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.

FDA 98

FDA 98

STAT

NOVEMBER 1, 2023

FDA staff said the new type of technology raised concerns about unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about efficacy. If the therapy is approved, Vertex has proposed a 15-year follow up of patients to evaluate the safety outcomes of the therapy.

FDA 111

FDA 111

Pharmacy Times

MARCH 7, 2025

The treatment is currently undergoing evaluation in an investigational preclinical program and is projected to be in human trials in 2026.

FDA 73

FDA 73

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.

FDA 91

FDA Immunization 91

pharmaphorum

AUGUST 6, 2020

The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the cohort.

FDA 87

FDA Adverse Reactions Packaging 87

STAT

JUNE 6, 2024

But the patent on semaglutide, the active ingredient in both drugs, expires in China in 2026. Ozempic won approval in China in 2021 and Novo Nordisk saw sales of the drug in that region double to $698 million last year. It expects Wegovy to be approved this year. Continue to STAT+ to read the full story…

FDA 108

FDA 108

The FDA Law Blog

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

Documentation 59

Documentation FDA Communication 59

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.

FDA 98

FDA Hospitals 98

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…

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 94

The FDA Law Blog

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. Prior to February 2, 2026, FDA also said that it does not intend to enforce complaint requirements under 21 CFR 820.198 for developers that are already in compliance with the complaint requirements under ISO 13485.

FDA 64

FDA Communication Labelling 64

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

FDA 59

FDA Labelling Packaging Documentation 59

The FDA Law Blog

MARCH 19, 2024

AMDM is known for serving as a “connector” for FDA and other regulatory bodies to share information and exchange ideas with industry. Mullen brings to the AMDM board a wealth of knowledge and expertise gained from her years of providing counsel to medical device and IVD manufacturers. Speaking about her appointment, Ms.

FDA 59

FDA 59

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.

FDA 69

FDA Vaccines 69

The FDA Law Blog

OCTOBER 12, 2023

Koblitz — For years, submitting a Suitability Petition has been like screaming into a void: You’d be lucky if FDA ever responds. This has been a big problem because FDA’s inattentiveness can delay entry of certain types of ANDAs for years—often resulting in the ANDA applicant’s abandonment of the Suitability Petition.

FDA 59

FDA Dosage 59

The FDA Law Blog

FEBRUARY 2, 2025

California pharmacists are still able to provide the oral therapeutics without requiring you to visit your primary care physician through January 1, 2026. The most common drug Californians may be looking for this winter is Paxlovid.

Packaging 59

Packaging Documentation Compounding 59

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

Compounding 110

Compounding FDA 110

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.

FDA 52

FDA 52

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

FDA 52

FDA Packaging Labelling 52

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.

FDA 98

FDA 98

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.

FDA 52

FDA Labelling 52

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.

FDA 52

FDA Labelling Immunization Vaccines 52

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.

FDA 52

FDA Documentation 52

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.

Vaccines 59

Vaccines FDA 59

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.

FDA 104

FDA 104

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.

FDA 98

FDA 98

pharmaphorum

JUNE 8, 2022

Analysts at Evaluate are predicting mosunetuzumab could make more than $500 million in sales in 2026, although other predictions go as high as $1 billion. The approval, meanwhile, raises expectations of a positive outcome from the FDA as it reviews the drug for the US market.

Chemotherapy 105

Chemotherapy FDA 105

The FDA Law Blog

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. The court found numerous flaws with this argument.

Dosage 64

Dosage 64

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.

FDA 52

FDA 52

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.

FDA 84

FDA 84

The Checkup by Singlecare

AUGUST 1, 2024

It is an antidepressant approved by the Food and Drug Administration (FDA) to treat major depressive disorder in adults. holds the patent for Trintellix, which is expected to expire in 2026, when a generic version may become available. Trintellix is a brand-name prescription drug containing the active ingredient vortioxetine.

Insurance 98

Insurance Mail-Order Pharmacies Insurance Coverage FDA 98

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.

FDA 64

FDA Labelling 64

The FDA Law Blog

JUNE 14, 2023

In the ever-changing landscape of medical device development, FDA is touting steps it is taking that it says will enhance efficiency, foster innovation, and address key challenges faced by developers. It remains to be seen how FDA would define and actually implement the role of a TAP Advisor.

FDA 45

FDA Communication 45

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.

FDA 52

FDA 52

The FDA Law Blog

JULY 7, 2024

Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements.

Labelling 64

Labelling FDA Communication Documentation 64

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

FDA 52

FDA 52

European Pharmaceutical Review

SEPTEMBER 26, 2023

This recent decision by the EC follows approval of Tyruko ® (natalizumab) by the US Food and Drug Administration (FDA) last month for the same indication. The site is planned to be completed by 2026. It covers the same indication approved by the EC for the reference medicine Tysabri ® * (natalizumab).

Packaging 59

Packaging Dosage FDA 59

The Checkup by Singlecare

FEBRUARY 10, 2025

Food and Drug Administration (FDA) approved Januvia in 2006. No generic version of Januvia is available in the United States, but this could change in 2026 when the main patent expires. The first patent, covering the dihydrogen phosphate salt of sitagliptin, expires on November 24, 2026.

Dosage 52

Dosage Labelling Insurance Coverage FDA 52