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

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.”

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Labelling Documentation Communication 70

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 87

Labelling Insurance Coverage and Processing 87

STAT

OCTOBER 26, 2022

But in the field of addiction medicine, the question presents something of a crisis. Even as drugs and alcohol claim 200,000 lives each year, many who seek addiction treatment are greeted by the harsh, stigmatizing labels that many Americans don’t think twice about: Words like addict, alcoholic, junkie, abuser, or worse.

Labelling 285

Labelling 285

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

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

STAT

MAY 22, 2024

A drug often used off-label to treat alcohol use disorder might provide better benefits than therapies approved for this indication, STAT tells us. Data presented this week at the Digestive Disease Week meeting in D.C. If you don’t believe me, just read these items.

Compounding 239

Compounding Labelling Hospitals 239

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 96

Compounding Labelling 96

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 44

Labelling 44

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

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

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

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

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

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 62

Labelling Communication 62

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 269

Hospitals Labelling 269

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

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

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

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 57

Biosimilars Labelling Communication 57

Express Pharma

NOVEMBER 14, 2024

per cent saw an improvement in at least 50 per cent of their NTM symptoms present at baseline. per cent of patients saw an improvement in at least 50 per cent of their NTM symptoms present at baseline and did not experience any worsening of any baseline symptom. Of the patients administered omadacycline, 34.1 Further, 34.1

Labelling 52

Labelling 52

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

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 94

Labelling 94

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 85

Labelling 85

FDA Law Blog: Biosimilars

AUGUST 11, 2024

Presenting only information about the benefits or efficacy of a prescription drug, like AUVI-Q, without any risk information is considered a false or misleading presentation under the Federal Food, Drug and Cosmetic Act (FDCA), and is considered misbranding of the product.

Labelling 57

Labelling Communication 57

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

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

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

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 91

Labelling 91

Pharmaceutical Business Review

OCTOBER 21, 2024

The positive opinion from CHMP is based on the results from the Phase III NATALEE trial, which is a global, multi-centre, open-label study. This also includes those with node-negative disease. Breast cancer remains the most prevalent cancer in Europe, with HR+/HER2- being the most common subtype, representing around 70% of all cases.

Dosage 52

Dosage Labelling 52

PharmaShots

MAY 31, 2023

Shots: The P-II trial results presented at CMSC 2023 evaluating high or low doses of frexalimab vs PBO in a ratio (4:4:1:1) in 129 patients for 12wks. & entered in an ongoing open-label part B The trial met its 1EPs & showed that high & low-dose frexalimab patients achieved a reduction in no.

Labelling 40

Labelling 40

Big Molecule Watch

MAY 3, 2024

Topics the FDA addresses include correctly identifying products, presenting comparative study data, and avoiding any suggestion that a biosimilar product may be less safe or effective, to highlight a few. Notably, the importance of truthful, non-misleading promotional practices is a recurring theme.

Biosimilars 62

Biosimilars Communication Labelling Documentation 62

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

MAY 8, 2023

Shots: The P-III open-label study (ECOSPOR IV) evaluating Vowst, the US FDA-approved orally administered microbiota-based therapeutic to prevent recurrence in 263 patients, showed that 91.3% of patients achieved clinical response @8wks. maintained a response through 24wk. achieved a clinical response @8wk.; 94.4% & 94.6%

Labelling 40

Labelling 40

European Pharmaceutical Review

MARCH 5, 2024

Conference, forums and highlights Parallel to the fair, the renowned analytica conference takes place in the ICM – International Congress Center Messe München, covering the breadth of modern analysis with around 180 presentations. ” Additionally, environmentally friendly alternatives to chemicals and consumables are presented.

Labelling 98

Labelling 98

Express Pharma

NOVEMBER 13, 2024

Walker concludes: “The upcoming presentation of the PHOENYCS GO results will reignite interest in dapirolizumab pegol in SLE and, riding on this success, the companies are moving forward with a second Phase III study, PHOENYCS FLY.

Labelling 96

Labelling Immunity Immunization 96

Eye on FDA

JUNE 14, 2023

The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). The agency acknowledged that full risk information was presented on the webpage, but felt that did not mitigate the overall characterization that minimized risk.

Labelling 82

Labelling Communication 82