F. Hoffmann-La Roche Ltd: Roche receives positive CHMP opinion for Evrysdi, the first and only at home spinal muscular atrophy (SMA) treatment with proven efficacy in adults, children and infants two months and older
More than 2,500 patients now treated with Evrysdi in clinical trial, compassionate use and real-world settings
Evrysdi is approved in seven countries, submitted in 30 more
Basel, 26 February 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Evrysdi (risdiplam) for the treatment of 5q spinal muscular atrophy (SMA) in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA is the most common form of the disease. SMA causes progressive muscle weakness and atrophy, and significant unmet need remains, particu
Roche: CHMP Opinion Supports Use Of Casirivimab-imdevimab Antibody Cocktail For COVID Treatment
SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) confirmed Friday that the European Medicines Agency s or EMA Committee for Medicinal Products for Human Use or CHMP has issued a scientific opinion supporting the use of the investigational antibody cocktail, casirivimab and imdevimab, as a treatment option for patients with confirmed COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19.
The CHMP scientific opinion supports national decision making within EU states on the use of the antibodies before a formal authorisation is granted during a public health emergency.
FIREFISH Part 1 data show treatment with Evrysdi at 12 months helped 90% of these infants survive without permanent ventilation and 33% sit without support, a key motor milestone not normally seen in the
Feb 24, 2021 10:41am
Novartis first DTC campaign for relapsing MS drug Kesimpta debuted in January, five months after it got an FDA nod. (Novartis)
Novartis’ first TV ad for Kesimpta offers the prospect of less drama less relapsing multiple sclerosis drama, that is.
During the commercial, phrases representing that drama such as “unpredictable relapses” and “disability progression” pop up around a young woman as she goes about her day. But another issue that pops up on screen infusion days may cause some drama itself.
That s because it s describing rival infusion treatments for MS, including Kesimpta’s chief competitor Ocrevus, a Roche drug that also works by targeting CD20-expressing B-cells.
Escapee from UK prison jailed for dealing cannabis in Cork Ikran Aslam (38) admitted possessing drugs for sale or supply and money laundering
Wed, Feb 24, 2021, 13:59
During a search of Ikran Aslam’s home, gardaí found a large quantity of cannabis herb, weighing scales and bags hidden behind the back panel of a wardrobe.
A man who fled from an open prison in the UK has been jailed for five years for possesssion of cannabis worth €34,000 in Cork city last year.
Ikran Aslam (38), a British citizen with an address at The Avenue, Pembroke Woods, Passage West, Co Cork, pleaded guilty at Cork Circuit Criminal Court to possessing cannabis herb for sale or supply and money laundering on September 24th, 2020.