The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 16] Even more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! From indoor pollutants like formaldehyde (yes, really!),

Health and Personal Care Stores

pharmaphorum

JULY 2, 2025

Skip to main content Wednesday 2 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Diabetes

pharmaphorum

JULY 7, 2025

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Diabetes

pharmaphorum

JUNE 30, 2025

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Vaccines

Pharmaceutical Technology

MARCH 29, 2024

Vemlidy was first approved to treat adults with HBV in 2016. Its label was expanded in 2022 for use in patients 12 years and older.

Labelling

pharmaphorum

JUNE 8, 2022

The new tool works as a component of Apple’s Health app and will let users add drugs or other health products like vitamins and supplements to a personal list – either by scanning a label or finding the product in a directory – and create custom schedules for them.

Documentation

pharmaphorum

JULY 1, 2021

neuroloop – a spinout of Freiburg University in Germany formed in 2016 – has been working to date on using its device as an implant to lower blood pressure, among other applications. The Merck collaboration will concentrate on using the device alongside anti-inflammatory drug therapies.

Labelling

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. In 2019, Bayer bought cell therapy company BlueRock Therapeutics, which was created in 2016 via a joint venture between Bayer and Versant Ventures.

Labelling

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

European Pharmaceutical Review

DECEMBER 1, 2022

Between 2016 and 2019, DNDi and its partners led an open-label, Phase II/III study to assess the safety and efficacy of acoziborole in patients with early- and late-stage g-HAT. About the Phase II/III study. 208 patients were recruited at 10 hospitals in the Democratic Republic of the Congo (DRC) and Guinea.

Labelling

pharmaphorum

JUNE 6, 2022

Xalkori is billed as an ALK inhibitor and has been approved to treat ROS1-positive NSCLC since 2016, with sales of $22 million in the first quarter, but is also used to treat ALK-mutated NSCLC and lymphoma. billion product, mainly from first-line use, if it can claim FDA approval for a broad label covering any ROS1-positive cancer.

Chemotherapy

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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