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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.

Novavax makes public offer to acquire Sweden's Isconova for $29.6 million

7 June 2013

In what seems to be confirmation that adjuvants are fast becoming a serious element in vaccine development, USA-based Novavax (Nasdaq: NVAX) revealed that it has made a public tender offer to acquire Sweden-based Isconova (OMX: ISCO) directly from shareholders and intends to make a private offer for all outstanding stock options.

FDA warns Novartis on Austrian generic manufacturing plant cGMP failures

7 June 2013

The US Food and Drug Administration has written to Joseph Jimenez, chief executive of Swiss drug major Novartis (NOVN: VX), relating to its investigation of the pharmaceutical manufacturing plant at Ebewe Pharma's Unterach am Attersee, Austria, production facility, which identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Ebewe was acquired by Novartis' generics subsidiary Sandoz in 2009.

Positive Ph III results for Regeneron/Bayer's Eylea in mCNV

6 June 2013

US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) and partner Germany's Bayer (BAYN: DE) have reported positive top-line results for Eylea (aflibercept) Injection from the Phase III MYRROR study in myopic choroidal neovascularization (mCNV).

New Florida law takes a major step in promoting access to biologic medicines

6 June 2013

Legislation amending the US state of Florida's existing prescription drug substitution law has the potential to create a pathway for biosimilar product substitution at the pharmacy. The bill, House Bill 365, passed both houses of the state's legislature in late April with nearly unanimous support, and has now must be signed by Governor Rick Scott.

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