Express Pharma

DECEMBER 2, 2024

This alarming trend presents a lucrative opportunity for drugmakers. The company’s Phase III product Rybelsus, already FDA approved for cardiovascular risk factors and type 2 diabetes, is being positioned for a label expansion to include obesity. The success of GLP-1R-targeting drugs highlights their viability as a treatment approach.

Labelling 126

Labelling Diabetes Drug Development 126

Express Pharma

JANUARY 17, 2025

Jos Opdenakker, Pharma Analyst at GlobalData, comments, J&Js acquisition of Intra-Cellular Therapies presents a significant synergy of expertise in neuropsychiatric conditions and signals J&Js intent to diversify its own portfolio of products within the CNS market. It is also currently under FDA review for major depressive disorder.

Labelling 105

Labelling 105

pharmaphorum

SEPTEMBER 10, 2021

The agency – which originally cleared the drug for all Alzheimer’s patients but narrowed its label to the population studied in clinical trials after an outcry, is currently under investigation by lawmakers in the US. Shares in Biogen closed down a little under 7% yesterday after the presentation.

Labelling 96

Labelling Insurance Coverage and Processing 96

Express Pharma

JANUARY 19, 2025

This study consists of a 36-week treatment phase, followed by a 16-week open-label extension. It is planned to present this Phase 2(a) trial data in an upcoming medical conference and publish in a medical journal. This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo.

Clinical Pharmacology 111

Clinical Pharmacology Labelling Medical Schools Drug Development 111

Express Pharma

MARCH 20, 2025

Eli Lilly and Company (India) announced the launch of Mounjaro in single-dose vial presentation following the marketing authorisation from the Central Drugs Standard Control Organization (CDSCO). Presented virtually at the American Diabetes Association’s 81st Scientific Sessions; June 25-29. Abstract 100-OR. Rosenstock, J, et.

Diabetes 101

Diabetes Labelling Communication 101

STAT

AUGUST 30, 2024

… Novo Nordisk’s obesity drug Wegovy cut the risk of severe complications in patients with a common form of heart failure, according to a new analysis that could boost the company’s efforts to expand the label for the blockbuster treatment , STAT writes. Continue to STAT+ to read the full story…

Hospitals 285

Hospitals Labelling 285

FDA Law Blog: Biosimilars

MAY 11, 2023

GSK skinny label case , the U.S. In the brief , the Government takes a strong position, stating “[t]he court of appeals’ holding that respondents presented sufficient evidence of petitioner’s intent to induce infringement is erroneous and warrants this Court’s review.”

Labelling 72

Labelling Documentation Communication 72

Safe Biologics

MARCH 21, 2024

On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. and Advisory Board Chair Philip Schneider, MS, FASHP.

Biosimilars 100

Biosimilars Labelling 100

LifeProNow

JANUARY 18, 2025

Data collected through the second quarter of 2024 and presented at the European Society for Medical Oncology (ESMO) 2024 Congress as alate-breaking oral presentationshowed an 83.5 The submission of this innovative intravesical drug releasing system is supported by data from the Phase 2b SunRISe-1 registration study.

Packaging 100

Packaging Labelling 100

Express Pharma

MAY 25, 2023

However, KOLs stated that Nuplazid is not very effective in managing the symptoms compared to other off-label antipsychotics. The post Parkinson’s unmet needs present significant opportunity for new entrants: GlobalData appeared first on Express Pharma.

Labelling 98

Labelling Compounding 98

Pharmaceutical Technology

JUNE 12, 2024

Written Medicine is a digital solution that provides bilingual dispensing labels, described in a presentation at the NHS ConfedExpo conference in Manchester.

Labelling 52

Labelling 52

ALiEM - Pharm Pearls

APRIL 14, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to procedures in the Emergency Department. Welcome to the AIR Procedures Module! Please go to the above link.

Labelling 246

Labelling 246

Pharmaceutical Technology

NOVEMBER 18, 2024

At AHA 2024, clinical trial results were presented from the ongoing open-label extension trial, LIBERATE-OLE, involving lerodalciep.

Labelling 52

Labelling 52

Express Pharma

JANUARY 17, 2025

In addition, the nutra market boom in APAC that began during the COVID-19 pandemic continues to accelerate looking for green-label, plant-based capsules for encapsulation. These findings present a significant opportunity for brands to turn cutting-edge science into game-changing products for consumers.

Labelling 104

Labelling Packaging 104

ALiEM - Pharm Pearls

NOVEMBER 3, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Digital Impact Factor [1], the ALiEM AIR Team is proud to present the highest quality online content related to related to trauma in the Emergency Department. Welcome to the AIR Trauma Module! Please go to the above link.

Labelling 211

Labelling 211

ALiEM - Pharm Pearls

OCTOBER 14, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Digital Impact Factor [1], the ALiEM AIR Team is proud to present the highest quality online content related to related to respiratory diseases in the Emergency Department. Welcome to the AIR Respiratory Module!

Labelling 169

Labelling Hospitals 169

European Pharmaceutical Review

AUGUST 30, 2023

The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products. After this date: Under the framework, medicines can have the same packaging and labelling across the UK. All medicines on the UK market must be labelled as for sale only within the UK, including in Northern Ireland.

Packaging 105

Packaging Labelling 105

European Pharmaceutical Review

JANUARY 25, 2023

Participants were enrolled into an open-label phase of the study, which enabled the assessment of durability of antidepressant effect, as well as the comparative efficacy and safety of a one versus two dose regimen of SPL026. No drug-related serious adverse events (SAEs) reported, including no reported suicidal ideation or behaviour.

Labelling 133

Labelling 133

ALiEM - Pharm Pearls

JULY 20, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to infectious diseases in the Emergency Department. Welcome to the AIR Infectious Disease Module! Please go to the above link.

Labelling 188

Labelling 188

pharmaphorum

DECEMBER 5, 2022

A vast majority of patients diagnosed with CRPC already present with metastases at the time of diagnosis. The findings will be presented at an upcoming medical meeting and submitted to the FDA for regulatory approval in 2023. Prostate cancer is the most frequently diagnosed cancer in men in 112 countries.

Chemotherapy 59

Chemotherapy Labelling Compounding Drug Development 59

pharmaphorum

FEBRUARY 17, 2022

The VALOR-HCM data will be presented at the American College of Cardiology meeting in April, and shared with regulatory authorities, said BMS in a statement. The post BMS builds case for mavacamten label ahead of FDA decision appeared first on.

Labelling 59

Labelling 59

Express Pharma

AUGUST 29, 2023

Akeega’s current predicted sales will experience only a slight increase as a result of its narrow label and fierce competition with other recently approved poly(ADP-ribose) polymerase (PARP) inhibitors, according to GlobalData. However, the combination presents with potentially higher efficacy than Akeega.

Labelling 98

Labelling 98

FDA Law Blog: Biosimilars

OCTOBER 24, 2023

The SIUU Guidance introduces two new concepts that are of note to industry regarding information it may choose to disseminate under this “safe harbor:” 1) application to firm-generated presentations of scientific information; and 2) material that meets a new evidentiary standard – scientifically sound and clinically relevant.

Labelling 64

Labelling Communication 64

Express Pharma

MAY 17, 2024

Longer-term biomarker and efficacy data from the open-label-extension were similar to those seen during the 6-month placebo-controlled treatment period, with sustained reductions in ATXN2 but no impact on NfL or clinical outcome measures over 40+ weeks of follow up. AEs leading to study discontinuation were higher in the BIIB105 group (8.3

Labelling 97

Labelling 97

pharmaphorum

OCTOBER 14, 2022

” The programme has been set up to develop four devices – an e-paper label, smart wearable sensor, smart pill box, and endo-cutter used in surgical procedures – with funding from the EU’s Horizon Europe programme and support from the Waste Electrical and Electronic Equipment (WEEE) Forum. .”

Labelling 124

Labelling 124

Express Pharma

MAY 5, 2024

These data were featured in an Oral Presentation Session (Abstract #PD48-02) 1 at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas. 2,3 At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the two cohorts.

Labelling 104

Labelling 104

European Pharmaceutical Review

NOVEMBER 21, 2022

The Modulation of SERCA2a In Cardiomyopathy (MUSIC) HFpEF (MUSIC-HFpEF1) clinical trial will enrol patients in an open-label, dose-escalation, 52-week Phase Ib/IIa clinical trial, assessing the safety and clinical efficacy of the intra-coronary infusion. The syndrome accounts for half of all heart failure cases globally.

Labelling 139

Labelling 139

European Pharmaceutical Review

JUNE 28, 2022

The Phase III Asclepios I/II trials and the Alithios open-label extension from Novartis , showed that earlier initiation with Kesimpta resulted in a more than three-fold increased likelihood of maintaining NEDA-3 throughout the study. The data were presented at the 2022 European Academy of Neurology (EAN) Annual Meeting.

Labelling 98

Labelling Hospitals 98

European Pharmaceutical Review

NOVEMBER 24, 2022

Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

Packaging 111

Packaging Labelling Documentation Dosage 111

Pharma Times

DECEMBER 20, 2023

Previous studies have linked the death of brain cells to the presence of pathological alpha-synuclein, a normal protein that is present in brain tissue. However, its relation to dopaminergic neuron death is unclear.

Labelling 121

Labelling 121

Pharmaceutical Technology

AUGUST 10, 2022

Presently, the therapy is being analysed in late-stage studies. The Reliance programme also comprises a long-term, open-label safety trial, Reliance-OLS, which is enrolling subjects who have completed the three trials, as well as de novo subjects.

Labelling 119

Labelling 119

ALiEM - Pharm Pearls

MARCH 1, 2023

After carefully reviewing all relevant posts in the past 12 months from the top 50 sites of the Social Media Index, the ALiEM AIR Team is proud to present the highest quality online content related to related to neurologic emergencies in the Emergency Department. Welcome to the AIR Orthopedics Lower Extremity Module!

Labelling 130

Labelling 130

Express Pharma

JULY 1, 2024

Wolfram syndrome is an inherited condition that generally includes childhood-onset, insulin-dependent diabetes mellitus, and on April 10, Amylyx released interim results from its ongoing HELIOS trial, a 12-participant, open-label Phase II study, aimed at investigating the safety and tolerability of AMX0035 for Wolfram syndrome.

Labelling 104

Labelling Diabetes Drug Development 104

FDA Law Blog: Biosimilars

APRIL 25, 2024

This Revised Draft Guidance provides considerations for manufacturers, packers or distributors (dubbed “firms”) of prescription biological reference products, biosimilar products, and interchangeable biosimilar products presenting data and information about such products in promotional materials in a truthful and non-misleading way.

Biosimilars 59

Biosimilars Labelling Communication 59

European Pharmaceutical Review

JANUARY 20, 2023

Clinical success begins early for small molecule drugs The MHRA authorisation for MZL is based on results from the multicentre, global, single-arm, open-label, Phase II MAGNOLIA trial in patients with R/R MZL who received at least one anti-CD-20 based regimen. “As

Labelling 119

Labelling Hospitals 119

Express Pharma

MAY 6, 2024

Among the attendees, contract manufacturing organisations, service providers and experts were present. Presentations covered diverse topics: Erika Diago Rufino, Director Regulatory Affairs of Johnson and Johnson Innovative Medicine, talked about e-labeling in Brazil. and Produlab Pharma.

Packaging 105

Packaging Pharmaceutical Manufacturing Labelling Pharmaceutical Companies 105

pharmaphorum

JULY 9, 2021

According to the EMA’s pharmacovigilance risk assessment committee (PRAC), labelling for Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax should be updated to reflect “very rare cases” of myocarditis and pericarditis with the shots. . ‘No evidence’ Zynteglo causes blood cancer.

Vaccines 105

Vaccines Labelling Immunity Immunization 105