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

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

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 265

Hospitals Labelling 265

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.

Compounding 98

Compounding Labelling 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

pharmaphorum

OCTOBER 21, 2020

The company announced several new data readouts, including outcomes data from the STARS-Adjunct trial, a multi-site open-label study testing EndeavorRx on impairments in daily life in children with attention-deficit/hyperactivity disorder (ADHD).

Labelling 69

Labelling 69

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

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

pharmaphorum

JANUARY 28, 2021

For PRISYM ID client RxSource , a Global Clinical Trial Supplies Specialist, it means being ready to partner with sponsor companies to get everything set up for a clinical trial within a week, including packaging and labeling. The post RxSource optimizes clinical labeling process with PRISYM 360 cloud-based solution appeared first on.

Labelling 52

Labelling Packaging Vaccines 52

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

PharmaShots

APRIL 20, 2023

treatment interruption/discontinuation due to low lgG & lgM in (0.2% & 10.3%)/ (0.2% & 3.6%) patients Ref: Novartis | Image: Novartis Related News:- Novartis Presents Results of Kesimpta (ofatumumab) in P-III (ASCLEPIOS I/II) and (ALITHIOS) Open-Label Extension Trial for RMS at EAN 2022 vs switch group (-0.42%/yr.)

Labelling 40

Labelling 40

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

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. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

Labelling 45

Labelling 45

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

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. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling 40

Labelling Vaccines Communication 40

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

PharmaShots

FEBRUARY 1, 2023

Shots: The EC has approved a label expansion of Hemlibra (bispecific factor IXa- and factor X-directed Ab) in patients with a mod. 88.9%, respectively The decision was also based on real-world data while the label expansion will provide an effective & convenient prophylactic treatment option for patients with a mod. haemophilia A.

Labelling 40

Labelling 40

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

FDA Law Blog: Biosimilars

MAY 23, 2023

We previously noted that “ the skinny label may be dead ” and, while we still can’t be sure if it’s truly gone (but not forgotten), we now know that the Supreme Court won’t hear this case at this time. So, while the skinny label may not actually be dead, there will certainly be a reluctance to use it.

Labelling 40

Labelling 40

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 120

Labelling 120

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § Vanda’s Hetlioz was, in fact, the first FDA-approved drug product to include braille labeling.

Labelling 40

Labelling Packaging 40

Pharma in Brief

MARCH 18, 2021

Health Canada is seeking input from industry stakeholders on a new draft guidance document that discusses the use of electronic media in prescription drug labelling. A drug’s “label” can include its inner or outer labels, a package insert, or its product monograph ( PM ). Guidelines for electronic labelling.

Labelling 40

Labelling Documentation Packaging 40

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