FDA Approves Updated Label for Altuviiio for Effective Bleed Protection in Children Younger than 12 Years
Drug Topics
MAY 13, 2024
Altuviiio was first granted approval by the FDA in February 2023.
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Drug Topics
MAY 13, 2024
Altuviiio was first granted approval by the FDA in February 2023.
pharmaphorum
AUGUST 2, 2023
Samsung seeks 'interchangeable' label for Humira biosimilar Phil.Taylor Wed, 02/08/2023 - 10:37 Bookmark this
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pharmaphorum
JUNE 28, 2023
AbbVie, Genmab eye label expansion for Epkinly Phil.Taylor Wed, 28/06/2023 - 13:04 Bookmark this
pharmaphorum
AUGUST 25, 2023
CVS Health launches private label biosimilars unit Phil.Taylor Fri, 25/08/2023 - 08:07 Bookmark this
pharmaphorum
NOVEMBER 17, 2023
AZ first to AKT finish line, but FDA clears narrow label Phil.Taylor Fri, 17/11/2023 - 09:46 Bookmark this
Drug Store News
JULY 26, 2023
Dollar General is debuting more than 100 new items in its Clover Valley private label line in 2023.
pharmaphorum
JUNE 6, 2023
ASCO: Enhertu data sets up tumour-agnostic label bid Phil.Taylor Tue, 06/06/2023 - 08:26 Bookmark this
Drug Store News
JULY 6, 2023
Several beauty trends will be revealed at PLMA’s 2023 annual Private Label Trade Show, Nov. 12-14 in Chicago.
Fierce Pharma
MAY 15, 2023
UPDATED: After Supreme Court rejection, Teva mulls options in GSK 'skinny label' feud fkansteiner Mon, 05/15/2023 - 10:59
Fierce Pharma
JANUARY 4, 2023
Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. Wed, 01/04/2023 - 11:35.
Drug Store News
MARCH 23, 2023
The award recognizes the men and women who have significantly contributed to the growth and development of the global private brand industry.
Pharmaceutical Technology
MARCH 22, 2023
In the US Drug Quality and Security Act (DSCSA), the FDA mandates that manufacturers and trading partners should have full interoperable electronic track and trace systems in place by November 2023. RFID is an important facet of smart labelling and its evolution, but not the only one.
Fierce Pharma
MARCH 20, 2023
Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom fkansteiner Mon, 03/20/2023 - 10:09
Pharmacy Times
MAY 13, 2024
Antihemophilic factor (recombinant) Fc-VWF-XTEN fusion protein-ehtl was initally approved in February 2023 for adults and children with hemophilia A for prophylaxis and on-demand treatment to control bleeding.
NF2 BioSolutions
JANUARY 4, 2023
Print our cake labels, bunting and flyers to make your event a great success. The post 2023 Fundraising Challenges appeared first on NF2 BioSolutions. You can set up a personal fundraiser on Peoples fundraising or simply choose the existing NBS UK fundraiser. Buy, bake or ask for donations of cakes.
The FDA Law Blog
MARCH 29, 2023
Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. By Kalie E. launch would be in early 2024.
The Checkup by Singlecare
DECEMBER 6, 2023
In 2023, the top medications with SingleCare customers included vitamin D supplements, inhalers, and anti-inflammatory drugs. It’s also often prescribed off-label—that is, for a use other than what it’s been approved for—as a treatment for fibromyalgia. Read on to see if any of your prescriptions made the list. Levothyroxine 1.
The Checkup by Singlecare
DECEMBER 5, 2023
In 2023, nine drugs made our annual list of top prescriptions by state, with vitamin D being the most filled. Keep reading to find out which medications were filled with SingleCare the most in your state in 2023. In 2022 and 2023, it was the most commonly prescribed drug in four states (versus six in 2021 ). People in the U.S.
Fierce Pharma
MARCH 31, 2023
In Teva vs. GSK skinny label feud, Biden admin urges Supreme Court to weigh in fkansteiner Fri, 03/31/2023 - 09:11
OctariusRx
AUGUST 28, 2023
The 2023 version of the OctariusRx medication safety quiz is about to be released. What does the Medication Safety Quiz 2023 cover and how do you get one? The quiz focuses on some of the most commonly encountered situations, including allergies, labeling medications and controlled substances. How are you assessing your staff?
OctariusRx
MAY 15, 2023
Our 2023 nursing calculations quiz is now available. Read the medication label carefully: This a critically important step and one that often leads to errors and potential patient harm. Label all syringes once drawn: Medications that are not for immediate use require proper labeling. Take the quiz and find out!
European Pharmaceutical Review
OCTOBER 24, 2023
Europe’s pharmaceutical packaging and labelling market is projected to reach $35.78 billion in 2022, the pharmaceutical packaging and labelling market in Europe is expected to expand at a compound annual growth rate (CAGR) of 4.78 percent between the forecast period: 2023 and 2028. percent between the forecast period 2023-2028.
Hospital Pharmacy Europe
MARCH 26, 2024
It is likely to be safe for penicillin allergy labels (PALs) to be removed for most patients, a study from the University of Birmingham has found. Some 97% of participants labelled with PALs were shown to have no allergy. However, a large body of evidence suggests that 90-95% of PALs are inaccurate.
European Pharmaceutical Review
AUGUST 30, 2023
The Windsor Framework, announced on 9 June 2023 by the Medicines and Healthcare products Regulatory Agency (MHRA), provides a long-term solution for the supply of medicines into Northern Ireland. The agreement stipulates that certain conditions must be met in the labelling and packaging of these medicinal products.
Drug Topics
APRIL 5, 2023
Off-label drug combinations are increasingly being used in cancer treatments, but there is the potential for overlapping or additive toxicities, explained a speaker at the 2023 HOPA Annual Conference.
The FDA Law Blog
FEBRUARY 16, 2023
Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status. By Kalie E.
Fierce Pharma
FEBRUARY 6, 2024
billion in sales, bringing its 2023 haul to $8.9 On a day when Vertex revealed trial data that indicate | On a day when Vertex revealed trial data that indicate its next-generation cystic fibrosis (CF) treatment will soon be ready to grab the baton, the Boston company also presented figures that show Trikafta remains formidable.
The Checkup by Singlecare
DECEMBER 6, 2023
In 2023, medications like Ozempic , Mounjaro , and Wegovy soared in popularity—so much so that many pharmacies faced a shortage. Read on to see what readers cared about the most in 2023. Whether you’re taking Ozempic for diabetes or off-label for weight loss, you might be curious if it’s safe to mix it with alcohol.
European Pharmaceutical Review
JULY 4, 2023
The International Organization for Standardization (ISO) has published its new standard Sterilization of health care products — Microbiological methods — Part 3 Bacterial endotoxin testing ( ISO 11737-3:2023). This includes products that must be non-pyrogenic based on either intended use or non-pyrogenic label claim, or both.
pharmaphorum
MAY 10, 2021
billion doses through 2023. Happy to announce that @EU_Commission has just approved a contract for guaranteed 900 million doses (+900 million options) with @BioNTech_Group @Pfizer for 2021-2023. The meeting did however recommend a change to the label for Comirnaty to include a risk of facial swelling with the jab.
STAT
JANUARY 25, 2024
One person also experienced hypoglycemia in 2023 after injecting a compounded version of Ozempic, said the organization, which represents 55 regional poison centers across the country and works with the U.S. Ozempic and similar diabetes medicines have been increasingly used off label for weight loss.
Pharmaceutical Technology
APRIL 17, 2023
On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Rexulti is an atypical antipsychotic.
BioPharm
OCTOBER 3, 2023
The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.
Hospital Pharmacy Europe
JANUARY 4, 2024
The alert supersedes previous guidance issued in July 2023 instructing prescribers not to initiate any new patients on GLP-1 RAs for the duration of the shortage, which was then predicted to continue until at least mid-2024. And it warned prescribers not to prescribe GLP-1 RAs licensed for type 2 diabetes for off-label indications.
European Pharmaceutical Review
OCTOBER 19, 2023
According to the European Medicines Agency (EMA), pre-filled pens falsely labelled as the type 2 diabetes medicine Ozempic ( semaglutide , 1mg, solution for injection) have been identified at wholesalers in the EU and the UK. The pens, with labels in German, originated from wholesalers in Austria and Germany.
The Checkup by Singlecare
DECEMBER 1, 2023
Department of Agriculture (USDA) requires it to be labeled “farmed” or” wild-caught.” Check the nutrition facts label to find the amount of vitamin D and other nutrients contained in individual products. As of January 2023, an increase of up to 560 IU of vitamin D per 100 g of cereal is allowed. mcg or 100–144 IU per cup.
European Pharmaceutical Review
MARCH 8, 2023
A placebo-controlled, Phase IIa, proof-of-concept, social anxiety clinical trial is expected to begin in the first half of 2023. The results are anticipated by the end of 2023. An open-label, Phase IIa, proof-of-concept clinical trial in women with PPD is expected to initiate in the second half of 2023.
European Pharmaceutical Review
OCTOBER 18, 2023
Further to the three Phase III trials for XPHOZAH, Ardelyx also declared that it has completed two open-label clinical trials (OPTIMIZE and NORMALIZE) to evaluate different options for integrating the treatment into clinical practice. XPHOZAH is expected to be available to eligible patients in the US in November 2023.
European Pharmaceutical Review
APRIL 19, 2023
percent from 2023, according to the data. This is driving the adoption of item-level smart labelling , the report noted. A market report has identified that global demand for electronic smart packaging will reach $2.6 billion in 2033. This represents a compound annual growth rate (CAGR) of 15.4
The Checkup by Singlecare
OCTOBER 4, 2023
In fact, the official FDA guidance about Vyvanse specifically warns against off-label use (a use that is not approved by the FDA) for weight loss, stating, “Vyvanse is not indicated or recommended for weight loss. Sources Vyvanse Label. Access FDA Eating & Physical Activity to Lose or Maintain Weight.
European Pharmaceutical Review
AUGUST 8, 2023
Novo Nordisk has stated it expects to file for a regulatory label indication expansion for the treatment in the US and the EU in 2023. Detailed results from the SELECT clinical trial will be presented at a scientific conference later in 2023. Currently, Wegovy is launched in Denmark, Norway, Germany as well as the US.
European Pharmaceutical Review
MAY 28, 2024
Considering material type, glass ampoule packaging was found to hold a market share of around 77 percent in 2023, in comparison to plastic. Other limitations include the small space available for labels on this type of packaging.
Pharmaceutical Technology
JANUARY 23, 2023
The results of this trial, if positive, are expected to be sufficient to grant approval in the US and EU through a supplemental new drug application and label expansion, respectively. in 2018 across the 7MM despite being an off-label therapy for lupus.
IDStewardship
MARCH 12, 2023
BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,
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