Amgen hits a snag after a long bull run; an NEJM letter provokes a response from Biogen Idec; AstraZeneca is troubled generics; Europe freezes, and so does a manufacturing facility.
Germany’s HTA IQWiG has approved Bristol/Pfizer’s Eliquis (apixaban) for atrial fibrillation but restricted the oral anticoagulant’s indication, leaving a potential gap for its rivals to fill.
Britain’s NICE has rejected Pfizer’s Xalkori (crizotinib) for lung cancer and Inlyta (axitinib) for kidney carcinoma within two days of each other, putting drug discounts back in the spotlight.
Europe's top scientific advisory panel, CHMP, granted positive opinions for Ariad's new leukemia therapy Iclusig, Gilead's four-drug HIV therapy, Stribild and Baxter's subcutaneous IgG formulation, HyQvia, at its March 2013 meeting,
Industry and regulators are showing more interest in implementing adaptive licensing in Europe. Both sides agree that increased trust and transparency could be stepping stones towards this goal.
A group of CEOs from Big Pharma, biotech and finance companies have joined forces with philanthropists and health care policy makers to call for a global action plan against Alzheimer's disease.
An alliance between the Medicines Patent Pool and ViiV Healthcare to supply HIV drugs to the developing world could form a framework for future IP exchanges between originators and generics firms.
The EMA has rejected Vivus’ Qsiva for obesity for the second time, citing potential long-term health issues and probably delaying the product’s European launch for at least two years.
Biosimilars have hit a snag in Germany that neither health insurers nor doctors want to remove, making it likely the government there may need to intervene if cost savings goals from use of such new medicines are to be achieved.
Vertex/FDA in discussions on “breakthrough therapies”; Ipsen earnings hurting in EU; Pfizer discusses biosimilars; Krka likes emerging markets; Novo sees GLP-1 market competition stiffening.
