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Hapten licenses HPT-721 to prevent poison ivy dermatitis

Hapten Sciences Inc. of Memphis, Tenn., has licensed a compound developed by ElSohly Laboratories Inc. and University of Mississippi pharmaceutical researchers to prevent reactions to poison ivy, oak and sumac.

27 Mar 2012

FDA issues Complete Response letter to MAP's NDA for LEVADEX

MAP Pharmaceuticals, Inc. today announced that the United States Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for LEVADEX (dihydroergotamine) inhalation aerosol.

27 Mar 2012

EMA accepts Arena's lorcaserin MAA for weight control

Arena Pharmaceuticals, Inc. announced today that the European Medicines Agency (EMA) has accepted the filing of a Marketing Authorization Application (MAA) for lorcaserin, an investigational drug candidate intended for weight control, including weight loss and maintenance of weight loss, in patients who are obese (BMI >30) or patients who are overweight (BMI >27) and have at least one weight-related co-morbid condition.

26 Mar 2012

Enrollment complete in Clovis' CO-101 pivotal study for metastatic pancreatic cancer

Clovis Oncology, Inc. announced today that it has reached the target enrollment in its pivotal LEAP (Low hENT1 and Adenocarcinoma of the Pancreas) study of CO-101 in metastatic pancreatic cancer.

26 Mar 2012

Medgenics to commence EPODURE Biopumps Phase IIa study in ESRD-related anemia

Medgenics, Inc., the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced receipt of clearance from the Israeli Ministry of Health to initiate a Phase IIa clinical study evaluating the safety and efficacy of sustained erythropoietin therapy produced and delivered by the Company's EPODURE Biopumps.

26 Mar 2012

FDA Advisory Committee to review Repligen's SecreFlo NDA on May 31

Repligen Corporation today announced that the U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the Company's New Drug Application (NDA) for SecreFlo for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis.

26 Mar 2012

Hyperion acquires worldwide rights to Ucyclyd's Ravicti

Hyperion Therapeutics, Inc. today announced that it has acquired worldwide rights to the investigational drug Ravicti from Ucyclyd Pharma, Inc., a wholly owned subsidiary of Medicis Pharmaceutical Corporation.

23 Mar 2012

Noven completes LDMP Phase 3 studies on menopausal VMS

Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical Co., Inc., today announced that it has completed the Phase 3 clinical development program evaluating low-dose mesylate salt of paroxetine (LDMP) for the treatment of vasomotor symptoms (VMS) associated with menopause.

21 Mar 2012

FDA approves Watson's generic BONIVA ANDA to treat osteoporosis in women

Watson Pharmaceuticals, Inc. today announced that its subsidiary Watson Laboratories, Inc. has received approval from the United States Food and Drug Administration on its Abbreviated New Drug Application (ANDA) for Ibandronate 150mg tablets, the generic equivalent to Roche's BONIVA tablets.

21 Mar 2012

Mylan receives final FDA approval for generic Boniva ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ibandronate Sodium Tablets, 150mg.

20 Mar 2012

QRxPharma, Actavis enter License and Option Agreement

QRxPharma Limited announced today execution of its License and Option Agreement with Actavis, Inc. which finalised the legal terms and conditions to commercialise MoxDuo IR in the US acute pain marketplace. The LOA completion follows a 20 December 2011 signing of a binding Letter of Intent secured by a US$6 million non-refundable upfront signing fee to QRxPharma.

19 Mar 2012

Abbott files suit against Watson over generic NIASPAN

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Niacin Extended-release Tablets, 500 mg and 1000 mg. Watson's ANDA products are generic versions of Abbott Laboratories' NIASPAN.

19 Mar 2012

Alnylam commences dosing in ALN-TTR02 Phase I clinical trial for TTR-mediated amyloidosis

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, announced today that it has initiated dosing in its Phase I clinical trial with ALN-TTR02, an RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR). The study is aimed at evaluating the safety and tolerability of ALN-TTR02 in healthy volunteers.

19 Mar 2012

Tarsa advances OSTORA NDA filing through $28M Series B financing

Tarsa Therapeutics, Inc. today announced completion of a $28 million Series B equity financing led by new investor Foresite Capital.

17 Mar 2012

Repligen total revenue increases to $7,165,000 for quarter ended December 31, 2011

Repligen Corporation today reported financial results for the quarter and nine-month fiscal year ended December 31, 2011.

17 Mar 2012

Teva commences commercial launch of Escitalopram Oxalate Tablets

Teva Pharmaceutical Industries Ltd. announced today that it has commenced commercial launch of Escitalopram Oxalate Tablets, the Company's generic version of Forest Laboratories' depression and generalized anxiety disorder treatment, Lexapro Tablets.

15 Mar 2012

Watson commences Esmya Phase 3 trial in women with anemia linked to uterine leiomyomas

Watson Pharmaceuticals, Inc. today announced it has initiated its Phase 3 trial to evaluate the efficacy and safety of Esmya (ulipristal acetate) in women with anemia associated with uterine leiomyomas, a medical condition often referred to as uterine fibroids (myomas). Leiomyomata are benign solid tumors that often lead to excessive menstrual bleeding, anemia and pain, which ultimately may require surgical intervention.

12 Mar 2012

FDA clears Aradigm IND for Pulmaquin Phase 3 clinical trial in non-cystic fibrosis BE

Aradigm Corporation today announced that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of Pulmaquin (dual release ciprofloxacin for inhalation) in non-cystic fibrosis bronchiectasis (BE) has been cleared by the U.S. Food and Drug Administration.

12 Mar 2012

Antares Pharma fourth quarter revenues increase 65% to $5.4 million

Antares Pharma, Inc. today reported financial and operating results for the fourth quarter and full year ended December 31, 2011 and outlined key objectives and milestones for 2012.

12 Mar 2012

FDA approves Boca Pharmacal's generic Tapazole Methimazole tablets ANDA

Boca Pharmacal, Inc., today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Methimazole Tablets USP, 5mg and 10mg, the generic version of King Pharmaceuticals' Tapazole® Methimazole tablets, indicated to treat hyperthyroidism.

10 Mar 2012