BioCentury | Jan 25, 2019
Politics, Policy & Law

101 problems with patent eligibility

The U.S. diagnostics industry is being strangled, and other life science inventions are being hobbled by, ill-conceived and contradictory patent policies. The USPTO director has signaled he wants to help, but only Congress has the...
BioCentury | Oct 6, 2017

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
BC Week In Review | Jul 27, 2017
Clinical News

CHMP recommends against Vanda's Fanaptum for schizophrenia

EMA’s CHMP recommended against approval of an MAA for Fanaptum iloperidone from Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) to treat schizophrenia. The serotonin (5-HT2) receptor and dopamine receptor antagonist is approved as Fanapt for schizophrenia in the...
BC Extra | Jul 21, 2017
Company News

Vanda, Nektar get thumbs down from CHMP

EMA’s CHMP adopted negative opinions on drug candidates from Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) and Nektar Therapeutics (NASDAQ:NKTR). Regarding an MAA for Vanda's Fanaptum iloperidone to treat schizophrenia, the committee said the candidate's efficacy was "modest,"...
BioCentury | Jul 8, 2017

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
BC Week In Review | Oct 31, 2016
Company News

Vanda, Taro Pharmaceutical deal

Vanda granted Taro non-exclusive, U.S. rights to manufacture and commercialize a generic version of Vanda’s Fanapt iloperidone, effective November 2027. The license settled patent litigation against Taro’s ANDA for the product. If Vanda obtains pediatric...
BC Week In Review | Jun 6, 2016
Clinical News

Fanapt iloperidone regulatory update

FDA approved an sNDA from Vanda for Fanapt iloperidone for maintenance treatment of schizophrenia in adults. The approval was based on data from the Phase III REPRIEVE trial (see BioCentury, July 27, 2015). In 2009,...
BC Week In Review | Jan 11, 2016
Clinical News

Fanapt iloperidone regulatory update

EMA accepted for review an MAA for Fanaptum iloperidone to treat schizophrenia in adults. In 2013, Vanda withdrew an MAA for the serotonin (5-HT2) receptor and dopamine receptor antagonist after EMA’s CHMP recommended against approval...
BC Week In Review | Jul 27, 2015
Clinical News

Fanapt iloperidone: Interim Phase III data

Interim data from 195 schizophrenia patients who remained clinically stable for >=12 weeks on a flexible dose regimen of twice-daily 4-12 mg oral Fanapt in the Relapse Prevention portion of the double-blind, international Phase III...
BC Week In Review | Jan 5, 2015
Company News

Novartis, Vanda deal

Vanda regained exclusive U.S. and Canadian rights from Novartis to Fanapt iloperidone. The deal settled a licensing dispute between the two companies in which Vanda had begun an arbitration proceeding in May seeking $539 million...
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