Infant Mortality Archives

FDA Intends to Withdraw Approval of Only Treatment for Reducing Preterm Birth

American College of Obstetricians and Gynecologists, Clinical Trials, Drug Market Withdrawal, Generics, Infant Mortality, Preterm Births, R&D

After a disappointing end to a nine-year trial, the U.S. Food and Drug Administration officially gave AMAG Pharmaceuticals notice of the proposal to withdraw approval of Makena, an injectable progestin treatment to reduce preterm births.

Biogen to study Spinraza in combination with $2 million Novartis drug

Analysts, Blockbusters, Clinical Trials, Gene Therapy, Infant Mortality, Pricing, R&D, Spinal Muscular Atrophy (SMA), Therapeutics

One of medicine’s costliest treatment areas could become even more pricey as Biogen seeks to layer the company’s $750,000 spinal muscular atrophy drug on top of the $2.1 million-per-patient Novartis gene therapy Zolgensma.

Novartis executive sold shares before drug data manipulation made public

Business, Data Manipulation, FDA, Gene Therapy, Infant Mortality, Shares, Spinal Muscular Atrophy (SMA)

An unnamed Novartis executive sold 925,400 Swiss francs ($946,000) worth of shares less than three weeks before the U.S. Food and Drug Administration announced data from tests of the company’s gene therapy Zolgensma had been manipulated.