Ranbaxy Slams Consumers For Seeking Lipitor Recall
Last November, Ranbaxy Laboratories recalled more than three dozen lots of generic Lipitor because some contained tiny glass particles and the generic drugmaker then halted all production of the cholesterol pill. Not surprisingly, the move prompted lawsuits, even though the FDA indicated the likelihood of patient harm appeared to be “extremely low” (back story here and here).
But several consumers are asking a federal judge to order a complete recall and Ranbaxy is arguing vociferously against such a move. And as part of its argument, the generic drugmaker – which is already operating under a consent decr...
Source: Pharmalot - February 21, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Consent Decree FDA Lipitor Ranbaxy Laboratories Source Type: blogs
Pfizer To Close CovX Unit In San Diego, Axe 100 Jobs
Five years after buying the privately held CovX biotech in hopes of bolstering its withering pipeline, Pfizer is now closing the unit as part of ongoing cuts and reorganization in research and development. At the time, the drugmaker touted CovX for its technology platform and preclinical work in metabolic and oncology research (read here).
“We continue to prioritize our R&D capital allocation to drive the next wave of innovative medicines and vaccines to patients, from a robust pipeline. There has been no change in the amount we invest in R&D, but rather in the way that we invest it. As a result of this, we...
Source: Pharmalot - February 16, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Corey Goodman CovX Pfizer Wyeth Source Type: blogs
Who’s Afraid Of A Pill? Not Isis CEO Stan Crooke
We reported every side effect in gory detail… And we believe the liver safety is significantly better and will be proven out in medical practice. Kynmaro lowers all athrogenic lipids and increases HDL based on the study and we think this will matter greatly to lipidologists.
Pharmalot: How do you convince insurers?
Crooke: The evidence of the value Kynamro brings is overwhelming and the benefit in terms of cv events is observed in a two-to five-year timeframe, which is relevant to payers… From what Genzyme tells us, there’s a been a favorable response. It’s a very specific equation that has to be written for each ...
Source: Pharmalot - February 13, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Aegerion Pharmaceuticals Cholesterol Genzyme HDL Isis Pharmaceuticals Juxtapid Kynamro LDL Lipitor Orphan Drugs Sanofi Source Type: blogs
Shire to Forest on Deal List for AstraZeneca: Real M&A - Bloomberg
For AstraZeneca Plc to reverse its worst profit slide, the drugmaker needs to make its biggest purchase since at least 2007. AstraZeneca reported a 37 percent drop in 2012 earnings and forecast profit this year will decline “significantly more than revenue” after the $59 billion company suffered setbacks in developing new therapies to replace best-selling drugs that are losing patent protection. While Chief Executive Officer Pascal Soriot said he will focus on internal efforts and purchases of $3 billion to $4 billion to help boost the lowest valuations in the industry, Exane BNP Paribas said only a “transformationa...
Source: PharmaGossip - February 12, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Baby Boomers Living Longer, But Less Healthy Lives!
I just read some surprising results of a study published in Arch Intern Med. (2013;173(2):1-2) regarding the overall health status of aging baby boomers compared with the previous generation. The authors analyzed data from the National Health and Nutrition Examination Survey (NHANES), including NHANES III (1988-1994) (for previous generation) and the NHANES for 2007 to 2010 (for baby boomers), focusing on respondents who were aged 46 to 64 years during either period. "The 2 cohorts were compared with regard to health status, functional and work disability, healthy lifestyle characteristics, and presence of chronic disease....
Source: Pharma Marketing Blog - February 4, 2013 Category: Pharma Commentators Tags: statins Cholesterol baby boomers diabetes Life Expectancy Source Type: blogs
Lipitor & Plavix: The Last of the Small Molecule Best Sellers?
Forbes just published a list of "Best Selling Drugs of All Time" (see here). I created the following chart from the data cited (click on it for a larger view):"Tellingly," notes the Forbes author, Simon King, "each of the products in the list above best positioned to record an increase in peak annual sales over the next five years is a biologic; Humira, Enbrel, Rituxan, Herceptin and Lantus being the chief candidates. This is driven by a number of factors – the later launch of certain brands, for example – but also illustrates the robustness of leading biologic franchises that do not face direct substitutable generic c...
Source: Pharma Marketing Blog - January 28, 2013 Category: Pharma Commentators Tags: Drug prices Plavix Humira Lipitor Pfizer drug pipeline orphan drugs Blockbuster Source Type: blogs
Time to Refill Your Prescription For Zxygjfb
The brand names of drugs are famously odd. But they seem to be getting odder. That's the conclusion of a longtime reader, who sent this along:
I was recently perusing through the recent drug approval list and was struck by how strange the trade names have become. Perhaps it is a request from the FDA so that there are fewer prescription errors, but some of these are really bizarre and don't quite roll off the tongue. USAN names I can understand, but trade names, to me anyway, used to be much more polished (Viagra, Lipitor etc). Could it have to do with the fact that most of these are for cancer? I have a list below compar...
Source: In the Pipeline - January 28, 2013 Category: Chemists Tags: Business and Markets Source Type: blogs
Pharma Sets Record: Number of "Pay-for-Delay" Deals Hits 40 in 2012 Says FTC
According a new Federal Trade Commission (FTC) staff report, in Fiscal Year (FY) 2012, the number of "potentially anticompetitive patent dispute settlements" (aka, "Pay for Delay" deals) between branded and generic drug companies increased significantly compared with FY 2011, jumping from 28 to 40 (find the report here).Here's a plot of the data showing the trend over the past 9 years:The study also found that in nearly half of these settlements, branded firms may have used the promise that they would not develop or market an authorized generic (AG) as a payment to stall generic drug firms from marketing a competing produc...
Source: Pharma Marketing Blog - January 18, 2013 Category: Pharma Commentators Tags: Pay for Delay Lipitor Pfizer FTC Androgel Source Type: blogs
Pfizer's Pfourteenth Settlement - a Small Reminder of Continuing Impunity
Well, that did not take long. Less than a month after its last legal settlements were announced, Pfizer had to settle again. The Details of the Settlement This case, involving charges filed by the Texas Attorney General, was only reported locally, e.g., here in the Houston Business Journal:The state of Texas will receive more than $36 million from two civil Medicaid fraud settlements with Pfizer Inc and Endo Pharmaceuticals, Attorney General Greg Abbott said Friday. Both companies will pay $18.17 million to the state, plus attorney fees and relator shares. The federal government is also entitled to a sha...
Source: Health Care Renewal - January 11, 2013 Category: Health Medicine and Bioethics Commentators Tags: executive compensation deception boards of directors impunity Pfizer legal settlements governance Source Type: blogs
Pharma Deals North of $10 Billion Seen Returning in 2013 - Bloomberg
Get ready for the return of the $10 billion-plus drug deal. Pharmaceutical companies including Pfizer Inc. (PFE) and Bristol- Myers Squibb Co. (BMY) have spent the last several years digesting earlier acquisitions, refocusing their product development and setting aside cash in anticipation of expiring patents. Now, the expectation is they’re ready to start buying again. Led by Pfizer, in New York, and Whitehouse Station, New Jersey-based Merck & Co. (MRK), five of the largest U.S. drugmakers had more than $70 billion in cash, near cash and short-term investments at the end of the third quarter. ...
Source: PharmaGossip - January 7, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
How Much? Payers And The New Pfizer RA Pill
Two months ago, the FDA approved a pill from Pfizer called Xeljanz that is being used to treat adults with moderately to severely rheumatoid arthritis who did not respond to, or cannot tolerate, methotrexate, a standard of care. Some Wall Streeters expect the drug, which competes with such biologics as Humira, to become a blockbuster.
The drug is the first in a class of medications known as JAK inhibitors for RA and data has indicated the pill would offer similar efficacy to such widely used injectables that, collectively, generate some $13 billion in annual sales for treating rheumatoid arthritis. As noted previously, Xel...
Source: Pharmalot - January 3, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Abbvie Amgen Enbrel Humira Pfizer Rheumatoid Arthritis Xeljanz Source Type: blogs
Merck’s Combination Of Ezetimibe And Atorvastatin Combo Back On NDA Path
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year. Merck said yesterday that the FDA had accepted Merck’s resubmission of its NDA, which included additional data provided ...
Source: CardioBrief - January 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs
Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year. Merck said yesterday that the FDA had accepted Merck’s resubmission of its NDA, which included additional data provided ...
Source: CardioBrief - January 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs
Some Interesting Pharma Predictions for 2013
It's appropriate that I present a few pharma industry predictions for 2013 in the last post of the year to Pharma Marketing Blog. To compile the following list, I used data from surveys, looked at the past year as an indication of what may be important in 2013, and reviewed predictions from the usual suspects (e.g., people in the #pharma100 list).It's also a good time to revisit a survey I started a couple of years ago that attempted to predict future healthcare market scenarios that would impact the drug industry. The survey asks respondents how likely it is for certain events or conditions to unfold ...
Source: Pharma Marketing Blog - December 31, 2012 Category: Pharma Commentators Tags: Apps predictions DTC Advertising social media marketing Sales and Sales Reps Mobile Advertising counterfeit medicine Source Type: blogs
