07:00 , Aug 10, 2015 |  BC Week In Review  |  Clinical News

Lyxumia lixisenatide: Phase IIIb data

The open-label, international Phase IIIb GetGoal Duo-2 trial in 894 Type II diabetics showed that once-daily subcutaneous Lyxumia plus Lantus insulin glargine met the co-primary endpoints of non-inferiority to once- and thrice-daily Apidra insulin glulisine...
07:00 , Aug 18, 2014 |  BC Week In Review  |  Company News

MannKind, Sanofi deal

MannKind granted Sanofi exclusive, worldwide rights to develop and commercialize Afrezza to treat adults with Type I and II diabetes. MannKind will receive $150 million in cash up front and is eligible for up to...
01:21 , Aug 12, 2014 |  BC Extra  |  Company News

MannKind licenses Afrezza to Sanofi

MannKind Corp. (NASDAQ:MNKD) granted Sanofi (Euronext:SAN; NYSE:SNY) exclusive, worldwide rights to develop and commercialize Afrezza inhaled insulin to treat adults with Type I and II diabetes. MannKind will receive $150 million in cash up front...
07:00 , Aug 11, 2014 |  BioCentury  |  Strategy

Profusion of exclusions

Express Scripts Holding Co. 's 2015 formulary exclusions offer hope that companies can renegotiate once-excluded drugs back into coverage. But the pharmacy benefits manager appears to be expanding the number of drugs and drug classes...
07:00 , Jul 28, 2014 |  BioCentury  |  Strategy

Partnering Afrezza

Now that Afrezza has crossed the regulatory finish line, MannKind Corp. 's task is to find a partner willing to take on the large Phase IV safety trial that is required by FDA - and...
08:00 , Dec 16, 2013 |  BioCentury  |  Strategy

Out in the cold

New excluded drugs lists devised by pharmacy benefits managers are raising the hurdle for reimbursement of drugs the PBMs' pharmacy and therapeutics committees consider to be clinically equivalent to cheaper drugs. Drugs that are not...
08:00 , Feb 28, 2011 |  BC Week In Review  |  Clinical News

Apidra insulin glulisine regulatory update

sanofi-aventis received 2 warning letters from FDA regarding the company's failure to adequately address cGMP deficiencies and postmarketing reporting violations identified during FDA inspections last year. The pharma has 15 days from the receipt of...
08:00 , Feb 28, 2011 |  BC Week In Review  |  Clinical News

Multaq dronedarone regulatory update

sanofi-aventis received 2 warning letters from FDA regarding the company's failure to adequately address cGMP deficiencies and postmarketing reporting violations identified during FDA inspections last year. The pharma has 15 days from the receipt of...
07:00 , Jul 19, 2010 |  BC Week In Review  |  Clinical News

Apidra insulin glulisine: Phase IV data

Data from the open-label, U.S. Phase IV RABBIT-2 Surgery trial in 211 Type II diabetics undergoing general surgery showed that a significantly higher proportion of patients receiving daily Lantus insulin glargine plus Apidra insulin glulisine...
07:00 , Jul 19, 2010 |  BC Week In Review  |  Clinical News

Hylenex: Phase I data

In a 6-way crossover, double-blind Phase I trial in 14 healthy volunteers, the addition of rHuPH20 to Apidra insulin glulisine, Humalog insulin lispro or NovoLog insulin aspart increased insulin exposure during the first hour after...