As Novartis AG works to streamline the company and finalized a long-considered plan to separate its Sandoz Inc. business by creating a standalone company, it temporarily stopped dosing in a study of branaplam for treating Huntington’s disease. Several findings from the phase IIb study suggested the presence of peripheral neuropathy in some participants. An independent data monitoring committee recommended the dosing halt but fell short of recommending the study be terminated. The VIBRANT-HD steering committee agreed with the committee’s recommendation.
Ophthalmic therapy and device developer Alcon SA, of Geneva, further strengthened its portfolio by buying Aerie Pharmaceuticals Inc. for about $770 million in equity. Aerie’s financial guidance for its glaucoma franchise puts net product revenue at $130 million to $140 million for all of 2022.
Alain Bouaziz, a French citizen and resident of the United Arab Emirates, pleaded guilty Aug. 12 to one count of lying to the U.S. FDA in an attempt to steal a discontinued Novartis AG weight loss drug. The charge carries a maximum prison term of five years and a fine of up to $250,000, or twice the gain or loss caused by the offense, whichever is greatest.
Canwell Biotech Ltd. raised more than ¥100 million (US$14.8 million) in a series A+ financing. The funds will help accelerate trials for its pipeline of anticancer assets, such as the TLR7 agonist CAN-1012, and preclinical development of other projects too, CEO Henry Yu told BioWorld. The State Development and Investment Corporation Venture Capital Co. Ltd. was the round’s sole investor.
Novartis AG’s attempt to repurpose its immunology drug canakinumab as an oncology therapy was always considered a long shot. Now, the chances of success have receded further after another phase III failure in lung cancer. The phase III Canopy-A study, which tested the drug as adjuvant treatment in adults with stages II-IIIA and IIIB completely resected non-small-cell lung cancer failed to meet its primary endpoint of disease-free survival vs. placebo.
Beta-site APP-cleaving enzyme 1 (BACE1) inhibitors have a long history of failure in patients with Alzheimer’s disease. Clinical development of verubecestat, elenbecestat, lanabecestat, umibecestat, atabecestat and LY-3202626 were all discontinued. The drugs largely showed that inhibiting BACE1 reduced amyloid beta (AB) in both cerebrospinal fluid and plasma, reduced AB plaques on PET scans and reduced phosphorylated tau. Unfortunately, patients had early cognitive worsening, and there were signs of lowering of brain volume and increases in psychiatric adverse events.
Novartis AG is making good on its plan to streamline the company so it can save $1 billion by 2024. The Basel, Switzerland-based company told BioWorld the restructuring that’s underway could impact 8,000 positions around the world, with 1,400 of them in Switzerland.
As fellow gene editing firm Crispr Therapeutics AG hosted an innovation day in which it confirmed plans for regulatory filings by year-end for an ex vivo gene editing therapy in sickle cell disease and beta-thalassemia, Precision Biosciences Inc. announced plans to develop an in vivo gene editing approach through a collaboration with Novartis AG that brings Precision an initial $75 million with up to $1.4 billion in potential milestones.
Novartis AG is not going quietly into the night after the U.S. Court of Appeals for the Federal Circuit reversed itself, invalidating a method patent covering a dosing regimen for the company’s blockbuster multiple sclerosis drug, Gilenya (fingolimod). After the split opinion came down June 21 from the three-judge panel, Novartis said it planned to file a petition seeking further review of the decision by the full court.
