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US District Court rules against Watson in generic Fentora patent suit

Watson Pharmaceuticals, Inc., today confirmed that the United States District Court for the District of Delaware has ruled that Watson's generic version of Fentora® (fentanyl buccal tablets C-II) infringes United States Patent No. 6,264,981 (the '981 Patent). The Company said that it was reviewing the court's decision and would evaluate all available options, including an appeal.

25 Mar 2011

Positive Phase 3 results from Tarsa's ORACAL study validates Unigene's oral peptide drug delivery technology

Unigene Laboratories, Inc. a leader in the design, delivery, manufacture and development of peptide-based therapeutics announced today that the statistically significant top-line results released by its licensee, Tarsa Therapeutics, validate its proprietary oral peptide drug delivery technology.

25 Mar 2011

Positive top-line results from POZEN's PA32540 Phase 1 study against cardiovascular disease

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, announced today positive top-line results of a Phase 1 study of PA32540, a novel coordinated-delivery tablet of enteric-coated aspirin and immediate-release omeprazole.

25 Mar 2011

Positive results from Tarsa's oral calcitonin Phase III trial against postmenopausal osteoporosis

Tarsa Therapeutics today announced that the Phase III ORACAL trial of its oral recombinant salmon calcitonin in the treatment of postmenopausal osteoporosis was successfully concluded and yielded statistically significant, positive top-line results.

25 Mar 2011

Affymax, Takeda's peginesatide Phase 3 data in dialysis patient to be presented at NKF meeting

Affymax, Inc. and Takeda Global Research & Development Center, Inc., U.S., today announced multiple posters on peginesatide have been accepted for presentation at the National Kidney Foundation 2011 Spring Clinical Meeting taking place April 26-30, 2011 in Las Vegas, Nevada.

24 Mar 2011

Cilag, POZEN enter license agreement to develop and commercialize MT 400

POZEN Inc., a pharmaceutical company committed to transforming medicine that transforms lives, today announced that it has entered into a license agreement with Cilag GmbH International, a division of Johnson & Johnson, for the development and commercialization of MT 400 in Brazil, Colombia, Ecuador and Peru.

23 Mar 2011

POZEN files motion for Treximet patent litigation against Par

POZEN Inc., a pharmaceutical company committed to transforming medicines that transform lives, today announced that it has filed a motion for a preliminary injunction seeking to prevent Par Pharmaceuticals, Inc. from launching a generic version of Treximet.

23 Mar 2011

SMR, RTU enter license agreement for RESCULA eye drops

Sucampo Pharmaceuticals, Inc. today announced that its wholly owned subsidiary, Sucampo Manufacturing & Research AG, and R-Tech Ueno, Ltd., a pharmaceutical company founded in Japan in 1989, have entered into a license agreement for RESCULA eye drops, expanding Sucampo's rights beyond its previously agreed territory of the United States and Canada to all countries in Europe and the rest of the world except Japan, Korea, Taiwan and the People's Republic of China.

23 Mar 2011

Watson introduces Famciclovir tablets to treat cold sores, genital herpes

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. has launched Famciclovir tablets, 125 mg, 250 mg and 500 mg, the generic version of Novartis' Famvir following approval of its Abbreviated New Drug Application by the U.S. Food and Drug Administration.

22 Mar 2011

Hi-Tech Pharmacal acquires rights to Nystatin Oral suspension ANDA from Bausch + Lomb

Hi-Tech Pharmacal Co., Inc. announced that it has acquired the rights to the Abbreviated New Drug Application (ANDA) for Nystatin Oral suspension from Bausch + Lomb, the global eye health company for an undisclosed upfront payment and a future royalty.

21 Mar 2011

FDA clears Insmed IND for ARIKACE Phase 3 clinical trial in nontuberculous mycobacteria lung infections

Insmed Incorporated, a biopharmaceutical company, announced today that the Company's Investigational New Drug Application (IND) to conduct a pivotal Phase 3 clinical trial of ARIKACE™ (liposomal amikacin for inhalation) in nontuberculous mycobacteria (NTM) lung infections has been cleared by the U.S. Food and Drug Administration (FDA).

21 Mar 2011

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

Shire plc, the global specialty biopharmaceutical company, today announced that the US Food and Drug Administration (FDA) has assigned a Prescription Drug User Fee Act (PDUFA) date of August 25, 2011 for the review of the New Drug Application (NDA) for FIRAZYR(R) (icatibant) for the treatment of acute attacks (Types I and II) of hereditary angioedema (HAE). This 6 month review timeline is consistent with review as a Class II resubmission.

21 Mar 2011

$CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma$

CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma

Cell Therapeutics, Inc. today announced that it has initiated its randomized pivotal trial of pixantrone for the treatment of relapsed/refractory diffuse large B-cell lymphoma ("DLBCL").

21 Mar 2011

Avid, Eli Lilly receive FDA complete response letter for Amyvid NDA

Eli Lilly and Company and its wholly owned subsidiary, Avid Radiopharmaceuticals, Inc., have received a complete response letter from the U.S. Food and Drug Administration for their New Drug Application for Amyvid, a Positron Emission Tomography imaging agent under investigation for the detection of beta-amyloid plaque in the brains of living patients.

18 Mar 2011

The Lancet Neurology publishes Neurologix NLX-P101 Phase 2 trial results against PD

Neurologix, Inc., announced today that the results of the Company's Phase 2 clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease were published in an online-first edition of The Lancet Neurology.

17 Mar 2011

Positive top-line results from IPX066 Phase III study in patients with PD

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc., today announced statistically significant, positive, top-line results of the ADVANCE-Parkinson's Disease Phase III clinical study of the safety and efficacy of IPX066 versus immediate-release carbidopa-levodopa in advanced PD patients experiencing motor fluctuations.

15 Mar 2011

Repligen reports positive results from RG1068 Phase 3 study to improve MRI of the pancreas

Repligen Corporation reported today positive top-line results from a Phase 3 study to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with pancreatic disease using endoscopy (ERCP) as a diagnostic reference.

14 Mar 2011

Omthera to fund Epanova Phase 3 development with $33.9 million in Series B funding

Omthera Pharmaceuticals, Inc., a privately-held emerging specialty pharmaceuticals company, announced today that it has raised $33.9 million in a Series B funding round, led by new investor, New Enterprise Associates ("NEA"), one of the world's leading venture capital firms. Existing investor, Sofinnova Partners, also participated in the financing.

14 Mar 2011

Biodel selects BIOD-105, BIOD-107 recombinant human insulin formulations for clinical testing, development

Biodel Inc. announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates. The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.

14 Mar 2011

Transcept initiates enrollment in TO-2061 Phase 2 study for treatment resistant obsessive compulsive disorder

Transcept Pharmaceuticals, Inc. today announced the first patient has been enrolled in a Phase 2 clinical study to evaluate TO-2061 as an adjunctive treatment for obsessive compulsive disorder (OCD) in patients who have responded inadequately to currently approved treatments. OCD affects 1 to 2 percent of the United States adult population and can significantly impair the lives of patients and their families.

14 Mar 2011

New Drug Application News and Research

US District Court rules against Watson in generic Fentora patent suit

Positive Phase 3 results from Tarsa's ORACAL study validates Unigene's oral peptide drug delivery technology

Positive top-line results from POZEN's PA32540 Phase 1 study against cardiovascular disease

Positive results from Tarsa's oral calcitonin Phase III trial against postmenopausal osteoporosis

Affymax, Takeda's peginesatide Phase 3 data in dialysis patient to be presented at NKF meeting

Cilag, POZEN enter license agreement to develop and commercialize MT 400

POZEN files motion for Treximet patent litigation against Par

SMR, RTU enter license agreement for RESCULA eye drops

Watson introduces Famciclovir tablets to treat cold sores, genital herpes

Hi-Tech Pharmacal acquires rights to Nystatin Oral suspension ANDA from Bausch + Lomb

FDA clears Insmed IND for ARIKACE Phase 3 clinical trial in nontuberculous mycobacteria lung infections

Shire announces FDA PDUFA date for FIRAZYR NDA in treatment of acute attacks of hereditary angioedema

CTI commences pixantrone PIX-R trial in relapsed/refractory diffuse large B-cell lymphoma

Avid, Eli Lilly receive FDA complete response letter for Amyvid NDA

The Lancet Neurology publishes Neurologix NLX-P101 Phase 2 trial results against PD

Positive top-line results from IPX066 Phase III study in patients with PD

Repligen reports positive results from RG1068 Phase 3 study to improve MRI of the pancreas

Omthera to fund Epanova Phase 3 development with $33.9 million in Series B funding

Biodel selects BIOD-105, BIOD-107 recombinant human insulin formulations for clinical testing, development

Transcept initiates enrollment in TO-2061 Phase 2 study for treatment resistant obsessive compulsive disorder

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