Pharmaceutical Technology

JUNE 27, 2024

Ohtuvaye is expected to rake in $1.1bn in global sales from the market for COPD patients with moderate to severe exacerbations by 2029.

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Pharmaceutical Technology

NOVEMBER 1, 2023

The Amgen biosimilar Wezlana has been approved for all indications and is forecasted to yield $455m in 2029.

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Pharmaceutical Technology

MAY 10, 2023

The FDA approved Truvada as the first PrEP treatment in July 2012, with Descovy receiving a nod for this use in October 2019. Truvada has since gone generic, with Teva Pharmaceuticals launching the first FDA-approved Truvada generic in October 2020. billion in global sales in 2029, while Truvada estimates amount to $30 million.

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Pharmaceutical Technology

AUGUST 31, 2023

Daiichi Sankyo and AstraZeneca’s blockbuster anti-cancer drug Enhertu could become a pan-tumour drug, with projected sales of $9.9bn by 2029.

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Pharmaceutical Technology

OCTOBER 23, 2023

The Remicade biosimilar is forecasted to have sales of $2.3bn by 2029 as a subcutaneous form is approved for the US market.

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STAT

SEPTEMBER 19, 2024

Compounded GLP-1 injections are fulfilled and shipped from Hims & Hers affiliated pharmacies and are regulated by the FDA. The pediatric rare disease priority review voucher program is set to end on Sept. The legislation would extend the program until Sept. Continue to STAT+ to read the full story…

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pharmaphorum

JUNE 14, 2022

Eli Lilly and Incyte’s Olumiant has secured the first FDA approval for a systemic drug to treat alopecia areata, an autoimmune condition causing patchy hair loss that affects more than 700,000 people in the US.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

It is expected to expire on 21 January 2029, with paediatric exclusivity lasting until 21 July 2029. Viatris is seeking approval from the US Food and Drug Administration (FDA) to market Januvia and Janumet’s generic versions in the country.

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European Pharmaceutical Review

FEBRUARY 5, 2024

Congressman Greg Murphy highlighted that under the IRA price-fixing model, small molecule drugs are eligible for selection to the “Medicare Drug Price Negotiation” programme following seven years after US Food and Drug Administration (FDA) approval. A two-year “negotiation period” follows and a price control then comes into force at year 9.

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pharmaphorum

JULY 14, 2021

Three FDA figures at the centre of the fallout over the approval Biogen and Eisai’s Alzheimer’s disease therapy Aduhelm have defended their actions, arguing that to do otherwise would have left millions of patients in limbo for years.

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pharmaphorum

OCTOBER 26, 2022

The first patient has already been enrolled into its FIBRONEER phase 3 programme for BI 1015550, which already has a breakthrough designation from the FDA after a positive phase 2 trial showed improved lung function in patients with IPF over a 12-week period.

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European Pharmaceutical Review

AUGUST 21, 2023

Submission for US FDA regulatory approval, anticipated to be received by the end of 2023, further drove this progress, GlobalData noted. billion sales globally by 2029, this could offset Keytruda’s decline sales expected after its loss of exclusivity in 2028, GlobalData highlighted. percent market capitalisation growth due to its $10.8

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Pharmaceutical Technology

MAY 19, 2023

Rituxan received its first FDA approval in 1997 for the treatment of B-cell non-Hodgkin’s lymphoma (B-NHL) and reached peak global sales of $7.5bn in 2014. Given the lower price of biosimilars, the patient share will be even higher than the market share, meaning that over 80% of US patients will have switched to biosimilar rituximab by 2029.

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Pharmaceutical Technology

APRIL 28, 2023

FDA approval follows the successful outcomes of the Sustain Forte trial (NCT03989232), the results of which displayed a superior reduction in HbA1c levels with once-weekly semaglutide 2.0mg, in comparison to once-weekly semaglutide 1.0mg, among individuals suffering from type 2 diabetes.

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pharmaphorum

AUGUST 31, 2022

from 2021 to 2029. FDA backing. Earlier this year, bluebird bio received the support of the FDA’s advisory committee for approval in a vote, which emerged 15 to 0 in favour of approval. This was followed up by an approval and the news that the treatment, Zyntelgo, would sell at a cost of $2.8

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Pharmaceutical Technology

JUNE 13, 2023

According to GlobalData’s analyst consensus forecast, global sales for ziftomenib will reach $255m by 2029. It received fast track and breakthrough designation from the FDA and is poised to be first to market. GlobalData forecasts total sales from this drug class to exceed $1bn by 2029.

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Pharmaceutical Technology

APRIL 24, 2023

Brukinsa was approved by the US Food and Drug Administration (FDA) in CLL in January 2023. billion in 2029, while Calquence is expected to make $5.31 billion in 2029. billion in 2029. While Imbruvica maintained a previously strong position on the market, competition has chipped away at the inhibitor’s market share.

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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. 8,414,921), which covers the co-formulation of sitagliptin and metformin and is due to expire in 2029. The US patent (No. That challenged the ‘708 patent – which expires in November 2026 – as well as one other (No.

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The Checkup by Singlecare

MAY 16, 2024

According to the FDA , biologics are complex mixtures that cannot be easily characterized or identified, whereas nonbiologic drugs are made with chemicals and have a known structure. Before being FDA approved, biosimilars are clinically tested to ensure they are as safe and effective as the reference product. What are biosimilars?

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pharmaphorum

FEBRUARY 23, 2022

AbbVie has filed with the FDA to extend the uses of its bipolar disorder therapy Vraylar to include adjunctive therapy for major depressive disorder, part of a plan to build sales of the drug to peak sales of $4 billion or more. Analysts at GlobalData are predicting peak sales of $383 million for the drug in 2029.

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Pharmaceutical Technology

APRIL 4, 2023

The Boston, Massachusetts-based Scorpion expects to submit an investigational new drug (IND) application for STX-721 to the US Food and Drug Administration (FDA) in mid-2023, with an IND application for STX-241 expected in H1 2024. billion in 2029. The biopharma aims to start the study as soon as the IND is cleared by the FDA.

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Pharmaceutical Technology

JULY 8, 2022

In December 2014, Amgen’s landmark FDA approval saw Blincyto (blinatumomab) approved for relapsed/refractory (R/R) B-cell progenitor acute lymphoblastic leukaemia (B-ALL), at the time being the only marketed BiTE. Currently, there are 110 BiTEs in oncology clinical trials, with seven in Phase III and three in pre-registration.

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Pharmaceutical Technology

JANUARY 10, 2023

billion in 2029, with drug sales almost doubling at a compound annual growth rate (CAGR) of 11.5%. billion in 2029, although its sales growth is likely to continue beyond 2029. GlobalData expects that the T2D market will see significant growth from 2019–29, with the 9MM having a total of $45.9

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PharmaShots

FEBRUARY 22, 2023

Some of its FDA-approved competitors include: Patents7 Eli Lilly carries big expectations from Trulicity to boost its revenue. Those with Medicare or Medicaid coverage are not eligible. Trulicity Competitors6 There are many other alternative types of diabetes medications present in the market that gives tough opposition to Trulicity.

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Pharmaceutical Technology

MAY 16, 2023

million by 2029. Pfizer is currently awaiting FDA approval on their RSV vaccine, expected by May 2023 Q1 2023 saw the top biopharmaceutical companies that found success with their Covid-19 drugs over the past two years experience a decline in market capitalisation. Sanofi and Regeneron’s market capitalisation grew by 12.4%

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The FDA Law Blog

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. had Part D expenditures on or before August 16, 2022).

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The Checkup by Singlecare

OCTOBER 8, 2024

It is approved by the Food and Drug Administration (FDA) to manage chronic kidney disease in people with Type 2 diabetes. The patent for this brand-name prescription drug may expire in 2029 at the earliest. Generics provide the same benefits and are FDA approved to ensure they have the same quality and effectiveness as the original.

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Roots Analysis

OCTOBER 4, 2023

During the research, I noticed a significant increase in the number of FDA approvals for bispecific antibodies in recent years. This allows them to potentially be more effective in treating diseases by targeting multiple pathways simultaneously. I, recently, worked on a market research report, titled Bispecific Antibodies Market , 2023-2035.

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The Checkup by Singlecare

FEBRUARY 10, 2025

Food and Drug Administration (FDA) approved Januvia in 2006. The second patent for Janumet lasts until January 21, 2029. While no generic version of Januvia is currently available, a generic version of sitagliptin is available under a different brand name: Zituvio, which received FDA approval in 2023.

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The Checkup by Singlecare

DECEMBER 6, 2023

How to get Xifaxan without insurance Xifaxan is a brand-name prescription drug approved by the Food and Drug Administration (FDA) to treat irritable bowel syndrome with diarrhea (IBS-D), traveler’s diarrhea, and overt hepatic encephalopathy (OHE). The earliest generic rifaximin may be put on the market is 2029.

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The Checkup by Singlecare

AUGUST 23, 2023

They are both FDA-approved to control blood sugar levels in people with Type 2 diabetes but are inappropriate for Type 1 diabetes. A generic version of sitagliptin may be available as early as 2026 or as late as 2029. | How much does Janumet cost without insurance? | Is Janumet covered by insurance?

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The Checkup by Singlecare

JANUARY 16, 2023

Generic Glyxambi could be available by 2029 , but this is not guaranteed. . At this time, all these FDA-approved alternatives are brand-name drugs without a lower-priced generic version. The active ingredients in Glyxambi are linagliptin and empagliflozin. There is no generic version of Glyxambi, linagliptin, or empagliflozin.

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European Pharmaceutical Review

MAY 10, 2024

The US Food and Drug Administration (FDA) has granted the first approval of an Epstein–Barr virus-related mRNA therapeutic cancer vaccine. The US Food and Drug Administration (FDA) has granted the first approval of an Epstein–Barr virus-related mRNA therapeutic cancer vaccine. billion by 2029.

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The FDA Law Blog

AUGUST 14, 2022

The number will begin in 2026 with 10 drug covered under Medicare Part D and will increase annually to 20 Part B and 20 Part D drugs by 2029 and thereafter, with the selected drugs accumulating from year to year.

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Pharmaceutical Technology

MAY 17, 2023

The US Food and Drug Administration (FDA) has awarded an orphan drug designation to Intercept Pharmaceuticals’ fixed-dose combination of obeticholic acid and bezafibrate for the treatment of primary biliary cholangitis. Data from the analyses will be used for a potential end-of-Phase II study meeting with the FDA. billion in 2029.

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The FDA Law Blog

DECEMBER 23, 2024

Earlier in the week, it was reported that there was a bipartisan agreement on a bill that would have funded the government and extended the first sunset date for the rare pediatric disease priority review voucher program for nearly 5 years, until September 30, 2029.

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The FDA Law Blog

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive.

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