November 9, 2018
As part of its third-quarter earnings, Pfizer reported lower-than-anticipated revenues from its Essential Health business segment primarily due to continued legacy Hospira sterile injectable pharmaceuticals (SIP) product shortages in the US. The company reported a 9% operational decline in its SIP portfolio in developed markets. The SIP product shortages relate to manufacturing issues in the Hospira manufacturing network, which Pfizer says it is remediating. Read More
Sandoz, the generics arm of Novartis, has decided to not pursue its submission for a biosimilar to Roche’s Rituxan (rituximab) in the US at this time following a request by the FDA for additional information to complement the submission. Sandoz has a rituximab biosimilar approved in the European Union. Rituxan is one of Roche’s top-selling drugs with 2017 global sales of CHF 7.3 billion ($7.8 billion).  Read More
ScieGen Pharmaceuticals, a generic pharmaceutical company, is voluntarily recalling in the US lots of its irbesartan tablets, an anti-hypertension drug, to the consumer level. The recall is due to the presence of a probable human carcinogen found in irbesartan manufactured and supplied by Aurobindo Pharma, a Hyderabad, India-headquartered generics and active pharmaceutical ingredient (API) manufacturer. Irbesartan is the third “sartan” API, which has been subject to impurity concerns in the industry; valsartan and lorsartan are the other two.  Read More
Boehringer Ingelheim (BI) has completed an expansion of its biomanufacturing facility in Fremont, California. With a two-year investment totaling EUR 200 million ($228 million), BI is increasing its worldwide bioreactor capacity to 290,000 liters. Read More
Sanofi and Denali Therapeutics, a biopharmaceutical company developing drugs for treating neurodegenerative diseases, have partnered in a deal worth up to $1 billion ($125 million upfront) to develop multiple molecules for treating neurological and systemic inflammatory diseases. Read More
Hikma Pharmaceuticals, an Amman, Jordan-based pharmaceutical company, has agreed to acquire Medlac Pharma Italy, an injectable manufacturing company in Hoa Lac Hi-Tech Park, Vietnam. The acquisition includes an injectable facility, adjacent vacant land, Medlac’s product portfolio of 23 injectable products, its pipeline, and all employees. Read More
A roundup of the latest news from suppliers, CDMOs, and CMOs, featuring WuXi Biologics and Recro Gainesville. Read More
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