Drugs & Medicaments

Drug maker Eli Lilly has agreed to pay more than $29 million to settle charges that four of its international subsidiaries paid bribes to win business, the Securities and Exchange Commission announced Thursday.
The SEC charged Eli Lilly (LLY, Fortune 500) with violating the Foreign Corrupt Practices Act due to payments made to government officials and associates by the company's subsidiaries in Russia, Brazil, China and Poland.

Drug maker Eli Lilly has agreed to pay more than $29 million to settle charges that four of its international subsidiaries paid bribes to win business, the Securities and Exchange Commission announced Thursday.
The SEC charged Eli Lilly (LLY, Fortune 500) with violating the Foreign Corrupt Practices Act due to payments made to government officials and associates by the company's subsidiaries in Russia, Brazil, China and Poland.

ScienceDaily (Nov. 2, 2011) -- A landmark study in mice identifies a biological mechanism that could help explain how tobacco products could act as gateway drugs, increasing a person's future likelihood of abusing cocaine and perhaps other drugs as well, according to the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health. The study is the first to show that nicotine might prime the brain to enhance the behavioral effects of cocaine.

Recently I have come across an interesting article from Dr. Mercola, Baking Soda staving off the cold and flu. What a wonderful find. The research and physiology meld for this common household item. It is inexpensive, safe, and a great addition to the acidic body. (More on acidic body later)

More evidence supporting the idea that rosiglitazone (Avandia, GlaxoSmithKline) does increase the risk of cardiovascular events has come from a new population-based study [1].

The retrospective case-control study, published in the December 12, 2007 issue of the Journal of the American Medical Association, was conducted in older patients with diabetes and showed that thiazolidinedione (TZD) treatment, primarily with rosiglitazone, was associated with an increased risk of congestive heart failure (CHF), myocardial infarction (MI), and mortality when compared with other combination oral hypoglycemic agent treatments.

The study has reignited the arguments surrounding the safety of rosiglitazone, with Dr Steven Nissen (Cleveland Clinic) issuing new calls for more forceful action on the drug from the Food and Drug Administration (FDA), while GlaxoSmithKline highlights limitations of the new study and continues to defend the cardiovascular profile of its product.

Desmopressin acetate intranasal formulations are no longer indicated for the treatment of primary nocturnal enuresis (PNE) because of the risk for severe hyponatremia that can lead to seizures and death, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday.

These formulations are currently marketed as DDAVP (sanofi-aventis US, LLC), Minirin (Ferring Pharmaceuticals, Inc), and Stimate (CSL Behring, LLC).

by David Gutierrez

(NewsTarget) A diabetes expert has claimed that pharmaceutical company GlaxoSmithKline threatened him with legal action after he raised concerns about the safety of the company's anti-diabetes drug rosiglitazone, marketed as Avandia.

In a written testimony to a congressional subcommittee, John Buse of the University of North Carolina said that he received phone calls from company executives in 1999, just after Avandia's release, warning him that his comments about the drug "were scurrilous enough to attempt to hold me liable for a loss in market capitalization." Buse later signed a statement, drafted by GlaxoSmithKline, attempting to alleviate the concerns that his comments had raised with stockholders.

LONDON–AstraZeneca PLC said yesterday it is buying U.S.-based biotech drug maker MedImmune Inc. in a $15.6 billion (U.S.) deal that will allow the British company to enter the vaccines market.

AstraZeneca, looking to strengthen its pipeline of future drugs as it faces patent challenges and escalating generic competition, will pay $58 per share for MedImmune, a 21 per cent premium to the stock's close Friday.

The deal, which AstraZeneca hopes to close in June, will increase the company's proportion of biotechnology drugs in its pipeline to 27 per cent from 7 per cent, and enlarge its total pipeline by 45 projects to 163 projects.

by Mike Adams, NewsTarget.com

The U.S. Senate Health, Education, Labor and Pensions Committee voted 15-5 to approve a bill that aims to strengthen FDA oversight of drug company advertising and post-approval follow-up studies. The bill was sponsored by Wyoming Republican Sen. Mike Enzi and Massachusetts Democrat Sen. Edward Kennedy. The primary motive for the bill is to give the FDA more power to stop a future Vioxx disaster from being repeated.

The Bush Administration is against the bill and offered sharp objections to the bill's provisions, saying it would slow down drug approvals. Republicans also argued that the banning of drug advertisements on television was "unconstitutional."

Genentech and FDA notified healthcare professionals of important new safety information regarding tracheoesophageal (TE) fistula formation in a recent clinical study in patients with limited-stage small cell lung cancer (SCLC).

This multicenter, non-randomized, single-arm phase II clinical trial study combined chemotherapy and radiation plus Avastin.

There have been two confirmed serious adverse events of TE fistula (one fatal) reported in the first 29 patients enrolled in this study. A third, fatal event (upper aerodigestive tract hemorrhage and de ath of unknown cause), was also reported, in which TE fistula was suspected but not confirmed. All three events occurred during the Avastin maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have also been reported in other lung and esophageal cancer studies using Avastin and chemotherapy alone or with concurrent radiation treatment.