Company Product Description Indication Status
Ascentage Pharma Group International, of Suzhou, China APG-2575 Bcl-2 selective inhibitor Relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma FDA cleared IND for phase Ib/II trial testing drug as single agent or in combination
Ascentage Pharma Group International, of Suzhou, China APG-2575 Bcl-2 selective inhibitor Waldenström macroglobulinemia FDA cleared IND for a phase Ib/II trial testing the drug as a single agent or in combination
Ascentage Pharma Group International, of Suzhou, China APG-2575 Bcl-2 selective inhibitor Relapsed/refractory acute myeloid leukemia China’s National Medical Products Administration approved start of phase Ib trial  testing the drug as a single agent or in combination
Athenex Inc., of Buffalo, N.Y. Tirbanibulin (formerly KX2-391 or KX-01) SRC tyrosine kinase inhibitor; tubulin binding agent Actinic keratosis FDA accepted NDA filing, setting PDUFA date of Dec. 30, 2020, with no advisory committee meeting planned
Avrobio Inc., of Cambridge, Mass. AVR-RD-04 CTNS gene stimulator Cystinosis FDA granted orphan drug designation
Boehringer Ingelheim GmbH, of Ingelheim, Germany Ofev (nintedanib) Small-molecule kinase inhibitor Chronic fibrosing interstitial lung diseases Approved by FDA for use in patients with a progressive phenotype
F2G Ltd., of Manchester, U.K. Olorofim (formerly F-901318) Dihydroorotate dehydrogenase inhibitor Invasive aspergillosis and lomentospora/scedosporium infections FDA granted orphan drug designation
Immutep Ltd., of Sydney Eftilagimod alpha (IMP-321) HLA class II antigen stimulator Metastatic breast cancer FDA approved IND for planned phase I AIPAC-002 combination study with paclitaxel in 24 participants
Mylan NV, of Hertfordshire, U.K.  MYL-1402O (bevacizumab biosimilar) VEGF ligand inhibitor Solid tumors FDA accepted BLA for review under 351(k) pathway for first- and second-line metastatic colorectal cancer in combination with fluorouracil-based chemotherapy; first-line use in nonsquamous non-small-cell lung cancer; and in recurrent glioblastoma, metastatic renal cell carcinoma in combination with interferon alfa and persistent, recurrent or metastatic cervical cancer; BsUFA date is Dec. 27, 2020
Myovant Sciences Ltd., of Basel, Switzerland Relugolix GNRH receptor antagonist Uterine fibroids MAA submitted to EMA for combination tablet (relugolix 40 mg + estradiol 1 mg + norethindrone acetate 0.5 mg) to treat moderate to severe symptoms
Nicox SA, of Sophia Antipolis, France Vyzulta (latanoprostene bunod) PGF2 alpha agonist Ocular hypertension; open-angle glaucoma Partner Bausch & Lomb Inc., a unit of Bausch Health Cos. Inc., received approval in Taiwan for ophthalmic solution (0.024%) to reduce intraocular pressure in either indication
Novartis AG, of Basel, Switzerland Isturisa (osilodrostat)  11‐beta‐hyrdoxylase inhibitor Cushing's disease FDA approved drug to treat adults who either cannot undergo pituitary gland surgery or have undergone surgery but still have Cushing's disease
Pharming Group NV, of Leiden, the Netherlands Ruconest (conestat alfa) Recombinant human C1 esterase inhibitor Hereditary angioedema FDA approved addition of new Netherlands production facility, expanding product manufacturing capacity
Valneva SE, of Saint-Herblain, France, Ixiaro (IC-51) Cell-derived vaccine Japanese encephalitis virus infection FDA approved extension of product shelf-life from 24 to 36 months; separately, U.S. Department of Defense issued request for proposal covering 3-year period that could lead to supply contract during first half of 2020

Notes

For more information about individual companies and/or products, see Cortellis.

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