Express Pharma

MAY 25, 2023

Wong adds, “ Acadia’s Nuplazid marks the first and only medication approved for the treatment of PD psychosis in the US since 2016. However, KOLs stated that Nuplazid is not very effective in managing the symptoms compared to other off-label antipsychotics.

Labelling 98

Labelling Compounding 98

European Pharmaceutical Review

JULY 5, 2022

In the future, the potential label expansion of Oncoral into other solid cancer indications will be investigated. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Gastrointestinal Cancers , 2016; 27(suppl. accessdata.fda.gov/drugsatfda_docs/label/2014/020571s048lbl.pdf [Accessed 25.01.22].

Chemotherapy 104

Chemotherapy Dosage Labelling Compounding 104

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. After all, back in 2016, the agency issued six letters in the month of December alone. Stay tuned.

Communication 68

Communication Packaging Labelling 68

Pharmaceutical Business Review

JANUARY 13, 2025

The Phase II, single-arm, open-label, multicentre study is said to be the first trial to assess such new therapy in Chinese LBCL patients and is currently underway. Founded in 2016, JW Therapeutics is a biotechnology company which focuses on developing, manufacturing and commercialising cell immunotherapy products.

Chemotherapy 52

Chemotherapy Labelling 52

pharmaphorum

AUGUST 11, 2022

These drugs have been rigorously tested by regulatory bodies around the world before they’re made available to ensure they work as labelled, but despite that, adverse events crop up. In 2016, the estimated annual cost of drug-related morbidity and mortality resulting from non-optimised medication therapy was $528.4

Dosage 98

Dosage Labelling 98

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

Labelling 59

Labelling Packaging Documentation 59

pharmaphorum

SEPTEMBER 25, 2020

The new data – presented at this year’s ESMO meeting – reinforce the massive improvement in patient care that Keytruda has achieved in previously-untreated NSCLC, which had a five-year survival rate of just 5% before the drug was approved in 2016.

Chemotherapy 75

Chemotherapy Labelling 75

Pharmaceutical Business Review

MARCH 29, 2024

Vemlidy, a targeted prodrug of tenofovir, was initially approved by the US regulator in 2016 for adults with chronic HBV infection and compensated liver disease. The trial results demonstrated that subjects in both the Vemlidy group and the placebo group who switched to open-label Vemlidy after 24 weeks, experienced significant improvements.

Labelling 59

Labelling 59

FDA Law Blog: Biosimilars

JANUARY 18, 2024

FDA conducted the eight-factor scheduling analysis required by the CSA in 2016 and found that marijuana continued to meet the scheduling criteria for remaining in schedule I. 12, 2016); Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed. Denial of Petition to Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Controlled Substances 69

Controlled Substances Chemotherapy Compounding Dosage 69

FDA Law Blog: Biosimilars

APRIL 21, 2024

Accordingly, had Taiho marketed the product with labeling containing those errors, that labeling would have been false. Thus, regardless of the technicality of an initial notification letter stating approval on September 30, 2022, Taiho was prohibited under the FDCA from marketing LYTGOBI with false labeling, 21 U.S.C.

Labelling 59

Labelling Controlled Substances 59

Eye on FDA

AUGUST 2, 2022

Most notably, while promotion of an unapproved drug is a relatively rare violation, comprising only 2 percent of all the letters issued since 2004, it is 13 percent of all letters issued since 2016. When you view enforcement activity through a broader lens to get more examples to analyze, a few things stand out.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

FDA Law Blog: Biosimilars

APRIL 25, 2023

Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD). Loose Ends IDEs.

Documentation 105

Documentation Labelling Communication 105

pharmaphorum

FEBRUARY 23, 2022

The drug was originally rejected for schizophrenia and bipolar by the FDA back in 2013 with a request for more clinical data, finally getting a green light two years later, and it then failed a phase 3 study in depression in 2016. Vraylar is now one of AbbVie’s fastest-growing products with sales expected to reach around $2.2

Labelling 52

Labelling 52

RX Note

FEBRUARY 11, 2024

Laboratory analysis of some homeopathic remedies found greater amounts of Atropa belladonna (deadly nightshade, an anticholinergic agent) than claimed on the label. Says, 2016 FDA takes action against the use of OTC benzocaine teething products due to serious safety risk, lack of benefit, 2018

Adverse Reactions 52

Adverse Reactions Labelling Community Pharmacies 52

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. 2016; 46: 479–93. The study included 92 adult patients with confirmed CDI. Intern Med J. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. Song JH, Kim YS.

Documentation 111

Documentation Labelling Hospitals 111

RX Note

MARCH 18, 2023

Self-Driven Initiatives Nonetheless, multiple unofficial attempts have been made, first started with My Blue Book by My Pharmacist House (last updated to FUKKM 2016-2) , followed with Blue Book (Updated+Brand Name Search) by Apicel (last updated to FUKKM 2020-2). Similarly, the off-label uses can be clearly highlighted too.

Hospitals 52

Hospitals Dosage Labelling 52

ID Stewardship

MARCH 12, 2023

It’s from 2016 about the future of antibiotics and resistance, but it remains highly relevant today and people consistently give positive feedback about it. ” Labeling the use of an antibiotic as inappropriate or appropriate cannot simply be done based upon whether it is FDA-approved for a given indication.

Medication Guidelines 119

Medication Guidelines Documentation Labelling Hospitals 119

RX Note

NOVEMBER 12, 2024

In my experience, there are increasingly more off-label uses and dosages included in this resource. Contents Apart from providing comprehensive drug information, I generally find the Clinical Teaching section in Drug Reference to be potentially useful in medication counselling , although it is not written in layman's language.

Dosage 52

Dosage Labelling 52

FDA Law Blog: Biosimilars

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). In fact, the priority designation for the final rule is labeled as “economically significant.” According to the Unified Agenda, the proposed rule is in the final rule stage.

Documentation 52

Documentation Labelling 52

pharmaphorum

JULY 12, 2021

Merck’s chief science and technology officer Laura Matz said that Innerva’s platform could become “a true enabler for digital personalised treatment of patients suffering from severe and chronic diseases such as inflammatory disorders” An open-label, proof-of-concept study looking at a vagus nerve-stimulating implant as a therapy (..)

Labelling 52

Labelling Diabetes 52

pharmaphorum

OCTOBER 27, 2020

The PolarisDMD study failed across the board, leaving Catabasis with no choice but to abandon the drug, including an ongoing open-label extension study from an earlier failed trial in the muscle-wasting disease. We are deeply saddened and disappointed by the results of our Phase 3 PolarisDMD trial,” said Jill Milne, Catabasis’ CEO. “I

Labelling 52

Labelling 52

Big Molecule Watch

JANUARY 25, 2024

The FDA approved Celltrion’s infliximab biosimilar, administered by intravenous infusion, in April 2016 under the trade name INFLECTRA (infliximab-dyyb). Recommendations regarding how to describe pediatric use data in a range of scenarios and how to incorporate immunogenicity data.

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

European Pharmaceutical Review

FEBRUARY 23, 2023

11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. Label-free, rapid and quantitative phenotyping of stress response in E. Sci Rep, 2016; 6:34359 Shakeel M. This is particularly important for commonly used bacteria such as E. coli via ramanome.

Labelling 121

Labelling Packaging Drug Development 121

pharmaphorum

JUNE 20, 2022

The serotonin (5-HT2A) receptor-selective inverse agonist has been approved for Parkinson’s psychosis since 2016, and brought in $481 million from that indication last year, but remains Acadia’s only commercial product. At one point it had been tipped as a future blockbuster.

Labelling 52

Labelling 52

Safe Biologics

JUNE 6, 2024

mL of 40 mg/mL) injectable solution to treat patients for the conditions listed above according to dosing regimens as recommended in the labeling. Pennsylvania Senate Introduces PBM Bill The Pennsylvania Senate Health and Human Services Committee recently unanimously amended SB 1000, An Act amending the act of November 21, 2016 (P.L.1318,

Biosimilars 100

Biosimilars Labelling 100

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

RX Note

JUNE 5, 2023

A simple method is to use a small adhesive label to mark the position and thus produce a measure with just one graduation.) Extemporaneous Preparations for Pediatric, Geriatric and Special Needs Patients, 2016 emphasized the need to prepare spironolactone suspension in compliance with USP 800 guidelines.

Compounding 52

Compounding Labelling Packaging Hospitals 52

pharmaphorum

AUGUST 5, 2020

In a recent analysis of data from 2016 at the Queen Elizabeth Hospital Birmingham, 75% of unplanned admissions, which account for almost 30,000 admissions per year, were for older adults. Senolytics in idiopathic pulmonary fibrosis: Results from a first-in-human, open-label, pilot study. The hallmarks of aging. EBioMedicine.

Hospitals 80

Hospitals Labelling Diabetes Drug Development 80

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Acad Emerg Med , 2018 [11] Systematic review & Meta-analysis, Multicenter, 2005 Through April 2016 N=1,773, Adults POCUS has modest diagnostic accuracy in adults for nephrolithiasis.

Labelling 177

Labelling Communication 177

pharmaphorum

JULY 11, 2021

The letter follows the extraordinary situation in which Biogen and partner Eisai asked the FDA to restrict the label for Aduhelm, as the agency approved the drug for all Alzheimer’s patients, not the mildly-affected population tested in clinical trials. pic.twitter.com/iWJNxdZ5Cs.

Labelling 52

Labelling Communication 52

Quality Matters

SEPTEMBER 9, 2024

By engaging in roundtable discussions, drafting stimuli articles, and developing work plans with HQS Expert Committees, USP is setting high-quality standards, covering aspects such as labeling, version control, classification, health equity, and accessibility.

Labelling 52

Labelling Diabetes 52

pharmaphorum

OCTOBER 27, 2022

The two companies have been working together on this microbiome project since 2016. In the open-label extension study ECOSPOR IV (SERES-013), 263 adults with rCDI were evaluated when given a commercial dose of SER-109 to fulfil FDA requirements for the oral therapeutic’s safety database.

Labelling 45

Labelling Hospitals 45

RX Note

JUNE 10, 2023

In several cases, the presentation of DKA was atypical with patients having only moderately elevated blood glucose levels, and some of them occurred during off-label use. Serious, life-threatening, and fatal cases of diabetic ketoacidosis have been reported rarely in patients taking an SGLT-2 inhibitor.

Diabetes 52

Diabetes Labelling Hospitals 52

RX Note

MARCH 25, 2023

Dermatology Use (Off-label) When used in melasma , the reported success rate is up to 89%, with results appearing as early as 8 weeks. Dosage varies, according to the heaviness and duration of bleeding: 1 to 1.5 g 3 or 4 times daily for the first 3-5 days of each cycle.

Dosage 40

Dosage Labelling 40

RX Note

OCTOBER 5, 2023

Meanwhile, an unnecessary health risk is created in the home whereby the patient or family members may accidentally consume expired medicines or wrong drug (due to unclear or damaged labels). Failure to discard medications properly may also contaminate the environment through poor disposal either via trash or sewer system.

Medication Dispensing 40

Medication Dispensing Community Pharmacies Hospitals Labelling 40

Pharmacy Joe

APRIL 20, 2022

This was a multicenter, open-label, noninferiority randomized clinical trial of 206 ICU patients with VAP. The Gram stain results were categorized as gram-positive cocci (GPC) chains, GPC clusters, gram-positive bacilli, gram-negative rods (GNR), or a combination of these.

Inpatient 40

Inpatient Labelling 40

European Pharmaceutical Review

FEBRUARY 22, 2023

Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. Results from the first open-label, single-centre study of RT-101,6 which was conducted in Australia, were reported at the start of 2020. Biologics represent an increasingly large part of the pharmaceutical industry.

Biosimilars 105

Biosimilars Diabetes Immunization Immunity 105