Fierce Pharma

JANUARY 10, 2024

With a late-stage pipeline spanning more than 120 clinical trials and a firm grasp of five major disease areas, AstraZeneca appears confident heading into 2024. | In AZ's push to reach industry-leading growth by 2030, confidence is key, chief financial officer Aradhana Sarin said at the J.P. Morgan Healthcare Conference.

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Labelling 101

Pharmaceutical Technology

JANUARY 22, 2024

Processa announced plans to begin a Phase II breast cancer study for its capecitabine combination therapy in Q3 2024.

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Labelling 69

The FDA Law Blog

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 Comments to the revised draft guidance are due to the docket by June 25, 2024.

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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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STAT

SEPTEMBER 13, 2023

The Boston-based company will continue offering its pediatric treatment, EndeavorRx, by prescription until it can convert it to over-the-counter labeling — it plans to submit data to FDA in 2024. In its second-quarter results reported in August, Akili said it earned just $114,000 on $15.3 million in expenses.

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Labelling FDA 124

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.

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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.

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Labelling 52

The FDA Law Blog

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 FDA Controlled Substances 59

The FDA Law Blog

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.

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Labelling FDA 59

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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Labelling 94

The Checkup by Singlecare

APRIL 10, 2024

In fact, as recently as April 2, 2024, the FDA announced that shortages of certain Mounjaro dosages were expected to continue at least through the end of April. Mounjaro’s weight loss effects have led to an increased demand for off-label prescriptions of the drug. clinical pharmacist practitioner in Minneapolis, Minnesota.

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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.

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Labelling FDA 84

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.

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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 80

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 90

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.

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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.

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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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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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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.)

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The Checkup by Singlecare

MARCH 7, 2024

Unfortunately, a law from 2003 prohibits Medicare Part D from covering weight loss drugs, which means it won’t cover Ozempic prescribed solely for weight loss , an off-label use. For the year 2024, Medicare Part D deductibles will be no more than $545 , and copayments can vary. But out-of-pocket maximums are much higher.

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The Checkup by Singlecare

MARCH 25, 2024

In January 2024, Novo Nordisk announced that it was boosting the supply of Wegovy and would more than double the amount of the lower dose strengths of Wegovy into the U.S. Because those drugs are not FDA approved for weight loss, like Wegovy, healthcare providers may prescribe them off-label. market throughout the rest of the year.

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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.

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Labelling FDA 96

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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The FDA Law Blog

MARCH 29, 2023

Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days. launch would be in early 2024. According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S.

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European Pharmaceutical Review

NOVEMBER 25, 2022

GlobalData’s report showed LY03010 is expected to launch in the US in 2024. The Luye Pharma drug demonstrated comparable bioavailability with Johnson and Johnson’s Invega Sustenna ® at steady state in a clinical trial ( NCT04922593 ). If successful, the drug is forecasted to reach sales of $63.5 million in 2031, representing 0.6

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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.

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Hospital Pharmacy Europe

MARCH 7, 2024

A 12-gene pharmacogenetic panel to prevent adverse drug reactions: an open-label, multicentre, controlled, cluster-randomised crossover implementation study. 2022 (accessed March 2024) Turgeon RD et al. 2022 (accessed March 2024) CAPRIE Steering Committee. accessed March 2024) Magavern E et al. 2023 (accessed March 2024).

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Hospitals Labelling 52

The FDA Law Blog

DECEMBER 12, 2023

The recommendations in the draft guidance address: The wording of UTH claims based on RSS for use on adult maintenance cat food labeling; The RSS criteria to substantiate those UTH claims; and The study data that CVM recommends to demonstrate the utility and target animal safety of the cat food.

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Labelling FDA 59

pharmaphorum

MARCH 8, 2022

Final OS results won’t be in until 2024, although the study does allow for an interim look at the data before then, according to the FAQ. Meanwhile, Gilead is continuing to follow patients to see if the drug has an impact on overall survival, saying it saw a trend towards an improvement with Trodelvy.

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Pharmaceutical Technology

APRIL 21, 2023

While the FDA sent Lilly a complete response letter detailing issues pertaining to the proposed manufacturing of mirikizumab, the regulator raised no concerns about the clinical data package or label for the medicine. The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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Pharmaceutical Technology

JUNE 16, 2023

The company aims to run an interim analysis of the trial by mid-2024 at the very latest. Additionally, the company plans to run a further open-label safety study that will serve as a long-term trial mostly made of past patients from the other two trials.

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pharmaphorum

DECEMBER 23, 2021

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.

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Labelling FDA 99

The FDA Law Blog

OCTOBER 24, 2022

The Federal Register notice states that the Advancing RWE Program “seeks to identify approaches for generating RWE that meet the regulatory requirements in support of labeling for effectiveness ( e.g. , new indications, populations, dosing information) or for meeting post-approval study requirements.”

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Pharmaceutical Technology

JULY 18, 2022

There are currently no approved therapies for the treatment of bronchiectasis; although some off-label medicines do exist, they only alleviate symptoms and manage frequent infections. Symptoms vary from excessive coughing, chest discomfort, and even weight loss, exacerbating other symptoms such as breathlessness.

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pharmaphorum

JANUARY 23, 2023

The drug achieved an impressive 84% overall survival rate over 18 months in patients with advanced GEA who received it as a first-line therapy in combination with chemotherapy, according to data from the open-label study. The median progression-free survival (PFS) of 12.5 months, with a median duration of response was 20.4

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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.

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Labelling FDA 52