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

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.

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Labelling 52

Eye on FDA

AUGUST 18, 2020

But it is not likely to surprise anyone that the first half of 2020 has caused not only an increase in communication from FDA, but a focus as well. Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019.

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Communication Documentation Labelling 61

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 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.

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Labelling Drug Pricing 52

Pharmaceutical Technology

DECEMBER 16, 2022

The endometriosis market is expected to grow from $1.05bn in 2020 to $2.72bn in 2030 at a compound annual growth rate (CAGR) of 10.0% The figure below summarises the endometriosis market growth across the 7MM from 2020 to 2030. At the end of 2030, the US will contribute approximately 81.3% of 7MM sales.

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Labelling Compounding 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.

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

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.

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Labelling Vaccines Communication 40

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.

Labelling 111

Labelling 111

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 135

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.

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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.

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Documentation Pharmaceutical Manufacturing 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.

Biosimilars 98

Biosimilars Labelling 98

Pharma in Brief

DECEMBER 3, 2020

continue to exclude COVID-19 drugs from brand-name assessments, including a look-alike/sound-alike assessment and labeling mock-ups, at the time of submitting an NDS. Consultation on the transition approach is open until December 21, 2020. Manufacturers would be required to provide bilingual labelling under certain circumstances.

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Vaccines Labelling Biosimilars Packaging 98

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 Immunity 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.

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Labelling Diabetes Hospitals 98

Eye on FDA

JUNE 14, 2023

It was the second letter for this company, the first having been issued in August, 2020 for a TV advertisement. The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation).

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Labelling Communication 82

FDA Law Blog: Biosimilars

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.

Biosimilars 59

Biosimilars Labelling Communication 59

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.”

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Labelling Vaccines 105

Express Pharma

AUGUST 13, 2024

per cent between 2020 and 2030. Many of these therapies are used off label. Filippos Maniatis, Healthcare Analyst at GlobalData, states, “It is an exciting time for the treatment landscape of AD as multiple therapies are coming closer to approval. Vtama and Zoryve possess interesting mechanisms of action (MoAs).

Labelling 105

Labelling 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.

Labelling 99

Labelling 99

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 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

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Labelling 105

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.

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Labelling 73

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.

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Packaging Labelling 98

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

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 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.

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Labelling Hospitals 111

pharmaphorum

NOVEMBER 15, 2021

Updated labelling for Invokana has already been approved to include data showing that it can reduce the risk of hospitalisation for heart failure and diabetic kidney disease in patients with type 2 diabetes, based on the CREDENCE trial. billion in 2016 before the product was linked to an increased risk of lower limb amputation.

Diabetes 105

Diabetes Labelling 105

pharmaphorum

SEPTEMBER 11, 2020

Results from the open-label phase 3b CASTING study showed 75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to Ocrevus.

Labelling 86

Labelling 86

pharmaphorum

DECEMBER 14, 2021

The 40-patient open-label study is the first to evaluate CAR-T therapy in treatment-naïve in high-risk LBCL, which is currently treated first-line mainly with rituximab and a chemo regimen known as CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone). .

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Chemotherapy Labelling 98

Express Pharma

MAY 22, 2023

In Japan, in September 2020, ASP-1929 received marketing approval from the Ministry of Health, Labour and Welfare for unresectable locally advanced or recurrent head and neck cancer as brand name Akalux, together with BioBlade Laser System, the medical device used in combination with the drug under the Conditional Early Approval System.

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Labelling Drug Development 98

pharmaphorum

NOVEMBER 26, 2020

Danyelza has been granted accelerated approval by the FDA on the strength of two open-label phase 2 studies. The first – study 201 – included 22 patients and showed an overall response rate of 45% with the antibody/GM-CSF combination, with 30% of responders seeing a benefit that lasted for at least six months.

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Chemotherapy Labelling 105

pharmaphorum

MAY 27, 2021

billion collaboration to develop the drug in women’s health and oncology in late 2020, including $650 million upfront and $200 million for regulatory milestones. The approval is good news for Myovant’s partner Pfizer too, as the big pharma agreed a $4.2

Labelling 98

Labelling 98

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.

Labelling 52

Labelling 52

Express Pharma

MAY 9, 2023

In 2020, we began partnering with My Green Lab to advance our sustainability efforts. This partnership started with select Agilent instruments being independently audited for the organisation’s Accountability, Consistency, and Transparency (ACT) Environmental Impact Factor Label.

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Packaging Labelling Pharmaceutical Manufacturing Research Laboratories 98