The Wall Street Journal has caught up with the Genervon controversy, recapping a series of events from the last few days that followed the big social media campaign to gain an instant approval for a new ALS drug based on the results of a 12-patient study. FierceBiotech readers will know already that the data were questioned by Steve Perrin, president and chief scientific officer of the ALS Therapy Development Institute, and that the FDA followed up a day later with an extraordinary challenge to Genervon to publish the data on a drug that the biotech has touted as a major advance for patients.
Eli Lilly's closely watched autoimmune treatment ixekizumab met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.
Eli Lilly's closely watched autoimmune treatment met its main goals in a Phase III psoriatic arthritis trial, rolling toward an FDA application and a shot at competing in a fast-crowding space.
St. Jude Medical will buy portfolio company Spinal Modulation. The startup has submitted a PMA for its Axium Neurostimulator System to treat chronic pain. St. Jude will pay up to $175 million upfront with additional undisclosed payments upon FDA approval of the Axium system and with the achievement of undisclosed revenue targets.
A novel immuno-oncology treatment from Novartis and the University of Pennsylvania came through in an early safety study on patients with solid tumors, encouraging investigators and burnishing its potential.
Roche inked a deal worth up to $555 million to work with India's Curadev Pharma on cancer treatments that use the body's immune system to combat tumors, expanding its trove of assets in one of the industry's hottest fields.
In a study, Janssen Pharmaceuticals' once-a-month injectable for schizophrenia resulted in better outcomes than daily oral competitors, as measured by real-world (as opposed to strictly clinical) outcomes like arrest or psychiatric hospitalization.
The immuno-oncology drug Opdivo from Bristol-Myers Squibb continued on its charmed path today when the drugmaker cut short another trial for lung cancer because it had nailed its goal for overall survival. This comes after accelerated FDA approval of Opdivo for melanoma and then lung cancer, which has led analysts to keep jacking up earnings forecast, now to $7 billion in annual sales in 5 years.
Takeda has struck up a 10-year partnership with Japan's Kyoto University to develop potential stem cell treatments for an array of diseases, committing about $270 million to the effort.
Boston Scientific enrolled the first patient in its renal denervation trial as the quest to prove the procedure's efficacy at lowering hypertension continues in the wake of the Medtronic's disastrous SYMPLICITY trial results, from which the field is still recovering.