Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and welcome to another working week. And this looks to be a hot one. Nonetheless, we hope to keep the Pharmalot corporate campus relatively cool by resoting to iced glasses of stimulation. After all, our neurons are not fussy about such things, which is helpful, since there is much to do. We trust you relate. So time to dig in and get going. Here are some tidbits to help you along. Have a grand day and do stay in touch... AstraZeneca CFO Simon Lowth To Join BG Group (Dow Jones) Aveo SEC Subpoena Raises Scrutiny Of Co-Founder (Houston Business Journal) Discrimination Suit Filed By Former Glaxo Employee Gets...
Source: Pharmalot - July 15, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Hello, folks, and how are you today? Summer may be in full swing, but we are as busy as ever here on the Pharmalot corporate campus, where clouds are hovering and wildlife is roaming. Our mission today, which involves reading documents and chatting up interesting people, requires several cups of stimulation. We trust you relate. So grab something stimulating yourself and dig in to the tidbits below. Hope you conquer the world and feel free to write us at ed@pharmalot.com We accept classified information... FTC Asks Actavis For More Info On Warner-Chilcott Deal (Associated Press) Vivus Shareholder To Vote For Dissident Dire...
Source: Pharmalot - July 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

The Last PPAR Compound?
Roche has announced that they're halting trials of aleglitazar, a long-running investigational drug in their diabetes portfolio. I'm noting this because I think that this might be the absolute last of the PPAR ligands to fail in the clinic. And boy howdy, has it been a long list. Merck, Lilly, Kyorin, Bristol-Myers Squibb, Novo Nordisk, GlaxoSmithKline, and Bayer are just the companies I know right off the top of my head that have had clinical failures in this area, and I'm sure that there are plenty more. Some of those companies (GSK, for sure) have had multiple clinical candidates go down, so the damage is even worse tha...
Source: In the Pipeline - July 11, 2013 Category: Chemists Tags: Drug Development Source Type: blogs

Start With Three Drugs?
By David Spero A new study says that people newly diagnosed with Type 2 can do better if they are immediately started on a three-drug combo. Does this make sense to you? Is it good science or bad medicine? Muhammad A. Abdul-Ghani, MD, from the University of Texas Health Science Center at San Antonio, presented the findings at the ADA Scientific Sessions in Chicago. The study enrolled 155 people with Type 2 diabetes. The average time after diabetes diagnosis was five months. None of them were taking diabetes medications at the beginning of the trial. Their average HbA1c was 8.6%. Half the subjects got "conventional therap...
Source: Diabetes Self-Management - July 10, 2013 Category: Diabetes Authors: David Spero Source Type: blogs

Pharmalot... Pharmalittle... The Weekend Nears
Greetings, everyone. This may be the middle of the week, but a long holiday weekend will soon begin on this side of the pond and so we are getting a head start on one of our favorite pasttimes: daydreaming about our plans. The possibilities seem almost endless, but we know that our list does include hanging with the short people, catching up on reading, puttering about the mansion and taking a nap or three. We may even find time to socialize. But what about you? Anything special on the menu? You could catch up with friends and other important people. This is a lovely time of year to enjoy the great outdoors. Or perhaps you...
Source: Pharmalot - July 3, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Final June Diabetes News Snippet Post
Jennysaid... The FDA is taking another look at Avandia's relationship to heart disease. http://www.forbes.com/sites/matthewherper/2013/06/04/battleground-fda-how-tomorrows-avandia-panel-could-help-shape-the-future-of-diabetes/But whatever they conclude about whether or not Avandia causes heart attacks, we know that it, like Actos, also weakens the bones over time and makes them prone to fracture, since it converts that stem cells that should become bone cells into baby fat cells.It, like Actos, also raises the chances of experiencing retinal edema--swelling in the blood vessels in your eye that can contribute to blindn...
Source: Diabetes Update - July 3, 2013 Category: Diabetes Authors: Jenny Source Type: blogs

Has pancreatic damage from glucagon suppressing diabetes drugs been underplayed? - BMJ
BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3680 (Published 10 June 2013) Cite this as: BMJ 2013;346:f3680Article Related content Article metrics Deborah Cohen, investigations editor Author Affiliations dcohen@bmj.com Incretin mimetics have been called “the darlings of diabetes treatment” and they may soon also be licensed for treating obesity. But a BMJ investigation has found growing safety concerns linked to the drugs’ mechanism of action. Deborah Cohenasks why patients and doctors have not been told. They’ve been touted as th...
Source: PharmaGossip - June 11, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Takeda And The Millenium Reorganization: Protopapas Explains
Last month, Takeda Pharmaceuticals undertook yet another reorganization, but its latest effort to jumpstart operations held a surprise. Deborah Dunsire, who ran the autonomous Millenium Pharmaceuticals unit that the Japanese drugmaker purchased five years ago for $8.8 billion, resigned after it became clear the streamlining meant she would no longer be a ceo. And so, one of her long-time lieutenants, Anna Protopapas, 48, who has worked at Millennium for 16 years, most recently as executive vice president and head of global business development, replaced her and now runs the Takeda oncology operation in Cambridge, Massachus...
Source: Pharmalot - June 7, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Takeda loses cancer suit over Actos
LOS ANGELES – Takeda Pharmaceutical Co. owes $6.5 million in damages to a California man who said Asia’s largest drugmaker failed to warn consumers its Actos diabetes drug could cause cancer, a jury said in the first of more than 3,000 lawsuits over the medication to go to trial. http://www.japantimes.co.jp/news/2013/04/29/national/takeda-loses-cancer-suit-over-actos-2/#.UX1LFny9KK0 (Source: PharmaGossip)
Source: PharmaGossip - April 28, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

First-in-Class Drug for Type 2
By Diane Fennell On March 29, the US Food and Drug Administration (FDA) approved the diabetes drug Invokana (generic name canagliflozin) for use, in conjunction with a healthful diet and physical activity, in adults with Type 2 diabetes. It is the first drug in a new class of medicines known as sodium glucose cotransporter 2 (SGLT2) inhibitors. In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Invokana blocks the reabsorption of glucose by ...
Source: Diabetes Self-Management - April 5, 2013 Category: Diabetes Authors: Diane Fennell Source Type: blogs

FDA Approves First SGLT2 Inhibitor For Diabetes
The FDA said today that it had approved canaglifozin (Invokana, Johnson & Johnson), the first of a new class of diabetes drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canaglifozin is indicated to improve glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The drug has been studied as monotherapy and in combination with other common treatments for type 2 diabetes including metformin, sulfonylurea, pioglitazone, and insulin. Click here to read the full post on Forbes. (Source: CardioBrief)
Source: CardioBrief - March 29, 2013 Category: Cardiology Authors: Larry Husten Tags: People, Places & Events Prevention, Epidemiology & Outcomes canaglifozin Diabetes mellitus food and drug administration type 2 diabetes Source Type: blogs

March Diabetes News Snippet Post
Here are all the news items posted in March: Jennysaid... People taking Byetta, Victoza, Januvia, and Onglyza had less heart failure than those not on these drugs. http://www.sciencedaily.com/releases/2013/03/130310164109.htmHowever, it is likely this is because Avandia and Actos CAUSE heart failure, rather than that these other drugs prevent it. People are rarely put on both families of drugs at once. It may also be because these GLP-1 related drugs are mostly prescribed to affluent, younger people with diabetes and good health insurance, while poorer people are put on the cheap sulfonylurea drugs which are now known to ...
Source: Diabetes Update - March 11, 2013 Category: Diabetes Authors: Jenny Source Type: blogs

Takeda Didn’t Warn of Actos Cancer Risk, Lawyer Says
Takeda Pharmaceutical Co. (4502), Asia’s biggest drugmaker, failed to warn doctors of the cancer risk associated with its Actos diabetes treatment, a lawyer said as the first of more than 3,000 lawsuits over the drug goes to trial. Takeda sales representatives never warned a doctor for California resident Jack Cooper in more than 195 visits, Cooper’s lawyer Michael J. Miller said today in opening statements in state court in Los Angeles. The doctor prescribed the drug to Cooper in 2006. The Osaka-based company is facing thousands of lawsuits alleging Actos caused bladder cancer or other ailments among patients, accor...
Source: PharmaGossip - February 28, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs

Pancreatitis Risks And A Pair Of Diabetes Drug
Yet another potentially worrisome sign for a pair of widely used diabetes drugs. A new study indicates that Merck’ Januvia and Bristol-Myers Squibb’s as Byetta can double the risk of developing pancreatitis, which is an inflammation of the pancreas that is linked to cancer and kidney failure. This is the same issue that has plagued both drugs over the past few years. The study, which examined insurance records for more than 2,500 diabetics between February 2005 and December 2008, found that patients hospitalized with pancreatitis were twice as likely to be taking either of the drugs than a control group of Type...
Source: Pharmalot - February 26, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Bristol Myers Squibb Byetta Diabetes Eli Lilly Januvia Merck Novo Nordisk Victoza Source Type: blogs

Three New Drugs for Type 2 Diabetes Approved
By Diane Fennell On January 26, pharmaceutical manufacturer Takeda announced the approval of its Type 2 diabetes drug, Nesina (generic name alogliptin) by the US Food and Drug Administration (FDA). It is the fourth drug in a class of medicines known as DPP-4 inhibitors, joining Januvia (saxagliptin), Onglyza (sitagliptin), and Tradjenta (linagliptin). Approved simultaneously with Nesina were the drugs Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone [brand name Actos]). DPP-4 inhibitors work to lower blood glucose by blocking the action of an enzyme known as dipeptidyl peptidase 4, or DPP-4. DPP-...
Source: Diabetes Self-Management - February 8, 2013 Category: Diabetes Authors: Diane Fennell Source Type: blogs