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Home » Newsletters » BioWorld

BioWorld

Sep. 22, 2011

View Archived Issues

FDA Offers Path for Contrave Approval; Orexigen Soars

Following a meeting with officials in the FDA's Office of New Drugs, Orexigen Therapeutics Inc. has received the green light to resolve its complete response letter for Contrave (naltrexone HCI/bupropion HCI) and resubmit the new drug application. Read More

'Plodding, Methodical' Paper Punctures Ideas on Sirtuins

British researchers published experiments today that challenge one of the more compelling scientific stories of the past decades: the idea that the enzyme Sir2, a member of an enzyme class known as the sirtuins, affects life span, and is activated by caloric restriction. Read More

FDA Urged to Stop Regulating By Guidance, Enforcement

WASHINGTON – The FDA's increasing tendency to regulate by guidance and enforcement in lieu of formal rulemaking is getting some pushback. Read More

Finnish Start-up Emerges Post Merck/Schering-Plough Merger

LONDON – Merck & Co Inc. out-licensed a portfolio of gene therapy products into a new Finnish company, FKD Therapies OY, which was co-founded by Nigel Parker, former CEO of UK gene therapy specialist firm Ark Therapeutics plc. Read More

Financings Roundup

New Health Capital Partners LLC, of New York, closed its New Health Capital Partners Fund I LP with an initial $150 million commitment from ORIX USA Asset Management. Read More

Other News To Note

Applied Genetic Technologies Corp., of Gainesville, Fla., received a $1.5 million grant from the Foundation Fighting Blindness to fund preclinical studies of a gene therapy for X-linked retinoschisis. Read More

Stock Movers

Read More

Clinic Roundup

Repros Therapeutics Inc., of The Woodlands, Texas, said it started dosing of the final cohort in its Phase II low-dose trial of Proellex, which will involve a dose of 12 mg per day. Read More

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