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 110

pharmaphorum

JUNE 22, 2021

That was followed by another first-in-class FDA approval for Farxiga in CKD in April, leaving Boehringer/Lilly playing catch-up with Jardiance once again. Now, the approval of Jardiance for HFrEF in Europe – with an FDA decision due in the coming weeks – gives them a chance to reset the playing field.

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FDA 98

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Paxlovid, the company’s small-molecule Covid-19 oral therapy, was shown to reduce Covid-19 infections by 32% in adults and is forecast to be the top-selling drug by total sales, generating $81bn between 2021 and 2028. AbbVie reported a 22.7% Bristol Myers Squibb (BMS) documented a 9.1%

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Vaccines Documentation Compounding FDA 108

pharmaphorum

AUGUST 4, 2022

Ten months after ChemoCentryx scored an unexpected FDA approval for autoimmune disease therapy Tavneos, Amgen has swooped in with a $3.7 billion bid to buy out the company.

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FDA 98

pharmaphorum

AUGUST 2, 2022

Roche isn’t the only pharma company looking at subcutaneous checkpoint inhibitors, but the phase 3 readout and a plan to submit the data for approval with regulators including the FDA and EMA puts it among the leaders in the category. Results from a trial in first-line NSCLC are due in early 2023.

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Chemotherapy FDA 105

pharmaphorum

JANUARY 12, 2021

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

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Labelling FDA 76

pharmaphorum

DECEMBER 24, 2020

It says Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6 It’s also looking at chronic kidney disease (CKD), and has picked up a breakthrough designation from the FDA for this indication. billion, assuming a launch for HFrEF in 2021.

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FDA 98

pharmaphorum

AUGUST 18, 2021

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. It predicts that Farxiga will reach peak sales of $9 billion in 2028, with Jardiance forecast to reach $4.6

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FDA 52

pharmaphorum

AUGUST 8, 2022

billion in 2028 – a leap forward from the $195 million it made last year and $127 million in the first half of 2022. $PFE $GBT [link] pic.twitter.com/52AMCbvFHF. — Brad Loncar (@bradloncar) August 8, 2022. Oxbryta is the main asset in the deal, with Evaluate predicting sales could reach $1.5

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Vaccines FDA 111

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.

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Vaccines FDA 98

PharmaShots

MAY 2, 2023

Shots: The US FDA has conditionally approved the first drug, Varenzin-CA1 (molidustat oral suspension) for the management of nonregenerative anemia in cats with CKD.

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FDA Vaccines 45

Pharmaceutical Technology

DECEMBER 11, 2022

Due to the rarity of the disease, no FDA-approved therapy exists specifically for RT, and these patients are treated using regimens derived from the DLBCL treatment paradigm and other small-scale clinical trials. GlobalData’s consensus analyst forecast database projects peak sales for pirtobrutinib to reach $892 million by 2028, and $4.8

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Labelling FDA 59

European Pharmaceutical Review

FEBRUARY 14, 2023

In August 2021, mRNA-1345 gained Fast Track designation from the US Food and Drug Administration (FDA) in adults over 60 years old. According to a recent market research report , a total of five marketed mRNA non-vaccine products will generate over $2 billion by 2028. billion during 2028, GlobalData forecasted in its report.

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Vaccines Immunization FDA 105

Pharmaceutical Technology

SEPTEMBER 2, 2022

Previously, J&J’s/Legend Biotech’s Carvykti (cilta-cel) and Bristol Myers Squibb’s (BMS) Abecma (ide-cel), anti-BCMA chimeric antigen receptor (CAR) T-cells, were approved by both the EMA and the US Food and Drug Administration (FDA) for R/R MM. Does Blenrep have an efficacy advantage over Tecvayli?

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FDA Labelling 59

Pharmaceutical Technology

AUGUST 16, 2022

Enhertu has already achieved regulatory approval as a second-line therapy for metastatic or recurrent HER2-positive breast cancer, as well as HER2-positive gastric or gastroesophageal junction adenocarcinoma, with annual sales for these indications alone expected to exceed $1.3bn by 2028.

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Chemotherapy Immunization FDA 59

Pharmaceutical Technology

NOVEMBER 8, 2022

Oyster Point Pharma introduced Tyrvaya, a nasal spray approved by the Food and Drug Administration (FDA) to treat dry eye disease, in November last year. These acquisitions could possibly add a minimum of $1bn in sales of Viatris by 2028. Famy Life Sciences has an ophthalmology portfolio that complements Viatris.

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FDA 59

The FDA Law Blog

OCTOBER 6, 2023

Javitt & Philip Won — As we reported last week, FDA has issued a 26 page, single spaced, tiny-font Proposed Rule of Laboratory Developed Tests (LDTs). The brevity of this change belies the foreseeably seismic impact of FDA regulation of clinical laboratories on the healthcare system. By Allyson B. Mullen & Gail H.

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FDA Labelling 64

Pharmaceutical Technology

MAY 16, 2023

This growth is expected to continue, with a 62% growth in annual consensus sales forecast from 2023 to 2028, fuelled by the company’s semaglutide portfolio, according to GlobalData’s report, ‘Looking ahead to 2023 – the future of pharma’. Novo Nordisk reported an 18.2%

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Vaccines FDA 52

European Pharmaceutical Review

MAY 2, 2023

billion in 2028, according to GlobalData’s Pharma Intelligence Center. The C5 inhibitor reduced the rate of GA progression with statistical significance across two pivotal clinical trials (GATHER1 and GATHER2) and has received breakthrough therapy designation from the Food and Drug Administration (FDA) for this indication.

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FDA 52

Pharmaceutical Technology

MARCH 30, 2023

billion in 2028. Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs. Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs.

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Chemotherapy Packaging FDA Documentation 52

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. Roche’s anti-CD20 monoclonal antibody Rituxan/MabThera (rituximab) is one of the most successful oncology drugs of all time.

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FDA 59

The Checkup by Singlecare

AUGUST 29, 2023

Food and Drug Administration (FDA) in 2012 as a brand-name drug. Although a generic was approved in 2019, generic apixaban will not be available on the market until at least April 2028. The FDA approved two applications for generic versions of Eliquis by the companies Micro Labs Limited and Mylan Pharmaceuticals, Inc.

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Dosage Labelling Insurance FDA 52

PharmaShots

JUNE 21, 2023

Shots: The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. with schizophrenia. from various breeds or breed mixes. The drug is only available by prescription from a licensed veterinarian 3.

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FDA Hospitals 40

pharmaphorum

OCTOBER 10, 2022

Keytruda is due to lose patent protection in around 2028, and the threat of generic competition to it and other top sellers like type 2 diabetes therapy Januvia (sitagliptin) gives it one of the steeper patent cliffs among to-tier pharma groups. The post Boost for Merck as Acceleron drug clears key phase 3 hurdle appeared first on.

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FDA 52

Pharmaceutical Technology

OCTOBER 28, 2022

In June 2021, the FDA approved Pfizer’s Prevnar 20 for adult use, although a nod for paediatric use is pending. Merck, known outside of the US and Canada as MSD, is developing its portfolio of pneumococcal vaccines , and has secured an FDA approval for the paediatric use of its 15-serotype vaccine Vaxneuvance in June.

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Vaccines FDA Immunization 64

Pharmaceutical Technology

MARCH 23, 2023

Among other late-stage trials, Padcev is being evaluated in combination with Keytruda (pembrolizumab) in the frontline setting, with the trial granted priority review by the FDA. GlobalData analysts forecast the total revenue from Seagen products to be around $36bn from 2023 to 2028, with a 29.3%

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Chemotherapy Compounding FDA 59

Pharmaceutical Technology

JULY 12, 2022

The success of chimeric antigen receptor T-cells (CAR-T) in blood cancers has led to the US Food and Drug Administration's (FDA) approval of six products with a pipeline of cell therapies that numbers in the thousands. The total market for cell therapies in oncology is projected to exceed $37bn worldwide by 2028.

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FDA 52

Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. None of these products are in a registrational trial, and as such, GlobalData does not anticipate their entry into the AML market earlier than 2028.

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FDA 52

pharmaphorum

OCTOBER 18, 2022

Akouos has a portfolio of experimental gene therapies led by AK-OTOF, which uses an adeno-associated virus (AAV) vector to a functional copy of the otoferlin (OTOF) gene and was recently approved for clinical testing by the FDA. per month if conditions are not met, until the end of 2028 when they will all expire.

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FDA 52

pharmaphorum

SEPTEMBER 13, 2022

2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001. Today, the bone marrow donor registry comprises more than 39,527,166 donors and 804,246 cord blood units. 2002 – Emergence of CAR-T therapy.

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Chemotherapy Immunization FDA Documentation 98

pharmaphorum

AUGUST 16, 2021

With quarterly sales already running at well over $1 billion, analysts have predicted that the IL-4 and IL-13 inhibitor could make around $7 billion from AD alone in 2028, with half as much again from follow-up indications like severe asthma.

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FDA 52

The FDA Law Blog

JANUARY 18, 2023

The topics focus on issues relevant in the first three years of the Negotiation Program—2026 to 2028. Upcoming CMS Guidance CMS provides a list of topics on which it plans to issue guidance. The Agency has promised it will provide comment periods for each guidance.

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Dosage 59

The FDA Law Blog

DECEMBER 3, 2023

CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028. Sunsetting of Coverage Gap Discount Program: The 70% coverage gap discount under the CGDP will continue until December 31, 2024. Final Guidance at 2.

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Pharmaceutical Technology

AUGUST 24, 2022

CAGR between 2020 and 2028. The FDA and/or other regulatory agencies typically request validation reports to evaluate the assay performance for the intended purpose.2,3. Patients provide blood samples for clinical trial sponsors to develop and deliver these emerging immunotherapies.

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Method Validation Immunization FDA 52

The Checkup by Singlecare

JANUARY 11, 2024

The earliest a generic version will be available is 2028. Other FDA-approved acne treatments that block testosterone are taken as pills. As a brand-name drug with no generic alternative, it pays to explore cost-saving options. What is the generic for Winlevi? There is no generic version of Winlevi cream. However, they are less costly.

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Insurance 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.

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Chemotherapy Immunization FDA 40

The Checkup by Singlecare

DECEMBER 12, 2024

manufactures, was approved by the Food and Drug Administration ( FDA ) in August 2015 for hypoactive sexual desire disorder ( HSDD ) in pre-menopausal women. Addyi is currently only available as a brand-name drug , but a generic Addyi may be available after 2028. What is the generic for Addyi ? Is Addyi covered by insurance?

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Insurance Insurance Coverage Documentation FDA 52