Teva has lowered its 2017 guidance on the back of higher-than-expected generic price erosion and lower-than-expected Copaxone sales due to competition.
Pfizer has attributed a 12% operational decline from its sterile injectable products on “capacity constraints and technical issues” stemming from former Hospira facilities.
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.
Generics industry group Medicines for Europe says proposed supplementary protection certificate (SPC) waiver will help European API manufacturers compete.
Around half the products made at the Broomfield facility will be discontinued or divested says Novartis, blaming increased US generics competition and customer consolidation for the closure.
Antimalarial drug resistance in Southeast Asia is threatening the control and elimination of malaria, and drug makers can help, says a tropical medicine expert.
Rare disease therapies need to be administered in a way that suit the patient according to Shire CEO Flemming Ørnskov, who says smart, flexible delivery devices are core to the firm's product development strategy.
Recipharm has acquired a Spanish manufacturing plant and signed a supply deal with former owner Roche for a range of solid dose products worth €35m a year.
Bristol-Myers Squibb will also make up to $160m in milestone payments for each candidate developed using Halozyme Therapeutics’ large-volume biologics delivery platform.
