A year after enduring a stinging FDA rejection, the Medicines Company convinced regulators to change their minds on the blood-thinning cangrelor, winning approval to treat a smaller group of patients after years of development.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.
Siemens scored FDA approval for its HIV combo test, a win for the company as it looks to its diagnostics unit to chart some growth amid lagging fortunes.
A move by Australia to be the first country to allow pharmacies in some cases to substitute biosimilars for originator drugs has drawn a rebuke by the U.S.-based Alliance for Safe Biologic Medicines, which includes members such as Amgen and the Biotechnology Industry Organization.
India's Natco Pharma said all it needs is the approval from the U.S. FDA to launch a generic version of Teva's Copaxone and put it on track to compete with versions from Sandoz, Momenta Pharmaceuticals and Mylan.
China's BeiGene has received U.S. FDA approval on an IND application for clinical development of BGB-3111, a proprietary Bruton tyrosine kinase inhibitor for the treatment of B-cell malignancies, putting a fresh round of funds to use as it works on three main oncology candidates.
A steady march of investments in U.S. high-technology sectors by Chinese companies from telecom to biotech will come into focus this week in high-level talks in Washington, DC, that will cover a proposed bilateral investment treaty, Reuters reports.
The FDA approved a device that enables blind users to interpret the shape, size, location and motion of objects from patterns of electrical stimulation on the surface of their tongue.
The FDA released an overview of its considerations and process for reviewing so-called investigational device exemptions, which give researchers permission to test developmental devices on humans.
Celgene has high hopes for its anti-inflammatory drug Otezla, shooting for blockbuster sales of the med with the help of new indications for psoriatic arthritis and psoriasis. But the company is off to a rough start with the drug in the U.K., as the country's cost gatekeeper decided not to recommend Otezla to treat psoriatic arthritis.