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.

FDA 52

FDA 52

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.

Dosage 52

Dosage Compounding Labelling FDA 52

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.

Pharmaceutical Companies 105

Pharmaceutical Companies Pharmaceutical Companies FDA 105

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.

FDA 80

FDA 80

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.

Labelling 98

Labelling FDA Insurance 98

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.

FDA 52

FDA 52

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.

FDA 52

FDA 52

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.

Labelling 98

Labelling FDA 98

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

Vaccines 86

Vaccines FDA 86

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.

FDA 52

FDA 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.

Vaccines 57

Vaccines FDA 57

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

Labelling 52

Labelling Compounding Pharmaceutical Companies Pharmaceutical Companies 52

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.

Labelling 52

Labelling FDA 52

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.

Chemotherapy 59

Chemotherapy Immunization FDA 59

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%

Vaccines 52

Vaccines FDA 52

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.

Chemotherapy 40

Chemotherapy Immunization FDA 40

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.

Insurance 52

Insurance Dosage Labelling FDA 52

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?

Insurance 52

Insurance Insurance Coverage FDA 52

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.

Insurance 52

Insurance FDA 52

pharmaphorum

OCTOBER 4, 2021

The FDA has approved Kite Pharma’s Tecartus as a treatment for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL), making CAR-T therapy an option for an entirely new group of patients. billion in 2029 across eight major markets – the US, France, Germany, Italy, Spain, the UK, Japan, and China.

FDA 107

FDA 107

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.

FDA 59

FDA 59

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.

FDA 52

FDA 52

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.

Immunization 143

Immunization FDA 143

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.

Insurance 64

Insurance Compounding Dosage Communication 64

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

FDA 98

FDA Compounding Vaccines 98

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).

Labelling 105

Labelling Compounding Payment Processing Vaccines 105

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.

Vaccines 98

Vaccines Immunization 98

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.

FDA 52

FDA Communication Immunization 52