FDA says manufacturing delays are constraining EpiPen supply
NEW YORK (Reuters) – The U.S. Food and Drug Administration added Mylan NV’s (MYL.O) EpiPen to its list of drugs in shortage on Wednesday, saying that manufacturing delays were creating…
FDA clears Pluristem radiation treatment for emergency use
HAIFA, Israel (Reuters) – Pluristem Therapeutics Inc, a developer of placenta-based stem cell products, said the U.S. Food and Drug Administration has cleared the emergency use of its therapy to…
FDA declines to approve Pfizer’s biosimilar to Roche’s cancer drug
(Reuters) – Pfizer Inc said on Monday the U.S. Food and Drug Administration (FDA) declined to approve the company’s biosimilar to Roche’s breast cancer drug, Herceptin, and sought additional technical…
FDA approves Ultragenyx’s drug for rare form of rickets
(Reuters) – The U.S. Food and Drug Administration has approved Ultragenyx Pharmaceutical Inc’s treatment for a rare and inherited form of rickets, a condition that causes weak bones, the agency…
Medical studies in humans often launched on faulty evidence base
(Reuters Health) – New research reveals serious flaws in the animal studies that regulators and ethicists use to decide if an experimental drug should be tested in humans. Dr. Daniel…
Pfizer signs deal with Allogene to develop cancer cell therapy
(Reuters) – Pfizer Inc said on Tuesday it signed an agreement with Allogene Therapeutics, a company formed by a consortium in which the drugmaker will hold a 25 percent stake,…
FDA refuses to review Alkermes’ depression treatment, seeks more trials
(Reuters) – Alkermes Plc has been told to conduct more clinical trials of its experimental depression treatment after the U.S. Food and Drug Administration rejected its initial application for approval,…
Biohaven plunges as investors pit migraine data against Allergan’s drug
(Reuters) – Biohaven Pharmaceutical Holding said its treatment for acute migraine cleared two late-stage studies, but investors worried about its commercial viability as the efficacy data failed to distinguish from…