First shipment of ShanIPV to be distributed in India
1 December 2015 | By Victoria White
These first vaccine doses will be available to implement one dose of IPV for all infants in the country...
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COMP issues positive opinion for ODD for avelumab in MCC
1 December 2015 | By Victoria White
An official decision on the Ophran Drug Designation is expected from the European Commission in December...
FDA approves Empliciti for the treatment of multiple myeloma
1 December 2015 | By Victoria White
Empliciti (elotuzumab) has been approved as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies.
Janssen seeks approval of Stelara for Crohn’s disease
30 November 2015 | By Victoria White
Stelara (ustekinumab), approved for the treatment of plaque psoriasis and active psoriatic arthritis in many countries, is a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines...
EMA to review Helsinn’s anamorelin HCI marketing authorisation application
30 November 2015 | By
The European Medicines Agency (EMA) has accepted for review, the marketing authorisation application (MAA) for Helsinn Group’s anamorelin HCI...
Phase III study of sirukumab in giant cell arteritis starts
27 November 2015 | By Victoria White
Sirukumab is an investigational human anti-IL-6 monoclonal antibody that selectively binds with high affinity to the IL-6 cytokine...
Lannett completes acquisition of Kremers Urban Pharmaceuticals
27 November 2015 | By Victoria White
Lannett has acquired KU from UCB for a total consideration of approximately US$1.23 billion...
Re-Pharm awarded patent for re-purposed compound RP0217
27 November 2015 | By Victoria White
This patent protects the topical use of RP0217 for the treatment or prevention of respiratory and gastrointestinal inflammatory disorders...
CPhI and P-MEC India 2015 to create regional knowledge and business hub
27 November 2015 | By Victoria White
CPhI and P-MEC India will return to the Bombay Convention and Exhibition Centre, Mumbai, India from 1 to 3 December 2015...
EC gives nod to haemophilia A treatment Elocta
26 November 2015 | By Victoria White
Elocta will be the first haemophilia A treatment in the EU to offer prolonged protection against bleeding episodes with prophylactic injections every three to five days...
Hikma sells Ben Venue manufacturing facilities to Xellia
26 November 2015 | By Victoria White
Xellia has said that it plans to invest significantly in the facilities to resume manufacturing in the four sterile injectable manufacturing plants at the site...
EC approves label update for Pfizer’s Xalkori in NSCLC
26 November 2015 | By Victoria White
The EC has approved a label update to expand the use of Xalkori (crizotinib) to first-line treatment of adults with ALK-positive NSCLC...
EC approves anticoagulant reversal agent idarucizumab
26 November 2015 | By Victoria White
Idarucizumab (Praxbind) rapidly and specifically reverses the anticoagulant effects of dabigatran etexilate (Pradaxa) in cases of emergency surgery /urgent procedures or in uncontrolled bleeding...
Amgen submits Biologices License Application for biosimilar ABP 501 to the FDA
26 November 2015 | By Victoria White
ABP 501 is a biosimilar candidate to AbbVie’s Humira (adalimumab), an anti-TNF-α monoclonal antibody, which is approved in many regions for the treatment of various inflammatory diseases...
EC approves Cotellic plus Zelboraf in advanced melanoma
25 November 2015 | By Victoria White
The approval is based on data that showed Cotellic plus Zelboraf helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live for more than a year without their disease worsening...
