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Salix first quarter total product revenue increases 62% to $171.1M

Salix Pharmaceuticals, Ltd. today announced financial and operating results for the first quarter ended March 31, 2012 and other business updates.

8 May 2012

Affymax first quarter total revenue increases to $63.2 million

Affymax, Inc. today reported financial results for the first quarter ended March 31, 2012. The net income for the first quarter of 2012 was $31.5 million (or $0.87 per share) compared to a net loss of $9.6 million (or $(0.36) per share) for the first quarter of 2011.

8 May 2012

Keryx, Aeterna Zentaris execute perifosine license termination and technology transfer agreement

Keryx Biopharmaceuticals, Inc. today announced that the Company and Aeterna Zentaris Inc. have executed a License Termination and Technology Transfer Agreement, whereby the KRX-0401 (perifosine) license agreement has been terminated and all license rights have reverted back to Aeterna Zentaris.

7 May 2012

Data from Idera IMO-8400 preclinical studies for SLE and psoriasis presented at AAI meeting

Idera Pharmaceuticals, Inc. today announced data from preclinical studies of IMO-8400, demonstrating a novel mechanism of action that may be applicable to the treatment of systemic lupus erythematosus (SLE) and psoriasis. IMO-8400 is an inhibitor of specific Toll-like receptors (TLRs).

7 May 2012

Positive results from Dainippon Sumitomo Pharma's LATUDA trials for bipolar I depression

Dainippon Sumitomo Pharma Co., Ltd. announced today results from two Phase 3 clinical trials designed to evaluate the efficacy and safety of LATUDA as adjunctive therapy and monotherapy, respectively, in patients with bipolar I depression (PREVAIL 1 and PREVAIL 2; PRogram to EValuate the Antidepressant Impact of Lurasidone).

7 May 2012

Flamel first quarter total revenues increase to $7.3 million

Flamel Technologies today announced its financial results for the first quarter of 2012.

7 May 2012

MAP Pharmaceuticals first quarter net loss increases to $17.8 million

MAP Pharmaceuticals, Inc. today announced financial results for the first quarter ended March 31, 2012.

5 May 2012

NPS first quarter net loss increases to $10.6 million

NPS Pharmaceuticals, Inc., a specialty pharmaceutical company developing orphan therapeutics for rare gastrointestinal and endocrine disorders, today reported its results for the first quarter of 2012.

4 May 2012

Alnylam first quarter revenues decrease to $20.6 million

Alnylam Pharmaceuticals, Inc., a leading RNAi therapeutics company, today reported its consolidated financial results for the first quarter 2012, and company highlights.

4 May 2012

FDA issues Complete Response Letter to Alexza’s ADASUVE NDA

Alexza Pharmaceuticals, Inc. announced today that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ADASUVE (loxapine) inhalation powder, 5 mg and 10 mg.

4 May 2012

XenoPort first quarter revenues increase to $10.4 million

XenoPort, Inc. announced today its financial results for the first quarter ended March 31, 2012. Revenues for the quarter were $10.4 million, compared to $0.4 million for the same period in 2011.

3 May 2012

Arena's first quarter net loss decreases to $29.4 million

Arena Pharmaceuticals, Inc. today reported financial results for the first quarter ended March 31, 2012, and reviewed recent developments.

2 May 2012

Biogen Idec first quarter revenues increase 7% to $1.3 billion

Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing and commercialization of innovative therapies, today announced its first quarter 2012 results.

2 May 2012

Idera to present data from IMO-8400 preclinical studies on SLE, psoriasis at AAI meeting

Idera Pharmaceuticals, Inc. today announced that it will be presenting data from preclinical studies of its Toll-like receptor (TLR) inhibitor, IMO-8400, in models of systemic lupus erythematosus (SLE) and psoriasis, which suggest that IMO-8400 may be useful for the treatment of both indications.

2 May 2012

Teva, Mylan settle patent infringement litigation for Nuvigil

Teva Pharmaceutical Industries Ltd., one of the world's largest producers of pharmaceuticals, announces that it has settled patent infringement litigation regarding U.S. Patent Number 7,132,570 (the "'570 patent") with respect to Mylan Inc.'s ANDA for Teva's wakefulness product NUVIGIL (armodafinil) tablets.

30 Apr 2012

FDA approves VIVUS’ STENDRA for treatment of erectile dysfunction

VIVUS, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved STENDRA (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S.

30 Apr 2012

FDA ODAC to review Onyx’s NDA for carfilzomib

Onyx Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) will review the company's new drug application (NDA) for carfilzomib for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior therapies. ODAC will review carfilzomib at its meeting on June 20, 2012.

27 Apr 2012

Mylan receives final FDA approval for generic Zyprexa 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 Olanzapine Tablets USP, 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg.

25 Apr 2012

FDA extends review period for linaclotide NDA to treat constipation

Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).

23 Apr 2012

TPU, Eisai amend Aricept patch licensing agreement

Eisai announced today that the company has amended the licensing agreement with Teikoku Pharma USA, Inc. (TPU), a subsidiary of Teikoku Seiyaku Co., Ltd., pertaining to exclusive overseas marketing rights for the Aricept patch (once weekly donepezil HCl transdermal system).

21 Apr 2012