England-based rare disease drug maker Cycle Pharma revealed an $8-per-share offer for Vanda, representing a total buyout offer of $466 million.
Future Pak Increases Bid for Vanda Pharmaceuticals to Include CVRs in Addition to $7.25 to $7.75 Per Share in Cash
WASHINGTON, April 2, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt® is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.
Vanda Pharma announces the publication of Efficacy and Safety of Iloperidone
Fanapt® Shown to be Effective in Bipolar I Disorder in Phase III Clinical Study
WASHINGTON, Jan. 13, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced today that the U.S. Supreme Court has denied the petition for a writ of certiorari filed by West-Ward Pharmaceuticals (West-Ward), a subsidiary of Hikma Pharmaceuticals, relating to Vanda's U.S. Patent number 8,586,610 (the '610 Patent) for Fanapt®. This order by the U.S. Supreme Court ensures that the '610 patent will remain exclusive at least through November 2, 2027, absent further challenges from other parties.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting.
Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today the refusal of the marketing authorization application (MAA) of Fanaptum™ (oral iloperidone tablets) for the treatment of schizophrenia in adult patients in the European Union. In July 2017, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the Fanaptum™ MAA. Vanda requested a re-examination of the initial opinion. After considering the grounds for this request, the CHMP re-examined the opinion and confirmed the refusal of the Fanaptum™ MAA on November 9, 2017.
The European Medicines Agency (EMA) on Friday recommended the approval of eight new medicines after its Committee for Medicinal Products for Human Use (CHMP) met to discuss the drugs earlier this week.
Vanda Pharmaceuticals Inc. (Vanda), a specialty pharmaceutical company, has entered into a License Agreement (the License Agreement) with Apotex Inc. and Apotex Corp. (collectively, Apotex) to resolve Vanda's patent litigation against Apotex regarding Apotex's Abbreviated New Drug Application seeking approval of its generic version of Vanda's Fanapt (iloperidone).