BioCentury | Apr 1, 2013
Strategy

Shire sees opportunity

With two ophthalmics deals in as many weeks, Shire plc has revealed the next specialty area in which it wants a foothold. The company believes the small size of the ophthalmic practitioner population - about 42,000...
BC Week In Review | Jan 2, 2012
Company News

Santarus, Shore Therapeutics sales and marketing update

Shore granted Santarus exclusive rights to commercialize 40 and 120 mg Fenoglide fenofibrate in the U.S. Santarus will pay $11 million up front. Beginning in 2013, Shore is eligible for 5% royalty on sales up...
BC Week In Review | Jun 27, 2011
Clinical News

LCP-Tacro tacrolimus: Phase III data

The open-label, international Phase III Study 3001 trial in 326 stable kidney transplant patients showed that once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus on a composite of death, graft failure,...
BioCentury | Jun 27, 2011
Finance

What to do with $101M

Last week's $101M tranched series B round for oncology play Tesaro Inc. is expected to get the company to NDA submission for its lead candidate, in-license up to two additional compounds and advance a preclinical...
BioCentury | Jun 27, 2011
Finance

Highlights of weekly biotech stock moves

Regulatory milestones Acura Pharmaceuticals Inc. (NASDAQ:ACUR) gained $0.63 (16%) to $4.50 on Monday after FDA approved an NDA from partner Pfizer Inc. (NYSE:PFE) for Oxecta oxycodone (formerly Acurox oxycodone without niacin) to manage acute and...
BC Extra | Jun 22, 2011
Clinical News

LCP-Tacro meets Phase III endpoint

LifeCycle Pharma A/S (CSE:LCP) said once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus on a composite of death, graft failure, biopsy-proven acute rejection or loss to follow-up at 12 months as...
BC Week In Review | May 9, 2011
Clinical News

Antara fenofibrate regulatory update

FDA issued a new quarterly report on safety information emerging from its Adverse Events Reporting System (AERS) during 4Q10 in which the agency identified a "paradoxical" reduction in HDL cholesterol in patients receiving fenofibrate products....
BC Week In Review | Apr 18, 2011
Company News

LifeCycle Pharma board of directors update

LifeCycle Pharma A/S (CSE:LCP), Horsholm, Denmark   Business: Metabolic, Transplant, Drug delivery   Appointed: Kim Bjornstrup as chairman, formerly vice chairman of Octapharma AG ; he replaces Paul Edick, CEO of Durata Therapeutics Inc.  ...
BC Week In Review | Jan 10, 2011
Clinical News

Tacrolimus: Phase II data

Top-line data from an open-label Phase II trial in 58 patients showed that once-daily LCP-Tacro tablets demonstrated comparable tolerability to twice-daily Prograf tacrolimus capsules over 1 year. The trial was not powered for safety or...
BC Week In Review | Oct 25, 2010
Clinical News

Tacrolimus: Phase III started

LifeCycle began the double-blind, double-dummy, international Phase III Study 3002 trial to compare once-daily LCP-Tacro vs. twice-daily Prograf tacrolimus in 540 patients. The trial will include a 12-month treatment period followed by a blinded, 12-month...
Items per page:
1 - 10 of 90
BioCentury | Apr 1, 2013
Strategy

Shire sees opportunity

With two ophthalmics deals in as many weeks, Shire plc has revealed the next specialty area in which it wants a foothold. The company believes the small size of the ophthalmic practitioner population - about 42,000...
BC Week In Review | Jan 2, 2012
Company News

Santarus, Shore Therapeutics sales and marketing update

Shore granted Santarus exclusive rights to commercialize 40 and 120 mg Fenoglide fenofibrate in the U.S. Santarus will pay $11 million up front. Beginning in 2013, Shore is eligible for 5% royalty on sales up...
BC Week In Review | Jun 27, 2011
Clinical News

LCP-Tacro tacrolimus: Phase III data

The open-label, international Phase III Study 3001 trial in 326 stable kidney transplant patients showed that once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus on a composite of death, graft failure,...
BioCentury | Jun 27, 2011
Finance

What to do with $101M

Last week's $101M tranched series B round for oncology play Tesaro Inc. is expected to get the company to NDA submission for its lead candidate, in-license up to two additional compounds and advance a preclinical...
BioCentury | Jun 27, 2011
Finance

Highlights of weekly biotech stock moves

Regulatory milestones Acura Pharmaceuticals Inc. (NASDAQ:ACUR) gained $0.63 (16%) to $4.50 on Monday after FDA approved an NDA from partner Pfizer Inc. (NYSE:PFE) for Oxecta oxycodone (formerly Acurox oxycodone without niacin) to manage acute and...
BC Extra | Jun 22, 2011
Clinical News

LCP-Tacro meets Phase III endpoint

LifeCycle Pharma A/S (CSE:LCP) said once-daily LCP-Tacro met the primary endpoint of non-inferiority to twice-daily Prograf tacrolimus on a composite of death, graft failure, biopsy-proven acute rejection or loss to follow-up at 12 months as...
BC Week In Review | May 9, 2011
Clinical News

Antara fenofibrate regulatory update

FDA issued a new quarterly report on safety information emerging from its Adverse Events Reporting System (AERS) during 4Q10 in which the agency identified a "paradoxical" reduction in HDL cholesterol in patients receiving fenofibrate products....
BC Week In Review | Apr 18, 2011
Company News

LifeCycle Pharma board of directors update

LifeCycle Pharma A/S (CSE:LCP), Horsholm, Denmark   Business: Metabolic, Transplant, Drug delivery   Appointed: Kim Bjornstrup as chairman, formerly vice chairman of Octapharma AG ; he replaces Paul Edick, CEO of Durata Therapeutics Inc.  ...
BC Week In Review | Jan 10, 2011
Clinical News

Tacrolimus: Phase II data

Top-line data from an open-label Phase II trial in 58 patients showed that once-daily LCP-Tacro tablets demonstrated comparable tolerability to twice-daily Prograf tacrolimus capsules over 1 year. The trial was not powered for safety or...
BC Week In Review | Oct 25, 2010
Clinical News

Tacrolimus: Phase III started

LifeCycle began the double-blind, double-dummy, international Phase III Study 3002 trial to compare once-daily LCP-Tacro vs. twice-daily Prograf tacrolimus in 540 patients. The trial will include a 12-month treatment period followed by a blinded, 12-month...
Items per page:
1 - 10 of 90