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

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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Clarivate

JANUARY 8, 2024

Clarivate data indicates a 90% probability that datopotamab deruxtecan will win marketing authorization in the United States, and projects 2029 sales of $2.7 billion in 2029 for CASGEVY alone. FDA accelerated approval in August, Clarivate projects the drug will see $850 million in sales by 2029. billion in 2029 revenues.

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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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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

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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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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Pharmaceutical Technology

JUNE 12, 2023

In 2022, the FDA awarded VX-548 breakthrough therapy and fast-track designations for post-operative pain, and the drug is forecast to reach sales of $416m by 2029. A promising example includes Vertex Pharmaceuticals’s VX-548, a sodium channel subunit blocker.

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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

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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Pharmaceutical Technology

MARCH 27, 2023

In 2022, the US FDA disappointingly approved almost a third fewer of the most innovative drugs than it did in 2021. Veklury is currently a blockbuster drug, but its revenues are predicted to drop by 2029. During 2013–2022, NME approvals were lower only in 2013 and 2016. There are ongoing Phase II/III trials of Veklury in children.

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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

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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Food and Drug Administration Biopharma FDA Pharmaceutical 52

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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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

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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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

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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Medico Reach

OCTOBER 17, 2022

billion by 2029. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. However, current orthopedic medical device trends all point towards the increasing use of such systems.

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PM360

SEPTEMBER 21, 2023

In March, the FDA approved several new naloxone products using the pathway, including one from Amphastar, which will compete with other intranasal on the market. This increases to 15 Part D drugs in 2026, as well as 15 Part B and D drugs in 2028, and a full 20 Part B and D drugs in 2029.

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Medico Reach

OCTOBER 17, 2022

billion by 2029. Quite recently, the Food and Drug Administration (FDA) marked a historical moment when it approved Patient Specific Talus Spacer 3D-printed implants in 2021. However, current orthopedic medical device trends all point towards the increasing use of such systems.

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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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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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Clarivate

OCTOBER 17, 2024

The ruling is likely to impact the healthcare industries, particularly around FDA decision-making on drug approvals, drug labelling and dietary supplements.

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