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.

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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.

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Labelling 188

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FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars- Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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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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Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

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Labelling Biosimilars Adverse Reactions Dosage 62

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REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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

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pharmaphorum

MAY 15, 2023

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

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Labelling 52

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.

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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.

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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.

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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).

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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.

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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.

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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.

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Labelling 44

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 (..)

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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.

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Labelling 104

FDA Law Blog: Biosimilars

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. So, what is special about September 24, 2023? Devices can have both a UPC code and a UDI on their label and package.

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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/

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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.

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Packaging Labelling 52

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.

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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.

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Labelling 40

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.

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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.

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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.

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Packaging Labelling 105

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.

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Labelling Communication 82

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.

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PharmaTech

MAY 30, 2023

Webinar Date/Time: Friday, June 23, 2023 at 11am EDT | 10am CDT | 8am PD

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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

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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

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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 (..)

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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.

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Labelling 46

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: (..)

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Labelling 40

FDA Law Blog: Biosimilars

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). In fact, the priority designation for the final rule is labeled as “economically significant.” According to the Unified Agenda, the proposed rule is in the final rule stage.

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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.

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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.)

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Labelling 40

Pharma Pathway

FEBRUARY 14, 2023

Candidates from OSD and Injectibels can attend interview.

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Pharma Pathway

FEBRUARY 14, 2023

Candidates from OSD and Injectibels can attend interview.

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European Pharmaceutical Review

JULY 31, 2024

Data insights from GlobalData has reported that in 2023, major players in the biopharma sector generated “significant” revenue growth from obesity drugs. Between 2022 and 2023, companies including Novo Nordisk and Eli Lilly had “year-on-year (YoY) revenue growth of 31.3 billion in 2023” GlobalData added. percent, respectively”.

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