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UK's NICE plans to recommend Abilify for children with bipolar disorder

10 June 2013

UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued new draft guidance proposing to recommend Abilify (aripiprazole), from Japanese drugmaker Otsuka Pharmaceutical (TYO: 4578) and Danish partner Lundbeck (LUND: DC), for treating moderate to severe manic episodes in adolescents aged 13 and older with bipolar I disorder.

Arena/Eisai's Belviq at last to launch in the USA

7 June 2013

USA-based Arena Pharmaceuticals (Nasdaq: ARNA) says that its long-awaited weight loss drug Belviq (lorcaserin) will finally become available to US patients on June 11, on prescription via pharmacies. The US subsidiary of Japanese drug major Eisai (TYO: 4523) is responsible for the marketing and distribution of Belviq.

Valneva to sell French CMO operations to India's Biological E

7 June 2013

Biotech firm Valneva (Euronext: VLA), the company recently created through the merger of France's Vivalis and Austria's Intercell (The Pharma Letter May 14) (Valneva), says it has signed a binding term sheet to sell its Clinical Manufacturing Operations (CMO) in Nantes, France, to Biological E, an Indian biopharmaceutical company.

Shire's Elvanse shows significantly faster response in ADHD symptoms than Strattera

7 June 2013

Ireland-headquartered Shire (LSE: SHP, NASDAQ: SHPG) presented positive scientific data comparing the efficacy and safety of the attention-deficit hyperactivity disorder (ADHD) treatments lisdexamfetamine dimesylate (LDX; Elan's Elvanse)) and atomoxetine (ATX; Eli Lilly's Strattera) at the 4th World Congress on ADHD, Milan, Italy.

Life Sciences IPOs have biggest month - May - in 13 years, reports Burrill

7 June 2013

A total of eight life sciences companies went public on US exchanges in May, the busiest month for initial public offerings in the sector since August 2000 when 16 issues debuted, global life sciences financial services firm Burrill & Co reported.

CytomX signs up to $635 million oncology deal with Pfizer

7 June 2013

US biotech firm CytomX Therapeutics, which is developing a new generation of targeted antibody therapeutics, has entered into a global strategic collaboration with global pharma behemoth Pfizer (NYSE: PFE) to develop and commercialize multiple Probody-Drug Conjugates (PDCs) that could provide the smaller company with as much as $635 million in upfront and milestone payments.

Endo Health to slash workforce, view options for HealthTronics and branded pharma unit

7 June 2013

USA-based Endo Health Solutions (Nasdaq: ENDP) has outlined the strategic, operational and organizational steps it is taking to refocus the company and drive shareholder value. These actions are the result of a comprehensive assessment of Endo's strengths and challenges, its cost structure and execution capabilities, and its most promising opportunities to drive future cash flow and earnings growth.

Boehringer Ingelheim to build biopharma facility in China

7 June 2013

German family-owned drug major Boehringer Ingelheim has signed a strategic alliance agreement and contract to build a current Good Manufacturing Practices (cGMP) biopharmaceuticals facility with China's Zhangjiang Biotech & Pharmaceutical Base Development Company (ZJ Base) in Pudong, Shanghai.

European Medicines Agency and EUnetHTA review progress of their cooperation

7 June 2013

The European Medicines Agency and EUnetHTA, the European network for Health Technology Assessment (HTA), met to review the progress of their cooperation in London on May 14, it was reported today (June 7). This was the sixth meeting since the start of their collaboration in 2010.

Majority vote from FDA advisory panel to ease restrictions on GSK's Avandia

7 June 2013

A joint advisory committee to the US Food and Drug Administration (FDA) voted to continue to make UK pharma giant GlaxoSmithKline's (LSE: GSK) diabetes drug Avandia (rosiglitazone) available to appropriate patients with the majority of the 26 panel members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market.

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