ALiEM - Pharm Pearls

OCTOBER 14, 2023

Author information Chris Belcher, MD Editor, ALiEM AIR Series Assistant Professor and Assistant Program Director Department of Emergency Medicine University of Kentucky College of Medicine | Twitter | The post ALiEM AIR Series | Respiratory 2023 Module appeared first on ALiEM. Please go to the above link.

Labelling 166

Labelling Hospitals 166

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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”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 62

Labelling Biosimilars Adverse Reactions Dosage 62

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FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

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

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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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

pharmaphorum

MAY 15, 2023

SCOTUS won’t hear ‘skinny label’ lawsuit Phil.Taylor Mon, 05/15/2023 - 14:35 Bookmark this

Labelling 52

Labelling 52

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

FDA Law Blog: Biosimilars

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. A recent state law failure-to-warn case in the SDNY makes that very point.

Labelling 40

Labelling Vaccines Communication 40

FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). a)(8)(iv), interpret these provisions to also allow changes due to an aspect of labeling protected by patent or exclusivity. 355(j)(2)(A)(v). 355(j)(2)(A)(v).

Labelling 40

Labelling Packaging 40

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 57

Biosimilars Labelling Drug Pricing 57

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 239

Labelling Diabetes Compounding 239

FDA Law Blog: Biosimilars

MAY 23, 2023

Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact. The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

Labelling 45

Labelling 45

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

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

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

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

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

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 CDW, low brain volume change over 5yr.

Labelling 40

Labelling 40

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 102

Packaging Labelling Compounding Pharmaceutical Companies 102

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 Compounding Labelling 52

PharmaShots

MARCH 17, 2023

5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted 5-Adapted Bivalent Booster to Treat COVID-19 in Children ≤5 Years Date: Mar 15, 2023 | Tags: Pfizer, BioNTech, Omicron BA.4/BA.5-Adapted

Biosimilars 40

Biosimilars Labelling Diabetes 40

PharmaShots

JUNE 16, 2023

Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B Date: June 12, 2023 | Tags: Novartis, Chinook Therapeutics, Atrasentan, Zigakibart, BION-1301, IgA nephropathy, M&A, ~$3.5B

Diabetes 40

Diabetes Labelling 40

PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

Biosimilars 40

Biosimilars Diabetes Labelling 40

PharmaShots

APRIL 21, 2023

Oblato Reports the First Patient Enrolment of OKN-007 in the P-I Clinical Trial for Recurrent High-Grade Glioma Date: Apr 21, 2023 | Tags: Oblato, OKN-007, Recurrent High-Grade Glioma, Regulatory, Henry Ford Health System CARsgen's CT041 Receives the US FDA’s IND Clearance for the Postoperative Adjuvant Therapy of Pancreatic Cancer Date: (..)

Labelling 40

Labelling 40

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

PharmaShots

MARCH 23, 2023

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. haemophilia A. haemophilia A with a sev. haemophilia A with a sev. & moderately sev. vs 13.8mos.)

Labelling 40

Labelling 40

Pharma Pathway

FEBRUARY 14, 2023

Candidates from OSD and Injectibels can attend interview.

People Management 83

People Management Labelling Hospitals 83

Pharma Pathway

FEBRUARY 14, 2023

Candidates from OSD and Injectibels can attend interview.

People Management 82

People Management Labelling 82

Express Pharma

MAY 5, 2024

First results were featured at the European Society for Medical Oncology 2023 Congress, with interim results presented at the European Association of Urology (EAU) 2024 Annual Congress. 2,3 At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the two cohorts.

Labelling 99

Labelling 99

PharmaShots

MAY 25, 2023

AbbVie’s Rinvoq (upadacitinib) Receives EC’s Approval for the Treatment of Moderately to Severely Active Crohn's Disease Rinvoq Active ingredient: upadacitinib Approved: April 17, 2023 Company: AbbVie Disease: Active Crohn's Disease The approval was based on 3 P-III trials incl. (U-EXCEED and (15 & 30mg) @52wks.

Labelling 56

Labelling 56

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

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 78

Biosimilars Drug Pricing Labelling 78

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 97

Documentation Labelling 97

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

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

Drug Channels

DECEMBER 11, 2023

Click here to see the original post from September 2023. Rather than announce multiple biosimilars for its pharmacy benefit manager (PBM) formulary, the company will instead launch Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. d/b/a Drug Channels Institute.

Biosimilars 67

Biosimilars Labelling 67

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.

Diabetes 98

Diabetes Labelling 98