STAT

JANUARY 10, 2024

Food and Drug Administration responded to decades of escalating concerns about Singulair, a widely prescribed drug for asthma and allergies, by adding a stark warning on the labeling that it could cause aggression, agitation and even suicidal thought. in 2022, The New York Times writes. The

Labelling 258

Labelling 258

European Pharmaceutical Review

JULY 3, 2023

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products.

Pharmaceutical Manufacturing 105

Pharmaceutical Manufacturing Labelling 105

Pharmaceutical Technology

APRIL 11, 2023

This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.

Labelling 98

Labelling Communication 98

ALiEM - Pharm Pearls

JULY 20, 2023

Highlighted Quality Posts: Infectious Disease Site Article Author Date Label SGEM Lumbar punctures in febrile infants with positive urinalysis – it’s just overkill Dennis Ren, MD December 31, 2022 AIR EMDocs Bacterial Meningitis Mounir Contreras Cejin, MD January 28, 2023 HM ALiEM The Febrile Infant Corey Ziemba, MD, Justin Hacnik, MD and J.D.

Labelling 188

Labelling 188

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 in 2022. percent in 2022. billion in 2028, according to a report by Arizton.

Packaging 118

Packaging Labelling Compounding Pharmaceutical Companies 118

ALiEM - Pharm Pearls

OCTOBER 14, 2023

Highlighted Quality Posts: Respiratory Site Article Author Date Label EMCrit IBCC: Asthma Josh Farkas, MD April 12, 2023 AIR EMCrit IBCC: Severe Community Acquired Pneumonia Josh Farkas, MD October 11, 2022 AIR EM Docs Empyema: ED Presentation, Evaluation, and Management Heath Garner, MD April 11, 2022 AIR Rebel EM Pigtail Catheter vs Large Bore Chest (..)

Labelling 169

Labelling Hospitals 169

Digital Pharmacist

OCTOBER 24, 2022

Date of Approval: 9/30/2022. Date of Approval: 9/29/2022. Date of Approval: 9/22/2022. Date of Approval: 9/21/2022. Date of Approval: 9/14/2022. Date of Approval: 9/9/2022. Below we will be listing some of the new drug therapy advances and approvals that the FDA had in the month of September.

Adverse Reactions 75

Adverse Reactions Labelling Pharmacy Management Immunity 75

ALiEM - Pharm Pearls

NOVEMBER 3, 2023

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Labelling 211

Labelling 211

European Pharmaceutical Review

JANUARY 16, 2023

According to 2022 data gathered by the World Health Organization (WHO), there are around 24 million schizophrenia patients. An open-label pharmacokinetic and safety study of LY03004 evaluated an escalating single intramuscular injection in stable patients with schizophrenia or schizoaffective disorder.

Labelling 122

Labelling Drug Development 122

Pharmaceutical Technology

MARCH 29, 2024

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

Labelling 52

Labelling Drug Development 52

Pharma Pathway

SEPTEMBER 15, 2022

Intas Pharmaceuticals Ltd-Walk-In Drive for Manufacturing & Packaging Department On 18th & 25th Sept’ 2022. Experience: 03 to 09 years in Visual Inspection, Track & Trace, Labelling, E BMR, Packing Planning & Manpower Deployment. Date: 18th Sept’ 2022. Date: 25th Sept’ 2022. Job Description.

Packaging 67

Packaging Labelling 67

The Thyroid Pharmacist

NOVEMBER 11, 2022

It turns out that many of the ingredients in laundry detergent aren’t listed on the label (and can irritate one’s skin!), And definitely take advantage of their Black Friday/Cyber Monday sale, which runs from November 26 to December 2, 2022. The post Holiday Gift Ideas: 2022 Edition appeared first on Dr. Izabella Wentz, PharmD.

Labelling 98

Labelling Packaging 98

Big Molecule Watch

NOVEMBER 7, 2024

In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., Part 1 was an open-label pilot study, comparing HLX14’s pharmacokinetics with EU-sourced PROLIA after subcutaneous injection, setting the foundation for Part 2. EU, and Canada.

Biosimilars 59

Biosimilars Labelling 59

Express Pharma

JUNE 26, 2023

Vishruth Srivastava, Managing Director of Yodaplus, a leading player in AI technology, asserts that AI can assist in generating label claims with up-to-date perspectives on each compound and making informed decisions regarding the necessity for further clinical trials or general precautions.

Labelling 122

Labelling Compounding 122

Express Pharma

NOVEMBER 8, 2023

per cent across the seven major markets (7MM*) from $3 billion in 2022 to $6.7 Barbora Salcman, Neurology Analyst at GlobalData, comments, “Until 2017, all MG patients were dependant on a range of off-label treatments, such as steroids, immunosuppressants or acetylcholinesterase inhibitors, independent of their diagnosis or MG class.

Labelling 105

Labelling Compounding 105

pharmaphorum

OCTOBER 14, 2022

” The programme has been set up to develop four devices – an e-paper label, smart wearable sensor, smart pill box, and endo-cutter used in surgical procedures – with funding from the EU’s Horizon Europe programme and support from the Waste Electrical and Electronic Equipment (WEEE) Forum.

Labelling 124

Labelling 124

European Pharmaceutical Review

JUNE 28, 2022

The Phase III Asclepios I/II trials and the Alithios open-label extension from Novartis , showed that earlier initiation with Kesimpta resulted in a more than three-fold increased likelihood of maintaining NEDA-3 throughout the study. The data were presented at the 2022 European Academy of Neurology (EAN) Annual Meeting.

Labelling 98

Labelling Hospitals 98

Pharmaceutical Technology

NOVEMBER 25, 2022

In recent months, Wegovy (semaglutide), indicated for obesity, has been subjected to widespread supply shortages due to high demand, in addition to manufacturer production problems, with Novo Nordisk intending to relaunch Wegovy by the end of 2022.

Diabetes 111

Diabetes Labelling 111

PharmaShots

FEBRUARY 1, 2023

Shots: The EC has approved a label expansion of Hemlibra (bispecific factor IXa- and factor X-directed Ab) in patients with a mod. 88.9%, respectively The decision was also based on real-world data while the label expansion will provide an effective & convenient prophylactic treatment option for patients with a mod. haemophilia A.

Labelling 40

Labelling 40

pharmaphorum

APRIL 23, 2021

Calliditas Therapeutics is on course to launch its first product, Nefecon for rare disease primary IgA nephropathy (IgAN), in the first half of 2022 after getting the green light for an accelerated review by the EMA. . The post Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon appeared first on.

Labelling 52

Labelling Immunity Immunization 52

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.

Labelling 111

Labelling Immunity Immunization 111

LifeProNow

DECEMBER 22, 2023

The most recent inspection of the company’s facilities in 2022 found the majority of the inspectional observations repeated those found in past FDA inspections and detailed in a 2019 warning letter. Despite repeated warnings, the company and Badia continued to violate the law.

Labelling 130

Labelling Pharmaceutical Companies Pharmaceutical Companies 130

European Pharmaceutical Review

DECEMBER 13, 2024

This authorises a novel CE-labelled needle for intravitreal injection. Expanding market availability of Vabysmo Vabysmo injection was approved by the European Commission (EC) in 2022 to treat these retinal conditions. Wykoff et al. ).

Diabetes 97

Diabetes Labelling Hospitals 97

FDA Law Blog: Biosimilars

JANUARY 5, 2025

We described the 2022 proposed rule and the ten-plus year history leading up to its issuance in our blog post here. Turning first to the four areas in which changes were made, the focus of two of those areas were the requirements for the required labeling statements for a product approved with an ACNU. 105288 (Dec.

Labelling 59

Labelling 59

Express Pharma

MARCH 12, 2025

Private label distributors, such as Walmart, are an exception to this rule, but their products still indicate India as the country of origin. It has also introduced the Foreign Unannounced Inspection Pilot programme, conducting multiple unannounced and short-term notice inspections in India since March 2022.

Generic Medicine 63

Generic Medicine Process Improvement Dosage Pharmaceutical Manufacturing 63

Express Pharma

JULY 1, 2024

Relyvrio/Albrioza was first approved in the US and Canada in September 2022 for the treatment of ALS. In March, Amylyx announced that Relyvrio, a neuroprotective agent, failed to achieve its primary efficacy endpoints in the global Phase III PHOENIX trial for ALS.

Labelling 104

Labelling Diabetes Drug Development 104

FDA Law Blog: Biosimilars

APRIL 21, 2024

But that’s the controversy here: Did FDA approve LYTGOBI NDA 214801 on September 30, 2022 when the Agency issued its initial approval letter , or on October 5, 2022 when FDA issued a corrected approval letter ? Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter.

Labelling 59

Labelling Controlled Substances 59

Pharma Marketing Network

MARCH 25, 2022

Pharma can help with caregiver-relevant labeling, training to perform nursing duties, and a multitude of other support services. Accessed March 21, 2022. Accessed March 12, 2022. Accessed March 15, 2022. Accessed February 28, 2022. Accessed March 12, 2022. Accessed March 17, 2022. February 2019.

Labelling 98

Labelling Drug Development 98

LifeProNow

JANUARY 19, 2024

The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization.

Labelling 130

Labelling 130

European Pharmaceutical Review

SEPTEMBER 5, 2023

It was in February 2022 that NICE recommended the obesity treatment in its draft guidance. Novo Nordisk’s obesity treatment is also expected to be filed for a label expansion in the US this year. Prior to this new market launch, Wegovy was only available in Norway, Denmark, Germany and the US.

Labelling 98

Labelling Pharmaceutical Companies Pharmaceutical Companies 98

PharmaShots

APRIL 20, 2023

treatment interruption/discontinuation due to low lgG & lgM in (0.2% & 10.3%)/ (0.2% & 3.6%) patients Ref: Novartis | Image: Novartis Related News:- Novartis Presents Results of Kesimpta (ofatumumab) in P-III (ASCLEPIOS I/II) and (ALITHIOS) Open-Label Extension Trial for RMS at EAN 2022 vs switch group (-0.42%/yr.)

Labelling 40

Labelling 40

Pharmaceutical Technology

JUNE 7, 2023

In 2022, Lilly reported sales for Mounjaro were approximately $500m, but this is expected to increase significantly in 2023 due to strong demand for the T2D drug. Mounjaro’s approval in 2022 for T2D has already led to many prescribers providing the therapy off-label to their patients to help them lose weight.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Labelling Diabetes 98

European Pharmaceutical Review

MARCH 8, 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. 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.

Labelling 98

Labelling 98

Pharma in Brief

AUGUST 9, 2021

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The amendments contemplate labelling flexibilities for special containers.

Labelling 98

Labelling Packaging Biosimilars 98

European Pharmaceutical Review

JANUARY 25, 2023

Clinical trials for exa-cel The ongoing Phase I/II/III open-label trials, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of exa-cel, the CRISPR-based medicine, in patients ages 12 to 35 years with TDT or with SCD, respectively.

Labelling 111

Labelling 111

pharmaphorum

OCTOBER 12, 2021

Sanofi said in a statement that supply of all four formats of Kevzara (sarilumab) – 150 mg or 200 mg pre-filled syringes or auto-injectors – will be short until early 2022 based on current demand. Now, Sanofi’s rival therapy Kevzara has also been hit by supply constraints.

Labelling 105

Labelling 105

pharmaphorum

SEPTEMBER 14, 2021

The phase 1b trial should generate results in early 2022 and is something if a departure for the use of psychedelic medicines, which are typically being tested at higher doses in carefully controlled environments and alongside psychological therapy for indications like depression and post-traumatic stress disorder (PTSD).

Labelling 105

Labelling Compounding 105