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US regulators reject Valeant’s Duobrii pharmatimes
June 21, 2018
The US Food and Drug Administration has rejected Valeant group Ortho Dermatologics’ plaque psoriasis therapy Duobrii.
Novartis’ US Oncology head makes leap to become biotech CEO pharmafile
June 07, 2018
The departure of high-level, big pharma executives to tiny biotechs is steadily becoming a constant stream; the latest is Bill Hinshaw, former Executive Vice President of US Oncology at Novartis, who exits the company to head to Axcella Health, becoming i
Bayer/Loxo’s larotrectinib gets speedy review in the US pharmatimes
June 06, 2018
Bayer/Loxo Oncology’s larotrectinib has been granted a priority review by the US Food and Drug Administration, which will consider its use to treat metastatic solid tumours carrying a certain genetic mutation.
US approves UCB’s Cimzia for psoriasis pharmatimes
June 06, 2018
US regulators have expanded the reach of UCB’s Cimzia, allowing its use to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
US OKs first biosimilar of Amgen's Neulasta pharmatimes
June 06, 2018
Mylan and Biocon's Fulphila has become the first biosimilar of Amgen's Neulasta to be approved by the US Food and Drug Administration.
US approves Lilly/Incyte’s Olumiant pharmatimes
June 06, 2018
As expected, US regulators have approved the lower dose of Eli Lilly/Incyte’s once-daily JAK inhibitor Olumiant as treatment for rheumatoid arthritis (RA).
Lupin recalls 43,922 cartons of contraceptive pills from US financialexpress
June 01, 2018
Lupin Pharmaceuticals has initiated voluntary recall of 43,922 cartons of My Way (levonorgestrel) tablets from the US market as they were not approved by the US health regulator.
Lupin appoints Nicholas Hart as President – Specialty for US Business financialexpress
June 01, 2018
Lupin has announced the appointment of Nicholas (Nick) Hart as President – Specialty for its US business.
US OK’s first-in-class drug Aimovig for migraine prevention pharmatimes
May 24, 2018
The monoclonal antibody offers patients a novel therapeutic approach as the first to block the calcitonin gene-related peptide receptor (CGRP-R), which is thought to play a critical role in migraine.
US green light for AZ’ Lokelma pharmatimes
May 24, 2018
The treatment, an insoluble, non-absorbed compound with a structure that was designed to preferentially capture potassium ions, was previously rejected by twice by the regulator largely because of manufacturing issues.

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