Safe Biologics

MARCH 21, 2024

From the Executive Summary: The ASBM has supported the INN Group’s Biological Qualifier (BQ) scheme since its inception in 2012, and since then has doggedly presented data on the importance of a BQ to enhancing patient safety and pharmacovigilance (PV).

Biosimilars 100

Biosimilars Labelling 100

pharmaphorum

JULY 4, 2022

There is already a GLP-2 analogue drug on the market for SBS – Takeda’s Gattex (teduglutide) which was approved for SBS in adults in 2012 and children in 2019 – while AstraZeneca’s GLP-1 drug Byetta/Bydureon (exenatide) has also been used off-label to treat the disorder.

Labelling 98

Labelling 98

RX Note

NOVEMBER 12, 2024

In my experience, there are increasingly more off-label uses and dosages included in this resource. NeoFax is one of the most widely used neonatal drug dosing but has been discontinued in print format since June 2012 (The last copy was the 2011 edition ).

Dosage 52

Dosage Labelling 52

RX Note

NOVEMBER 4, 2023

The remedies may provide a placebo benefit or may be labelled as homeopathic but actually contain measurable concentrations of drugs, nutrients or dietary supplements. The Science Most evidence does not support the validity of homeopathy; however, many are advocates.

Labelling 52

Labelling Community Pharmacies 52

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. In 2012, J&J agreed to pay US $181 million to 26 states in order to settle these claims – though another lawsuit related to the drug (for $8 billion, eventually reduced to $6.8 CEO Alex Gorsky, who was appointed in 2012.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

pharmaphorum

SEPTEMBER 2, 2021

The regulator is adding new and revised warnings labels to the Pfizer products as well as Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib), which are also approved to treat arthritis and other inflammatory conditions. The result? billion, but fell 15% in the second quarter.

Labelling 52

Labelling 52

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. 2012/1916). 3 Is two too few? Ethnopharmacol.

Drug Development 103

Drug Development Biosimilars Documentation Compounding 103

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. 2012; 18 (6): 21-27. The study included 92 adult patients with confirmed CDI. Intern Med J. 2016; 46: 479–93. Can we identify patients at high risk of recurrent Clostridium difficile infection? Song JH, Kim YS.

Documentation 111

Documentation Labelling Hospitals 111

RX Note

JULY 29, 2023

Nonetheless, there are also circumstances where we have to read up the clinical practice guidelines or clinical journals to justify the dosing of a particular drug, especially those off-label indications. Hence, with a dosing of 1 mg, an ampoule of 3mg granisetron can be used for 3 patients, making it very cost effective.

Chemotherapy 40

Chemotherapy Labelling 40

pharmaphorum

AUGUST 31, 2021

Roche’s Genentech unit bought into the programme in 2012 and amended it three years later. Data an open-label extension being carried out by Roche “may be important in elucidating the potential of semorinemab in this patient population,” she added.

Immunity 52

Immunity Immunization Labelling Vaccines 52

RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

Health and Personal Care Stores 80

Health and Personal Care Stores Labelling Immunity Immunization 80

The Thyroid Pharmacist

OCTOBER 7, 2022

Sure enough, she read all the labels on her supplements and in her pantry, and gave her kitchen a stevia-free makeover. It was also introduced as a sweetener in the EU in 2011, as well as in Canada in 2012. I encourage you to read the labels and look for 100% pure, USDA-approved stevia products where possible. Thyroid Res.

Diabetes 98

Diabetes Immunity Immunization Labelling 98

The Thyroid Pharmacist

AUGUST 19, 2022

Published 2012 Jul 6. Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial. doi:10.6061/clinics/2012(06)18. Evidence-Based Complementary and Alternative Medicine 2012, Article ID 216970, 9 pages, 2012. Clin Rev Allergy Immunol. 2012;42(1):71-78.

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

FDA Law Blog: Biosimilars

APRIL 30, 2023

112-144 (2012). Subsection 505(q) initially was added by Section 914 of the 2007 FDA Amendments Act (“FDAAA”), Pub. 110-85 (2007), as amended by Section 301 of Pub. 110-316 (2008) and by Section 1135 of the FDA Safety and Innovation Act (“FDASIA”), Pub.

Immunity 59

Immunity Immunization Biosimilars Labelling 59

PharmaShots

APRIL 13, 2023

Johnson & Johnson delivered solid results in 2012 with profitable growth due to their top and newly developed products that lead to a revenue of $67.2B. Bayer’s Matetial Science subgroup moved ahead effectively in 2004 showing a rise of 15.3% Bayer's sales of general medicine increased by 1.2%

Biosimilars 40

Biosimilars Vaccines Pharmaceutical Companies Pharmaceutical Companies 40

PharmaShots

MAY 2, 2023

OraGrowtH212 is our single site, randomized, open-label study evaluating the pharmacokinetics (PK) and pharmacodynamics (PD) of LUM-201 in prepubertal PGHD patients who have never been treated with rhGH. Mr. Hawkins has served on the Lumos Pharma Board since 2012 and Chairman since March 2020. mg/kg/day or 3.2 mg/kg/day of LUM-201.

Labelling 40

Labelling 40

The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” Published 2012 Mar 27. thingsIlearnedthehardway). Accessed October 19, 2022.

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105

The Thyroid Pharmacist

DECEMBER 28, 2022

When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it. Gluten can have a significant impact on the thyroid because of a phenomenon called molecular mimicry, which works like this: gluten can leak into the bloodstream, as it can create permeability in the gut barrier.

Immunity 111

Immunity Immunization Clinical Pharmacology Doctor of Pharmacy 111

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S. Int J Mol Sci.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

JULY 14, 2023

Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. doi:10.5402/2012/126720 [12] Mikhailov V, Alexandrova O, Denisov I, editors editors. However, they are not FDA-approved for specific uses, such as thyroid health, in the U.S. ISRN Endocrinol. 2012;2012:126720.

Dosage 98

Dosage Immunity Immunization Documentation 98

The Thyroid Pharmacist

OCTOBER 25, 2022

Fibrocystic breasts used to be labeled as a disease, but given how common they are, they’re now simply referred to as “fibrocystic breasts.” (7) doi:10.1155/2012/184745. Evid Based Complement Alternat Med. 2010;7(1):129-136. doi:10.1093/ecam/nem161. Sears ME, Kerr KJ, Bray RI. J Environ Public Health. 2012;2012:184745.

Compounding 61

Compounding Mayo Clinic Labelling Immunity 61

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. doi:10.1155/2012/590648.

Dosage 122

Dosage Labelling Communication Compounding 122

Safe Biologics

MAY 10, 2024

From the Executive Summary: The ASBM has supported the INN Group’s Biological Qualifier (BQ) scheme since its inception in 2012, and since then has doggedly presented data on the importance of a BQ to enhancing patient safety and pharmacovigilance (PV).

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

The Thyroid Pharmacist

OCTOBER 27, 2023

Precautions Do not take more than the recommended dose on the label. If you’re experiencing these symptoms, reduce your dosage to ⅛ teaspoon daily, increasing usage slowly, as tolerated, to get to the recommended label usage. boulardii preventatively when I travel to help prevent travel diarrhea (it’s been my go-to since 2012!).

Health and Personal Care Stores 99

Health and Personal Care Stores Immunity Immunization Compounding 99

The Thyroid Pharmacist

JULY 20, 2023

pylori , taking betaine with pepsin and digestive enzymes, eating liver, taking liver pills, cod liver oil, and chlorophyll from 2012 to 2015. 2012-2465 [12] R V, Dhiman P, Kollipaka R, P S, V H. 2012 Dec;23(12):1600-8. [17] A reinvestigation using Fe-labelling and non-invasive liver iron quantification. Saudi Med J.

Health and Personal Care Stores 95

Health and Personal Care Stores HIV Treatment and Prevention Agents Immunity Immunization 95

The Thyroid Pharmacist

JULY 7, 2023

Back in 2012-2014, it was available as a supplement that was marketed for Hashimoto’s, due to promising clinical trials. [59] Vitamin D supplementation reduces thyroid peroxidase antibody levels in patients with autoimmune thyroid disease: An open-labeled randomized controlled trial. 61] Chaudhary S, Dutta D, Kumar M, et al.

Immunity 105

Immunity Immunization Diabetes Dosage 105

RX Note

MARCH 31, 2023

Approval from Medicine Advertisements Board is not required Food advertisement - under Food Act 1983 Medical devices advertisement - under Medical Device Act 2012 Advertisement Advertisement includes Any notice, circular, report, commentary, pamphlet, label, wrapper, or other document, and Any announcement made orally or by any means of producing or (..)

Documentation 52

Documentation Labelling Diabetes Hospitals 52

Pharmaceutical Technology

MARCH 20, 2023

According to GlobalData figures, the worldwide percentage of clinical trials started and completed in Africa between 9 December 2012 and 8 March 2023 was 2.2%. Therefore, the available patient pool of a majority Black population in Africa represents an invaluable opportunity to develop medical products for patients with unmet clinical needs.

Communication 52

Communication Diabetes Labelling 52

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In doi:10.1155/2012/674142 [56] Meena H, Pandey HK, Arya MC, Ahmed Z. However, as with all substances, they can affect each individual differently. Phytother Res. 2014;28(4):475-479. doi:10.1002/ptr.5018

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

FDA Law Blog: Biosimilars

JANUARY 9, 2025

Although FDA has long taken the position that it has broad authority in how it conducts its inspections, it was not until 2012 that Congress put some teeth behind FDAs policy position. to take photographs as necessary; to collect samples; talk to pertinent staff ; or to collect food labels and labeling).

Documentation 105

Documentation Labelling 105

FDA Law Blog: Biosimilars

DECEMBER 1, 2024

. §374(a)(1)(B)) has required, for years, FDA-regulated industry to allow FDA “officers or employees” to “inspect, at reasonable times and within reasonable limits and in a reasonable manner,” any facility and “all pertinent equipment, finished and unfinished materials, containers, and labeling therein.” 331(f)).

Documentation 113

Documentation Labelling 113

The Thyroid Pharmacist

NOVEMBER 15, 2024

Ozempic is a GLP-1 agonist and is actually marketed as a diabetes drug, but many physicians are prescribing it for weight loss (off label-use). Ozempic’s label warns, “In studies with rodents, Ozempic® and medicines that work like Ozempic® caused thyroid tumors, including thyroid cancer. 2012 Mar;166(3):477-85. Eur J Endocrinol.

Diabetes 75

Diabetes Immunity Immunization Compounding 75

pharmaphorum

FEBRUARY 5, 2021

The FDA did go on to add warning labels in the following years and eventually decided to require a class-wide monitoring programme, with training for doctors. But that was in 2012 and although the FDA has taken several steps to tighten regulation on opioids, they remain on the market with addiction still a major problem in the US.

Vaccines 119

Vaccines Biosimilars Labelling 119

FDA Law Blog: Biosimilars

JANUARY 12, 2025

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

Drug Development 64

Drug Development Communication Labelling 64

The Thyroid Pharmacist

NOVEMBER 8, 2024

As such, I re-analyzed the data for the “presence” of parasite DNA labels, and the incidence was substantially higher… 274 total parasites were detected! 2012 Oct;4(11)1552-3]. I’ve seen people who were symptomatic for Giardia , with just the presence of the parasite vs. a positive test. Dtsch Med Wochenschr. 1991;116(18):695-698.

Immunity 72

Immunity Immunization Diabetes Adverse Reactions 72