EMA’s CHMP committee has recommended Shire’s Lanadelumab, a new rare disease treatment which has blockbuster potential. Lanadelumab has been endorsed for prevention of recurrent attacks of hereditary angioedema (HAE) a rare, genetic disorder that results in recurring attacks of oedema in parts of the body, including the abdomen, face, feet, genitals, hands and throat. Laryngeal
The Food and Drug Administration has approved Fast Track designation for Shire’s SHP607, a treatment used in the prevention of chronic lung disease in extremely premature infants. SHP607, which is currently in Phase 2 Clinical Development, is a recombinant human version of the naturally occurring protein complex of insulin-like growth factor 1 (IGF-1) and its
The EC has approved Shire’s Onivyde for the treatment of adults with metastatic adenocarcinoma of the pancreas, thereby making it the first licensed treatment for this patient group in the EU. Authorised as a second-line combination therapy, Onivyde will be administered with 5-fluorouracil and leucovorin in adult patients who have progressed following treatment with Lilly’s
The US Food and Drug Administration (FDA) have ruled against Shire in a clash surrounding generic copies of their ADHD medication, Adderall XR, by approving a cheap version of the drug from Watson’s Actavis division. The verdict is a setback to Shire’s near-term earnings and shares, with the drug maker’s shares falling 12.4% to £17.23
