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...
List view / Grid view
News
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...
FDA approves Keytruda for patients with metastatic NSCLC
5 October 2015 | By Victoria White
Keytruda is now the first and only anti-PD-1 ((programmed death receptor-1) therapy approved for both squamous and non-squamous metastatic NSCLC...
Teva acquires Mexican company Rimsa for $2.3b
2 October 2015 | By Victoria White
Through the Rimsa acquisition, Teva will become a leading pharmaceutical company in the second largest market in Latin America...
FDA accepts Sandoz’s BLA for biosimilar etanercept
2 October 2015 | By Victoria White
Sandoz is seeking approval for all indications included in the label of etanercept which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis...
Vernalis acquires US rights to Moxatag
2 October 2015 | By Victoria White
Moxatag is a penicillin-class antibacterial indicated for the treatment of tonsillitis and pharyngitis secondary to streptococcus pyogenes...
Santhera launches Raxone in its first EU market
2 October 2015 | By Victoria White
Raxone is also the first approved treatment for any mitochondrial disease, a therapeutic area which is in the focus of Santhera...
Merck and DNAtrix announce glioblastoma collaboration
2 October 2015 | By Victoria White
Merck and DNAtrix will evaluate the efficacy and safety of DNX-2401 in combination with Keytruda in a Phase 2 study...
Allergan completes $2.1 billion acquisition of Kythera
1 October 2015 | By Victoria White
The acquisition of Kythera adds Kybella, an injection for improvement in the appearance of moderate to severe submental fullness, to Allergan’s portfolio...
