News

ISTA shares slides as FDA rejects eye therapy

The FDA turned thumb's down on ISTA Pharmaceuticals T-Pred topical steroid for inflammatory eye conditions. Regulators rejected ISTA's contention that the trial data supported its position that the therapy was equivalent to other products already approved to treat similar conditions. ISTA shares plunged 19 percent on the news.

"We believe our clinical study met the endpoints that ISTA and the FDA agreed to in the Special Protocol Assessment," chief executive Vicente Anido said in a …

Schering-Plough CEO applauded for turnaround

BusinessWeek adds to the praise that's been heaped around Schering-Plough CEO Fred Hassan. After giving shareholders a dose of realism in 2003 when he took over, Hassan has been steadily rebuilding the company and positioning it for the future. Through it all he's had to inspire demoralized workers as well as investors, and has been given a tremendous amount of credit …

Abbott reports success in mid-stage psoriasis trial

Abbott Laboratories announced positive data from a mid-stage study of its experimental psoriasis drug ABT-874, a follow-up drug to Humira. Aside from the control group, researchers divided up patients into five groups which received different doses. At least 90 percent of the patients in four of the five groups saw a 75 percent improvement in the severity of their skin lesions.

- check out the release on the …

Reimportation issue makes a comeback in Senate

The U.S. Senate easily passed a bill allowing for drug reimports. Supporters harshly criticized drug makers for pushing the world's highest prices in the United States while critics fell back on their position that regulators couldn't guarantee the safety of imported drugs. White House advisers said they would back a veto of any reimportation bill, which has been repeatedly rejected by top federal officials.

Reimportation has been a big issue in biotechnology. With drug developers …

GPC to shutter Waltham, MA facility in consolidation

Germany's GPC Biotech announced on Thursday that it is shuttering its operations in Waltham, MA and laying off 16 percent of its workers as it consolidates its drug discovery programs in Munich. The decision follows the termination of a collaboration with Altana in Waltham. GPC bought Axxima Pharmaceuticals in 2005 and hired its research scientists.

- for more, check out this release on the closing
- here's the report from The Boston Globe

SPOTLIGHT: No new adverse Tysabri events


Ten months and 10,000 patients after Tysabri was returned to the market for MS, there have been no new occurrences of the lethal infections that triggered its sudden removal in early 2005. Neurologists welcomed the news but said there was still plenty of reason to remain cautious about using the drug. Even after safety questions had been raised about Tysabri, though, many patients had …

ALSO NOTED: Actavis out of race for Merck KGaA unit; Actavis to buy Glaxo drug; and much more...

> Concerned that they aren't addressing the different ways various ethnic groups respond to medication, researchers are mounting major efforts to recruit varied racial and ethnic groups for clinical trials. Report

> Actavis has been asked to pull out of the bidding for Merck KGaA's generic drug unit after submitting a bid a few hundred million euro below the offers …

Press Release: Medarex to Receive Milestone Payment from Amgen

Press Release: Medarex to Receive Milestone Payment from Amgen

Press Release: Expression Genetics Receives Orphan Drug Grant from FDA

Press Release: Expression Genetics Receives Orphan Drug Grant from FDA

Press Release: New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

Press Release: New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

Press Release: Cougar Biotechnology Announces $50 Million Private Placement

Press Release: Cougar Biotechnology Announces $50 Million Private Placement

Press Release: Lyrica Significantly Reduced Pain and Helped Patients Manage the Symptoms of Fibromyalgia

Press Release: Lyrica Significantly Reduced Pain and Helped Patients Manage the Symptoms of Fibromyalgia

Press Release: Once-yearly Reclast Significantly Reduced Bone Fractures in Women with Postmenopausal Osteoporosis

Press Release: Once-yearly Reclast Significantly Reduced Bone Fractures in Women with Postmenopausal Osteoporosis

Press Release: AVEO Pharmaceuticals Closes $53 Million in Series D Funding

Press Release: AVEO Pharmaceuticals Closes $53 Million in Series D Funding

Press Release: FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

Press Release: FDA Proposes New Warnings About Suicidal Thinking, Behavior in Young Adults Who Take Antidepressant Medications

Press Release: Lyrica Significantly Reduced Pain and Helped Patients Manage the Symptoms of Fibromyalgia

Press Release: Lyrica Significantly Reduced Pain and Helped Patients Manage the Symptoms of Fibromyalgia

YM posts positive inhaled pain drug data

Bouncing back from discouraging preliminary results, YM BioSciences is reporting that a Phase IIb trial of AeroLEF in patients with post-operative pain following orthopedic surgery met the primary endpoint of the study. AeroLEF is an inhaled-delivery composition of free and liposome encapsulated fentanyl for the treatment of moderate to severe acute pain, including cancer …

Pfizer touts blockbuster drug for fibromyalgia

Pfizer is touting a late stage study of its painkiller Lyrica for the treatment of fibromyalgia, a little-understood chronic pain condition that is thought to result from neurological changes in how patients perceive pain. Patients taking the drug reported a 50 percent decrease in pain compared to those taking placebo, as well as improvements in overall health status and outcomes. The study results were submitted to the FDA as part of a supplemental NDA for Lyrica for the treatment of …

Once-yearly osteoporosis drug proves promising

A new study finds a once-yearly treatment with Novartis' zoledronic acid, a drug already approved for Paget's disease, could offer an alternative for women suffering from postmenopausal osteoporosis. Results from the study of 7,700 women show zoledronic acid reduced the frequency of fractures among the areas of the body that are typically affected by osteoporosis, including the hip, spine and …

AVEO gains $53M in financing

Cambridge, MA-based AVEO Pharmaceuticals gained $53 million in its fourth round of financing. AVEO says it will use the funding to accelerate the development of the company's pipeline of cancer therapies. New investors include Biogen Idec, Bessemer Venture Partners, Merlin BioMed Group, Mitsubishi UFJ Financial Group and Vatera Holdings. This round includes a $10 million equity investment from Schering-Plough as part of the collaboration agreement to develop and commercialize AVEO's …