, 2024

Although GLP-1 drugs have been around since 2005, Ozempic was only made available in 2017. Taking medication for a reason that isn’t FDA approved is considered an “ off-label ” use. First, using a drug off-label—especially one that’s fairly new, like Ozempic—can be unsafe.

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Labelling FDA Insurance Insurance Coverage 52

pharmaphorum

APRIL 30, 2021

BMS and bluebird had been hoping for a label allowing third-line use. Janssen entered into a worldwide collaboration and license agreement for cilta-cel with the drug’s originator – China’s Legend Biotech – in December 2017.

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Immunization FDA Labelling 82

pharmaphorum

SEPTEMBER 25, 2020

The drug is approved both as a monotherapy in first-line NSCLC and also got the green light for use in combination with chemo in 2017. The new data is a boost to Merck’s franchise just as other drugmakers have started to cast jealous eyes at the lucrative market, which accounts for the bulk of Keytruda’s sales.

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Chemotherapy Labelling Patient Care FDA 75

The Checkup by Singlecare

FEBRUARY 13, 2023

A 2017 meta-review of 11 randomized controlled trials found that participants who took a dose that ranged between 365 to 450 mg per day experienced decreases in both systolic and diastolic blood pressure. Read the labels. The FDA encourages people to read the directions and take the supplement only as described on the label.

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Mayo Clinic Labelling FDA 119

pharmaphorum

OCTOBER 14, 2021

The findings were based on an ALITHIOS Phase 3b open-label extension study of Kesimpta, a targeted B-cell therapy that Novartis says, “delivers superior efficacy with a similar safety and tolerability profile compared with teriflunomide, a first-line treatment for MS.”. years vs initiation two years later. billion in 2019.

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Labelling Immunization FDA 59

pharmaphorum

SEPTEMBER 21, 2020

The committee also recommended Lynparza should get its label extended to cover first-line maintenance treatment of ovarian cancer in combination with Roche’s Avastin (bevacizumab), in patients with homologous recombination deficient (HRD)-positive disease.

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Labelling Vaccines FDA 52

European Pharmaceutical Review

FEBRUARY 23, 2023

11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. 2017; 88, Art. Label-free, rapid and quantitative phenotyping of stress response in E. B, 2017; 372:20160138. This is particularly important for commonly used bacteria such as E. coli via ramanome.

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Labelling Packaging 121

The Checkup by Singlecare

NOVEMBER 3, 2023

Read food labels carefully. When buying packaged foods, carefully scan the label and look for added sugars. “Fruits are and should be one of the main components in our daily meals,” says Dr. Makhija. Fruit is a power-packed food and provides nutrients beyond the ‘sweet’ component of it.” Added sugar can go by many names.

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Labelling Packaging Immunization 116

Pharma Marketing Network

MARCH 25, 2022

Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. 2015-2017 Behavioral Risk Factor Surveillance System (BRFSS) Data from adults in 44 States, Puerto Rico, and the District of Columbia. Connect at linkedin.com/in/sunnywhite/ . REFERENCES: Gilda’s Club.

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Labelling FDA 98

pharmaphorum

MARCH 16, 2022

The Belgian biotech, which was spun out from the Vrije Universiteit Brussel in 2014, is developing a pipeline of radio-labelled, single-chain antibodies led by CAM-H2, currently in a phase 1/2 study in patients with HER2-positive metastatic breast and gastric cancers.

Labelling 59

Labelling 59

pharmaphorum

OCTOBER 7, 2021

In 2017, Teva won approval for Austedo (deutetrabenazine), a tweaked version of tetrabenazine that also claims to offer fewer side effects, but carries a black box warning for depression and suicidality. Sales were $638 million last year and according to Teva will approach the $1 billion mark in 2021, despite the warning label.

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Labelling 72

European Pharmaceutical Review

JULY 5, 2022

In the future, the potential label expansion of Oncoral into other solid cancer indications will be investigated. accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22]. 2017; 8(23):38022-38043. For more information about Oncoral, please visit www.ascelia.com/pipeline/oncoral. About the author.

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Chemotherapy Dosage Labelling Compounding 104

The Checkup by Singlecare

APRIL 3, 2024

According to a 2017 study , the beverage acts in an anti-inflammatory manner on different components of the immune system, such as natural killer (NK) cells, monocytes, and neutrophils. This can reduce stomach upset unless your medication is labeled “enteric coated” or “gastro-resistant.” Take it in the morning.

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Immunization Specialty Pharmacies Dosage Labelling 105

The Checkup by Singlecare

NOVEMBER 8, 2023

It gained approval in 2017 but has surged in popularity recently due to the medication’s ability to help with weight loss. You’ve likely heard about Ozempic (semaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist approved by the Food & Drug Administration (FDA) to manage blood sugar levels for people with Type 2 diabetes.

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FDA Labelling 105