pharmaphorum

DECEMBER 15, 2021

Apellis Pharma and partner Sobi have won EU approval for their paroxysmal nocturnal haemoglobinuria (PNH) drug pegcetacoplan in Europe, with a more restricted label than in the US. The post EU gives narrower label to Apellis, Sobi’s PNH drug appeared first on.

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Labelling FDA Immunization 52

pharmaphorum

AUGUST 10, 2020

Wokingham, United Kingdom — 6 August 2020. A survey conducted among global healthcare companies by PRISYM ID, a leading provider of data-led label and artwork management solutions, shows that a fifth of them experience quality control issues with clinical labeling on a monthly basis.

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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 Comments to the revised draft guidance are due to the docket by June 25, 2024.

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Labelling Communication FDA 59

pharmaphorum

FEBRUARY 17, 2022

billion takeover of MyoKardia in 2020. The post BMS builds case for mavacamten label ahead of FDA decision appeared first on. The phase 3 VALOR-HCM trial in adults with obstructive HCM eligible for a procedure called septal reduction therapy (SRT) met its primary endpoint, according to BMS.

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Labelling FDA 57

STAT

SEPTEMBER 13, 2023

Akili Interactive, which in 2020 made waves by receiving Food and Drug Administration clearance for its video game that improves symptoms of ADHD in children, on Wednesday announced it would reorient its business around selling its products directly to users over the counter, rather than by prescription.

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Labelling FDA 134

pharmaphorum

JANUARY 12, 2021

Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million. After a couple of years of declining sales due to concern about a risk of lower limb amputation, Invokana managed a 25% gain to $224 million in third-quarter 2020.

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Labelling FDA 74

STAT

JANUARY 31, 2024

Experts say that the Singulair incident highlights a flawed system, both in the U.S. and globally, for monitoring adverse reactions after a drug is on the market — one that will require extensive changes to address.

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Adverse Reactions FDA Labelling Hospitals 117

The FDA Law Blog

DECEMBER 15, 2022

Not deterred by this denial, Americans for Homeopathy Choice submitted another citizen petition in 2020. The 2020 petition requested that FDA issue a proposed regulation for homeopathic drugs.

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FDA Labelling 98

STAT

JANUARY 10, 2024

… In 2020, the U.S. Food and Drug Administration responded to decades of escalating concerns about Singulair, a widely prescribed drug for asthma and allergies, by adding a stark warning on the labeling that it could cause aggression, agitation and even suicidal thought. We enjoy hearing your tips and tidbits.

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FDA Labelling 106

pharmaphorum

AUGUST 16, 2022

Lynparza was approved in 2020 as a second-line therapy for homologous recombination repair (HRR) gene-mutated mCRPC last year, but extending its label to include non-HRR patients in the frontline setting would dramatically increase the number of patients eligible for treatment. months and 16.6 months, respectively.

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FDA Labelling 109

pharmaphorum

AUGUST 24, 2022

The biotech has confirmed it will not launch the biosimilar until March 2025 however, honouring the terms of its 2020 agreement with Alexion that resolved litigation over the validity of patents covering Soliris (eculizumab) in the US.

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Labelling FDA 98

Pharmaceutical Technology

JANUARY 23, 2023

in revenue across seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) in 2018, and also was the first approved biologic therapy for LN in the US, having gained approval in 2020. in 2018 across the 7MM despite being an off-label therapy for lupus.

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Labelling Immunization 111

The Guardian - Pharmaceutical Industry

DECEMBER 5, 2023

Since 2020, there has been Kaftrio, which is a triple combination. Kaftrio is the latest to be labelled unaffordable for a cash-strapped NHS. Its groundbreaking Kalydeco drug was licensed in Europe in 2012 and useful at first to only a small percentage of sufferers. Continue reading.

Labelling 50

Labelling 50

pharmaphorum

DECEMBER 7, 2020

Wokingham, United Kingdom — 7 December 2020 — PRISYM ID, a leading provider of regulated content and label management solutions for the life sciences sector, announced today that PRISYM 360 version 1.10 has achieved SAP® certification using SAP Cloud Platform Integration Suite. – Ends – About PRISYM ID.

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Labelling Communication 52

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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FDA Documentation Packaging Labelling 94

pharmaphorum

OCTOBER 4, 2022

This week has seen two readouts for rivals from Clovis Oncology and Pfizer in prostate cancer – one of several indications on the Lynparza (olaparib) label – that could lead to a challenge to the $3 billion blockbuster.

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Chemotherapy Labelling FDA 52

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

European Pharmaceutical Review

AUGUST 16, 2022

HCC accounted for more approximately 85 percent of the 900,000 new liver cancer cases in 2020, according to the Globocan 2020 database. . The RATIONALE 301 Phase III randomised, open-label study included more than 600 patients in the US, Europe and Asia.

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Labelling Immunization 98

Pharmaceutical Technology

JULY 25, 2022

In June, Bavarian Nordic submitted a rolling type-II variation application seeking label expansion for the vaccine usage in accordance with the company and Emergency Task Force (ETF) of the EMA, Rapporteurs and the European Health Emergency Preparedness and Response Authority (HERA). .

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Vaccines Labelling 52

The Checkup by Singlecare

FEBRUARY 8, 2024

For example, one 2020 study from Taiwan compared brand-name and generic antidepressants. for 30, 10 mg tablets of cetirizine (must present prescription to apply SingleCare savings) Free coupons Zyrtec coupons Cetirizine coupons What are the off-label uses for Zyrtec? mL or 5 mL once daily or 2.5 mL every 12 hours.

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Dosage Labelling FDA Hospitals 52

PharmaShots

FEBRUARY 6, 2023

Shots: The company reported the results from the PoC P-II open-label (UNITY) trial evaluating nipocalimab (IV, qw) in 14 patients who are at high risk for sev. HDFN The trial met its 1EPs i.e., the results showed that patients treated with nipocalimab achieved a live birth at or after the gestational age of 32wks.

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Labelling FDA 40

pharmaphorum

MAY 26, 2022

As Vidaza is a standard first-line therapy for AML the new indication makes Tibsovo an option for a wider range of patients, although the drug has reportedly been used off-label in this setting. Servier refiled the drug in Europe in March, thanks to the results of the AGILE trial which form the basis of the latest FDA approval.

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FDA Chemotherapy Labelling 52

pharmaphorum

MARCH 15, 2022

It currently appears highly unlikely that the majority of conferences will simply return to typical face-to-face only formats as they were before 2020. This article summarises the most important lessons learnt during 2020 – 2021. Lessons learnt 2020-2021. Part 2 will assess possible scenarios for 2022 and beyond.

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Labelling Vaccines Communication 104

The Checkup by Singlecare

OCTOBER 12, 2023

Abilify generic | Abilify vs. aripiprazole | Cost | Off-label use | How to switch Abilify is a brand-name medication approved to treat certain mental health conditions, including the treatment for schizophrenia , bipolar disorder , and major depressive disorder. In fact, in 2020, an estimated 8.3 Is there a generic for Abilify?

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Dosage Labelling FDA Adverse Reactions 52

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

pharmaphorum

SEPTEMBER 20, 2021

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications. billion respectively during 2020 as the pandemic reduced patient access to treatment. billion, but fell back to $1.4

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FDA Labelling 70

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

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FDA Labelling Packaging Documentation 52

pharmaphorum

AUGUST 23, 2022

The phase 1/2 trial will be an open-label, dose-escalation study that will test various doses of BV-101 in between 12 and 18 subjects. AskBio acquired BrainVectis in 2020, ahead of its own $4 billion takeover by Bayer, which was part of a push by the Germany group into the regenerative cell and gene therapy space.

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Labelling 104

Hospital Pharmacy Europe

MARCH 10, 2023

Cutaneous melanoma is the most serious form of skin cancer worldwide with an estimated 325,000 new cases and 57,000 deaths in 2020. For the current study, US researchers performed a randomised, phase 2, open-label trial, in patients with measurable stage IIIB to IVC melanoma that was amenable to surgical resection.

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Labelling Hospitals 96

The Checkup by Singlecare

APRIL 3, 2024

It may worsen the side effects of prednisone One study published in 2020 showed that consuming caffeine , especially in high amounts, can cause sleep disturbances and sleep disorders like insomnia, while another 2020 study indicated that caffeine may play a role in migraine headaches. ” These may be taken without food.

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Immunization Specialty Pharmacies Dosage Labelling 105

pharmaphorum

JANUARY 29, 2021

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. billion in the first nine months of 2020. Now, a study designed to prove its safety has achieved the opposite.

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Labelling Patient Care FDA 135

The Checkup by Singlecare

SEPTEMBER 7, 2023

In 2020, an estimated 6.3 For example, in this 2020 study , people who took generic antidepressant medications were at higher risk of being hospitalized compared to those who took their brand-name counterparts. Using an approved drug for an unapproved use is called “ off-label ” use. million people used escitalopram.

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Dosage Labelling FDA Insurance 52

pharmaphorum

MARCH 1, 2021

In September 2020, the French government published the draft of their annual review of spending on health and social care, which will form the basis of the Social Security and Finance Bill in 2021 (PLFSS 2021). Compassionate access is for off-label treatments that aren’t in development for an indication. CEPS negotiates prices. .

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Insurance Labelling 78

pharmaphorum

SEPTEMBER 7, 2020

Wokingham, United Kingdom —4 September 2020 — PRISYM ID, a leading provider of regulated content and label management solutions, has announced the appointment of Robert Bowdish as Director of Clinical Trials Sales for North America. PRISYM ID makes new senior appointment to drive further growth in clinical trials arena.

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Labelling 52

The People's Pharmacy

JUNE 12, 2023

It is rare for pharmacies to put the expiration date on the label if they transfer the pills from the manufacturer’s original container. She asked: “When I picked up a prescription from the pharmacy, the pharmacy label had a ‘use before’ date of 09/04/10. Why is this?”

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Labelling Mail-Order Pharmacies Adverse Reactions FDA 62

pharmaphorum

APRIL 22, 2022

A year ago, Astellas recorded a $540 million charge in relation to the AT132 hold, which was first implemented in December 2020. Without going into further details, the company said today that it has now “revised the eligible treatment population based upon an anticipated future product label compared to our initial assessment.”

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Labelling Vaccines FDA 104

pharmaphorum

NOVEMBER 10, 2022

However, turnover fell back to $148 million in 2021, mainly as a result of strong competition from AstraZeneca and Merck & Co’s class-leading Lynparza (olaparib) – which has a much broader product label – as well as GSK’s Zejula (niraparib). With finances tight, Clovis has deferred a $1.9

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Chemotherapy Labelling FDA 57