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FDA Watch: Approvals for Medtronic, CSL; designations for Merck & Co., J&J

Approvals and designations made by the U.S. Food and Drug Administration for the week ended March 16.

Approvals

* Medtronic PLC's Guardian monitoring system, to monitor glucose levels in diabetes patients 14-75 years old. The company said the product will be available in the first quarter of fiscal 2019.

* CSL Ltd.'s Hizentra, for chronic inflammatory demyelinating polyneuropathy, a rare autoimmune disorder. The FDA previously approved CSL's Privigen for the same indication.

* Koninklijke Philips NV's ProxiDiagnost N90, a digital radiography-fluoroscopy system. The company received 510(k) approval.

* TSO3 Inc.'s Sterizone VP4 Sterilizer, for heat- and moisture-sensitive medical devices. The FDA gave the device 510(k) clearance.

SNL Image
FDA headquarters in Silver Spring, Md.
Source: Associated Press

Complete response letters — update

* Hikma Pharmaceuticals PLC's generic version of GlaxoSmithKline PLC's asthma treatment Advair Diskus. The FDA upheld its May 2017 decision, citing the need for further data.

Priority review

* Merck & Co. Inc.'s Keytruda, for advanced cervical cancer. The FDA will reach a decision by June 28.

Breakthrough therapy

* Johnson & Johnson's erdafitinib, for urothelial cancer. The drug was discovered under a partnership between the company's Janssen Pharmaceutical Cos. and privately held Astex Pharmaceuticals Inc.

* Proteostasis Therapeutics Inc.'s PTI-428, for cystic fibrosis. The FDA granted the status to treat certain patients receiving Vertex Pharmaceuticals Inc.'s Orkambi as background therapy.

Other designations

* Rare pediatric disease, for Abeona Therapeutics Inc.'s ABO-202, to treat infantile Batten disease. The FDA previously granted the gene therapy orphan drug status.

* Orphan drug, for Tetra Bio-Pharma Inc.'s PPP001, for complex regional pain syndrome. The status does not extend to the drug's actual formulation.

* Orphan drug, for CSPC Pharmaceutical Group Ltd.'s DL-3-n-butylphthalide, for amyotrophic lateral sclerosis. The China FDA previously approved the drug to treat stroke in 2005.