Analysts say black box warning of anaphylaxis risk and REMS were anticipated. Company plans a gradual rollout of Palynziq, focusing first on Phase III clinical trial sites and patients.

Norbert Bischofberger returns to his start-up roots, exiting Gilead after nearly 30 years to become CEO of Kronos, which is developing novel drugs directed at tough cancer targets. He's one of several big pharma/large biotech executives to venture recently into entrepreneurial opportunities.

Recent deal-making has seen new developments to further existing agreements, including Allergan licensing a depression candidate from the spinout of a company it bought in 2015. Also, updates on deals involving Celgene, AstraZeneca and Daiichi Sankyo.

The price of new oncology brands doubled in the US from 2013 to 2017, bringing the median annual price to more than $160,000 last year, up from $79,000 in 2013, according to a new IQVIA report. Spending on cancer drugs in the US has doubled since 2012, reaching nearly $50bn in 2017.

Chugai's new CEO Tatsuro Kosaka took up his position in March and is charged with taking the major Japanese company through the next stage of development as key products reach the global market and others begin to face biosimilar competition. In this first part of a two-part exclusive interview, he outlines the firm's vision, approach to R&D and how the strategic alliance with Roche is playing out. 

As updated Phase I/II results for BioMarin's hemophilia A and Spark's hemophilia B gene therapies were presented on May 22, it was revealed that FDA plans to make hemophilia the first gene therapy indication eligible for accelerated approval based on a surrogate endpoint.

As the Congo grapples with the latest outbreak of Ebola, China has approved its first domestically developed vaccine in record time, hailing it a national innovation champion. But as the World Health Organization starts vaccinations in Africa, can China make the cut and compete with global players including Merck & Co?

After delays caused by two complete response letters, AstraZeneca’s Lokelma has been approved in the US with label benefits over its major competitor, Vifor Pharma’s Veltessa.

Denmark's diabetes specialty company has linked up with a US biotech to evaluate a lysophosphatidic acid receptor antagonist in diabetic and chronic kidney disease.

The French drugmaker and partner Lexicon now have a PDUFA date of March 22 next year for their dual inhibitor of SGLT-1 and SGLT-2 which is well placed to become the first oral antidiabetic to get the green light for use by adults with the type 1 form of the disease, in combination with insulin.

Esperion reported positive results from the third of five Phase III studies expected to read out this year, but data for a bempedoic acid/ezetimibe fixed-dose combo expected in August may be the key to the drug's commercial future.