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FT - Professor turns to internet to distribute polypill. By Andrew Jack
A medical professor frustrated by regulatory barriers has turned to the internet to distribute a combination of existing medicines for preventing heart attacks in healthy people. Professor Sir Nicholas Wald from the Wolfson Institute...Show More Summary
Lundbeck Fined $125M Over Pay-To-Delay Deal In Europe
In the latest move by regulators to clamp down on so-called pay-to-delay deals, the European Commission has fined Lundbeck and four other drugmakers for reaching agreements to block entry of generic versions of the best-selling Celexa antidepressant. Show More Summary
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and how are you today? Another busy day is unfolding here on the Pharmalot corporate campus, where the maintence crew is tending to a number of important projects. As for us, we are quaffing the usual cup of stimulatin - we are still enjoying Hazelnut Cinnamon Creme - and invite you to join us with a cup of your own. Show More Summary
For AZ's Onglyza SAVOUR is not a saviour
AstraZeneca has suffered another drug trial setback. Its diabetes drug Onglyza, developed with Bristol-Myers Squibb, failed to reduce heart risks or strokes in a large scale clinical trial. Despite investor hopes, the Savor trial showed...Show More Summary
EU fines Lundbeck for paying off pharma rivals
The European Commission has fined Danish pharmaceutical Lundbeck €93.8 million after the EU executive ruled that it had paid rival companies to delay market entry of generic versions of anti-depressant Citalopram. Prices of Citalopram fell by 90% when cheaper generic versions of the drug became widely available. http://euobserver.com/tickers/120551?
With a Top Secret Letter, HRSA Blesses Amgen’s New 340B Distribution Plan
Here’s some crucial 340B news—along with a perfect illustration of why the 340B drug discount program urgently needs fundamental reform and oversight.
Amgen just announced that Neulasta purchases by 340B covered entities must be made exclusively from such specialty distributors as AmerisourceBergen’s ASD Healthcare business. Show More Summary
Pharmaguy EU Tour 2013 - The Infographic
The following infographic was created as I was making my presentation -- "Overcoming Pharma's Social Media & Mobile Challenges" -- at Bayer Healthcare in Berlin last week. See here for more details about the venue and download the presentation here (pdf). Show More Summary
Young Law Group Announces Initiative Prosecuting Alleged Pharmaceutical Industry Kickbacks
Philadelphia, PA (PRWEB) June 18, 2013 Young Law Group, a leader in whistleblower law and False Claims Act litigation, announces a False Claims Act initiative aimed at ferreting out alleged, unlawful kickbacks in the healthcare industry. Show More Summary
New Photos, Same Blather
I've been meaning for some time to put up some new photos on the site, what with the original one being over ten years old by now. So here we are - a progress through time. The beard remains a constant, and I still have the T. S. Eliot paperback that I'm reading in the 1983 shot. Show More Summary
FDA Probes Deaths Linked to Long-Acting Zyprexa
By John Gever, Deputy Managing Editor, MedPage Today Published: June 18, 2013 SILVER SPRING, Md. -- Two patients died 3-4 days after injections with the long-acting antipsychotic drug olanzapine pamoate (Zyprexa Relprevv), prompting an FDA investigation. The agency has not determined whether the drug caused the fatalities. Show More Summary
ADA's Ratner: We Expect Patient Level Data From All Drugmakers
Last week, the NIH ran a workshop to examine the safety of several widely used diabetes drugs called GLP-1 inhibitors and whether a definitive link can be established to acute pancreatitis and pancreatic cancer, which were the subject of recent studies that generated considerable controversy. Show More Summary
Forcing Fungi to Make Stranger Compounds
Natural products come up around here fairly often, as sources of chemical diversity and inspiration. Here's a paper that combines them with another topic (epigenetics) that's been popular around here as well, even if there's some disagreement...Show More Summary
FDA Investigates Two Deaths In Zyprexa Patients
Here is a mystery that will be closely tracked. The FDA is probing the unexplained deaths of two people who were injected with long-acting Zyprexa, the antipsychotic, which is sold by Eli Lilly. Each died three to four days after receiving...Show More Summary
SCOTUS Opens Door For FTC, Congress to Stop Collusive Pay-for-Delay Deals
FOR IMMEDIATE RELEASE June 18, 2013 Contact: Kathy Melley Community Catalyst (617) 275-2861/ (617) 791-0708 kmelley@communitycatalyst.org Statement by Wells Wilkinson, Director of the Prescription Access Litigation Project at Community...Show More Summary
Is It Time To Overhaul The FDA? A Panel With Pharmalot
Is the FDA doing the right job? Some critics argue the agency fails to move fast enough to approve new drugs and still others maintain some decisions may be compromised by industry user fees or ties held by advisory panel members who made important recommendations. Show More Summary
Spinal Tap: Reviews Question Benefit Of Medtronic Spinal Product
As the result of an unusual effort designed to bolster transparency in clinical trials, two independent analyses have found that a Medtronic product used as a bone graft substitute in spinal fusion surgeries offers little benefit over...Show More Summary
Bernard Munos on The Last Twelve Years of Pharma
Bernard Munos (ex-Lilly, now consulting) is out with a paper reviewing the approved drugs from 2000 to 2012. What's the current state of the industry? Is the upturn in drug approvals over the last two years real, or an artifact? And is it enough to keep things going? Over that twelve-year span, the average drug approvals ran at 27 per year. Show More Summary
Pharmalot... Pharmalittle... Good Morning
Top of the morning to you. A shiny day is unfolding here on the Pharmalot corporate campus, where are the birds are chirping, the official mascots are fertilizing the assorted weeds and short people are hustling off to their final rounds of learning at the schoolhouses. Show More Summary
A holy mess
A Supreme Court decision Monday allowing federal regulators to continue challenging "pay-for-delay" deals between pharmaceutical companies and generic drug makers on anti-competitive grounds was greeted with dismay by industry observers after the court failed to rule whether such arrangements are always legal or illegal. Show More Summary
Repost: The Pay-for-Delay Tactic
Today, the Supreme Court ruled in favor of the Federal Trade Commission in its lawsuit against Actavis over so-called pay-for-delay tactics (PDF of Opinion). That is, paying money to a generic manufacturer to delay production of a drug …
- Supreme Court
- Affordable Care Act
- Office of Prescription Drug
- Federal Trade Commission
- European Medicines Agency
- School of Medicine
- Big Pharma
- Centers for Medicare
- New England Compounding Center
- Boehringer Ingelheim
- Eli Lilly
- Express Scripts
- Bristol-Myers Squibb
- Medicaid Services
- Off-Label Promotion
- Novo Nordisk
- Philadelphia Inquirer
- Clinical Trials
- Marcia Angell
- Bayer Healthcare
