Pharmaceutical Technology

JUNE 20, 2023

UK-based biotech F2G was dealt a blow as the US’ FDA issued a complete response letter rejecting its latest new drug application (NDA). F2G claimed in a June statement that the FDA requested additional data and analysis that extended beyond the current review period. Please check your email to download the Report.

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The Checkup by Singlecare

JANUARY 20, 2023

Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs. Just follow these three easy steps: Download our iOS or Android app or go to our website. Chances are, you’ve taken a generic or authorized generic medication, and for good reason—according to the U.S.

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Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. weight reduction in obese individuals, as per its label. Download the full report to understand what to expect and how to align your strategies for success. compared to a 5.1% By GlobalData.

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Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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The Checkup by Singlecare

JANUARY 6, 2023

Mounjaro (tirzepatide) is a brand-name prescription medication that has been approved by the Food and Drug Administration (FDA) to improve blood sugar control in adults with Type 2 diabetes (along with diet and exercise). As a result, the medication is now on a fast track to get FDA approval for the treatment of obesity.”

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

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Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. weight reduction in obese individuals, as per its label. Download the full report to understand what to expect and how to align your strategies for success. compared to a 5.1% By GlobalData.

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Labelling Insurance Communication FDA 98

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Please check your email to download the Report.

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Pharmaceutical Technology

JANUARY 15, 2023

In the same month, the EMA expanded the label of Gilead Sciences’ Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) to include its use for virologically suppressed HIV-positive children. The EMA also expanded the label of AbbVie’s Skyrizi (risankizumab) to include its use to treat moderate-to-severe Crohn’s disease.

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The Checkup by Singlecare

MAY 14, 2024

Metformin is an FDA-approved prescription drug for treating Type 2 diabetes. It is sometimes used off-label to prevent weight gain, manage polycystic ovary syndrome (PCOS), and treat or prevent gestational diabetes. For example, set a recurring alarm on your phone or download an app that will send you reminders.

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Pharma Marketing Network

FEBRUARY 19, 2025

Challenges in Pharma Email Marketing Pharma brands face unique barriers that other industries dont , such as: Strict compliance regulations (FDA, GDPR, HIPAA) that limit messaging. FDA and Fair Balance Messaging All promotional emails must include fair balance messaging benefits and risks must be presented equally. Ideal: 2-5% CTR ).

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Pharmaceutical Technology

DECEMBER 16, 2022

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. The CAR-T cell therapy received Orphan Drug Designation from the Food and Drug Administration (FDA) and a Breakthrough Designation from the China Center of Drug Evaluation (CDE). By Cytiva Thematic.

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Pharmaceutical Technology

DECEMBER 4, 2022

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Please check your email to download the Report. By GlobalData. Afghanistan.

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Pharmaceutical Technology

APRIL 18, 2023

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics licence application for Abecma. This FDA acceptance marks another step forward in our mission by bringing us closer to offering this potentially transformative, one-time CAR T treatment option to more patients.”

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Pharmaceutical Technology

JUNE 16, 2023

Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. Please check your email to download the Report.

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Impact Pharmaceutical Services

AUGUST 9, 2022

Download a PDF of this case study. Subsequent to the on-time submission of the NDA, IMPACT was asked to author the client’s FDA Advisory Committee Briefing Document. After the submission of the amended application, IMPACT wrote the client’s Briefing Document for their second meeting with the FDA Advisory Committee.

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Pharmaceutical Technology

MAY 30, 2023

The US Food and Drug Administration (FDA) approval was based on results from the Phase III EMERALD study (NCT03778931). The data is exploratory and the company has not yet announced any plans to expand Orsedu’s label. Download the full report to understand what to expect and how to align your strategies for success.

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Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. Please check your email to download the Report.

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Pharmaceutical Technology

APRIL 26, 2023

The primary packaging is subject to stringent regulations, including the EU Medical Device Regulation (MDR), US Food and Drug Administration (FDA) regulations and other regulatory requirements, in different countries. Please check your email to download the Buyers Guide.

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Pharmaceutical Technology

NOVEMBER 25, 2022

Furthermore, the experience that comes from having been through numerous FDA inspections – including general and preapproval inspections – and familiarity with local teams of FDA inspectors are invaluable. To find out more, download the whitepaper below.

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The Thyroid Pharmacist

JUNE 30, 2023

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. Dr. Bernard Bihari is credited with making these discoveries about using naltrexone off-label, at lower doses. It is used at a higher, standard dose of 50 mg per day. LDN is truly an intriguing drug.

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The Thyroid Pharmacist

DECEMBER 28, 2022

I cover the effects of these nutrient deficiencies more in-depth in the nutrient deficiencies chapter of my book Hashimoto’s: The Root Cause , which you can download for free by signing up here. When it leaks into the bloodstream, the body does not recognize it, and labels the structure as a foreign invader and attacks it.

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Roots Analysis

APRIL 15, 2024

Other factors that could present opportunities for future growth, include establishing fill finish facilities in developing nations, utilization of complex administration techniques and improved product labelling to reduce counterfeiting.

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Pharmaceutical Technology

MAY 12, 2023

As the next step in the FDA’s efforts to reduce prescription drug deaths , the agency is requiring updates to the boxed warning and other information for attention deficit hyperactivity disorder (ADHD) prescription stimulants. Download the full report to understand what to expect and how to align your strategies for success.

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Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

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OctariusRx

JUNE 5, 2023

Use warning labels for both Look-Alike-Sound-Alike and High-Alert medications. If the labels on the shelf are bent, frayed or in any way hard to read, replace them with fresh and clear versions. Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility ? According to a 2019 report from the U.S.

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Pharmaceutical Technology

MARCH 21, 2023

FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older. A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure.

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Pharmaceutical Technology

FEBRUARY 27, 2023

FDA decisions In December 2022, the FDA expanded the label for Novo Nordisk’s Wegovy (semaglutide), to include its use as an anti-obesity drug in adolescents with an initial body mass index over a certain threshold. Download the full report to understand what to expect and how to align your strategies for success.

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OctariusRx

JUNE 7, 2022

Use warning labels for both Look-Alike-Sound-Alike and High-Alert medications. If the labels on the shelf are bent, frayed or in any way hard to read, replace them with fresh and clear versions. Is the pharmacy providing the compounded drugs an FDA registered 503B outsourcing facility ? According to a 2019 report from the U.S.

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Pharmaceutical Technology

MARCH 16, 2023

Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.

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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. This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA.

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Pharmacy Friday Pearls

MARCH 9, 2022

Download PDF. It is important to note that at present, Anavip ® is only FDA approved for North American rattlesnake envenomations, even though it is expected that it is safe and effective to use for copperhead and water moccasin envenomations as well. Introduction . Most are bitten by members of the Crotalinae subfamily (a.k.a.

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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. The usual recommended dose of ibuprofen is 200 mg; do not exceed 1200 mg in 24 hours.

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The Checkup by Singlecare

JUNE 21, 2023

Wegovy , another weekly injection of semaglutide, is FDA approved for use in patients with obesity, says Minisha Sood, MD , a board-certified endocrinologist at Northwell Health’s Lenox Hill Hospital in New York. At this time, Ozempic does not have FDA approval for weight loss, but it may be prescribed off-label for this purpose.

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The Thyroid Pharmacist

JULY 20, 2023

Just this year, the FDA approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia caused by chronic kidney disease, for adults who have been receiving dialysis for at least four months. [58] A reinvestigation using Fe-labelling and non-invasive liver iron quantification. 1989;114(4 Pt 1):657-663. Int J Sports Med.

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The Thyroid Pharmacist

FEBRUARY 10, 2023

25] The daily pill has not had a lot of positive results, and has even been flagged by the FDA as a substance that could be high risk. Food and Drug Administration (FDA) approved a product named Intrarosa®, which contains the active ingredient prasterone (DHEA). Its benefits seem limited and it has numerous side effects.

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The People's Pharmacy

MAY 4, 2023

The FDA has not approved its use to prevent or treat heart attacks. This would be considered an off-label use. An alternate approach would be to scroll to the bottom of the page and click on the “ Download the mp3 ” link to download the free podcast. By the way, colchicine is a very old drug. Here is a link.

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