PharmaShots

MAY 12, 2023

Sanofi Reports P-IIIb Trial (HARMONIE) Results of Nirsevimab for the Prevention of Hospitalizations due to RSV-Related LRTD Date: May 12, 2023 | Tags: Sanofi, Nirsevimab, RSV-Related LRTD, Clinical Trial, P-IIIb, HARMONIE Trial G1 Therapeutics Presents Preliminary Results from P-II Trial of Trilaciclib for Triple-Negative Breast Cancer at ESMO 2023 (..)

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PharmaShots

FEBRUARY 3, 2023

4D Molecular Therapeutics Receives the US FDA’s IND Clearance of 4D-150 for the Treatment of Diabetic Macular Edema Date: Feb 03, 2023 | Tags: 4D Molecular Therapeutics, 4D-150, Diabetic Macular Edema, Regulatory, US, FDA, IND AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma (..)

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pharmaphorum

DECEMBER 24, 2021

The anti-amyloid drug, which also claimed a breakthrough tag from the FDA in July, is being developed for the treatment of early-stage Alzheimer’s disease. The $56,000-a-year price tag for the drug, which has now been cut in half in the US, also hasn’t helped the drugmakers make a case for Aduhelm with US payers.

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pharmaphorum

NOVEMBER 19, 2021

Roche’s oral treatment Evrysdi for the rare genetic disease spinal muscular atrophy (SMA) will be made available on the NHS in England, after NICE reached a three-year access agreement with the company. million price tag make it is the most expensive treatment ever approved for NHS funding.

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pharmaphorum

JANUARY 9, 2023

Along with Zolgensma – which made its debut in 2019 – Biogen has had approval to market its antisense-based therapy Spinraza (nusinersen) since 2016, while Roche got a green light for its orally-administered therapy Evrysdi (risdiplam) in 2020. ” Zolgensma is one of the most expensive therapies available, with a price tag of around $2.1

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pharmaphorum

JUNE 2, 2021

NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a surprise to patient association SMA UK. The post NICE ‘no’ to Roche’s risdiplam for SMA not unexpected, says patient group appeared first on.

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pharmaphorum

AUGUST 25, 2022

The category is getting increasingly crowed, with Pfizer also anticipating approval of its BCMA-targeting bispecific elranatamab in the coming months, with several more multiple myeloma bispecifics coming through the pipeline from the likes of Regeneron, AbbVie, Amgen and Roche.

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pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year. billion by 2028.

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pharmaphorum

NOVEMBER 19, 2020

But it has been a source of controversy – it works by attacking the rogue blood vessels that build up in the retina that are the root cause of wet AMD, something that Roche’s Avastin (bevacizumab) cancer drug can do in an off-label use at a fraction of the price.

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pharmaphorum

OCTOBER 29, 2021

Rival drug Tecentriq (atezolizumab) – had its accelerated approval in first-line TNBC withdrawn by developer Roche in the US after failing a confirmatory trial, but is in late-stage testing as a treatment for early-stage TNBC. The post Gilead tags Merck for first-line triple negative breast cancer trial appeared first on.

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Pharmaceutical Technology

MAY 15, 2023

Innovation S-curve for the pharmaceutical industry Peptide nano-particle conjugates is a key innovation area in the pharmaceutical industry By tagging peptides with nanoparticles, peptide nano-particle conjugates allow enhanced control over their biological behaviour, overcoming intrinsic limitations of the individual materials.

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Pharmaceutical Companies Pharmaceutical Companies Immunization Vaccines 52

pharmaphorum

DECEMBER 17, 2021

Aduhelm (aducanumab) was approved by the FDA in June, but has been held back by a glacial rollout as clinicians have questioned the data on which the decision to clear the drug was based, plus a $56,000 per year price tag, which has in turn led to pushback by payers.

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pharmaphorum

FEBRUARY 22, 2021

That therapy uses an adeno-associated virus (AAV) as a vector rather than a lentivirus, a vector type that features in approved gene therapies such as Roche’s Luxturna and Novartis’ Zolgensma. The case comes just weeks after UniQure halted a trial of its haemophilia B gene therapy AMT-061 after an unexpected case of liver cancer.

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Viseven

NOVEMBER 30, 2022

We create structured, well-categorized content, where we have to tag it manually or automatically, and we create a whole taxonomy structure. There’s no point in reinventing these things because this is where partnership makes much sense, and it is happening. Puneet Srivastava , Head of Digital Content and Services Lab at?

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pharmaphorum

AUGUST 10, 2020

Roche is hoping to undercut hugely expensive rivals after the FDA approved its oral spinal muscular atrophy (SMA) drug Evrysdi (risdiplam). Roche has decided to price Evrysdi according to its weight, costing up to $340,000 per year, with the cost being under $100,000 annually for some younger patients. Zolgensma costs about $2.1m

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pharmaphorum

AUGUST 26, 2022

BioMarin will no doubt have an eye on the earlier experience of bluebird bio, which secured EU approval for rare disease gene therapy Zynteglo (betibeglogene autotemcel) in 2019 for beta thalassaemia with a price tag of around €1.6 million spread over five years.

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pharmaphorum

DECEMBER 2, 2020

US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. The post TG Therapeutics challenges Roche with FDA filing for CLL drug appeared first on. TG said it expects the data submission to be complete in the first half of 2021.

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