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RSS FeedPosted by Michael Wonder on 04 Jun 2018
Palatin Technologies announces FDA acceptance for review of bremelanotide NDA
4 June 2018 - PDUFA target action date 23 March 2019. ...
Posted by Michael Wonder on 04 Jun 2018
Clovis Oncology submits application to EMA to expand use of Rubraca (rucaparib) to include maintenance treatment for women with recurrent ovarian cancer
4 June 2018 - Submission based on positive phase 3 ARIEL3 clinical trial in which rucaparib significantly improved PFS in all ...
Posted by Michael Wonder on 04 Jun 2018
Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
1 June 2018 - Agreement now operational between 14 EU Member States and FDA. ...
Posted by Michael Wonder on 04 Jun 2018
Apotex builds momentum in Canada's biosimilar market after world's first approval
1 June 2018 - Health Canada leads the way by approving the first-ever pegfilgrastim biosimilar in any highly regulated world ...
Posted by Michael Wonder on 04 Jun 2018
FDA chief expects agency to play role in overseeing requests for unproven drugs
3 June 2018 - Scott Gottlieb reacts to new ‘Right to Try’ law aimed at weakening FDA’s power in such cases. ...
Posted by Michael Wonder on 04 Jun 2018
FDA wants to shorten new drug monopolies to cut costs
4 June 2018 - In an effort to increase competition and bring down prescription drug prices, FDA Commissioner Dr. Scott Gottlieb ...
Posted by Michael Wonder on 04 Jun 2018
Peptilogics receives qualified infectious disease product designation from FDA for lead compound PLG0206 as a treatment for prosthetic joint infection
2 June 2018 - Builds on PLG0206 studies published in Nature Scientific Reports. ...
Posted by Michael Wonder on 03 Jun 2018
FDA chief outlines new ways to speed cancer drug approvals
2 June 2018 - The U.S. FDA is taking steps to streamline the approval process for cancer drugs, reviewing clinical ...
Posted by Michael Wonder on 02 Jun 2018
Akcea and Ionis receive positive EU CHMP opinion for Tegsedi
1 June 2018 - Akcea Therapeutics and Ionis Pharmaceuticals announced today that the CHMP of the EMA has adopted a positive ...
Posted by Michael Wonder on 02 Jun 2018
Amgen statement on complete response letter from the U.S. FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab)
1 June 2018 - Amgen received a complete response letter from the US FDA in response to the biologics license ...
Posted by Michael Wonder on 02 Jun 2018
Lundbeck and Otsuka's Rxulti (brexpiprazole) receives positive opinion in EU from CHMP for the treatment of schizophrenia in adults
1 June 2018 - A final decision from the European Commission is expected within 67 days. ...
Posted by Michael Wonder on 02 Jun 2018
FDA approves Olumiant (baricitinib) 2 mg tablets for the treatment of adults with moderately-to-severely active rheumatoid arthritis
1 June 2018 - The approval of Olumiant is based on the Phase 3 clinical trial program that demonstrated efficacy for ...
Posted by Michael Wonder on 02 Jun 2018
Sandoz receives positive CHMP opinion for proposed biosimilar adalimumab
1 June 2018 - Sandoz is seeking approval of proposed biosimilar adalimumab for use in all reference medicine indications including those ...
Posted by Michael Wonder on 02 Jun 2018
Novartis receives positive CHMP opinion for Aimovig (erenumab) for the prevention of migraine
1 June 2018 - If approved, Aimovig (erenumab) is expected to be the first and only available therapy designed specifically for ...
Posted by Michael Wonder on 01 Jun 2018
EMA restricts use of Keytruda and Tecentriq in bladder cancer
1 June 2018 - Data show lower survival in some patients with low levels of cancer protein PD-L1. ...