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

Labelling 105

Labelling 105

pharmaphorum

JUNE 6, 2023

ASCO: Enhertu data sets up tumour-agnostic label bid Phil.Taylor Tue, 06/06/2023 - 08:26 Bookmark this

Labelling 97

Labelling 97

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.

Labelling 272

Labelling Diabetes Compounding 272

Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. ASBM Exhibits at ACR Convergence 2023 From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. Learn more about ACR Convergence 2023 here.

Biosimilars 130

Biosimilars Labelling Drug Pricing Packaging 130

Safe Biologics

NOVEMBER 12, 2023

FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. Read the new FDA’ Guidance here.

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Biosimilars Drug Pricing Packaging Labelling 130

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. Read it here.

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

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.

Labelling 105

Labelling Data Entry Communication Hospitals 105

Express Pharma

JANUARY 19, 2025

This study consists of a 36-week treatment phase, followed by a 16-week open-label extension. 1162 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Three Patients with Cryopyrin-Associated Periodic Syndromes, Clinical Pharmacology in Drug Development, 2023, 0(0) 18. DOI: 10.1002/cpdd.1162 DOI: 10.1002/cpdd.1318.

Clinical Pharmacology 111

Clinical Pharmacology Labelling Medical Schools Drug Development 111

Express Pharma

NOVEMBER 26, 2024

billion in 2023. billion in 2023. Acoramidis is probably going to have most of its uptake among patients who are newly diagnosed, at least initially, Greg Harrison, Scotiabank analyst said, adding that having mortality benefit on the label would make it more competitive. billion at its peak by 2035.

Dosage 105

Dosage Labelling 105

FDA Law Blog: Biosimilars

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.

Labelling 105

Labelling 105

Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

Express Pharma

JANUARY 17, 2025

The deal is the biggest biotech M&A transaction since 2023. Opdenakker continues, The addition of Caplyta could be particularly significant, given its versatility as a proven treatment for schizophrenia and bipolar disorder, as well as a potential label expansion into MDD.

Labelling 105

Labelling 105

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.

Packaging 118

Packaging Labelling Compounding Pharmaceutical Companies 118

ALiEM - Pharm Pearls

APRIL 14, 2023

Highlighted Quality Posts: Procedures Site Article Author Date Label Rebel EM Intra Articular Lidocaine vs Sedation in Shoulder Reductions Nordia Matthews, MD 30 Jan 2023 AIR EM Docs Video Laryngoscopy in the ED Cameron Jones, MD 8 Aug 2022 AIR First 10 EM Lacerations: Does closure technique matter? Please go to the above link.

Labelling 246

Labelling 246

Express Pharma

MARCH 20, 2025

As of 2023, adult obesity prevalence in India stood at around 6.5 Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. per cent, affecting nearly 100 million people (13).

Diabetes 101

Diabetes Labelling Communication 101

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.

Packaging 105

Packaging Labelling 105

Express Pharma

JANUARY 17, 2025

This capsule was recognised as the recipient of the 2023 Medicine Maker Innovation Award. In addition, the nutra market boom in APAC that began during the COVID-19 pandemic continues to accelerate looking for green-label, plant-based capsules for encapsulation. What opportunities do you see in the APAC capsule market?

Labelling 104

Labelling Packaging 104

LifeProNow

JANUARY 18, 2025

In December 2023, the FDAgrantedBreakthrough Therapy Designation (BTD) to TAR-200 for the treatment of adult patients with BCG-unresponsive HR-NMIBC with CIS who are ineligible for or have elected not to undergo radical cystectomy.

Packaging 100

Packaging Labelling 100

Pharmaceutical Technology

APRIL 17, 2023

The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.

Labelling 52

Labelling 52

Eye on FDA

JUNE 14, 2023

The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). It was the second letter for this company, the first having been issued in August, 2020 for a TV advertisement.

Labelling 82

Labelling Communication 82

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

Pharma Pathway

FEBRUARY 14, 2023

Candidates from OSD and Injectibels can attend interview.

People Management 64

People Management Labelling Hospitals 64

Pharma Pathway

FEBRUARY 14, 2023

Candidates from OSD and Injectibels can attend interview.

People Management 63

People Management Labelling 63

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.

Documentation 111

Documentation Labelling 111

Express Pharma

JULY 29, 2023

In this video: Ravleen Singh Khurana, MD, Nitika Pharmaceutical Specialities Topic: Future of lubricants Key Highlights: 1) Customisation of lubricants is need of the hour 2) Sodium Stearyl Fumarate would be the choice of lubricant in future due to its lower impact on tablet attributes 3) Demand for special lubricants for effervescent tablets, clean (..)

Labelling 52

Labelling 52

Big Molecule Watch

DECEMBER 28, 2023

According to PWC , “2023 was a reasonably strong year for the pharmaceutical and life sciences sector with both deal value and volume of M&A close to pre-pandemic levels.” Below is a recap of the top M&A deals in 2023 that focus on biologics and biosimilars and were covered on the Big Molecule Watch.

Biosimilars 69

Biosimilars Labelling 69

Pharma Pathway

JANUARY 26, 2023

Operators On 28th Jan’ 2023 Job Description We are hiring for the following vacancies in RPL On urgent Basis. Operators On 28th Jan’ 2023 Rakshit Pharmaceuticals Ltd- Walk-In Interviews for Production-Jr. Department: Production Position: Jr. Operators Experience: 0 years Qualification: S.S.C/

Documentation 52

Documentation Labelling 52

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.

Vaccines 122

Vaccines Labelling Immunization Immunity 122

Drug Channels

OCTOBER 3, 2023

This week, I’m rerunning some popular posts while I put the finishing touches on our new 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. CVS Health launched Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. The Humira biosimilar market has arrived!

Biosimilars 98

Biosimilars Drug Pricing Labelling 98

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. Below are some of the top regulatory developments from 2023. Janssen and Amgen settled their BPCIA litigation regarding Amgen’s ustekinumab biosimilar product in May 2023.

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

PharmaShots

MAY 3, 2023

Our team at PharmaShots has summarized 15 key events of the biosimilar space of April 2023 1. Celltrion Reports 24 Week P-III Trial Results of CT-P42 (biosimilar, aflibercept) for Wet Age-Related Macular Degeneration and Diabetic Macular Edema Date- April 03, 2023 Product: CT-P42 (biosimilar, aflibercept) The company highlighted the 24wk.

Biosimilars 56

Biosimilars Labelling Diabetes 56

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. This week’s action makes a total of three letters sent this year, all within a three-month period.

Communication 68

Communication Packaging Labelling 68

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.

Medical Schools 96

Medical Schools Labelling Communication 96

PharmaTech

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.

Packaging 52

Packaging Labelling 52

Pharmaceutical Technology

DECEMBER 11, 2023

Novartis is seeking approval for Kisqali as a treatment of early breast cancer, with an FDA application planned by the end of 2023.

Labelling 52

Labelling 52

LifeProNow

MARCH 30, 2023

March 29, 2023: “The U.S. In accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling.

Grocery Stores 130

Grocery Stores Labelling Dosage 130

Pharmaceutical Technology

APRIL 28, 2023

Novo Nordisk’s leading drug Ozempic (semaglutide) is forecast to demonstrate a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales of $12.5bn consolidate its position as the dominant market leader, with projected sales in 2023 54% greater than closest competitor Trulicity (dulaglutide) by Eli Lilly, which anticipates sales of $8bn.

Diabetes 52

Diabetes Dosage Labelling Compounding 52