FDA Law Weekly

Abiomed, Inc. - FDA approval sought for AbioCor replacement heart

Adolor Corp. - FDA accepts Entereg (alvimopan) NDA for review

Advanced Stent Technologies - FDA conditional approval granted to use Petal Stent System in BOSS trial

Advanced Viral Research Corp. - Successful pre-IND meeting for AVR118 with FDA reported

Aeolus Pharmaceuticals, Inc. - IND allowed for ALS treatment

Akiba Hebrew Academy - Agent-based analysis of smallpox preparedness performed

Alliant Pharmaceuticals, Inc. - FDA approves Methylin Chewable Tablets, Methylin Oral Solution for ADHD

Altus Pharmaceuticals, Inc. - TheraCLEC selected for FDA's Continuous Marketing Application Pilot 2 program

Amarillo Biosciences, Inc. - Request submitted to FDA for designated new animal drug listing

Andrx Corporation - Pharmaceutical firm reports on meeting with FDA about manufacturing facilities

Animas Corporation - Health Canada approves Animas IR 1200 insulin pump for distribution

Antidepressants - FDA advisers want stronger suicide risk warnings about child antidepressants

Antigenics, Inc. - Alastair Wood joins immunotherapeutics company board of directors

Axis-Shield - Automated test to monitor Rapamune (sirolimus) submitted to FDA

Bayer HealthCare Pharmaceuticals - Aprotinin injection during artery bypass graft surgery may reduce risk of stroke

7TM Pharma - Additional drug discovery deal with Synaptic signed

ARC Pharmaceuticals, Inc. - Paper describes new treatment for prevention of postsurgical adhesions

Academic Network - Prize for modern nutrition from the Federation of Swiss Milk Producers awarded

Acadia Pharmaceuticals, Inc. - Study shows ACP-103 improves clinical profile of haloperidol treatment

Aerocrine AB - Hand-held device measures airway inflammation

Akita University Hospital - Shiga toxin 1-neutralizing Fab fragment isolated

Alfacell Corporation - Biotech firm's shares to trade on NASDAQ SmallCap market

All India Institute of Medical Science - Antisense repression of p53 raises cancer cell chemosensitivity

American College of Chest Physicians - Guidelines offer new recommendations for travelers

American Medical Association - Outline provided for developing national clinical trials registry

Anadys Pharmaceuticals, Inc. - Pharmaceutical companies sign drug discovery deal

Assisted Reproduction - Patient drop-out rate is an indicator of an IVF program's quality

Assoc. of Clinical Research Org. - CRO group establishes global influence with Input to EMEA

Association of Oral and Maxillofacial Surgeons - Oral surgeon warns: Herbals, surgery, and anesthesia don't always mix

AstraZeneca - Crestor reaches 10M prescription milestone

AstraZeneca - New data presented for Crestor in patients with metabolic syndrome

Boehringer Ingelheim - Evotec enters agreement to help identify GPCR modulator-based new medicines

Boston Scientific Corp. - FDA completes inspection of stent-maker's Galway facility; no problems reported

Bristol Myers Squibb Co. - Monoclonal antibody augments tallysomycin S-10b potency

Cancer de Lutte Contre Cancer Francois Baclesse - Suicide gene therapy makes ovarian cancer susceptible to chemotherapy

Cel-Sci Corporation - Multikine immunotherapy drug lowers cholesterol in cancer study patients

Celal Bayar University, Manisa - TGF-beta₁ may be involved in the pathogenesis of chronic liver disease

Cellegy Pharmaceuticals, Inc. - Interim results reported for phase II study using Tostrelle gel

Center Brasileiro Pesquisas Fis, Rio De Janeiro - Novel HIV glucosidase inhibitors developed with computer-aided technology