Schering Plough

C&L: Somnus names executive team

Wed, 28 May 2008 06:59:52 -0400

Gary Cupit, PharmD, has been named CEO of Somnus Therapeutics. The rest of the executive team: Mary Osbakken, MD, PhD, chief medical officer; Christine Blumhardt, PharmD, chief regulatory officer; Linda Hogan, MS, MBA, chief business officer; Anne McCormick, MSW, director, clinical project management.

Altus Pharmaceuticals has appointed Georges Gemayel as CEO and member of the board of directors.

Amazon Biotech announced that Eliyahu BenTal Tolchinsky has been appointed as director and CEO.

NicOx said development chief Damian Marron will leave May 30 and will be replaced by Sanjiv Sharma, vice president of commercial affairs, and Gavin Spencer, senior director of business development. Marron will become CEO of another, unnamed biopharmaceutical company.

CyDex Pharmaceuticals announced that Theron E. Odlaug, Ph.D. has been appointed to the newly established position of president and chief operating officer.

Nektar Therapeutics named Bharatt Chowrira chief operating officer and head of the company's PEGylation Business Unit.

Nanobiotix it has appointed Elsa Borghi, MD, as medical director.

Adolor named Eliseo Oreste Salinas senior vice president of research and development and chief medical officer, effective June 2.

Schering-Plough Corporation announced that Janet M. Barth has been appointed vice president, investor relations. Endo Pharmaceuticals Holdings has named Blaine T. Davis vice president, investor relations and corporate communications. Ipsen has named Gerard Picot vice-president, global regulatory affairs.

Orchid Cellmark has named Jeffrey S. Boschwitz, Ph.D., vice president of North America marketing and sales.

Elan Corporation has named Patrick Kennedy and Donal O'Connor to the board of directors.

VentiRx Pharmaceuticals named Dr. Elliott Grossbard to its board of directors.

Struggling VaxGen put Paul De Stefano and Lori Rafield onto its board after three members quit.

ALSO NOTED: Cancer-sniffing dog being cloned; Investment spurs Bioton shares; Genetic Chemistry wins $23M contract; Tioga touts

Wed, 21 May 2008 06:59:50 -0400

> The world's top cancer-sniffing canine has been cloned, and her owners are planning a pack of clones to join the hunt for canine cancer detection. Researchers have been testing dogs' ability to detect early-stage cancer cells in urine and breath. Report

> Shares of Poland's Bioton surged on the news that one of the country's richest men, Zygmunt Solorz-Zak, bought a 10 percent stake in the company worth $89 million. Report

> Genetic Chemistry has won a $22.8 million contract from the U.S. Army Research Office to develop novel compounds that act against bacterium that is classified as a Category B bioterror threat. Report

> Tioga Pharmaceuticals says that a recent Phase IIb study of its oral kappa opioid receptor agonist, asimadoline, produced statistically significant results in the treatment of Irritable Bowel Syndrome. Release

> Sunesis Pharmaceuticals has launched a Phase II trial of voreloxin (SNS-595), the company's lead anti-cancer therapeutic. Report

> The news that the FDA had put a 'clinical hold' on Geron's plans to launch the first U.S. clinical trial of a stem cell therapy is attracting considerable scrutiny from researchers. Geron report

> Twenty-five years after the discovery of the human immunodeficiency virus, top scientists from around the world gathered at the Pasteur Institute to mark major advances in the field and come to terms with some of the grim realities that now afflict their work. Report

> Perrigo has formed a joint development agreement with Cobrek Pharmaceuticals and taken a minority stake in the new drug company. Report

> Merck made a $58 million deal to settle claims of deceptive Vioxx advertising with a 29 attorneys general. Report

> Fresh on the heels of their DTC hearing, Congressmen John Dingell and Bart Stupak have issued letters to four top pharma execs--CEOs at Merck, Pfizer, Schering-Plough, and Johnson & Johnson--asking them to commit to honest-Abe advertising. DTC report

Special Report: The top 17 salaries in Big Pharma. List

And Finally… The National Institutes of Health has created a new research program that is devoting itself to studying patients with mystery diseases. Report

ALSO NOTED: Salix gets approvable letter; Intermune drug hits the fast track; and much more...

Mon, 19 May 2008 06:59:50 -0400

> Should Fred Hassan (photo) give back his bonus? That's what Forbes is asking this week, saying that the Schering-Plough CEO's 2007 compensation package was probably artificially inflated by the fact that sales-damaging study results were held back until early January 2008. Report

> Salix says it has received an approvable letter from the FDA for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. The company says it should be able to provide a complete response to the letter in a matter of days. Release

> The FDA has put Intermune's drug pirfenidone--for idiopathic pulmonary fibrosis--on the regulatory fast track. Story

> Holmes Biopharma announced that its clinical research operations in Omaha, Nebraska have been disrupted due to a working capital deficiency. Release

> MorphoSys has extended its research contract with Schering-Plough by a year. Report

> Biophage Pharma has sold the assets of its Immunotox Labs Division to Validapro BioSciences Inc. for $400,000 in cash and the assumption by Validapro Biosciences of certain liabilities. Release

> In a deal with the U.S. Department of Justice, the Canadian drugmaker agreed to pay almost $25 million to settle claims that it paid docs and their office managers to get patients onto its Cardizem heart drug. Report

> The FDA is warning doctors again that organ-transplant drugs CellCept (from Roche) and Myfortic (Novartis) have been linked to miscarriages and birth defects when taken by pregnant women. Report

And Finally... A simple gene test may soon be available that will eliminate up to half of the potential patients for the therapy. Report

Novacea cuts staff after partner dumps collaboration

Tue, 13 May 2008 06:59:54 -0400

A month after Schering-Plough pulled the plug on its collaboration with Novacea for a new prostate cancer therapy--Asentar--the little biotech company announced that it will cut its work force by more than half. Over the next two months Novacea's head count will dwindle from 37 to 15.

"While we believe the company is in a good financial position, the work force reduction was a very difficult decision for the management team, and we extend our sincere gratitude and appreciation to all of the affected employees," said Chairman and Chief Executive John P. Walker.

- see Novacea's release for more on the cuts
- read the AP report

ALSO NOTED: Washington biotech investing in growth; Merck CEO: 'I can't blame the media'; NeuroMetrix's CEO resigns; and much m

Fri, 02 May 2008 06:59:50 -0400

> Despite the economic slowdown, Washington state biotechs are investing hundreds of millions of dollars in new facilities. Report

> Merck CEO Dick Clark worried publicly about the media at a Morgan Stanley conference yesterday. In response to a question about the negative bent to Merck coverage these days, Clark said Merck and pharma as a whole both need to "do a better job...I don't think we're aggressive enough in getting our stories out there. Merck Report

> Chutes & Ladders: NeuroMetrix's CEO Gary L. Gregory is leaving the company to pursue new professional opportunities. Release

> Researchers for Sweden's Independent Pharmaceutica are launching a mid-stage study of a new nicotine vaccine designed to help people give up smoking. Vaccine report

> A team of researchers at Emory University and the Oklahoma Medical Research Foundation has found a way to radically upend the way new vaccines are developed to fight a pandemic. Report

> A large group of American parents are having a tough time keeping up with their kids' vaccination schedules. Report

> Enbrel's new black box is now official. Wyeth and Amgen have put the final touches on a boxed warning about tuberculosis and other life-threatening illness; the label states that patients using the drug have contracted infections that led to hospitalization and death. Enbrel report

> Next week, Rep. Bart Stupak will preside over testimony from Pfizer, Merck, Schering-Plough, and Johnson & Johnson at the Subcommittee on Oversight and Investigations' hearing on direct-to-consumer ads. Report

And Finally... A federal advisory panel is calling for closer regulation of companies that provide genetic tests. Report

ALSO NOTED: Dyax to close R&D facility;Nastech sells shares; and much more...

Mon, 28 Apr 2008 06:59:50 -0400

> Dyax says it plans to close its research facility in Belgium as it focuses on commercializing DX-88 to treat hereditary angioedema. Dyax report

> Nastech Pharmaceutical plans to sell $8 million in shares to advance its RNAi programs. Report

> North Park Aesthetics says it's reached an agreement with Biophysica, Inc. and Interpharma Praha for the exclusive worldwide rights to develop and commercialize products containing fluridil, the primary ingredient in NP-619, North Park's Phase II product for pattern baldness. Release

> FDA officials say that drugmakers needed to bear the responsibility for drug safety. FDA report

> Will all medical schools bar the door to pharma giveaways? The Association of American Medical Colleges hopes so. Pharma gift report

> In another blow to the Merck/Schering-Plough joint venture, the FDA rejected a proposed allergy and asthma treatment that would have combined Schering's Claritin and Merck's Singulair into one pill. Report

> The Brazilian government recently deemed the anti-HIV med Tenofovir a "public interest." That's code for, "We're thinking about issuing a compulsory license for this drug." Brazil report

> One of the things media love to do is get two people to go head-to-head on an issue. Today's topic: Allowing drugmakers to distribute peer-reviewed journal articles in support of off-label uses for their products. On the pro side is Scott Gottlieb (photo), an ex-FDA deputy commissioner who's now at the conservative American Enterprise Institute. Former New England Journal of Medicine editor Jerome Kassirer is on the con side. Report

And Finally... Indonesia has begun to drill health workers on responding to a human outbreak of bird flu. Article

ALSO NOTED: Shire nabs orphan product; New prez at Cell Therapeutics; and much more...

Thu, 24 Apr 2008 06:59:50 -0400

> Shire has acquired arylsulfatase, an orphan enzyme replacement therapy in Phase I/II for Metachromatic Leukodystrophy, from the Danish company Zymenex. Release

> Sepragen and Neugenesis are collaborate to develop a high-throughput, low-cost production platform for mAbs and vaccines for pandemic flu. Release

> Chutes & Ladders: Cell Therapeutics has named Craig W. Philips, the former vice president and general manager of Bayer Healthcare Oncology, as president. Report

> Are fault lines in the Merck/Schering-Plough joint venture beginning to open up? Report

> We love it when pharma CEOs depart from their usual talking points about financial results and restructurings and pipelines, to wax philosophical on their place in the word. This week, we heard an entire trio musing on the state of the industry: Merck chief Richard Clark, GlaxoSmithKline's putative chief Andrew Witty, and Pfizer's Jeff Kindler. Report

> Big Pharma is dragging its feet on conducting promised post-marketing studies. Report

> Schering-Plough CEO Fred Hassan got a $30M pay package. Report

And Finally... It may not be an ideal topic for polite conversation, but human beings are swarming with bacteria: Even the average healthy adult plays host to about 100 trillion microscopic organisms. Infection takes place when the bacteria get out of hand. Release

ALSO NOTED: FDA approves Orencia; Delay on Amgen clotting drug decision; Icahn files suit for Biogen Idec papers; and much more

Wed, 09 Apr 2008 06:59:50 -0400

> The FDA has approved Bristol-Myers Squibb's Orencia for juvenile arthritis. Release

> Amgen says that the FDA will delay a decision on its blood clotting drug by three months. A decision had been expected by April 23. Release

> Not satisfied with Biogen Idec's explanation of its failed effort to find a buyer, Carl Icahn has filed suit to get a hold of internal documents on the search. No way, responds Biogen Idec, which says it's just another ploy aimed at forcing a sale. Report

> Antigenics has raised $21 million in a private placement. The money will be used to market Oncophage, a cancer vaccine that just won regulatory approval in Russia. Release

> Potentia Pharmaceuticals has completed a $12 million round of financing. The funds will allow Potentia to complete Phase I and move into Phase II clinical development of Potentia's novel investigational drug candidate, POT-4. Release

> Schering-Plough has officially terminated its partnership with Novacea for its Asentar prostate cancer program. A clinical trial was halted earlier due to an imbalance of deaths between the two treatment arms. Release

> The FDA has rebuked GlaxoSmithKline for failing to regularly report post-marketing Avandia data. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

> The heparin death toll is far worse than we originally thought. The FDA has tripled the number of deaths it's attributing to allergic reactions to the blood thinner since January 2007, to 62 from 19. Report

> Just why would Novartis pay $11 billion for one-fourth of eye-care Alcon company and promise another $28 billion for another big chunk? Report

> Expect the FDA to stay out of the Vytorin fray, at least for now. Report

> In the latter part of the 20th century, the conventional wisdom in the drug industry was simple: bigger is better. But now the Big-Big management model is cracking up. Report

And Finally... It turns out that hundreds of bacteria can actually 'eat' antibiotics, according to researchers at Harvard Medical School. Report

SPOTLIGHT: NJ to take the brunt of Schering's cuts

Fri, 04 Apr 2008 07:59:53 -0400

Fasten your seat belts, New Jersey, it's going to be a bumpy ride. Schering-Plough CEO Fred Hassan said that the budget ax will fall hardest in New Jersey as the company cuts more than $1 billion in spending. Report

ALSO NOTED: Dendreon shares jump on investment deal; Iomai in pact with Merck; Foundation antes millions for MS leads; and much

Thu, 03 Apr 2008 07:59:50 -0400

> Schering-Plough has proven quick on the layoff trigger. The company announced a plan to cut costs by $1.5 billion by 2012 in the wake of the latest round of Vytorin controversy. Roughly 5,500 employees will lose their jobs, or about 10 percent of the company's workforce. Report

> Shares of Dendreon jumped seven percent on the news that an institutional investor will buy up 47 million in shares and warrants. That money is earmarked for Dendreon's prostate cancer drug Provenge and other drug candidates in its pipeline. Release

> Iomai has forged a deal with Merck to conduct proof-of-principle preclinical studies evaluating the use of the Iomai needle-free immunostimulant patch. Merck has first option to negotiate an exclusive license. These preclinical proof-of-principle studies will be conducted using an undisclosed Merck vaccine. Release

> The Myelin Repair Foundation has spent $10 million so far to identify 18 new drug leads for multiple sclerosis. Report

> Chutes & Ladders: Akers Biosciences has promoted Robert J. Paratore to chief financial officer. Report

> Two lawmakers asked the FDA yesterday to mandate that all TV ads for prescription drugs include contact info for patients to report serious side effects to the agency. The impetus? A Consumer Reports poll that showed 16 percent of respondents had a side effect serious enough to send them to the doctor or hospital--but 35 percent of respondents didn't know they could report side effects to the FDA. Report

> The U.K.'s National Health Service is spending around $3.9 billion annually to treat patients for adverse reactions to prescription drugs. Report

And Finally... A professor at the California Institute of Technology is walking away with the $1 million Gotham Prize for an original approach to killing cancer cells. Report

Vertex shares jump on positive telaprevir data

Tue, 01 Apr 2008 07:59:56 -0400

Vertex Pharmaceuticals got a much-needed boost to its share price after investors responded positively to the latest data analysis on its closely-watched hepatitis C therapy. Vertex stock jumped 28 percent after researchers noted that patients responded to telaprevir in a mid-stage study. The data will be featured in a late-breaker poster presentation during the 43rd Annual Meeting of the European Association for the Study of the Liver in Milan, April 23-27. There's a $3 billion market for hep C drugs in the U.S. and Europe. Schering-Plough is also developing a hep C drug--boceprevir.

- check out the press release
- read the AP report

Related Articles:
Investors disappointed in Vertex despite strong data. Report
Vertex hep C drug impresses in Phase IIb. Report
Vertex inks rich pact with J&J. Report

ALSO NOTED: ImClone hires Zuerblis for CFO post; Tekmira plans merger; Argos touts HIV data; and much more...

Mon, 31 Mar 2008 07:59:50 -0400

> ImClone Systems has hired Kenneth Zuerblis as its new chief financial officer. Zuerblis has been CFO at Enzon before his resignation in 2005 for personal reasons. Report

> After posting a $2.6 million loss for last year, Tekmira Pharmaceuticals announced that it will merge with Protiva Biotherapeutics. Release

> Argos Therapeutics says its Phase I trial of AGS-004 for HIV demonstrated positive safety and feasibility data. "Initial data revealed no serious adverse events," said Jean-Pierre Routy, M.D. "Mild adverse events observed were consistent with immune response induction and typical of similar therapies." Release

> Japanese regulators have approved Naglazyme for as Maroteaux-Lamy syndrome. The drug is being developed by AnGes MG and Biomarin Pharmaceuticals. Report

> Business leaders in Arizona are touting a $1.4 billion bond package that would provide funds to expand biomedical research in the state. Story

> Crucell has pushed its rabies monoclonal antibody combination into Phase II, hitting a milestone in its development deal. Report

> Genta announced that the Data Safety Monitoring Board for its Phase III trial of Genasense Injection, its lead oncology product, has recommended that the trial be continued as originally planned after initial review of blinded safety data from the study. Release

> Encorium Group has inked a $1.6 million contract with Protherics for a Phase II trial of its novel immunotherapeutic vaccine, Angiotensin Therapeutic Vaccine for hypertension. Release

> Neurosearch has begun an early-stage trial of NSD-788, an experimental therapy for anxiety and depression. Report

> If Merck and Schering-Plough really expected their Enhance presentation to turn the tide on Vytorin and Zetia, then they were sorely disappointed this weekend. Report

> Some cholesterol med-makers do have reason to rejoice today. AstraZeneca stopped a study of its blockbuster Crestor, saying the pill had already demonstrated clear benefits over placebo. Report

>What's the long-term impact of the heparin scare? It's shattered U.S. claims of "it can't happen here," for one thing. Report

And Finally… A new study links pesticides with Parkinson's disease. Release

ALSO NOTED: Analysts offer conflicting forecasts for Auxilium; test sheds light on cancer therapy; MAP touts new data; and much

Mon, 24 Mar 2008 07:59:50 -0400

> Two analysts assessed Auxilium Pharmaceuticals' chances in a late-stage study of Xiaflex and came up with radically different conclusions. Data is expected in the second quarter. Report

> A new test that analyzes microRNAs can tell doctors the source of some mysterious cancers and help provide a short-cut for treating them, according to media reports quoting researchers in Nature Biotechnology Monday. Report

> MAP Pharma is touting data from a pharmacokinetic trial comparing the systemic drug exposure of UDB compared to the currently marketed conventional nebulized budesonide. Release

> Isolagen has sold its facility in Switzerland for approximately $6.4 million. Release

> Merck and Schering-Plough officials overseeing the Enhance study saw a threat to Vytorin back in late 2005, the Wall Street Journal reports. Report

> Could full clinical trial data disclosure avert scandals? Report

> As Eli Lilly went up to bat in the big Zyprexa trial in Alaska, the judge said lawsuits play a vital role in drug safety. Without them, claims of safety problems "might well go unaddressed," Judge Mark Rindner told the court. Evidence the State of Alaska presented over the past two weeks, he said, shows that the FDA "isn't capable of policing this matter." Report

> The Securities and Exchange Commission charged Biovail, its founder Eugene Melnyk (photo), and three other current and former executives with fraud, alleging that they repeatedly overstated earnings and hid losses. Report

And Finally... A new UN report on tuberculosis control concludes that efforts to rein in the disease have slowed down. Report

Committee ok's Schering-Plough's sugammadex

Wed, 12 Mar 2008 07:59:57 -0400

An FDA committee has unanimously recommended Schering-Plough's sugammadex for approval. The drug, which is being developed to reverse the effects of anesthesia used during surgery, allows doctors to reverse the depth of a patient's muscle relaxation within minutes. The FDA usually follows the committee's recommendation. The drug gained priority review in January.

Schering gained sugammadex in its massive $14.4 billion buyout of Organon one year ago. Sugammadex will be sold under the name Bridion if approved.

Related Articles:
FDA to give Schering program priority review. Report
Organon touts late-stage data for sugammadex. Report

ALSO NOTED: Amgen analysts bearish; FDA hands Kyowa not-approvable letter; Valeant plans review; and much more...

Thu, 28 Feb 2008 06:59:50 -0500

> Oh, the curse of duplication. Schering-Plough embarked on a company-wide downsizing yesterday, eliminating hundreds of jobs in nearly all departments, including finance, research, information technology, and marketing. Report

> Faced with what they see as the likelihood of some significant restrictions on the use of Amgen's anemia drugs--as well as new data on risks associated with the drugs--analysts have been turning distinctly bearish on the biotech giant's stock. Report

> Kyowa Pharmaceutical has received a not-approvable letter from the FDA for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease. Release

> Valeant Pharmaceuticals says it will undertake a strategic review after reporting weak results for the fourth quarter. Release

> The U.S. Patent office has upheld the validity of Geron's patent for human embryonic stem cells. Report

> Any attempt to track down the source of problems with the blood thinner heparin are likely to run into trouble following a convoluted supply trail in China. Report

> The FDA has nixed Eli Lilly's plans for a long-acting formulation of its antipsychotic Zyprexa. Report

> GSK's secret vaccine adjuvant is drawing attention. Report

And Finally... The CDC has greatly expanded the population of people it's recommending for an annual flu shot, saying everyone aged six months to 18 should get the an annual jab. Report

ALSO NOTED: Ablynx pockets upfront fee; Plexxikon publishes cancer data; Solvay drug on fast track; and much more...

Tue, 19 Feb 2008 06:59:50 -0500

> Belgium's Ablynx says it has received an undisclosed milestone payment from Novartis for an exclusive license for a program involved in their alliance on therapeutic nanobodies. Release

> Plexxikon has published data demonstrating that its targeted cancer compound selectively destroys tumor cells which contain the B-RafV600E cancer-causing mutation, a defect present in most melanomas and thyroid tumors and a large number of colorectal and other cancers. Release

> Sanofi-Aventis and UCB have received FDA approval of an oral solution version of the allergy drug Xyzal. Release

> The FDA has accepted Cephalon's NDA for the chemo drug Treanda. Release

> Chelsea Therapeutics says it has reached an accord with the FDA regarding the design of a late-stage trial for Droxidopa, a therapy for neurogenic orthostatic hypotension. Release

> Marshall Edwards has received orphan drug status for NV-196, a treatment for Stage IIB through Stage IV malignant melanoma. Report

> The FDA has put Solvay's Duodopa, the intestinal gel being developed for patients with advanced Parkinson's disease, on its fast track. Report

> Biolex Therapeutics announced that it has entered into an agreement with Merck KGaA to evaluate antibody optimization and production in Biolex' proprietary LEX System. Release

> Behind the scenes at Enhance: Schering-Plough statisticians reviewed some data before the study was complete, according to New Jersey's Star-Ledger. Report

> It was a glitch. That's what the FDA said last week when confronted with the news that it hadn't inspected the Chinese plant that made the main ingredient for Baxter's recalled batches of heparin. Now we know just how big that glitch was: The FDA inspected and approved the wrong plant. Report

> The FDA has finally released proposed rules that would allow pharma to distribute journal articles that support off-label uses of their products--two months after an irate Congressman pulled the veil off the same proposal. Report

And Finally… The Bill & Melinda Gates Foundation has come under a rare attack for its contributions to research efforts targeted at malaria. Report

ALSO NOTED: AstraZeneca may shake up R&D with spin-off; Vertex sells stock; and much more...

Tue, 12 Feb 2008 06:59:50 -0500

> AstraZeneca is considering spinning off its GI research institute into a separate company that would go out into the market and hunt for venture capital backing, according to Swedish newspaper reports. The news reports say that the pharma company is looking at spinning off five research projects. Report

> Vertex plans to sell 6 million common shares as well as $250 million in convertible senior subordinated notes due 2013. Report

> Belgium's Innogenetics says it plans to shelve new investments at its therapeutics business Genimmune. Report

> Docs needing blood-thinning drugs may be in a fix. Allergic reactions prompted Baxter to stop making multiple-dose vials of heparin, and the FDA told physicians to stop using them except when absolutely necessary--and then, very carefully. Report

> Finally, someone asked the question we've been wanting to ask ourselves: Even if the Enhance study data remained blinded, could Merck or Schering-Plough have divined its overall sway? Sen. Charles Grassley, who's been shooting out letters to the two companies at the rate of at least two a week, made the query in another round of correspondence yesterday. Report

> Schering-Plough, Sanofi and Teva have announced their earnings. Report

> While they were reporting their earnings, Schering-Plough and Sanofi-Aventis executives both found themselves on a hot seat. Report

> A protein may hold the key to a new vaccine that could effectively target pneumonia, according to Children's Hospital of Pittsburgh of UPMC. Report

> If you can't afford $350,000 to have your genome sequenced, wait awhile. The price is dropping fast. Report

And Finally… The World Health Organization says that without urgent action a billion people will be killed by tobacco this century. Release

ALSO NOTED: LAB Research gains financing; BMS, AstraZeneca, Wyeth report earnings; and much more...

Thu, 31 Jan 2008 06:59:50 -0500

> Stem Cell Sciences says a new pact with the Myelin Repair Foundation will provide it with a stable supply of uniform human brain cells for their research program on multiple sclerosis. Report

> Canada's LAB Research--a non-clinical contract research organization--has raised $21.1 million in fresh financing for its expansion plans. Release

> A handful of drug makers released their earnings, and it's a mixed bag: some up, some down, some hit by one-time charges. Here's a roundup. Report

> PsychoGenics has inked a new drug discovery pact with Eli Lilly covering the evaluation of neuropsychiatric drug candidates. Report

> Chutes & Ladders: Genelabs Technologies CEO James Smith has resigned. The company chairman and CFO will run the company until a new CEO is hired on. Report

> The FDA has granted priority review status to Schering-Plough's Peginterferon Alfa-2b, an adjuvant treatment for Stage III melanoma, a rare skin cancer. Release

> If remorse is proportional to the amount you're willing to pay to absolve it, then Eli Lilly must be feeling pretty guilty about Zyprexa. Report

> Can we trust a Chinese manufacturer that not only sold contaminated cancer drugs but tried to cover up the fact? Apparently, the FDA thinks so. Report

> Good news, needle-phobes. South Korean researchers have successfully tested a new approach to delivering vaccines, applying it under the tongue rather than through a needle. Report

And Finally... See that other blue-eyed person at the next table? Go say hi, because genetics proves that you're related to a common ancestor. Release

ALSO NOTED: Rituxan aces RA, leukemia trials; Two die after Gardasil jab; Galapagos earns milestone; and much more...

Fri, 25 Jan 2008 06:59:50 -0500

> Roche's antibody med MabThera (Rituxan) just aced two trials aimed at expanding uses for the drug: one that pitted MabThera against rheumatoid arthritis and another that used it against adult leukemia. Release

> Two young women died suddenly and mysteriously after getting the Gardasil vaccine, European regulators announced yesterday. Did the vaccine precipitate their deaths? No one knows. Report

> Galapagos has achieved a milestone under its alliance agreement in rheumatoid arthritis with Johnson & Johnson's Janssen Pharmaceutica. The milestone triggered a cash payment of €3.4 million to Galapagos. Release

> Lawyers, Congressional reps, and now Senators are circling around Merck and Schering-Plough as the Vytorin brouhaha escalates into a full-blown scandal. Report

> A small clinical trial of a malaria vaccine funded by the National Institute of Allergy and Infectious Diseases has delivered positive data, triggering a move to expand the research into a second trial that enlisted 400 children in Mali. Report

> Health plans are drawing scrutiny for paying physicians to prescribe cheaper generics rather than brand-name drugs. Report

And Finally... American adults are largely ignoring a slate of important new vaccines that can prevent serious illness, according to a new survey from the National Foundation for Infectious Diseases. Report

ALSO NOTED: Stalevo posts positive Parkinson's data; Genzyme applauded for aggressive strategy; Philogen pulls IPO; and much mo

Thu, 24 Jan 2008 06:59:50 -0500

> Novartis has told Orion Corp.--which put out a press release--that Stalevo has produced positive data in a late-stage Parkinson's trial. Release

> Analysts are bullish about Genzyme's aggressive position in the orphan drug market. Its approach has paid off with a 22 percent increase in sales during the fourth quarter. Article

> Italy's Philogen has decided against getting on the public market roller coaster. The developer is postponing its IPO, citing "market conditions." Report

> In a pipeline update, BioCryst says that it is now "planning to initiate a Phase II clinical trial that will evaluate the 300mg dose and a higher dose of peramivir later this year. As a result, BioCryst will not continue to pursue a pivotal Phase III program for i.m. peramivir in the current influenza season." Release

> Italy's Gentium says that an interim analysis of late-stage data on Defibrotide for veno-occlusive disease demonstrated no safety concerns. Release

> When Johnson & Johnson announced that it would create a so-called "Office of Strategy and Growth," there wasn't much detail to be had. Now, the new chief of that office, Nick Valeriani, has spoken to the Star-Ledger about his new task. Report

> Remember how the American Heart Association rushed to the defense of Vytorin after the results of the Enhance study were released last week? Well, now several news outlets are pointing out that the association gets almost $2 million annually from Merck and Schering-Plough. Report

> Yesterday, Gilead Sciences saw its four key patents on its anti-HIV med Viread (tenofovir disoproxil fumarate, also found in the Atripla combo pill) declared invalid. Report

> Researchers have made a key breakthrough in the quest to discover a vaccine or therapy to cure the deadly ebola virus. Report

And Finally… By transplanting stem cells from donors' bone marrow, kidney recipients were able to live without needing to take a steady regimen of immunosuppressive drugs. The new approach could revolutionize the entire field. Article