Biotechnology / Medical Research

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Auspex announces pricing of follow on offering

Friday, 11 Jul 2014 08:00am EDT

Auspex Pharmaceuticals Inc:Prices its underwritten public offering of 3,150,000 shares of common stock at a price to the public of $19.25 per share.Gross proceeds to Auspex from this offering are expected to be about $60.6 mln.Joint book-running managers for the offering are Stifel and BMO Capital Markets.Robert W. Baird & Co. Incorporated, William Blair and Company, L.L.C. and Ladenburg Thalmann are acting as co-managers.

Serendex Pharmaceuticals starts trading on Oslo Axess

Friday, 11 Jul 2014 03:05am EDT

Serendex Pharmaceuticals A/S:Says trading in its share (ticker: SENDEX) commences on July 11 at Oslo Axess following an IPO process raising 65 million Norwegian crowns in new capital.

Biotie Therapies Oyj decides not to exercise option to acquire Neurelis Inc but retains economic interest in future success of NRL-1

Friday, 11 Jul 2014 02:01am EDT

Biotie Therapies Oyj:Decides not to exercise option to acquire Neurelis, Inc. but retains economic interest in future success of NRL-1.

KYTHERA Biopharmaceuticals announces FDA acceptance of ATX-101 New Drug Application

Thursday, 10 Jul 2014 04:32pm EDT

KYTHERA Biopharmaceuticals Inc:Announces that its New Drug Application (NDA) for ATX-101 (deoxycholic acid), has been accepted for filing by the U.S. Food and Drug Administration (FDA).Acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review.NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 13, 2015.

Can Fite Biopharma Ltd's CF102 approved for compassionate use in Israel for liver cancer patient

Thursday, 10 Jul 2014 07:00am EDT

Can Fite Biopharma Ltd:Announced that Israeli Ministry of Health (MOH) has approved use of its drug CF102 for patient with hepatocellular carcinoma, the most common form of liver cancer, under country's Compassionate Use Program.Program allows doctor-initiated single-patient access to investigational treatments for innovative or investigational products not yet registered in any country worldwide.Can-Fite has also previously received Orphan Drug Designation from the U.S. Food and Drug Administration for CF102 in treatment of advanced hepatocellular carcinoma.

Zafgen receives Orphan Drug Designation in european union for Beloranib

Thursday, 10 Jul 2014 07:00am EDT

Zafgen Inc:Says the European Commission (EC) has granted orphan drug designation for beloranib for the treatment of Prader-Willi syndrome (PWS), a rare disease.

Addex Therapeutics ADX71441 positive results in preclinical model of nicotine addiction

Thursday, 10 Jul 2014 01:07am EDT

Addex Therapeutics Ltd:Announces positive results with ADX71441 (GABAB receptor positive allosteric modulator) in preclinical models of nicotine addiction.Results were generated as part of an ongoing research collaboration with the United States National Institute for Drug Abuse (NIDA).Study with ADX71441 examined its effects on mecamylamine precipitated physical and affective withdrawal signs in mice rendered dependent on chronic nicotine.Study was conducted as described by Jackson et al. (2008).Compared to saline-infused mice, nicotine-withdrawn mice showed increased anxiety-related response, in somatic signs and hyperalgesia compared to vehicle controls.Oral treatment with ADX71441 at 1, 3 and 10 mg/kg administered 60 minutes prior to the precipitant, mecamylamine, dose-dependently reversed the somatic signs of withdrawal in nicotine-dependent mice.ADX71441 also reversed hyperalgesia at highest dose of 10 mg/kg.Highest dose of ADX71441 alone did not precipitate withdrawal anxiety-like behavior, somatic signs or hyperalgesia in saline-treated mice.Overall these data indicate that ADX71441 could alleviate the physical signs associated with nicotine withdrawal and help patients to achieve smoking cessation.

Biotest says Bernhard Ehmer to become new CEO

Wednesday, 9 Jul 2014 12:12pm EDT

Biotest AG:Says Bernhard Ehmer to become new CEO of Biotest AG.Says as of Jan 1, 2015, Ehmer will take over role as CEO from Gregor Schulz, whose appointment will then end.

Sunesis Pharmaceuticals Inc announces European Medicines Agency acceptance of pediatric investigation plan for Qinprezo (Vosaroxin) for AML

Wednesday, 9 Jul 2014 07:00am EDT

Sunesis Pharmaceuticals Inc:Says Pediatric Committee of European Medicines Agency (EMA) has issued apositive opinion on company's Pediatric Investigation Plan (PIP) for Qinprezo (vosaroxin), Sunesis' lead drug candidate.Sunesis is conducting the VALOR trial, a pivotal Phase 3, randomized, double-blind, placebo-controlled clinical trial in patients with first relapsed or refractory acute myeloid leukemia.Says PIP is part of the EMA approval process and must be accepted prior to submission of a Marketing Authorization Application (MAA) for the drug in the European Union.Says PIP describes how a company intends to evaluate the use of a given drug in children.Completion of studies outlined in the PIP prior to European Union approval is not a requirement for MAA submission if deferral for completion has been received.

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