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Study: Serious adverse events associated with pediatric vaccines extremely rare

BY Michael Johnsen

ELK GROVE VILLAGE, Ill. — A study published Tuesday online by the journal Pediatrics found that the protective benefits provided by vaccines for children significantly outweighed the extremely rare possiblity of an adverse event. 

 
"Our findings may allay some patient, caregiver and health care provider concerns," wrote Margaret Maglione, lead researcher on the study. "Strength of evidence is high that MMR vaccine is not associated with the onset of autism in children; this conclusion supports findings of all previous reviews on the topic," she noted. "There is also high-strength evidence that MMR, DTaP, Td, Hib, and hepatitis B vaccines are not associated with childhood leukemia."
 
And while evidence was found for an association of several serious adverse events with vaccines, these events were extremely rare, Maglione noted. "For example, strength of evidence is moderate for association of vaccines against rotavirus with intussusception (a serious disorder in which part of the intestine slides into an adjacent part of the intestine). "Although one large U.S. epidemiologic study found no association, a recent analysis of the U.S. PRISM program 90 found both RotaTeq and Rotarix associated with intussusception in the short term." Estimated rates were 1.1 to 1.5 cases per 100,000 doses of RotaTeq and 5.1 cases per 100,000 doses of Rotarix.
 

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Genentech buys Seragon Pharmaceuticals and its breast cancer portfolio for $725 million

BY Michael Johnsen

BASEL, Switzerland — Roche on Wednesday announced that Genentech, a member of the Roche Group, has entered into a definitive agreement to acquire Seragon Pharmaceuticals, a privately held biotechnology company based in San Diego. 

 
With this acquisition, Genentech obtains rights to Seragon’s entire portfolio of investigational next-generation oral selective estrogen receptor degraders (SERDs), for the potential treatment of hormone receptor-positive breast cancer.
 
“This year, breast cancer will claim the lives of nearly 40,000 women in the United States, and up to half of these women will have a disease that is driven by the estrogen receptor,” stated Richard Scheller, EVP and head of Genentech Research and Early Development. “We believe these investigational oral SERDs could one day redefine the standard of care for hormone receptor-positive breast cancer.”
 
Under the terms of the agreement, Genentech will make an upfront cash payment of $725 million, plus additional contingent payments of up to $1 billion based on achievement of certain predetermined milestones. The closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. The transaction is expected to close in the third quarter of 2014. Once the transaction is completed, Seragon’s portfolio will be integrated into Genentech Research and Early Development.
 
Up to 60% of breast cancers depend on the hormone estrogen and the estrogen receptor to grow and spread. This type of breast cancer is called hormone receptor-positive breast cancer. It is typically treated with medicines, such as tamoxifen and aromatase inhibitors, that are designed to block the action at the estrogen receptor or interfere with the body’s production of estrogen. Many women who receive these current hormonal agents will eventually see their disease return or worsen.
 
Scientists at Seragon have developed next-generation selective estrogen receptor degraders (SERDs). This class of medicines is designed to both block estradiol action at the estrogen receptor and also eliminate the estrogen receptor from the cell altogether. It is believed that SERDs change the shape of the estrogen receptor in a manner that targets it for elimination by the cell. These next-generation dual-acting SERDs may offer an improved approach to treating hormone receptor-positive breast cancer, and potentially other cancers driven by the estrogen receptor.
 
Seragon’s lead product candidate, ARN-810, is a next-generation SERD that is currently in Phase I clinical trials for patients who have hormone receptor-positive breast cancer and have failed current hormonal agents. These next-generation SERDs complement Genentech’s existing research and development programs in breast cancer.
 

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Research: Omega-3 is beneficial to gut bacteria; omega-6 is not

BY Michael Johnsen

STOCKHOLM — New research released Wednesday found that dietary fats impact gut bacteria — some for the better (omega-3 polyunsaturated fatty acids or PUFAs) and some for the worse (omega-6 PUFAs). The omega-3s EPA and DHA found in seafood and marine oils may reduce inflammation and increase beneficial microorganisms to protect against gastrointestinal diseases. 

 
The research showed that dietary choices and certain microorganisms in the GI tract can contribute to the prevention or development of inflammatory bowel disease, colitis (inflammation of the colon) and Crohn's disease. PUFAs in particular affect microbes living in the intestine known as "gut microbiota."
 
Deanna Gibson, assistant professor at the University of British Columbia, Canada, and colleagues examined the effects of omega-3 and -6 PUFAs in mice infected with GI bacteria that causes colitis. Those fed omega-6 PUFA (corn oil) diets had higher intestinal damage, immune cell damage and production of harmful bacteria. In contrast, diets high in EPA and DHA increased anti-inflammatory microbes, which reduced immune cell damage and inflammation as well as protected against the damage of colitis. However, the mice taking these omega-3 fats suffered sepsis (whole body inflammation due to severe infection) because their immune responses needed to survive infection were impaired.
 
"While too much inflammation isn't good in the context of autoimmune disease, we also need inflammation to survive against infections," Gibson noted. "These observations suggest that excess omega-6 PUFA intakes may be harmful to gut health. Conversely, while omega-3 PUFA supplementation promotes beneficial microbes in the gut, thereby decreasing inflammation, this advantage under normal conditions may be problematic in the presence of harmful bacteria," she said. 
 
"Curiously, when a saturated fat-rich diet was supplemented with fish oil, the mice did not suffer from sepsis," Gibson added. "These intriguing findings suggest that omega-3 PUFA supplementation with a diet high in saturated fat may be more protective to the GI tract than a diet rich in omega-6 PUFAs."
 
Jing Kang, professor at Harvard Medical School and Massachusetts General Hospital, USA, reported a mouse study showing a lower ratio of omega-6 to omega-3 PUFAs alters gut microbiota and reduces the production of harmful bacteria while increasing colonies of beneficial bacteria. These changes led to less inflammation.
 
"Chronic low-grade inflammation contributes to the development of many chronic diseases and can be induced by harmful gut microbiota," Kang said. "Therefore, dietary strategies that lower the omega-6/omega-3 PUFA ratio to optimize gut microbiota — such as reducing intake of vegetable oils high in omega-6 fat, processed foods and grain-raised livestock and increasing intake of fish and green vegetables — could prove effective for managing such diseases. For management of certain health conditions, a high quality, concentrated omega-3 supplement is also practical."
 

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