Pharmacy in jobs, news, schools

Malaise and despair seem to have taken over the biotech venture and startup community of late. “Venture’s stress” is the cover story of BioCentury.  Biotech VCs are so distraught they are taking the case to Washington DC to lament the fate of our industry.  Venture funds focused on life sciences have struggled to raise money, and several diversified funds with healthcare have cut their allocations.  Prospect  Ventures decided not to move ahead with its recent fund because they didn’t have enough capital to deploy against their strategy.  The head of the NVCA, Mark Hessen, recently said that venture capital won’t return until the IPO market opens up again.  Times certainly seem tough for venture capital and for the biotechs we fund. Read more…

TRENTON, N.J. (AP) — The first combination pill for the millions of people with the dangerous combination of diabetes and high cholesterol won U.S. approval Friday, offering convenience — and savings — to patients taking multiple pills.Juvisync, a probable blockbuster developed by Merck & Co. Inc., will be launched in a few weeks. It combines Merck’s Type 2 diabetes pill Januvia with Zocor, a former Merck blockbuster in the widely used class of cholesterol drugs called statins.

The combination pill will sell for the same price as Januvia alone, about $215 per month. Generic versions of Zocor cost roughly $30 a month.That should make Juvisync attractive for the millions of diabetics currently not taking a statin. Guidelines from the American Diabetes Association recommend that diabetics who have heart disease or are over age 40 take a statin pill daily.”This provides a way to simplify their regimen and improve adherence,” said Dr. Susan Spratt, an endocrinologist at Duke University Medical Center.Spratt said many diabetes patients are taking six or more pills a day, including different types of pills for diabetes, blood pressure and high cholesterol. Read more…

Over the last few years there’s been a big increase in Big Pharma’s interest in rare diseases. With Genzyme’s success with drugs like Myozyme helping light the way, giants like GlaxoSmithKline, Pfizer, Merck and Novartis have been organizing their own rare disease drug shops. And the FDA’s more flexible attitude in how it judges the data from clinical trials for these drugs–as well as the 7 years of marketing exclusivity they earn along with some hefty tax credits–hasn’t hurt. Read more…

Today, the U.S. patent expires on the Pfizer’s Lipitor, the best-selling drug of all time. The first generic versions will go for sale, marking the end of a brand that has dominated the drug industry, lowered the cholesterol of tens of millions of patients, and generated more in annual sales than Major League Baseball or the entire box office of U.S. movies.

There may never be another medicine like it. That’s because of fundamental shifts in our understanding of biology, because of the demands made by patients, doctors, and society on new drugs, and because new drugs now have to compete with the super-cheap, generic versions of every medicine ever invented. Already, eight of ten prescriptions are for generics, and the drug industry is focusing on higher priced, specialty products for patients who are not helped by existing options. Good luck creating a new cholesterol drug as potent, safe for most people, and widely tested as Lipitor. Read more…

Ranbaxy, Lipitor Generic, FDA, Pfizer, Pfizer Sales

Ranbaxy Laboratories Ltd. (RBXY)’s copy of the $10.7 billion Lipitor cholesterol pill was released in the U.S., sending its share up the most in six months and threatening sales for Pfizer Inc. (PFE)

Ranbaxy, India’s biggest drugmaker, won approval to sell generic versions of the world’s top-selling medicine by the Food and Drug Administration yesterday. The company, based near New Delhi, will share profit on the first six months’ sales with Israel’s Teva Pharmaceutical Industries Ltd. (TEVA), Ranbaxy said today, adding that terms of the agreement won’t be disclosed.

Ranbaxy sought to persuade the FDA that its copies are equivalent to the original and that approval shouldn’t be thwarted by an ongoing dispute about plant violations in India. The FDA approval was for products made at a plant in New Jersey which may have been contingent on a deal with Teva, said Bino Pathiparampil, a health-care analyst at IIFL Ltd. in Mumbai. Read more…

Any drug developers which relied on Cetero Research for early-stage research or bioanalytics may have a real problem on their hands. The FDA says that two inspections of its Houston lab in 2010 revealed a “pattern of misconduct” that raised serious questions about the research work the CRO carried out between April 2005 and June 2010. And some developers may be required to pay for a do-over in order to keep the FDA’s seal of approval. Read more…

(Reuters) – Drug companies that had medicines tested by contractor Cetero Research might have to reevaluate results, U.S. regulators warned after the firm was found faking documents and manipulating samples.

The Food and Drug Administration said on Tuesday two 2010 inspections, an internal company investigation and a third-party audit uncovered “significant instances of misconduct and violations” at a Cetero facility in Houston. Read more…

FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require Reevaluation

The FDA is notifying pharmaceutical companies that bioanalytical studies conducted by Cetero Research, Houston, Texas (Cetero) between April 2005 and June 2010 in support of marketing applications may need to be repeated or confirmed. Cetero is a contract research organization (CRO) that performs bioequivalence and pharmacokinetic testing for a number of pharmaceutical companies. Read more…

Is it too soon for the FDA to call 2011 a good year for drug approvals? Maybe not. CDER director Janet Woodcock claims that new chemical and molecular entity approvals have reached a 20-year high, and that two-thirds of drug applications are reviewed in a timely manner. So far this year 20 drugs have been approved, compared to just 21 in all of 2011. Her remarks were delivered in testimony before a U.S. House of Representatives subcommittee on health. Read more…