Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

Labelling 52

Labelling FDA 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.

Labelling 59

Labelling FDA 59

pharmaphorum

JULY 15, 2022

The case hinges around the concept of “ skinny labelling ” which was introduced to stop drugmakers extending the exclusivity period for their branded medicines – through a stream of new indications or patient populations – that can be protected with so-called “use” patents. The substance patent expired in 2007.

Labelling 52

Labelling 52

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.

FDA 98

FDA Labelling 98

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.

Labelling 52

Labelling FDA Immunization 52

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.

Labelling 59

Labelling FDA 59

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.

FDA 111

FDA Labelling 111

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.

Adverse Reactions 114

Adverse Reactions FDA Labelling Hospitals 114

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. Most OTC drugs, particularly drugs that have been around for a while, are primarily marketed pursuant to OTC monographs.

Labelling 40

Labelling FDA Vaccines Communication 40

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.

Labelling 135

Labelling Patient Care FDA 135

The FDA Law Blog

DECEMBER 22, 2022

In brief, that case involved the appeal of a 2020 Final Rule in which FDA banned the use of an Electrical Stimulation Device (“ESD”) only in the treatment of self-injurious behavior or aggressive behavior. In other words, Congress is proposing to let FDA ban devices for particular uses, including off-label uses.

FDA 114

FDA Labelling 114

European Pharmaceutical Review

NOVEMBER 24, 2022

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

Packaging 111

Packaging Labelling Documentation Dosage 111

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.

FDA 105

FDA Documentation Packaging Labelling 105

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.

Labelling 98

Labelling FDA 98

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.

Labelling 105

Labelling Vaccines Communication 105

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.

Labelling 111

Labelling Immunization 111

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.

FDA 104

FDA Labelling 104

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.

Labelling 98

Labelling Immunization 98

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.

Labelling 98

Labelling Hospitals 98

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.”.

Labelling 97

Labelling Communication FDA Medical Schools 97

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. .

Insurance 78

Insurance Labelling 78

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.

Labelling 105

Labelling 105

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.”

Labelling 105

Labelling Vaccines FDA 105

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.

FDA 99

FDA Labelling 99

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

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.

Labelling 97

Labelling FDA 97

European Pharmaceutical Review

OCTOBER 31, 2023

Alfasigma said the proposed transaction will strengthen its pipeline, adding a new Phase III programme” Alfasigma said in a statement the proposed transaction will strengthen its pipeline, “adding a new Phase III programme aiming at expanding Jyseleca’s label to a third indication.” “The

Labelling 105

Labelling 105

The Checkup by Singlecare

JULY 22, 2024

It can also treat parasitic infections, like giardia, and is frequently used off-label (for a non-FDA-approved use) to help treat Crohn’s disease, bite wounds, and oral infections. Be sure to check food labels carefully for either of these ingredients. What should you eat while taking metronidazole?

Labelling 105

Labelling Packaging FDA 105

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

FDA 72

FDA Labelling 72

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores 59

Health and Personal Care Stores Labelling Immunization Packaging 59

pharmaphorum

SEPTEMBER 15, 2022

It had been held up in the US by compliance issues that forced Mallinckrodt to change its packaging and labelling manufacturing facility and resulted in the FDA rejecting its application in February.

FDA 98

FDA Packaging Labelling 98

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 73

Labelling 73

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.

Labelling 96

Labelling Hospitals 96

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.

Labelling 52

Labelling Communication 52

pharmaphorum

SEPTEMBER 16, 2020

There’s one possible shadow over the findings, which is the black box warning on Olumiant labelling that it can cause thrombosis or blood clots. The post Trial backs Lilly’s Olumiant plus remdesivir as combo COVID-19 therapy appeared first on.

Labelling 111

Labelling FDA Hospitals 111

pharmaphorum

NOVEMBER 6, 2020

The transaction is expected to close at the end of 2020. The new label extensions cover BRCA1/2-mutated metastatic castration-resistant prostate cancer and first-line maintenance treatment for HRD-positive advanced ovarian cancer.

Labelling 85

Labelling 85

pharmaphorum

SEPTEMBER 15, 2021

It is thought that around five million women in the US have uterine fibroids that cause symptoms, with two-thirds of them inadequately treated with current drugs – generally off-label oral contraceptives or injectable GnRH agonists like leuprolide acetate or goserelin acetate.

FDA 98

FDA Labelling 98