FDA grants HAE drug Ruconest 12-years of exclusivity
8 October 2015 | By Victoria White
The exclusivity ensures that the FDA will not approve any applications for biosimilars of the drug before July 2026...
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Novartis releases long-term efficacy results for Gilenya in MS
8 October 2015 | By Victoria White
The analysis evaluated the proportion of Gilenya patients achieving 'no evidence of disease activity' (NEDA-4) every year over seven years...
NICE says ‘yes’ to pembrolizumab for advanced melanoma
7 October 2015 | By
Pembrolizumab was the first drug to be approved through the Medicines and Healthcare Products Regulatory Agency’s Early Access to Medicine Scheme (EAMS)...
Multiple sclerosis therapeutics market to reach $20b by 2024
7 October 2015 | By Victoria White
The value of the multiple sclerosis therapeutics market will rise slowly from $17.2 billion in 2014 to approximately $20 billion by 2024...
New data shows sustained efficacy of Tecfidera in RRMS
7 October 2015 | By Victoria White
Biogen is to present the data at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS)...
FDA approves schizophrenia treatment Aristada
7 October 2015 | By Victoria White
Aristada is the first atypical antipsychotic with once-monthly and six-week dosing options for delivering and maintaining therapeutic levels of medication in the body through an injection...
New data suggests Aubagio slows brain atrophy in RMS
7 October 2015 | By Victoria White
MRI data from Genzyme’s Phase III TEMSO study demonstrate that Aubagio significantly slowed brain atrophy in people with relapsing multiple sclerosis (RMS)...
AcelRx initiates Phase 3 study of pain treatment ARX-04
6 October 2015 | By Victoria White
AcelRx is developing ARX‑04 for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including the emergency room...
FDA grants priority review for HCV treatment Daklinza sNDAs
6 October 2015 | By Victoria White
The applications are for the treatment of patients with chronic HCV coinfected with HIV-1, patients with advanced cirrhosis, and for patients with post-liver transplant recurrence of HCV...
MHRA and India regulators agree deal to improve public safety
6 October 2015 | By Victoria White
A Memorandum of Understanding will increase collaboration between the two countries in the area of medicines and medical devices with the aim of further improving public safety...
Cotellic Zelboraf combo demonstrates significant overall survival results
6 October 2015 | By Victoria White
Results from a Phase III study show that Cotellic plus Zelboraf helped people with advanced melanoma live significantly longer compared to Zelboraf alone...
HCV therapy Elbasvir/grazoprevir shows sustained virologic response
6 October 2015 | By Victoria White
Elbasvir/grazoprevir showed sustained virologic response in patients with chronic hepatitis C virus with advanced chronic kidney disease...
Baxalta and Momenta initiate trial for Humira biosimilar M923
5 October 2015 | By Victoria White
The trial is a global study in patients with chronic plaque psoriasis to compare the safety, efficacy and immunogenicity of M923 with Humira...
Eluvia Stent System demonstrates 12-month primary patency of 96.1%
5 October 2015 | By Victoria White
The Eluvia Stent System is an advanced treatment option for patients with narrowing or blockages in the superficial femoral artery or proximal popliteal artery...
FDA approves Letairis plus tadalafil for pulmonary arterial hypertension
5 October 2015 | By Victoria White
The combination is approved to reduce the risks of disease progression and hospitalisation for worsening PAH, and to improve exercise ability...
