Article Listing - US FDA delays Eisai's Dacogen for AML; accepts perampanel NDA

Meda expands collaboration with India's Cipla on Dymista

6 June 2013

Swedish drugmaker Meda (OMX: MEDA A) is broadening its collaboration with Indian pharmaceutical company Cipla, thereby expanding its exclusive rights to Dymista (azelastine and fluticasone nasal spray) and future product development. Through the extended partnership, Meda now has full coverage in all growth markets in Latin- and South America, Middle East and Africa and Asia, including more than 120 new markets.

Alliance Pharma buys expanded rights to Syntometrine from Novartis

6 June 2013

UK specialty drugmaker Alliance Pharma (AIM: APH) says it has acquired all existing rights to Syntometrine (oxytocin and ergometrine) from Swiss pharma major Novartis (NVN: VX) for a consideration of $11.5 million. Shares of Alliance, which already owns the UK rights to Syntometrine, an obstetric drug used in the final stage of labor, rose 2.4% to 37.38 pence on the news.

Improved symptom control and quality of life among greatest unmet needs in metastatic-resistant prostate cancer therapy

6 June 2013

Symptom control and quality of life is one of the factors the most influences surveyed US and European oncologists' treatment decisions for second- and subsequent-line metastatic castrate-resistant prostate cancer (mCRPC), and that improved symptom control and quality of life is one of the greatest unmet needs in this indication.

Zydus' diabetes drug Lipaglyn becomes India's first NCE to reach the market

6 June 2013

Indian drugmaker Zydus Cadila today (June 5) made a breakthrough in its research efforts with Lipaglyn (saroglitazar), a novel drug targeted at treating diabetic dyslipidemia or hypertriglyceridemia in type 2 diabetes, not controlled by statins alone, gaining approval for launch in India by the Drug Controller General of India (DCGI).

Flamel Technologies gains US approval of Bloxiverz

6 June 2013

French drug delivery firm Flamel Technologies (Nasdaq: FLML) announced yesterday (June 5) that the US Food and Drug Administration has approved its New Drug Application for Bloxiverz (neostigmine methylsulfate), which came with last year's acquisition of US specialty pharma company Eclat Pharmaceuticals (The Pharma Letter March 19, 2012).

Second Genome in deal with Janssen on microbiome drug discovery in ulcerative colitis

6 June 2013

Second Genome has entered into an agreement with Janssen Biotech, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ) on microbiome drug discovery. With the goal of advancing novel drug targets, the agreement is focused on therapeutic mechanisms in ulcerative colitis mediated by the bacterial ecosystem living within the human gut, referred to as the microbiome. Second Genome will apply its microbiome modulation discovery platform to characterize the role of bacterial populations in ulcerative colitis.

Actavis confirms patent challenge on Bayer's Safyral

6 June 2013

USA-based generics major Actavis (NYSE: ACT) yesterday (June 5) confirmed that it has filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium tablets, a generic version of German drug major Bayer's (BAYN: DE) Safyral, which is approved to prevent pregnancy in women who elect to use an oral contraceptive, and to provide a daily dose of folate supplementation.

Ferrer's Ozenoxacin shows superiority in Ph III impetigo trial

5 June 2013

Privately-held Spanish drugmaker Ferrer Internacional says that it has successfully completed a Phase III clinical trial in adult and paediatric patients with impetigo involving Ozenoxacin formulated as a topical treatment for dermatological infectious conditions. The product is available for licensing worldwide from Ferrer, except in China, Japan, Korea and Taiwan.

GW Pharma posts six-month results; progresses cannabinoid pipeline including into diabetes and UC

5 June 2013

UK biopharma company GW Pharmaceuticals (AIM: GWP), which is developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced financial results half year ended March 31, 2013, showing that total revenue £12.9 million ($19.6 million) compared to £11.1 million in first-half 2012.

Astellas signs enzalutamide distribution deal in Latin America; Oxford Pharmascience links with Ache

5 June 2013

The US subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) has entered into a distribution agreement with Tecnofarma International to distribute enzalutamide (trade name Xtandi in the USA) in Latin America, excluding Brazil, upon regulatory approvals in the various countries. Financial terms of the agreement were not disclosed.

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