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NICE has rejected routine NHS funding for Roche’s Evrysdi (risdiplam) for spinal muscular atrophy drug in draft guidance, a decision which doesn’t come as a surprise to patient association SMA UK.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.

Gene Therapy 52

Gene Therapy Gene Drugs Medicine 52

The Pharma Data

OCTOBER 9, 2021

Roche (SIX RO, ROG; OTCQX RHHBY) now posted that gantenerumab, ananti-amyloid beta antibody developed for subcutaneous administration, has been granted Improvement Rectifier Designation by theU.S. About Roche Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives.

Antibody 52

Antibody In-Vitro Trials Development 52

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.

Antibody 98

Antibody Marketing Drugs Medicine 98

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.

Sales 110

Sales Medicine Drugs Marketing 110

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.

FDA Approval 63

FDA Approval Marketing Drugs Clinical Development 63

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Rival drug Tecentriq (atezolizumab) – had its accelerated approval in first-line TNBC withdrawn by developer Roche in the US after failing a confirmatory trial, but is in late-stage testing as a treatment for early-stage TNBC.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.

Trials 52

Trials Sales FDA Approval Production 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.

Trials 52

Trials Sales Marketing FDA Approval 52

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.

Gene Therapy 52

Gene Therapy Gene Gene Sequencing Gene Expression 52

Delveinsight

DECEMBER 3, 2020

Roche receives FDA authorization for the quantitative COVID-19 antibody test. Roche has got an authorization from the FDA for a more accurate COVID-19 blood test capable of measuring the levels of specific antibodies, which target the cell-unlocking spike protein of coronavirus. Janssen buys a gene therapy asset.

Gene Therapy 52

Gene Therapy Gene Antibody Research 52

XTalks

APRIL 29, 2022

Wegovy had a price tag of $1,297 a month when it was first launched. In addition to Saxenda and Wegovy, there are three other FDA-approved obesity drugs for long-term use: Roche and GlaxoSmithKline’s Xenical/Alli (orlistat), Vivus Inc.’s s Qsymia (phentermine-topiramate) and Currax Pharmaceuticals’ Contrave (naltrexone-bupropion).

Trials 98

Trials Drugs FDA Approval Clinical Trials 98

XTalks

MARCH 22, 2023

Within 2009 and 2010, Swiss pharmas Roche and Novartis acquired Genentech and Alcon , respectively. Roche had been a majority stakeholder in Genentech since 1990. In addition, nearly half of all new drugs launched between 2020 and 2021 came with a price tag of $150,000 per year, or more.

Life Science 97

Life Science Drugs FDA Approval Vaccination 97

The Pharma Data

MAY 5, 2021

India approves Roche/Regeneron antibody cocktail to treat COVID-19 ( Reuters ). AbbVie’s Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along ( Fierce ). . India is suffering immensely under the weight of Covid. Coronavirus Pandemic.

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52

Drug Discovery World

NOVEMBER 13, 2023

The presentations are as follows: Fabian Schmich, PhD, Senior Data Scientist, pRED Informatics, Roche Diagnostics Deutschland, on: ‘scifAI: An explainable machine learning framework applied to functional characterisation of therapeutic antibodies’.

Protein 59

Protein Antibody Engineer Scientist 59

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

FDA Approval 58

FDA Approval Drugs Gene Therapy Protein 58

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.

Gene Therapy 110

Gene Therapy Gene Antibody Marketing 110

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.

Drugs 52

Drugs Trials Antibody Marketing 52

Drug Discovery World

NOVEMBER 9, 2023

Esperanza Rivera de Torre, PhD, Assistant Professor, Center for Antibody Technologies, Department of Bioengineering, Technical University of Denmark, on: ‘Venom on demand: optimising snake toxin yield, folding, and purity in E coli and P pastoris with biotinylation, solubility, and purification tags’.

Engineer 52

Engineer Antibody Protein In-Vivo 52