Archive for the 'Vaccines' Category

Novartis to File Meningitis Vaccine for Infants

Swiss drugmaker Novartis AG wants to file its meningitis vaccine Menveo for use in small infants in the United States and Europe after a late-stage study with children of this age group was successful.  In the phase III study, a high percentage of the 4,500 infants as young as 2 months showed the immune response when given Menveo, Novartis said. The vaccine was well tolerated, with a safety profile similar to routine infant vaccines.

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Nearly 400 Medicines and Vaccines in Development to Fight Infectious Diseases

Critical challenges remain in the centuries-old battles against infectious diseases, particularly as bacteria and viruses mutate and as the threat of bioterrorism grows. Responding to this need, America’s biopharmaceutical research companies this year have 395 new medicines and vaccines in the pipeline to fight infectious diseases. All 395 are in later stages of development, meaning in clinical trials or under Food and Drug Administration (FDA) review.

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Feds Aim to Fortify Biodefense by Fixing Product Development Pipeline

A leaky product development pipeline is hampering the country’s ability to ensure a steady output of new medical countermeasures, such as medications, vaccines, equipment and supplies needed for health emergencies, HHS Secretary Kathleen Sebelius said.

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WHO Declares H1N1 Pandemic Alert Over

World Health Organization (WHO) Director-General, Dr. Margaret Chan, announced that the world is no longer in phase six of influenza pandemic alert — we are now moving into the post-pandemic period and the new H1N1 virus has largely run its course. Dr. Chan went on to say: “As we enter the post-pandemic period, this does not mean that the H1N1 virus has gone away. Based on experience with past pandemics, we expect the H1N1 virus to take on the behavior of a seasonal influenza virus and continue to circulate for some years to come.

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Payers OK Provenge as Scripts Hit 500

Dendreon (NASDAQ: DNDN) has reason to cheer. Its launch of the prostate cancer vaccine Provenge is going well, with sales growing at a quick clip and, more importantly, key payers deciding they’ll cover the cost. Considering that Provenge’s list price is $93,000, that’s quite a cost.

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Merck Buys Vax Unit from Bankrupt Hawaii Biotech

Merck (NYSE: MRK) has agreed to purchase bankrupt Hawaii Biotech’s dengue fever vaccine unit for an undisclosed sum. It’s a critical move for Hawaii, which filed for Chapter 11 bankruptcy protection last year and will deplete a $2 million credit line by the end of this month. The sale leaves Hawaii with a West Nile virus vaccine in development.

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Milestones Mitigate Risk in Biotech Deals

Milestone payments are becoming an increasingly familiar aspect of many biotech deals, as buyers try to mitigate the risks inherent with big purchases. Take Celgene’s $2.9 billion buyout of Abraxis; the biotech giant set aside $650 million in milestone payments if Abraxis’ key drug Abraxane hit certain goals. “These structures are a great way for buyer and seller to share the risk that’s related to drug development,” says analyst Brett Skolnik. Milestones also encourage buyer and seller to look beyond the merger, making it more likely the deal will be beneficial to both sides in the long term.

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Fastest Growing Therapeutic Classes (by Sales)

Oncologics, lipid regulators, respiratory agents, antidiabetics and anti-ulcerants are the five largest drug classes by sales. But annual sales are only half the story. Which drug classes are booming, and which have plateaued–or even dropped? IMS Health has released top-line industry data revealing the 15 largest drug classes, and we’ve crunched the numbers to take a closer look at the average sales growth of the 15 largest therapeutic classes over the last five years.

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Pipeline to Soften Lilly Patent Losses

Eli Lilly (NYSE: LLY) is looking to its pipeline to fill the gaps left by a number of high-profile drugs coming off patent. In October 2011, blockbuster Zyprexa will fall to generic competition; additionally, about three-quarters of Lilly’s current revenue comes from eight drugs that will lose patent protection between now and 2017. ”We have the challenge of replenishing our product portfolio from our pipeline,” says CEO John Lechleiter in a USA Today interview. “Fortunately, we have the most exciting pipeline today in our history.”

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Merck KGaA’s Pancreatic Cancer Vaccine Ready for Testing

In the quest for a cancer vaccine, Merck KGaA is again stepping into the ring. Vaximm Holding AG, the company’s joint venture with a Switzerland’s BB Biotech Ventures III, will start testing a therapeutic cancer vaccine in patients next year. The vaccine, VXM01, harnesses the body’s immune system to fight cancer by using T-cells to close off the tumor’s blood supply. Roche’s Avastin also focuses on the tumor’s blood supply, but it focuses on eliminating a protein that creates the blood vessels to the tumor.

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