Archive for the 'FDA' Category

Which Specialty Drugmakers Should Big Pharma Buy?

Every so often, someone sets up a dartboard of likely targets for Big Pharma buyouts. This time, the target-setter is Barron’s, and the focus is on companies with market values of $10 billion or less. Most of them have at least one marketed product: “It’s less dangerous playing smaller outfits with approved drugs than those with treatments still awaiting an okay from an increasingly demanding FDA,” the magazine points out.

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J&J Teams up with Sanford-Burnham on Alzheimer’s Pact

The drug development arm of Johnson & Johnson is joining research forces with scientists at the prestigious Sanford-Burnham Institute in an effort to blaze a relatively short path to new drugs for psychiatric disorders as well as Alzheimer’s. And the collaboration–the latest in a string of R&D pacts that have been struck between pharma companies and academic groups–could reportedly be worth more than $85 million to the research institute.

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Researchers ‘Unzip’ MRSA’s Armor for Possible Vaccine

MRSA (methicillin-resistant staphylococcus aureus) is one tough nut to crack. Researchers have failed to produce a vaccine because agents cannot break through the life-threatening bacteria’s armor. So, while other research has targeted the surface of the bacteria, a team from the University of Rochester Medical Center has discovered an antibody that reaches beyond the microbe’s surface and can stop the MRSA bacteria from growing, according to a report in Drug Discovery & Development.

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GSK Malaria Vax Shows Promising Results

Mosquirix, an experimental malaria vaccine from GlaxoSmithKline, provides African children with long-lasting protection and reduces the risk of infection by the parasite that causes severe malaria by 46 percent over 15 months, according to researchers.

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Alfred Mann Doubles Down on Biotech

As investors lay down their final bets on the FDA’s looming decision on MannKind’s Afrezza, the company’s wealthy CEO has opted to put his money where his mouth has been–doubling down on an ambitious wager that the much-maligned inhaled insulin treatment Afrezza will get a green light from regulators.

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PneumRx lands $33M for Lung Device

Gearing up for a pivotal trial of its RePneu Lung Volume Reduction Coil system, Mountain View, CA-based PneumRx has $33 million in working capital commitments. Forbion Capital Partners and Endeavour Vision led the round. The company’s lung device is designed to improve lung function in emphysema patients by implanting Nitinol coils into the lungs to compress damaged tissue and restore elastic recoil to the lung, according to the company’s release.

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J&J Recalls Rolaids on Wood-Particle Contamination

Once again, we have Johnson & Johnson recall news. And once again, it’s a product sold by J&J operating unit McNeil Consumer Healthcare. The company says wood and other particles have been found in Softchews Rolaids, so it’s expanding the November Rolaids recall to include all lots of the Softchews products.

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FDA Loses Battle in War Against e-cigarettes

Electronic cigarettes are nicotine-delivery devices that include a heating element that vaporizes chemicals in replaceable plastic cartridges. Researchers at the University of California, Riverside recently evaluated five e-cigarette brands and, finding design flaws, lack of adequate labeling, and several concerns about quality control and health issues, concluded that e-cigarettes are potentially harmful and urged regulators to consider removing e-cigarettes from the market until their safety is adequately evaluated.

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Dry Powder Inhaler Stays Strong Even if Breath is Weak

MedGadget blog tells us about a new dry powder inhaler that, according to Cambridge Consultants and India’s Sun Pharma Advanced Research Company (SPARC), delivers an even drug dose deep into the lungs no matter how strong the patient’s inhalation.

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H1N1 Vaccine Linked to 700% Increase in Miscarriages?

Recent data presented to the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Children’s Vaccines has revealed some shocking information about the effects of the H1N1 / swine flu vaccine on pregnant women. According to the National Coalition of Organized Women, the rate of miscarriage among pregnant women during the 2009 H1N1 / swine flu pandemic soared by over 700 percent compared to previous years, pointing directly to the vaccine as the culprit — but the CDC denies the truth and continues to insist nobody has been harmed.

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