Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA accepted for filing and granted priority review to its new drug application (NDA) for oral investigational compound riociguat in chronic thromboembolic pulmonary hypertension (CTEPH) that is inoperable or persistent or recurrent CTEPH after pulmonary endarterectomy and pulmonary arterial hypertension

Titan submitted the application in October under the 505(b)(2) pathway, and the NDA was granted priority review, with a PDUFA date of April 30

Algeta ASA, of Oslo, Norway, said that its partner Bayer AG, of Leverkusen, Germany, has received notification that the New Drug Application (NDA) for the investigational compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the FDA

Algeta ASA, of Oslo, Norway, said that its partner Bayer AG, of Leverkusen, Germany, has received notification that the New Drug Application (NDA) for the investigational compound Radium Ra 223 Dichloride (radium-223) has been accepted for filing and granted priority review by the FDA

Bayer HealthCare Inc., of Wayne, N.J., said the new drug application for the oncology compound radium Ra 223 dichloride has been accepted for filing and granted priority review by the FDA for the treatment of castration-resistant prostate cancer patients with bone metastases

For any products on that list, the FDA's Office of Generic Drugs is using a priority review system to expedite review of applications

The application was granted priority review status, and an FDA decision is expected in the second quarter...Boehringer Ingelheim GmbH, of Ingelheim, Germany, said its new drug application for afatinib was accepted for filing and granted priority review by the FDA

The application was granted priority review status, and an FDA decision is expected in the second quarter

Boehringer Ingelheim GmbH, of Ingelheim, Germany, said its new drug application for afatinib was accepted for filing and granted priority review by the FDA

Under the agreement, Pepscan will use its CLIPS platform and other protein mimicry technologies to help discover new antibodies...to purchase up to 1 million shares, or about 1.06 percent of the company's outstanding stock, at a price of $161.25 per share, marking a 4.46 percent discount to the Dec. 27 closing price

The QIDP designation, included as part of FDASIA, provides the company access to certain incentives, including priority review for a new drug application and a five-year extension of exclusivity under the Hatch-Waxman Act upon approval

Titan Pharmaceuticals Inc., of South San Francisco, said its new drug application for probuphine, a subdermal implant and long-acting product designed to deliver six months of buprenorphine hydrochloride, was accepted and granted priority review for the maintenance treatment of opioid dependence in adults

The designations will enable the company to benefit from certain incentives for the development of new antibiotics, including priority review, eligibility for fast-track status, and if CXA-201 or CB-315 are ultimately approved by the FDA, a five-year extension of Hatch-Waxman exclusivity

Eisai Inc., of Woodcliff Lake, N.J., said the FDA accepted for priority review Eisai's NDA for AcipHex Delayed-Release Sprinkle Capsules 5mg and 10mg for the proposed indication of healing of gastroesophageal reflux Disease (GERD), maintenance of healing of GERD and improvement of symptoms of GERD in children 1 to 11 years of age

Zaltrap gained FDA approval in mCRC in early August following a priority review. (See BioWorld Today, Aug. 6, 2012

Auxilium Pharmaceuticals Inc., of Malvern, Pa., submitted a supplemental biologics license application to the FDA and requested priority review for Xiaflex (collagenase clostridium histolyticum) in Peyronie's disease (PD...Genentech Inc., of South San Francisco, a member of the Roche Group, said the FDA accepted a biologics license application for trastuzumab emtansine (T-DM1) and granted it priority review

Durata Therapeutics Inc., of Morristown, N.J., said the FDA designated dalbavancin as a Qualified Infectious Disease Product, providing it priority review by the FDA, eligibility for fast-track status and extension of statutory exclusivity periods for an additional five years beyond approval in acute bacterial skin and skin structure infections

Xarelto is the first and only oral anticoagulant approved to treat DVT and PE without the need for injections or routine blood monitoring, and was approved for these three new indications on a priority review timeline

Onyx Pharmaceuticals Inc., of South San Francisco, said partner Bayer HealthCare, of Wayne, N.J., a unit of Bayer AG, said the FDA granted priority review for the new drug application for Stivarga (regorafenib) in patients with metastatic and/or unresectable gastrointestinal stromal tumors whose disease has progressed despite prior treatment with two kinase inhibitors...Titan is seeking priority review designation