Express Pharma

MAY 5, 2024

These data were featured in an Oral Presentation Session (Abstract #PD48-02) 1 at the 2024 American Urological Association (AUA) Annual Meeting taking place 3-6 May, 2024, in San Antonio, Texas. 2,3 At the data cutoff of March 22, 2024, 64 patients had been treated with TAR-210 across the two cohorts.

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Labelling 99

FDA Law Blog: Biosimilars

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. Comments to the revised draft guidance are due to the docket by June 25, 2024.

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Biosimilars Labelling Communication 59

Pharmacy Times

APRIL 9, 2024

In March 2024, the label for bempedoic acid was expanded to reduce cardiovascular risk and expand the low-density lipoprotein-C (LDL-C) lowering in both primary and secondary prevention patients.

Labelling 57

Labelling 57

Pharmaceutical Technology

MARCH 30, 2023

Table 1: Medical product (drugs, devices, and diagnostics) safety budget, 2023 vs. 2024 Source: FDA; GlobalData © GlobalData Whether the proposal passes, and with what alterations, will depend on US Congress. This is made up of $2.1bn in direct funding and $2.4bn in user fees.

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Controlled Substances Labelling 59

Big Molecule Watch

MAY 3, 2024

The 60-day comment period for this revised draft guidance ends on 6/24/2024. Topics the FDA addresses include correctly identifying products, presenting comparative study data, and avoiding any suggestion that a biosimilar product may be less safe or effective, to highlight a few.

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Biosimilars Communication Labelling Documentation 62

Pharmaceutical Technology

OCTOBER 26, 2023

GSK plans to submit the data to regulatory agencies to support label expansion for Arexvy in the younger adult patient population in 2024.

Labelling 52

Labelling Vaccines 52

LifeProNow

MARCH 8, 2024

March 06, 2024: “The U.S. Consumers can find lot codes listed on the product’s label. The agency sent a letter to all cinnamon manufacturers, processors, distributors and facility operators in the U.S., The FDA is working with the firms listed below to voluntarily recall the products, with the exception of the MTCI cinnamon.

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Labelling 130

Pharmaceutical Technology

JULY 17, 2023

The complete data readouts of two-Phase II trials are expected in 2024, with an additional open-label extension study currently in the works.

Labelling 52

Labelling 52

FDA Law Blog: Biosimilars

APRIL 21, 2024

In January 2024, FDA affirmed to the PTO in a letter that “NDA 214801 was approved on September 30, 2022, which makes the submission of the patent term extension application on November 29, 2022, not timely within the meaning of 35 U.S.C. It’s not terribly uncommon for FDA to issue corrected approval letters (and corrected labeling).

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Labelling Controlled Substances 59

Drug Channels

DECEMBER 11, 2023

This week, I’m rerunning some popular posts while I prepare for Friday’s Drug Channels Outlook 2024 live video webinar. Click here to see the original post from September 2023. Here’s the press release: CVS Health Launches Cordavis.

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Biosimilars Labelling 67

FDA Law Blog: Biosimilars

NOVEMBER 13, 2023

On January 23-24, 2024, the American Conference Institute (“ACI”) will host its “ Advanced Legal, Regulatory and Compliance Forum on OTC Drugs ” conference at the Sofitel New York, NY. Director Deborah L.

Labelling 59

Labelling 59

Quality Matters

MARCH 8, 2024

Further, the proclaimed health benefits found on an unverified supplement’s label are not necessarily true or accurate. FDA of nearly 70 dietary supplements for sale at major online retailers revealed that most of these products included active ingredients that were not listed on the label. A recent test conducted by the U.S.

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Labelling 98

European Pharmaceutical Review

MARCH 8, 2024

Novo Nordisk stated it expects to file for regulatory approvals of a label expansion for Ozempic ® in the US and EU this year. The company added that the detailed results from FLOW will be presented at a scientific conference in 2024.

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Diabetes Labelling 93

Safe Biologics

DECEMBER 3, 2023

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. They may be submitted here and are due by January 5, 2024 Read the full statement here. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber.

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Biosimilars Labelling Drug Pricing Packaging 130

Big Molecule Watch

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law.

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Biosimilars Labelling 52

LifeProNow

JANUARY 19, 2024

January 08, 2024: “The U.S. 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.

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Labelling 130

Pharmaceutical Business Review

APRIL 2, 2024

INSPIRE Duchenne is also the first-in-human, open-label, as well as multi-centre trial, the company noted. By mid-2024, the company is planning to release an initial safety update related to the first three to four patients enrolled in the INSPIRE Duchenne trial.

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Labelling 59

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. Eligible drugs must: (i) be approved by Health Canada; and (ii) meet FDA-approval conditions for a drug currently marketed in the US (aside from US labeling). 01.014.13).

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Controlled Substances Labelling 52

European Pharmaceutical Review

NOVEMBER 28, 2023

“We are pleased with the broad label, which includes all progressing adult patients and specifically references improvement in pain, and believe Ogsiveo has the potential to become the new standard of care for people living with these devastating tumours,” Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics commented.

Labelling 83

Labelling 83

PharmaShots

MAY 31, 2023

& entered in an ongoing open-label part B The trial met its 1EPs & showed that high & low-dose frexalimab patients achieved a reduction in no. Shots: The P-II trial results presented at CMSC 2023 evaluating high or low doses of frexalimab vs PBO in a ratio (4:4:1:1) in 129 patients for 12wks.

Labelling 40

Labelling 40

European Pharmaceutical Review

MARCH 4, 2024

Importance of the new data for the Novartis gene therapy This data is “the first Zolgensma open-label clinical study to include older and heavier, as well as previously treated patients,” according to Dr Sandra Reyna, Chief Scientific Advisor and Head of Global Medical Engagement for SMA at Novartis.

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Labelling 79

European Pharmaceutical Review

SEPTEMBER 26, 2023

Patients who experienced disease progression while having a placebo treatment were offered resminostat in an open label treatment arm. In terms of drug development , the company stated that filing for marketing approval of the oral small molecule treatment in the EU, Switzerland and UK is planned for Q1 2024.

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Labelling Drug Development 89

Big Molecule Watch

APRIL 11, 2024

On April 4, 2024, Bristol Myers Squibb (“BMS”) and 2seventy bio, Inc.

Labelling 62

Labelling 62

Pharmaceutical Technology

MAY 19, 2023

The prescription drug user fee act (PDUFA) date is expected to be set as January 2024. In the long-term, open-label, safety ASCEND trial, 446 participants with more than 9,000 migraine attacks were treated with more than 10,500 STS101 doses for up to 18 months.

Labelling 59

Labelling 59

LifeProNow

MARCH 10, 2023

billion as part of the president’s fiscal year (FY) 2024 budget. The FY 2024 request, which covers the period from Oct. 30, 2024, includes new efforts for high priority program areas. million in investments in food safety and nutrition modernization, including food labeling and animal food safety oversight.

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Labelling Packaging Controlled Substances 130

Pharmaceutical Business Review

DECEMBER 26, 2023

The regulatory agency accepted the BLA, with a decision on the drug approval anticipated on 26 June 2024. A HER3 targeting DXd antibody-drug conjugate (ADC), patritumab deruxtecan is intended for usage in patients with locally advanced or metastatic EGFR-mutated NSCLC, who have been treated with two or more systemic treatments earlier.

Labelling 59

Labelling 59

Pharmaceutical Technology

JUNE 21, 2023

Ketarx will be marketed under the FDA-approved label of ketamine and in dosages that include 10mg/ml, 50mg/ml and 100mg/ml, with the option to boost the concentration and ready-to-administer applications. PharmaTher and Vitruvias Therapeutics have entered a collaboration deal to commercialise PharmaTher’s Ketarx (racemic ketamine) in the US.

Hospitals 52

Hospitals Dosage Labelling 52

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. Recommendations regarding how to describe pediatric use data in a range of scenarios and how to incorporate immunogenicity data.

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Biosimilars Labelling Drug Pricing 57

European Pharmaceutical Review

MARCH 14, 2024

To mark World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics, spoke with EPR about the challenges of treating kidney diseases, specifically IgAN, a condition caused by dysfunctional B cells. Internet] Vera Therapeutics. cited 2024Mar].

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Diabetes Labelling Immunity Immunization 94

European Pharmaceutical Review

MARCH 14, 2024

To mark World Kidney Day 2024, Dr Marshall Fordyce, CEO of Vera Therapeutics, spoke with EPR about the challenges of treating kidney diseases, specifically IgAN, a condition caused by dysfunctional B cells. Internet] Vera Therapeutics. cited 2024Mar].

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Diabetes Labelling Immunity Immunization 93

The Thyroid Pharmacist

NOVEMBER 29, 2023

This is because I had learned about various adulterants found in supplements, how some supplement manufacturers don’t actually put the products that are on the label in the bottle, or that the dosages listed on the label may be completely different from what’s in the products. We have 95 expiring in March 2024.)

Health and Personal Care Stores 54

Health and Personal Care Stores Immunity Immunization Labelling 54

Express Pharma

MAY 7, 2024

Steriline, the European manufacturer of standard and robotic lines for the aseptic processing of injectable drugs, will exhibit at Achema 2024, from June 10 to 14.It References: [1] [link] The post Steriline to exhibit its Robotic Vial Filling Machine at ACHEMA 2024 appeared first on Express Pharma. per cent per year until 2028 1.

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Packaging Pharmaceutical Manufacturing Labelling 59

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.

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Biosimilars Packaging Labelling Drug Development 130

pharmaphorum

OCTOBER 19, 2020

Both Repatha and Praluent have that in hand, but Novartis will have to wait for the results of the ORION-4 study – due in 2024 – before it has a chance of matching the labels of Amgen and Sanofi/Regeneron’s drugs. That said, Novartis is no stranger to building a slow-starting cardiovascular drug into a blockbuster franchise.

Labelling 98

Labelling 98

pharmaphorum

SEPTEMBER 20, 2021

The approval comes a few weeks after the biosimilar was cleared for marketing in the EU with a broader label, as it also includes diabetic macular oedema (DMO), another of Lucentis’ approved indications. Savings in the US from 2020 to 2024 as a result of biosimilars are projected to exceed $100 billion, according to IQVIA figures.

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Biosimilars Labelling Diabetes 70

Eye on FDA

JANUARY 22, 2024

Aside from being the first letter of 2024 – after 2023 when there were only 5 enforcement actions – the letter marks the second in a row concerning DTC TV ads, the last one being issued in October 2023. Before getting to the specifics of this particular letter, a look at how it stacks up against recent enforcement.

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Communication Labelling 86

pharmaphorum

NOVEMBER 1, 2021

The full approval for T315I-positive CML came on the back of a non-randomised, open-label phase 1 trial involving 330 patients that is also looking at combinations of Scemblix with other TKIs. It hopes to show that early treatment with the STAMP inhibitor could lead to a treatment-free period for patients.

Labelling 113

Labelling 113