Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2021
NICE approves life changing gene therapy for treating spinal muscular atrophy
8 March 2021 - A new and potentially curative one-off gene therapy for babies with the rare genetic disorder spinal muscular ...
Posted by Michael Wonder on 26 Feb 2021
Thousands of breast cancer patients to have routine access to NICE-approved drug combination
26 February 2021 - Another potentially life-extending drug combination for some people with advanced breast cancer will now be available for ...
Posted by Michael Wonder on 26 Feb 2021
Emgality (galcanezumab) now approved for use in Canada for the treatment of episodic cluster headache
25 February 2021 - The first and only anti-CGRP treatment with dual indications. ...
Posted by Michael Wonder on 26 Feb 2021
BioCryst receives positive CHMP opinion for Orladeyo (berotralstat), an oral, once daily therapy to prevent attacks in patients with hereditary angioedema
25 February 2021 - BioCryst Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending ...
Posted by Michael Wonder on 26 Feb 2021
Medexus announces expanded availability of Gleolan in Canada
25 February 2021 - Medexus Pharmaceuticals announced today that it has initiated the commercial launch of Gleolan in Canada, which had ...
Posted by Michael Wonder on 26 Feb 2021
Empirical Spine initiates PMA submission process for FDA approval of Limiflex for degenerative spondylolisthesis
25 February 2021 - The LimiFlex Paraspinous Tension Band is a new, investigational device designed as an alternative to spinal fusion ...
Posted by Michael Wonder on 26 Feb 2021
Retrotope granted rare paediatric disease designation from FDA for lead development candidate, RT001, in two life-threatening neurodegenerative indications
25 February 2021 - RT001 also granted fast track designation by FDA in Friedreich’s ataxia. ...
Posted by Michael Wonder on 25 Feb 2021
NHS patients to benefit from first full access deal in Europe for new CAR-T therapy recommended by NICE
25 February 2021 - NICE has agreed a managed access agreement, via the Cancer Drugs Fund with manufacturer Kite, so more ...
Posted by Michael Wonder on 25 Feb 2021
Allergan submits new drug application for investigational AGN-190584 for the treatment of presbyopia
25 February 2021 - If approved, this is expected to be the first eye drop to treat presbyopia. ...
Posted by Michael Wonder on 25 Feb 2021
Exelixis announces breakthrough therapy designation granted to cabozantinib for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer
25 February 2021 - Exelixis expects to submit supplementary New Drug Application in 2021. ...
Posted by Michael Wonder on 25 Feb 2021
FDA approves targeted treatment for rare Duchenne muscular dystrophy mutation
25 February 2021 - Today, the U.S. FDA granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular ...
Posted by Michael Wonder on 25 Feb 2021
NICE draft guidance recommends sapropterin for children with rare inherited metabolic condition phenylketonuria
25 February 2021 - NICE has today issued draft guidance for public consultation which recommends sapropterin (Kuvan, BioMarin) for treating phenylketonuria ...
Posted by Michael Wonder on 25 Feb 2021
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 25 Feb 2021
The common medicines hit with shortages as COVID supply issues worsen
24 February 2021 - Australians are being forced to take desperate measures to track down prescription medications they need as ...
Posted by Michael Wonder on 25 Feb 2021
Three steps can help companies speed FDA approval of new drugs
24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...