vaccine

Limerick raises $15M; Icahn offered $15B for Biogen; Neogen expands R&D

John Carroll — Thu, 12 Jun 2008 10:27:38 -0400

> Limerick BioPharma has ginned $11 million in venture funds and borrowed $4 million more to advance its work on the bioavailability of drugs. Arch Venture Partners, Sevin Rosen Funds and Altitude Funds are all listed as investors. Report

> Researchers have presented new data backing Cimzia over competitors for the rheumatoid arthritis category. Report

> Carl Icahn offered to pay up to $15 billion for Biogen Idec last October. Report

> Idenix reported positive phase I/II data on IDX899, which is being developed to treat HIV-1. Report

> Neogen says it intends to double its research and development efforts for its new fiscal year by hiring 23 additional R&D personnel by early fall. Neogen release

> Opexa Therapeutics announced favorable safety and efficacy data for Tovaxin, a T-cell vaccination therapy for multiple sclerosis, in the second year of open-label clinical re-treatment studies in patients with MS. Opexa release

> OPKO Health has acquired exclusive worldwide rights in the field of ophthalmology to a novel small molecule agent in Phase II clinical development for the treatment of viral conjunctivitis and other viral infections. OPKO release

> Vical has received $6.3 million from AnGes under a previously announced collaborative agreement for continued funding of the company's ongoing Allovectin-7 Phase III metastatic melanoma trial. Vical release

> Cell Therapeutics has sold $23 million in senior convertible notes. Report

And Finally... Baxter International says that a human trial of its Celvapan bird flu vaccine demonstrated that it spurred an immune response against three strains of the lethal virus. This is the first time that researchers have developed a flu vaccine using a virus grown in cell cultures rather than eggs. Vaccine report

ALSO NOTED: New vaccine/chemo combo effective in cancer study; Type 1 diabetes vaccine goes into human studies; and much more..

Thu, 29 May 2008 06:59:50 -0400

> Chutes & Ladders: Susan Windham-Bannister will take over as CEO of the Massachusetts Life Sciences Center Board. The board's function is to ensure the state retains its prominence in the life science industry. Report

> New trial data shows that the combination of a chemotherapy drug and a new vaccine significantly prolonged the survival of patients with glioblastoma, the aggressive brain cancer that now afflicts Senator Ted Kennedy. Vaccine report

> Denmark's Bavarian Nordic has launched a Phase I/II trial of an experimental HIV vaccine. Safety data from the study is expected by the end of this year with immunogenicity data following in the first half of next year. Report

> Researchers have begun human studies of a new vaccine that is designed to block or reverse type 1 diabetes. A team at Children's Hospital in Pittsburgh is loading microspheres with nucleic acid. Report

> Analysts are chatting up Gilead Science's HIV drug Viread as a treatment for hepatitis B. Report

> FDA is considering new, more detailed drug labeling aimed at pregnant and nursing women. FDA report

And Finally... Remember last month when Merck CEO Dick Clark remarked on Big Pharma's "trust deficit?" Well, here's quantitative evidence of it. A European Commission study found that healthcare professionals and payers are "mostly suspicious" of drugmakers as sources of information about drugs. Report

ALSO NOTED: Dor withdraws app; Researchers advance adenovirus therapy; and much more...

Thu, 22 May 2008 06:59:50 -0400

> Dor BioPharma has voluntarily withdrawn its European Marketing Authorization Application for orBec, a treatment of gastrointestinal Graft-versus-Host disease. Report

> Somnus Therapeutics announced the formation of an executive development team. Release

> Scientists at Saint Louis University School of Medicine say that an experimental therapy being tested by Durham, NC-based Chimerix may become the first candidate for human trials for adenovirus. Report

> In a first, researchers have developed a primate model for Huntington's disease, eliciting harsh criticism from animal rights experts even as it paves the way for future primate models for a host of degenerative brain disorders. Report

> The Federal Trade Commission is none too happy with Big Pharma's dealmaking with generics companies. FTC report

> More evidence that pharma is swinging blue--and that Republicans could have a tough time this election year. Drug and medical device companies, who once contributed to the GOP three-to-one over Democrats, have given $7.4 million to Democratic candidates this cycle. That compares with just $7 million for Republican candidates. Report

> It's been a tough week for outgoing GlaxoSmithKline CEO Jean-Pierre Garnier. Browbeaten during a BBC interview on Tuesday, he was "heckled" by annoyed shareholders at yesterday's annual meeting. GSK report

> Chantix suffered a one-two punch yesterday, as a watchdog group's report linked the stop-smoking med to a wide variety of health and safety problems, and the Federal Aviation Administration told pilots and air traffic controllers not to use it. Chantix report

And Finally... One of Senator Kennedy's best chances in defeating the malignant brain tumor that afflicts him could be an experimental vaccine, and reports are already circulating that he may be included in a trial. Vaccine report

ALSO NOTED: GSK releases new Cervarix data; FDA mulls DTC ads; and much more...

Fri, 16 May 2008 06:59:50 -0400

> GlaxoSmithKline has released new Cervarix data that demonstrates the vaccine's ability to generate a high and sustained level of antibodies to neutralize the two most prevalent strains of cervical cancer for up to 6.4 years. Cervarix report

> The French pharma industry worries that up to 32,000 jobs are fodder for the axe, citing pricing pressures, generics, and globalization among the threats to drugmakers. Report

> Brace yourselves: An FDA advisory committee meets today to hash over the possibility of putting a side-effects hotline number in every DTC television commercial. Release

And Finally... The five key vaccine makers say they plan to produce a record 143 million doses of flu vaccine for the U.S. market next season, which should be enough to satisfy demand. Vaccine report

ALSO NOTED: Cambrex names new CEO; Fate Therapeutics appoints CEO and chairman; and much more...

Thu, 15 May 2008 06:59:50 -0400

> Shares of the UK's Allergy Therapeutics surged on the news that its experimental hay fever vaccine--Pollinex Quattro--demonstrated positive results in a crucial Phase III study, which they say was the largest controlled allergy vaccine study ever conducted. Vaccine report

> Cambrex announced that it has named Steven M. Klosk president and CEO. James A. Mack, president and CEO since 1995 and chairman since 1999, has announced he will step down. The company will separate the positions of board chairman and CEO and John R. Miller, currently lead director, will assume the position of Non-Executive Chairman of the Board. Mack will remain a board member and advisor until his retirement on June 30, 2008. Cambrex report

> Paul A. Grayson and John Mendlein have joined Fate Therapeutics as president and CEO and executive chairman, respectively. Report

> Surface Logix announced that Jim Mahoney is stepping down as president and CEO to pursue other interests. Steven Gillis, Ph.D., managing director at ARCH Venture Partners, will assume the role of executive chairman until a new CEO is appointed. Release

> Novartis says that a mid-stage study of its MenB vaccine demonstrated broad protection from meningococcal B infections in infants. Novartis report

> New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, and the global market for cancer meds is advancing by leaps and bounds. Report

> A new study could be the last nail in Trasylol's coffin. Report

> Europe's competition commissioner is casting a wide net in her pharma-market antitrust probe. Report

> Dennis Quaid added some star power--and colorful language--to a dry legal debate yesterday. Testifying before Congress, Quaid backed people's right to sue drugmakers, saying that FDA approval shouldn't automatically negate patient lawsuits. Preemption report

And Finally... South Korea says it will build a bird flu vaccine factory next year. And the country says it will stockpile enough Tamiflu to be able to treat 10 million people in the event of a pandemic. Report

ALSO NOTED: AMA joins DTC advertising fray; U.K. toughening up on pharma promos; and much more...

Fri, 09 May 2008 06:59:50 -0400

> We all expected Democrats to rake DTC ads over the coals during yesterday's hearing before the House Energy and Commerce Committee's oversight arm. What we didn't expect was for the American Medical Association to join the fray. DTC report

> U.S. lawmakers aren't the only ones toughening up on pharma promos. In the U.K., the industry itself is strengthening its code. Report

> Sanofi-Aventis and Bristol-Myers Squibb may have squashed copycat Plavix in the U.S., but competition is now popping up in Europe. Plavix report

> We've all heard the safety warnings about the Ortho-Evra birth control patch and its link to life-threatening blood clots. Public Citizen is now campaigning to have the patch taken off the market completely. Ortho-Evra report

> Researchers are touting the early results from a study of a new brain cancer vaccine that combines protein antigens extracted from a patient's tumor and matches them with white cells also drawn from the patient. Vaccine report

And Finally... The headlines may have died down in recent months, but bird flu experts say that the threat of a global pandemic has actually been growing. Report

ALSO NOTED: Novartis buys bigger stake in Alnylam; FDA chastises ZymoGenetics' marketing campaign;and much more...

Thu, 08 May 2008 06:59:50 -0400

> Novartis has scooped up a bigger share of Alnylam stock. The pharma giant now owns 13.3 percent of the company. Alnylam release

> Curious how the FDA might spend its PDUFA fees? A new five-year plan shows that FDA will plow the money into post-marketing safety to meet its commitments under the new law passed last fall. FDA report

> The FDA has chastised ZymoGenetics' maiden effort to commercialize a therapy, saying that its claims for a genetically engineered form of Thrombin are "false or misleading." ZymoGenetics' marketing material notes that the drug has a lower level of antibody formation compared to a competitor, creating the impression that bovine thrombin's antibodies are less safe. Story

> Genzyme has expressed an interest in setting up an Israeli biotech incubator. Report

> Proteome Sciences said it has won a grant of €571,000 to study the proteomics end of a new generation of in-vitro assays. Report

> Did GlaxoSmithKline try to monopolize the Wellbutrin market? A lawsuit now certified as class-action says so. GSK report

> Will today's Congressional hearing on drug ads lead to new legislation? That's what Michigan Democrat--and vocal pharma critic--Bart Stupak hopes. DTC report

> New CEOs often clean house. Biovail's Bill Wells looks like he's trying to gut and rebuild it. The company announced it would shutter two plants in Puerto Rico as it shifts focus to specialize in central nervous system meds, "a market where unmet medical needs and growth potential are high," Wells said. Biovail report

> Merck's layoffs have inspired one newly unemployed poet to write in verse. Report

And Finally… Vaccine experts are pondering just how long vaccines will be able to provide immunity in a world where some diseases are all but eliminated and natural exposure to many common viruses has ended. Vaccine 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: ISTA announces positive data; Proteolix launches Phase II trial; and much more...

Thu, 01 May 2008 06:59:50 -0400

> If anyone doubted Andrew Witty's professed faith in emerging markets, those doubts can be put to rest. The incoming GlaxoSmithKline CEO lured Eli Lilly's Abbas Hussein to spearhead a new unit charged with building business in China, Russia, Brazil, India and the Middle East. GSK report

> ISTA Pharmaceuticals announced positive preliminary results from its second and final late-stage study of Bepreve. ISTA release

> Proteolix has launched a Phase II clinical trial of carfilzomib (PR-171), a selective blocker of proteasome activity, in relapsed solid tumors. Proteolix release

> Oncothyreon has filed an investigational new drug for PX-866, a small molecule phosphatidylinositol-3-kinase inhibitor for advanced cancers. Oncothyreon release

> The FDA has given Merck 15 days to decide how to fix manufacturing problems at its main vaccine plant in West Point, PA, according to a warning letter dated April 30. Report

> As the U.K. nears a long-term drug-pricing deal with pharma firms, drugmakers are grousing about the fact that the government decided to renegotiate at all. Report

> Pfizer is breathing a big sigh of relief. The U.S. Patent & Trademark Office has said it will confirm the drugmaker's basic patent on the blockbuster Lipitor drug. Report

Special Report... CEO Pay: Who makes what in Big Biotech? Report

And Finally... A large group of American parents are having a tough time keeping up with their kids' vaccination schedules. Vaccine report

Wyeth, Elan suspend Alzheimer's vaccine study

Fri, 18 Apr 2008 06:59:54 -0400

Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Studies of ACC-001 that have been mounted outside of the U.S. have also been suspended. Researchers, though, quickly sought to reassure investors that another late-stage program for AAB-001 wasn't affected by the unexplained case of lesions. AAB-001, or bapineuzumab, has demonstrated an improvement in cognitive function in Alzheimer's patients in a small study and is being closely followed by the investment community.

- read the story in the Wall Street Journal
- read the story in TheStreet.com

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