Andrew von Eschenbach

ALSO NOTED: Ambrilia touts data; Amarin raises $60M; and much more...

Wed, 14 May 2008 06:59:50 -0400

> Ambrilia Biopharma reported positive 24-week Phase III top-line results for prolonged-release formulation of Octreotide. Release

> Amarin is raising $60 million through a stock placement. Release

> Acorda Therapeutics CEO Ron Cohen has exercised stock options for 31,432 shares. Report

> A federal proposal requiring drug and device makers to disclose payments to doctors got a boost yesterday when Eli Lilly became the first Big Pharma to back it. Lilly report

> In an interesting twist on the usual generics news, it's the copycat makers who are predicted to suffer as competitors undercut their products. The source of this competition? None other than China. Generics report

> The NIH's Avastin/Lucentis trial could fundamentally reshape relations between payers and pharma, according to IMS Health. Report

> After weeks of pressure from Congress to request more money for the agency--and weeks of refusals to specify a figure for beefing up FDA's safety operations-FDA commissioner Andrew von Eschenbach has asked lawmakers for $275 million. FDA report

And Finally... South Korean officials have wiped out the poultry population of Seoul in an effort to combat the spread of the avian flu virus. Report

ALSO NOTED: MAP touts IIa data; Isis pockets $2M milestone;and much more...

Tue, 08 Apr 2008 06:59:50 -0400

> A surge of hopeful research reports on the potential of stem cells has helped fatten profits at Cryo-Save. The company says its stem cell storage work jumped 41 percent last year. Demand is particularly strong in Spain and Hungary. Report

> MAP Pharmaceuticals says that a Phase IIa trial demonstrated positive results for MAP0005, a combination of budesonide, a corticosteroid, and formoterol, a long-acting beta2-agonist. Release

> Isis Pharmaceuticals is pocketing a $2 million milestone payment on the announcement that Bristol-Myers Squibb Company has selected a compound from the companies' collaboration as a development candidate. Release

> Chelsea Therapeutics has licensed the global rights to Active Biotech AB's 1-3D compounds for autoimmune disease and transplant rejection. Release

> Sirion Therapeutics is touting data from late-stage studies of Durezol (difluprednate ophthalmic emulsion) 0.05% for postoperative ocular inflammation. Report

> Just about everybody agrees that the FDA needs a safety overhaul--including Commissioner Andrew von Eschenbach, who recently admitted the agency is in crisis. The agency itself drafted a five-year plan that would channel user fees into more safety evaluators, epidemiologists, regulatory project managers, and risk experts, all to beef up post-marketing drug-safety oversight. Report

> Should drugs be labeled with their country of origin? Report

> Europe is debating drug marketing--and the pharma industry is loudly protesting that it is not asking for the right to pursue DTC advertising. Report

And Finally... A case of human-to-human transmission of bird flu has been confirmed in China, but authorities say it is another instance where the spread of the disease has been limited to a close blood relative. In this case an experimental H5N1 vaccine demonstrated that it could possibly vanquish the lethal virus. Report

Eschenbach offers 'Andy's Take' on FDA issues

Fri, 04 Apr 2008 07:59:59 -0400

Eschenbach offers 'Andy's Take' on FDA issues

The ever-growing blogosphere has a new voice--none other than FDA commissioner Andrew von Eschenbach. At Andy's Take, Eschenbach offers an unprecedented look into the mind of the FDA's top official, which could give drugmakers and analysts insight into major issues affecting the industry. "I want to give you my take on the changes at the FDA and what we need to do to improve and be responsive to the rapidly changing world around us," states Eschenbach in his inaugural post.

Eschenbach's blog comes at a time when the FDA is under attack from all sides--the agency is dealing with staffing shortages, drug safety, complains about its overly-conservative approach to drug approval, missed PDUFA dates, and an anemic budget. Why is the FDA missing deadlines? What's with all the approvable letters? Why are some promising drugs shot down while others sail through the approval process? We'd all like to know, and it would be great to get feedback from the man himself on these issues.

The first topic Eschenbach tackles is the ongoing heparin dust-up. Eschenbach frankly admits that even if inspectors had examined the right plant (they didn't), they wouldn't have detected the contamination.

"…Our records error on the inspection emphasizes our need to accelerate the improvement of our data systems and computerization of all our records with internal checks and back-up verification…[N]o test we use will ever be 100% reliable, and we cannot rely only on inspections. We need a systems approach to quality that not only enables us to react effectively to problems but enables us to prevent problems by engaging FDA across the entire lifecycle of the products we regulate."

With all the criticism the agency has faced, I'm glad to see Eschenbach take a stab at transparency and attempt to explain just what the FDA's agenda is these days. One hopes that the Commissioner uses this opportunity to provide valuable explanations for the FDA's actions and plans. It will be disappointing if Andy's Take devolves into a just another PR outlet, or a place for Eschenbach to complain about criticism. A frank discussion of the agency's problems will help drugmakers understand the regulatory environment and how it impacts their business. Just don't expect to ask Eschenbach anything directly--readers can't comment on blog posts.

What do you think of the Commissioner's new blog? Email me your thoughts. - Maureen

ALSO NOTED: Rumor Mill: AstraZeneca a possible Shire suitor; Cardiome baits hook for partners; Vertex shares keep sliding; and

Tue, 18 Mar 2008 07:59:50 -0400

> Shire is suddenly the talk of the town as investors and investment banks publicly mull a match-up with AstraZeneca. Report

> Cardiome has brought in Merrill Lynch to handle the expected partnership offers for Vernakalant. Cardiome is bullish about its prospects after reporting positive interim Phase IIb data for atrial fibrillation. Release

> Vertex shares have been sliding as analysts assess its prospects for the once red-hot hep C drug telaprevir. Report

> Targacept is starting an early-stage trial of TC-5214 for major depression. A spin-off of RJ Reynolds, its researchers specialize in neuronal nicotinic receptors in the brain. Report

> Pharmacopeia is pocketing a $5 million payment from GlaxoSmithKline for completing early research discovery work. Release

> Fewer reps are knocking on doctors' doors these days. A consulting firm that advises most of Big Pharma says Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb have all culled their herds of reps. And more companies will be following suit soon. Report

> A measure that would force pharmaceutical companies and medical device makers to disclose gifts valued at more than $25 seems to be gathering momentum. Report

> The FDA's Andrew von Eschenbach got peeved during an appearance at the American Enterprise Institute when someone suggested that appointing Janet Woodcock (photo) to her former post at the top of CDER was a return to the "old ways" at the agency. Au contraire, he said. She's "going back as a very, very strong change agent," he responded. Report

And Finally... A UN agency has been alarmed by the 'critical' situation posed by the continued spread of avian flu in Indonesia. Report

ALSO NOTED: Manhattan Pharma closes JV deal; Abbott, Genentech, WEHI in cancer collaboration; and much more...

Wed, 27 Feb 2008 06:59:50 -0500

> Manhattan Pharmaceuticals has closed on its joint venture agreement with Nordic Biotech Venture Fund II K/S to develop and commercialize Hedrin for head lice for the North American market. Manhattan Pharmaceuticals pocketed a $2 million cash payment plus $2.5 million of equity in the newly established joint venture, named Hedrin Pharmaceuticals K/S. Release

> Abbott, Genentech, and WEHI have joined in a tripartite research collaboration to discover anti-cancer drugs. Release

> Stem Cell Therapy International and South Korea's Histostem have announced plans to merge. "We are very pleased with the opportunity for us to be working with Histostem. They have made remarkable progress in the field of umbilical stem cell research and therapy," says Calvin Cao, CEO of SCTI. Release

> Genentech has expanded its license regarding Sagamo BioScience's proprietary zinc finger DNA-binding protein nuclease (ZFN) technology. Release

> Tough luck to unwary buyers, Chinese regulators say. The country's drug safety agency said today that it strictly controls chemicals for use in pharmaceuticals but it's not ultimately responsible for product safety. Report

> A new analysis of the blockbuster anemia drugs sold by Amgen and Johnson & Johnson concludes they raise the risk of death among cancer patients by about 10 percent. Report

> The FDA piggy bank isn't near full enough to overhaul operations as they ought to be, agency chief Andrew von Eschenbach admits. And that's a big admission; von Eschenbach is in essence agreeing with critics who've said his agency simply isn't up to the task of ensuring drug and food safety. Report

> Here's a study guaranteed to put almost every drugmaker on the defensive. Researchers analyzed every antidepressant study they could get their hands on--including a bunch of unpublished data obtained via the U.S. Freedom of Information Act--and concluded that, for most patients, SSRI antidepressants are no better than sugar pills. Report

And Finally… Cases of drug-resistant tuberculosis have spiked to their highest level ever and may start spreading even faster. The highest rate was in a city in Azerbaijan, where one in four cases of TB is unresponsive. Article

House passes PDUFA: bill heads to Senate

Thu, 20 Sep 2007 06:59:57 -0400

The U.S. House of Representatives has passed a bill to renew the Prescription Drug User Fee Act (PDUFA), positioning it to be passed by the Senate and signed by the President before the Friday deadline. The PDUFA has to be renewed every five years. Recently FDA Commissioner Andrew von Eschenbach (photo) sent out a memo warning that 2,000 workers could get pink slips if Congress doesn't renew the act by Friday's deadline.

According to The New York Times, "The bill combined several pieces of legislation governing drug industry user fees, new rules involving the disclosure of clinical trial results, money for studies of older medicines, incentives for tests in children and even the conflicts of interest of drug agency advisers." There were, however several highly-debated issues that didn't make it into the bill. Many patient advocacy groups want the FDA to allow severely ill patients to have access to unapproved drugs; the bill passed yesterday doesn't address these concerns. And as anticipated, legislation that would pave the way for biosimilars was not part of the bill--much to the relief of branded drugmakers everywhere.

- see BIO's reaction to the bill
- read the New York Times article

Related Articles:
FDA: 2,000 layoffs if PDUFA not passed. Report
Bickering may stall trial database. Report
Congress juggles two crucial drug bills. Report
PDUFA debate highlights drug safety issues. Report

ALSO NOTED: FDA approves MedPointe's SOMA; EntreMed secures $20M loan; and much more...

Mon, 17 Sep 2007 06:59:50 -0400

> The FDA has approved MedPointe's SOMA (carisoprodol) 250 mg as a new recommended dose for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. Release

> EntreMed has completed a $20 million secured loan agreement with a syndicate of lenders led by GE Healthcare Financial Services. Release

> AstraZeneca is planning to outsource its manufacturing--all of it--starting with the basic, active ingredients in its products and then fanning out from there. Contract manufacturers in China and India are most likely to get the business. Report

> For years there's been talk of a centralized repository for all drug-testing data, one that's easily searchable and open to all comers. Now, as a September 30 deadline looms for the PDUFA, House and Senate negotiators are duking it out over the database. Report

> Speaking of the PDUFA, Andrew von Eschenbach (photo) sent out a memo saying that 2,000 workers could get pink slips this week if Congress doesn't renew user fees for drugs and medical devices. Report

And Finally... Researchers believe Chronic Fatigue Syndrome may be linked to a common stomach virus. Report

FDA to address nanotechnology standards

Fri, 27 Jul 2007 06:59:54 -0400

Nanotechnology has enormous potential to revolutionize the drug, medical device, cosmetic and food industries, but according to a new report, the FDA lacks a standard regulatory procedure for approving nanotech products. Last August the FDA created a task force to advise the agency on nanotech products to boost the agency's oversight of the technology. Now the FDA's Nanotechnology Task Force has concluded that the agency doesn't have the expertise, tools or regulatory pathways needed to assess the impact of nanotech drugs and medical devices on human health. In order for nanotechnology to safely achieve its potential, the task force recommends that the FDA take a number of steps to increase its in-house expertise and standardize the nanotech review process.

"Nanotechnology holds enormous potential for use in a vast array of products," said FDA Commissioner Andrew von Eschenbach, M.D. "Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.

- read this article for more
- check out the full FDA report

Related Articles:
FDA gathers expert advice on bionanotech. Report
The risks and rewards of nanotechnology. Report
Nanotech grows more common in drug dev research. Report

FDA offers safety reforms to skeptical lawmakers

Tue, 30 Jan 2007 19:01:36 -0500

The FDA has outlined new steps aimed at improving the way new drugs are monitored following approval. In response to a highly critical report from the Institute of Medicine, the FDA will begin to issue report cards 12 to 18 months after approval to highlight any safety problems that could come to light. Those report cards would include the results of follow-up studies. The agency also said it was taking steps to change the agency's culture and improve communications so that safety experts wouldn't feel shut out. The FDA is reaching out to CMS, the VA and insurers to gather more data on problems linked to drugs. And the agency is promising greater transparency in its choice of experts for the highly influential panels that often decide the fate of an experimental medicine.

Over the years the FDA has been held up to harsh criticism that it is too close to drug companies and is too focused on the approval process while ignoring the safety issues that arise after a drug is OK'd for marketing. A member of the IOM panel, R. Alta Charo (photo), told the Washington Post that the FDA had taken steps in the right direction, but that drug safety experts still didn't have the clout they needed. And members of Congress quickly swooped on FDA Commissioner Andrew von Eschenbach (photo), saying that the agency had far more work to do and offering new bills to force developers to publicly reveal all trial data.

- check out the FDA's release
- here's the article from The New York Times

Related Articles:
IOM slams FDA, calls for major reforms. Report
Report faults FDA's post-marketing vigilance. Report
FDA's Crawford charged with lying about stock. Report

Senate confirms von Eschenbach as chief of FDA

Thu, 07 Dec 2006 19:01:37 -0500

Andrew von Eschenbach gained the overwhelming support of the Senate in his long-delayed bid to become chief of the FDA. Senators supported his nomination by a vote of 80 to 11. Among the small band of opponents were several Republicans, including Senator Charles Grassley, who has been steaming over what he sees as a lack of cooperation at the agency in his investigation of the controversial antibiotic Ketek. Von Eschenbach has been acting head of the FDA for slightly more than a year now. During that time he erased a major obstacle to his confirmation by allowing access to Plan B, the morning after pill, without a prescription.

Von Eschenbach's confirmation as head of the FDA will likely trigger a collective sigh of relief in the drug development world. Over the past six years of the Bush administration, the agency has had an official chief for only 18 months. The previous head of the FDA resigned shortly after gaining confirmation to the office and was recently charged with a conflict of interest. Drug developers are looking to the FDA to deliver on the Critical Path Initiative and other projects aimed at streamlining the drug approval process. They're also wary of just how much new research work they'll be required to do on newly approved drugs as the FDA works to reassure a skeptical public that the drugs it approves are indeed safe. Von Eschenbach will play a major role in all of those decisions.

- here's the Washington Post's report on the vote
- read BIO's statement on von Eschenbach's confirmation

Related Articles:
Two Senators block von Eschenbach. Report
FDA clears way for Plan B to go OTC. Report
Investors anxious to see Eschenbach confirmed. Report