orphan drug status news from FierceBiotech
News
ALSO NOTED: FDA OKs Novalar therapy; StemCells files new patent suit; and much more...
> The FDA has OK'd Novalar's OraVerse (phentolamine mesylate) for the reversal of soft-tissue anesthesia and the associated functional deficits resulting from a local dental anesthetic. Read more...
Talecris' antibody drug gets priority review
The FDA has granted priority review to Talecris' drug Gamunex, meaning the FDA will review its application in six months rather than the standard 10. Gamunex is an IGIV therapy that contains Read more...
ALSO NOTED: PDL offers bonuses to top execs; Radius earns $28.3M for milestone;Cytokinetics surges on positive data; and much m
> PDL BioPharma says it will pay four top executives nearly $1 million in bonuses through the end of next year to keep them on board as the company undergoes a transformation into an antibody Read more...
Adherex's melanoma drug earns orphan status
North Carolina-based Adherex Technologies has won orphan drug designation from the FDA for its experimental melanoma therapy ADH-1. The drug is currently in Phase IIb trials in combination with Read more...
ALSO NOTED: Ablynx pockets upfront fee; Plexxikon publishes cancer data; Solvay drug on fast track; and much more...
> Belgium's Ablynx says it has received an undisclosed milestone payment from Novartis for an exclusive license for a program involved in their alliance on therapeutic nanobodies. Read more...
SPOTLIGHT: Synta, GSK gain orphan drug designation
The FDA has granted its orphan drug designation to elesclomol, an investigational drug that treats metastatic melanoma. The drug is being advanced by a collaboration between Synta and Read more...
ALSO NOTED: Osiris inks $224M contract; Baxter and Nektar to collaborate;and much more...
> Osiris Therapeutics has inked a deal with the U.S. Defense Department to supply a potential $224 million worth of Prochymal for use in treating military personnel exposed to radiation. Read more...
Altus shares dive as Genentech hands back drug rights
Shares of Altus Pharmaceuticals took a dive this morning after the biotech announced that it had reacquired the North American rights to a growth hormone program from Genentech. Altus immediately Read more...
ALSO NOTED: Pfizer to buy CovX; Florida commits $94M to Max Planck; Affymetrix buys USB; HGS touts animal trial results for ant
> Aggressively looking to expand its role in biologics, Pfizer has struck a deal to buy CovX. No figures were given. Read more...
EU, U.S. regulators offer single orphan drug path
Regulators in Europe and the U.S. have joined together to create a common application form for developers seeking orphan drug status. By making it easier to file the regulators are hoping that they Read more...
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