STAT

AUGUST 22, 2023

Jardiance, a diabetes medicine co-marketed by Boehringer, is expected to be among the first drugs to face negotiation once the law takes effect in 2026. Continue to STAT+ to read the full story…

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pharmaphorum

FEBRUARY 10, 2022

The FDA has granted fast-track status to Bayer’s oral Factor Xia inhibitor asundexian, which is in phase 2 testing as an anticoagulant that could offer safety advantages over current drugs. The post FDA fast tracks Bayer’s oral anticoagulant asundexian appeared first on.

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pharmaphorum

OCTOBER 17, 2022

The FDA is planning to take an additional three months to review Biogen’s experimental therapy for amyotrophic lateral sclerosis (ALS), setting back its decision date from January to April. There was no update from Biogen on whether the FDA will require an advisory committee meeting to review the data with the drug.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

It will expire on 24 November 2026, and the paediatric exclusivity lasts until 24 May 2027. Viatris is seeking approval from the US Food and Drug Administration (FDA) to market Januvia and Janumet’s generic versions in the country. Merck has also permitted the sale of generic versions of Janumet XR to the market in July 2026 or before.

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Pharmaceutical Technology

AUGUST 12, 2022

In the lead-up to a critical meeting that will influence the approval of a new drug for amyotrophic lateral sclerosis (ALS), the US Food and Drug Administration (FDA) has detailed its plans to advance rare neurodegenerative disease research. The Act authorizes the appropriation of $100,000,000 per fiscal year from 2022 to 2026.

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pharmaphorum

APRIL 29, 2021

Calliditas Therapeutics could have its first product on the market in the US this autumn, as the FDA has now started a priority review of Nefecon for rare disease primary IgA nephropathy (IgAN). . The post FDA sets September review date for Calliditas’ rare kidney disease drug appeared first on.

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pharmaphorum

SEPTEMBER 23, 2022

Chances of FDA approval for Spectrum Pharma’s lung cancer candidate poziotinib and Oncopeptides’ Pepaxto for multiple myeloma have taken a dive, after the regulator’s expert advisors voted that the drugs were not ready to reach the market. Shares in the company were down 27% in after-hours trading.

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pharmaphorum

SEPTEMBER 8, 2022

On the strength of phase 2 data, the FDA has awarded coveted breakthrough status to Pfizer’s vaccine against Group B Streptococcus (GBS), given to expectant mothers to prevent invasive infections in newborns and young infants. The post FDA gives Pfizer’s Group B strep vaccine breakthrough status appeared first on.

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pharmaphorum

FEBRUARY 7, 2022

Sanofi has won FDA approval for its sutimlimab for cold agglutinin disease (CAD) at the second time of asking, becoming the first approved therapy for the rare blood disorder in the US. The post Sanofi claims FDA okay for drug to treat rare blood disorder CAD appeared first on.

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pharmaphorum

SEPTEMBER 30, 2022

Viatris is seeking FDA approval to market generic versions of both Januvia and Janumet in the US. That challenged the ‘708 patent – which expires in November 2026 – as well as one other (No. Viatris appealed that decision to the Court of Appeals for the Federal Circuit, which has now upheld the earlier decision.

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pharmaphorum

JULY 8, 2021

The FDA has started a priority review of AstraZeneca and Amgen’s severe asthma antibody tezepelumab, setting a date for a decision in the first quarter of 2022. Tezepelumab was awarded a breakthrough designation for non-eosinophilic asthma by the FDA in 2018. Results from that programme are due in 2023.

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Pharmaceutical Technology

JANUARY 31, 2023

FDA director Robert Califf gave his prognosis for the pharma industry at this year’s JP Morgan Healthcare Conference in San Francisco over January 9–12. This “skinny” bill passed just in time to continue funding the FDA, with few of the planned amendments. billion in funding, a $226 million increase on the previous year.

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pharmaphorum

OCTOBER 1, 2020

Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused by myelofibrosis. The post CTI wins over FDA to claim early review of myelofibrosis drug appeared first on. Jakafi had sales of more than $1.1

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European Pharmaceutical Review

DECEMBER 22, 2023

Currently under review by the US Food and Drug Administration (FDA), KarXT is expected to launch in the US in late 2024. Registrational clinical trials are currently underway evaluating KarXT for the treatment of Alzheimer’s disease psychosis, with data expected in 2026.

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Pharmaceutical Technology

MARCH 10, 2023

Work on the new biologics production plant is expected to commence this year, and complete operations are scheduled to begin in late 2026. Last month, Sandoz announced that the US Food and Drug Administration (FDA) accepted its biologics license application (BLA) for its proposed biosimilar denosumab.

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pharmaphorum

JUNE 27, 2022

Tazverik is a first-in-class EZH2a inhibitor that was cleared by the FDA in 2020 as a third-line or later treatment for adults with relapsed or refractory follicular lymphoma (FL) whose tumours have an EZH2 mutation. Ipsen’s CVR offer includes $0.30

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Compounding FDA 101

pharmaphorum

FEBRUARY 4, 2022

billion in 2019, and is also developing the drug for paroxysmal nocturnal haemoglobinuria (PNH), another of Soliris and Ultomiris’ FDA-approved indications. UCB acquired rights to the drug when it bought US biotech Ra Pharma in a deal worth around $2.1

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The FDA Law Blog

NOVEMBER 22, 2022

Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. All records required under the final rule must be made available to FDA within 24 hours after a request is made. coli contamination.

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The FDA Law Blog

JUNE 26, 2023

September 1, 2023 will be the selection date for the 10 drugs that will be subject to “maximum fair price” ceilings under Medicare Part D starting in 2026. Chamber of Commerce makes all the arguments that the other plaintiffs have made, and also alleges that Congress has no power to levy the excise tax because it “compels” commerce.

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pharmaphorum

AUGUST 5, 2022

Sintilimab is partnered outside China with Eli Lily, but plans to bring the drug to the US market as a lower-cost rival to current PD-1/PD-L1 drugs were knocked back earlier this year when the FDA declined to approve it on data generated exclusively from Chinese studies.

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pharmaphorum

DECEMBER 22, 2021

The Japanese regulator looks like it could follow the European Commission and reject approval of Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm, leaving the FDA an outlier in its stance on the drug. Biogen is due to start a confirmatory trial of the drug next year, but it isn’t due to generate results until 2026.

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pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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pharmaphorum

JUNE 29, 2021

Final results are not due until 2026, according to the entry for the trial on the clinicaltrials.gov database, although interim results may be available sooner.

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The FDA Law Blog

NOVEMBER 17, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement. See Program Website.

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pharmaphorum

APRIL 24, 2022

” Aduhelm was approved by the FDA last year under an accelerated approval pathway, which allows a drug to be cleared on the back of surrogate endpoint data while more evidence of its efficacy on clinical endpoints is gathered.

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pharmaphorum

AUGUST 27, 2020

The FDA backed Blenrep for the same indication three weeks ago, despite some reservations about eye toxicity, which set the drug on course for what some analysts think could be revenues of around $1.5 billion in 2026. Among a crowded field, GSK has now won the race to bring an anti-BCMA drug to market in both Europe and the US.

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The FDA Law Blog

NOVEMBER 21, 2022

The TAP Pilot is one of the commitments agreed to between FDA and industry as part of the Medical Device User Fee Amendments of 2022 (MDUFA V) and the Agency hopes the program will help ensure that U.S. Devices in the Safer Technologies Program (STeP) will be included in FY 2026. See Announcement. See Program Website.

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Pharmaceutical Technology

MARCH 22, 2023

The device received Breakthrough Device Designation from the US Food and Drug Administration (FDA) in December 2020 as no standard of care for the condition existed. Expected to receive FDA approval by February 2026, the app tracks usage and provides personalised schedules to help reduce use, increase compliance, and reduce pain levels.

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The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Revised § 820.3

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pharmaphorum

APRIL 5, 2022

Leqvio meanwhile is only just getting started after a delayed FDA approval at the end of last year, although it has been available in Europe for a few months longer. Repatha and Praluent already have that data in hand, while Novartis already has a cardiovascular outcomes trial on the go, albeit with a readout not due until 2026.

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Pharmaceutical Technology

MAY 9, 2023

The 5th Panel of the Federal Court of the 1st Region (Tribunal Regional Federal da 1ª Região, TRF-1) upheld the existing expiry dates of two patents—one for semaglutide itself (2026), and the other for the delivery mechanism for the oral formulation of the drug, Rybelsus (2031).

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Labelling FDA 59

The Checkup by Singlecare

MARCH 21, 2024

Clinical studies on Ozempic’s effectiveness for insulin resistance Ozempic has not been officially approved by the Food and Drug Administration (FDA) to treat insulin resistance. These findings have spurred further research, with ongoing clinical trials set to conclude in October 2026. mg once a week.

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Pharmaceutical Technology

MARCH 7, 2023

In 2019, Sage Therapeutics’ drug Zulresso received FDA approval to treat postpartum depression. With an estimated completion date of May 2026, the study strives to utilise the endocrine biology of perimenopause to explain the behavioural and neurobiological features of depression in perimenopausal women.

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pharmaphorum

OCTOBER 11, 2020

Lilly’s drug reached the market in 2017 as a second-line therapy, picking up FDA approval for first-line use the following year, and sales doubled to around $580 million last year, adding another $400 million in the first half of 2020 despite the coronavirus pandemic.

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The FDA Law Blog

JANUARY 18, 2023

The memorandum outlines CMS’s priorities and timeline for the Initial Price Applicability Year 2026. The topics focus on issues relevant in the first three years of the Negotiation Program—2026 to 2028. Finally, the memorandum has a handy timeline of the key dates associated with the Initial Price Applicability Year 2026.

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Dosage 59

The FDA Law Blog

OCTOBER 4, 2023

Note that Astellas withdrew its lawsuit after none of its drugs were selected for price reduction in 2026—potentially because that fact cut against its argument for standing. Harm The Court reviewed the parties’ arguments on “irreparable harm to Plaintiffs.”

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The Checkup by Singlecare

DECEMBER 29, 2022

Generic perampanel won’t be available until 2026 at the earliest, but even that is uncertain. . Fortunately, healthcare professionals have some lower-cost FDA-approved generic anticonvulsants that may work just as well: generic Epitol ( carbamazepine ) or generic Trileptal ( oxcarbazepine ) are two common examples.

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