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ARIAD initiates multi-center ponatinib Phase 1/2 clinical trial for CML in Japan

ARIAD Pharmaceuticals, Inc. today announced the initiation of a multi-center Phase 1/2 clinical trial in Japan of ponatinib, the Company's investigational BCR-ABL inhibitor.

20 Aug 2012

Lilly, Boehringer Ingelheim receive FDA approval for Tradjenta sNDA to treat type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Tradjenta (linagliptin) tablets for use as add-on therapy to insulin.

18 Aug 2012

AstraZeneca enters agreement with Pfizer for OTC NEXIUM

Pfizer Inc. today announced that it has entered into an agreement with AstraZeneca for the over-the-counter (OTC) rights for NEXIUM (esomeprazole magnesium), a leading prescription drug currently approved to treat the symptoms of gastroesophageal reflux disease (GERD).

14 Aug 2012

FDA extends PDUFA target action date for review of Santarus' UCERIS NDA

Santarus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the review of the New Drug Application (NDA) for UCERIS (budesonide) tablets 9 mg for the induction of remission of mild to moderate active ulcerative colitis from October 16, 2012 to January 16, 2013.

14 Aug 2012

FDA accepts Teva's NDA for Quartette oral contraceptive

Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd., today announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for Quartette (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets).

13 Aug 2012

FDA extends PDUFA action date for NPS Gattex NDA

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing therapeutics for rare gastrointestinal and endocrine disorders, today announced that it has received a communication from the U.S. Food and Drug Administration extending the Prescription Drug User Fee Act action date for its New Drug Application for Gattex (teduglutide) by three months to December 30, 2012.

13 Aug 2012

FDA approves Perrigo's ANDA for clobetasol propionate shampoo

Perrigo Company today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for clobetasol propionate shampoo, 0.05%, the generic equivalent of Clobex Shampoo.

10 Aug 2012

FDA approves Mylan's ANDA for generic Provigil

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP,100 mg and 200 mg.

10 Aug 2012

Active Biotech, Teva to commence third Phase III study of laquinimod for RRMS

Teva Pharmaceutical Industries Ltd. and Active Biotech provided today an update on the clinical development program of once-daily oral laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS).

9 Aug 2012

Columbia Laboratories second quarter total net revenues decrease to $8.2 million

Columbia Laboratories, Inc. today reported financial results for the three- and six- month periods ended June 30, 2012.

8 Aug 2012

Orexigen Therapeutics reports net loss of $16.7 million for second quarter 2012

Orexigen Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the second quarter of 2012.

7 Aug 2012

Mylan receives final FDA approval for Montelukast Sodium Tablets ANDA

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Tablets, 10 mg, the generic version of Merck's Singulair Tablets.

7 Aug 2012

Mylan receives final FDA approval for generic Amidate ANDA

Mylan Inc. today announced that its business Mylan Institutional has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Etomidate Injection USP, 2 mg/mL packaged in 40 mg/20 mL single-use vials.

6 Aug 2012

Depomed submits Serada NDA with FDA for treatment of menopausal hot flashes

Depomed, Inc. today announced that it has submitted a New Drug Application (NDA) for Serada to the United States Food and Drug Administration. Serada is Depomed's proprietary extended release formulation of gabapentin in development for the treatment of menopausal hot flashes.

31 Jul 2012

Top-line results from Pfizer's tofacitinib Phase 3 study on moderate-to-severe active RA

Pfizer Inc. announced today top-line results from ORAL Start (A3921069), a Phase 3 study of the investigational agent tofacitinib, a novel, oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA).

31 Jul 2012

Watson seeks FDA approval to market Epiduo Gel for severe acne

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market Epiduo (adapalene and benzoyl peroxide) Gel, 0.1% / 2.5%.

30 Jul 2012

FDA accepts Exelixis’ cabozantinib NDA for filing

Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer (MTC).

30 Jul 2012

Arena transfers BELVIQ NDA to Eisai

Eisai Inc. and Arena Pharmaceuticals, Inc. announced today that Arena has transferred the BELVIQ (lorcaserin hydrochloride) New Drug Application (NDA) to Eisai.

30 Jul 2012

Takeda resubmits alogliptin and fixed-dose combination therapy NDAs with FDA

Furiex Pharmaceuticals, Inc. today confirmed that Takeda Pharmaceutical Company Limited announced that its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. has resubmitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for alogliptin and fixed-dose combination therapy alogliptin and pioglitazone for the treatment of type 2 diabetes in adults.

28 Jul 2012

Mylan receives FDA approval for generic Sporanox 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 Itraconazole Capsules, 100 mg.

27 Jul 2012