DIA Biosimilars 2013

United States

Cardeas Pharma completes $34M in Series B financing

Friday, May 24, 2013 10:59 AM

Cardeas Pharma, a biopharmaceutical company focused on multi-drug resistant (MDR) bacterial infections, has completed a $34 million Series B round of financing.

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Cenduit: Now with Patient Reminders

FDA approves Bayer’s Xofigo for advanced prostate cancer

Thursday, May 23, 2013 08:00 AM

The FDA has approved Bayer Pharmaceuticals’ Xofigo (radium Ra 223 dichloride) to treat males with symptomatic late-stage metastatic castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.

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CRF Health – eCOA Forum

eFFECTOR Therapeutics raises $45M in series A financing

Wednesday, May 22, 2013 11:32 AM

eFFECTOR Therapeutics, a newly established biopharmaceutical company, has completed a $45 million Series A financing. eFFECTOR is focused on inventing and developing small molecule drugs to selectively regulate protein synthesis, also known as translation, with an initial emphasis on cancer. 

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PRA Holdings submits draft registration statement for IPO

Wednesday, May 22, 2013 10:27 AM

PRA Holdings, a global CRO, has submitted a confidential draft registration statement on Form S-1 to the U.S. Securities and Exchange Commission (SEC) for a possible initial public offering of shares of its common stock. The number of shares to be offered and the price range for the offering have not yet been determined.

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Janssen Biotech’s Simponi receives FDA approval for ulcerative colitis

Monday, May 20, 2013 08:00 AM

The FDA has approved Janssen Biotech’s Simponi (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine.

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FDA approves GSK’s Breo Ellipta to treat COPD

Friday, May 17, 2013 01:25 PM

The FDA has approved GlaxoSmithKline and Theravance’s Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. 

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Regenesis Biomedical names Scott Brooks as CEO

Friday, May 17, 2013 11:28 AM

The board of directors of Regenesis Biomedical, a privately held medical technology company focused on tissue regeneration, has unanimously elected Scott Brooks as the next chief executive officer and member of the board of directors, succeeding Virginia Rybski. Brooks will assume his new role immediately.

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PCORI opens second year of research funding with $81M

Friday, May 17, 2013 10:30 AM

The Patient-Centered Outcomes Research Institute (PCORI), an independent, non-profit organization, opened its second year of funding of patient-centered comparative clinical effectiveness research (CER), revising its broad funding announcements to clarify key review criteria and application definitions.

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Third Rock Ventures expands, strengthens team

Wednesday, May 15, 2013 09:38 AM

Third Rock Ventures, a venture capital firm focused on building healthcare companies, has expanded and strengthened its team with several appointments and role changes. These additions allow Third Rock to continue to support the launch of new companies focused on disruptive areas of science and medicine, the maturation and development of its current portfolio companies and the overall strategy and direction of the firm.

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Quintiles completes IPO of 27,236,841 shares of common stock

Wednesday, May 15, 2013 09:18 AM

Quintiles completed its initial public offering of 27,236,841 shares of its common stock at a price to the public of $40.00 per share.

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September 30

Novartis-Walgreens pilot study blurring the line between retail pharmacy, investigative site

CISCRP to launch traveling science museum exhibit to demystify clinical trial participation

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The CenterWatch Monthly

October

New growth and decline in Asia clinical trials
South Korea, Japan, China see big growth in 1572s, while India posts huge drop

Harnessing Big Data to transform clinical trials
From protocol to patient recruiting, data analytics can yield valuable insights

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September

Sponsors look to collaborate on comparator drugs
Co-therapies, comparators are in 60% of studies, cost $25m per company a year

Early adopters implement risk-based monitoring pilot programs
Experiments aim to offer long-term solutions, despite short-term uncertainties

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