pharmaphorum

FEBRUARY 4, 2021

It comes as PRISYM ID announces five new business wins for the start of 2021, with new accounts spanning clinical trials, pharmaceutical and medical device sectors and with significant growth of the company’s flagship PRISYM 360 platform in the Cloud.

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Labelling 52

pharmaphorum

SEPTEMBER 23, 2022

The full approval also extends the Retevmo label to include patients with locally advanced as well as metastatic disease. ” Sales of Retevmo have been gathering momentum since its first approval in 2020, coming in at $87 million in the first half of the year, double the same period of 2021.

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Labelling FDA 59

European Pharmaceutical Review

JANUARY 16, 2023

Rykindo ® was approved for marketing in China in 2021 for the treatment of schizophrenia. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder. Clinical trials of the FDA approved Rykindo ®.

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FDA Labelling 122

Hospital Pharmacy Europe

MARCH 11, 2025

of NIHR Doctoral Fellowship applications between 2014 and 2021 came from pharmacy professionals. Neil has been funded by NIHR to investigate the best way to treat patients incorrectly labelled as allergic to penicillin , and how to integrate this decision-making process into routine clinical practice.

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Hospitals Patient Care Labelling Vaccines 80

Pharmaceutical Technology

JANUARY 23, 2023

However, the 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years. Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo in June 2021.

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Labelling Immunization 111

STAT

JANUARY 8, 2024

Cure Ventures , a Boston-based venture capital firm founded in 2021 by a trio of veteran biotech investors, has brought in two former executives from Sage Therapeutics to prepare them for investing in neuroscience startups. Continue to STAT+ to read the full story…

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Labelling FDA 120

The FDA Law Blog

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. of the total expenditures for all Part D drugs in 2021.

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Labelling Compounding Payment Processing Vaccines 105

European Pharmaceutical Review

NOVEMBER 22, 2022

The application is supported by results from the LBCL cohort of the EPCORE NHL-1 open-label, multi-centre Phase I/II trial evaluating the safety and preliminary efficacy of epcoritamab in adults with relapsed, progressive or refractory CD20+ mature B-cell non-Hodgkin’s lymphoma (NHL). EPCORE NHL-1 Trial of epcoritamab .

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FDA Labelling 98

The FDA Law Blog

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. Part 117, and the Food Allergy Safety, Treatment, Education and Research Act (2021).

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Labelling FDA 45

European Pharmaceutical Review

FEBRUARY 8, 2023

Research from data and analytics company GlobalData shows that the use of CD19 chimeric antigen receptor T-cell (CAR-T) agents for blood cancer is set to significantly increase between 2021-2031. GlobalData predicts Bristol-Myers Squibb’s Breyanzi and Gilead’s Yescarta are set to have high annual sales in the forecast period.

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Labelling Compounding 98

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

STAT

JUNE 29, 2023

He allegedly worked with several other individuals and pharmacies between 2017 and 2021 as part of the scheme. Reconfiguring bottles and labels for distributing medicines is known as misbranding or diverting legitimate prescription drugs. Steven Diamantstein, who runs Scripts Wholesale in Brooklyn, N.Y.,

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Labelling FDA 98

Pharma Marketing Network

APRIL 15, 2021

Download this infographic and learn which 6 digital tools are at the center of digitalization and how the will influence the future of Pharma marketing in 2021 and beyond. Company Email *.

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Labelling 98

European Pharmaceutical Review

NOVEMBER 10, 2022

Medicines Discovery Catapult (MDC) released a report 2 on complex medicines in 2021, proposing narrowing the definition to: ‘medicines requiring the application of novel technologies for their delivery and targeting of drugs, through the modification of an active pharmaceutical ingredient (API) or formulation, or a novel delivery route’.

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Labelling Compounding 105

European Pharmaceutical Review

JANUARY 18, 2023

In 2021, Peter Kohut, Director of Drug Safety at Arriello shared with EPR how European medical cannabis market lacks a common regulatory framework. “… there is a lack of standardisation in the manufacturing of medical cannabis products , their ingredients and labelling.”.

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Pharmaceutical Companies Pharmaceutical Companies Labelling 119

Pharmaceutical Technology

JULY 20, 2022

While the label expansion will likely increase avenues for patients to access the antiviral, Ganio adds one caveat: due to burnout and turnover seen across the healthcare field, including pharmacy staff, there are going to be sites that just don't have the resources to dedicate a pharmacist to do some of this work.

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Labelling Community Pharmacies Medical Records FDA 111

IDStewardship

MARCH 12, 2023

” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication. Article 5: A Baker’s Dozen of Top Antimicrobial Stewardship Intervention Publications for Hospitalized Patients in 2021 Find it here.

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Medication Guidelines Documentation Labelling Hospitals 299

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

NOVEMBER 1, 2022

The Phase III open-label, randomised trial ( NCT03682536 ) evaluated the efficacy and safety of Reblozyl versus epoetin alfa. in November 2021. The primary endpoint assessed in this study was RBC-TI for 12 weeks, with a mean haemoglobin increase ? The company will also discuss results with health authorities.

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Labelling 105

The FDA Law Blog

AUGUST 23, 2022

Instead of simply denying authorization, FDA responded by authorizing these tests with a requirement in the labeling for serial testing. For example, labeling stated: This test is authorized “when tested twice over three days with at least 24 hours (and no more than 48 hours) between tests.”.

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Labelling Communication FDA Medical Schools 97

STAT

OCTOBER 4, 2023

Lumakras received an accelerated — or conditional — approval in May 2021, making it the first KRAS drug on the market. The treatment, which is called Lumakras and made by Amgen, is designed to treat lung cancer caused by a specific genetic mutation to a protein called KRAS. Now, Amgen needs to prove it works.

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FDA Labelling 102

pharmaphorum

MARCH 3, 2022

The findings – published today in the journal Nature Medicine – come after Jardiance was approved for chronic heart failure with reduced ejection fraction (HFrEF) last year, with the label expanded to include patients with heart failure with preserved ejection fraction (HFpEF) last month. It has been used to treat type 2 diabetes since 2014.

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Labelling Hospitals 98

European Pharmaceutical Review

AUGUST 16, 2022

The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia. In January 2021, BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialise BeiGene’s tislelizumab in North America, Europe, and Japan.

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Labelling Immunization 98

pharmaphorum

MARCH 15, 2022

Towards the conclusion of 2021 many societies announced another shift in format; 2022 conferences would be hybrid, or increasingly and more realistically described as ‘physical with virtual participation options,’ or similar. This article summarises the most important lessons learnt during 2020 – 2021. Lessons learnt 2020-2021.

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Labelling Vaccines Communication 105

pharmaphorum

JUNE 4, 2021

— NEJM (@NEJM) June 3, 2021. Among patients who had mutations in BRCA1 or BRCA2 and were at high risk for disease progression, those who were assigned to a year of olaparib adjuvant therapy had 3-year invasive disease–free survival of 86%. billion in sales for AZ last year, with Merck booking $725 million in alliance revenues.

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Chemotherapy Labelling 98

European Pharmaceutical Review

OCTOBER 31, 2022

An ongoing Phase III, open-label, randomised trial ( 04628494 ) is currently evaluating epcoritamab as a monotherapy for patients with these cancers. Data from the dose escalation section of the investigation was published in The Lancet in 2021. The primary endpoint for the expansion part was overall response rate (ORR).

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Labelling FDA 98

pharmaphorum

MAY 5, 2021

After an indifferent period Novo Nordisk has kicked off 2021 on the front foot, raising its financial forecast after posting better than expected Q1 earnings and sales. He added: “The solid financial performance in the first three months of 2021 has enabled us to raise our outlook range for the full year.” billion DKK ($2.04

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Labelling FDA 72

The Checkup by Singlecare

AUGUST 6, 2024

Wegovy is a relatively new drug manufactured by Novo Nordisk and approved by the Food and Drug Administration (FDA) in 2021. While Wegovy can help manage blood sugar levels in people with Type 2 diabetes, it is considered an off-label use of the medication. Metformin has been around longer and was initially approved in 1995.

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Labelling Dosage Insurance Insurance Coverage 105

pharmaphorum

SEPTEMBER 24, 2021

The updated results come from the open-label RAINBOWFISH study, which investigate the effects of Evrysdi (risdiplam) in children from birth to six weeks who had yet to develop any symptoms of the muscle wasting disorder. Evrysdi is also on an upwards trajectory, bringing in around $250 million in the same period.

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Labelling FDA 97

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively.

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Labelling FDA 111

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.

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Labelling FDA Hospitals 59

pharmaphorum

FEBRUARY 21, 2022

DESTINY-Breast03 and 04 as well as data in HER2-positive non-small cell lung cancer (NSCLC) have gone a long way towards building positive sentiment to Enhertu among market watchers, who were nervous about the drug’s prospects when the ILD issue started to emerge.

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Chemotherapy Labelling 132

The Checkup by Singlecare

FEBRUARY 14, 2024

That’s why even though the medication is only approved by the Food and Drug Administration (FDA) for Type 2 diabetes, it’s also used off-label as a weight-loss medication. For managing blood glucose levels, a 2021 trial found tirzepatide to be slightly more effective than semaglutide (the active ingredient in brand-name Ozempic ).

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Dosage Labelling FDA Pharmaceutical Companies 115

pharmaphorum

JANUARY 7, 2022

billion on the first nine months of 2021, well ahead of Pfizer’s own forecasts. Ionis’ drug has however been held back by a limited label and some safety concerns and Ionis recently sold North American rights to the drug to Sobi.

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Labelling Immunization 116

pharmaphorum

OCTOBER 7, 2022

The UK was the first country to authorise Lagevrio, giving it a green light in November 2021 a few weeks ahead of the US, which cleared the drug with a more restrictive label. The European Commission has yet to approve it for use in the EU.

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Vaccines Labelling Hospitals 119

The Checkup by Singlecare

JANUARY 26, 2024

Healthcare professionals prescribe Ozempic off-label for weight management for patients with obesity. It received FDA approval for weight management in June 2021.) Approved by the Food and Drug Administration (FDA) in 2017 for blood sugar management, Ozempic has recently gained attention for its weight loss effects.

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Labelling FDA 111

pharmaphorum

JUNE 22, 2021

Labelling software firm has implemented six new software systems in the last few months in a sign that the market is now rebalancing after the upheavals of the last 12 months. The first few months of 2021 have been extremely busy for us as it is clear that the legacy of COVID-19 has focused people’s minds.

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Labelling 52