Archive for the ‘Allergies’ Category

Wednesday, May 2nd, 2007

Mylan Completes Acquisition of Generics Business of Merck KGaA

Wednesday, May 2nd, 2007

PITTSBURGH, October 02, 2007 /PRNewswire-FirstCall/ — Mylan announced today that it has completed its acquisition of Merck KGaA’s generics business (”Merck Generics”) to become one of the largest quality generics and specialty pharmaceuticals companies in the world. Mylan and Merck KGaA initially announced the signing of a definitive agreement under which Mylan would acquire Merck Generics for EUR 4.9 billion ($6.7 billion) in an all-cash transaction on May 12, 2007.

Robert J. Coury, Mylan’s Vice Chairman and Chief Executive Officer said, “The new Mylan now has all of the critical attributes we need to ensure future success and deliver powerful growth. We have enhanced scale and stability, a truly global reach, vertical and horizontal integration, and breadth and depth in our management team. Most importantly, we have a common purpose and dedication to executing on our strategy and delivering superior shareholder returns.”

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Women Less Likely than Men to Get ICDs

Wednesday, May 2nd, 2007

DURHAM, N.C., Oct. 2 — Women at risk of sudden cardiac death are two to three times less likely to receive an implantable cardioverter-defibrillator (ICD) than men who are at risk, investigators here have found. Action Points
Explain to interested patients that women are two to three times less likely to receive ICDs than men are for prevention of sudden cardiac death.

Point out that the reasons for the disparity are unclear.

Point out also that the findings were based on retrospective analysis of data, not a randomized, controlled clinical trial.
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Mylan Announces Appointment of Didier Barret as President, Europe,Middle East and Africa

Wednesday, May 2nd, 2007

PITTSBURGH, October 02, 2007 /PRNewswire-FirstCall/ — Mylan Inc. today announced the appointment of Didier Barret to the position of President, EMEA (Europe, Middle East and Africa) following the completion of Mylan’s acquisition of Merck’s Generics Group today.

At Merck Generics, M. Barret most recently served as Region Director, EMEA, reporting to the CEO. He was promoted to that position in 2004 following his role as Area Director for Southern Europe, where he was responsible for France, Belgium, Italy, Spain and Portugal. He established Merck Generics’ first operations in France in 1995, growing the business to exceed euro 341 million in sales by 2006. Prior to this, M. Barret held several positions within Merck’s branded division, including sales and marketing in the UK and France.

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FDA Approves Glaucoma Drug Combining Two Old-line Agents

Tuesday, May 1st, 2007

IRVINE, Calif., Nov. 1 — The FDA has approved an ophthalmic solution that combines brimonidine and timolol (Combigan) for reduction of intraocular pressure in patients with glaucoma or ocular hypertension, Allergan announced here.

In clinical trials, the combination of an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor significantly reduced mean intraocular pressure up to 7.6 mm Hg from baseline and was well tolerated, the company said.

Moreover, when compared with brimonidine tid or timolol bid monotherapy, the combination compound administered twice a day reduced intraocular pressure by an additional 1 to 3 mm Hg.

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Breastfeeding May Impair Lung Growth and Function When Mom Has Asthma

Tuesday, May 1st, 2007

MADISON, Wis., Nov. 1 — The longer a baby is breastfed, the better for lung growth and function later in childhood and adolescence — except when the mother has asthma or atopic allergies, researchers reported. Action Points
Explain to patients that, in this study, the longer a baby was breastfed, the better a child’s lung function, except when the mother had asthma or atopic allergies.

Note that when mom had asthma, lung growth and function was actually impaired with longer duration breastfeeding.

Explain, though, that it is premature to suggest women with asthma stop breastfeeding early, particularly since the benefits in other areas are well documented.

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‘Complementary ENT’: a systematic review of commonly used supplements.

Friday, April 27th, 2007

‘Complementary ENT’: a systematic review of commonly used supplements.: J Laryngol Otol. 2007 Aug;121(8):779-82 Authors: Karkos PD, Leong SC, Arya AK, Papouliakos SM, Apostolidou MT, Issing WJ

OBJECTIVE: To assess the evidence surrounding the use of certain complementary supplements in otolaryngology. We specifically focussed on four commonly used supplements: spirulina, Ginkgo biloba, Vertigoheel and nutritional supplements (cod liver oil, multivitamins and pineapple enzyme). MATERIALS AND METHODS: A systematic review of the English and foreign language literature. Inclusion criteria: in vivo human studies. Exclusion criteria: animal trials, in vitro studies and case reports. We also excluded other forms of ‘alternative medicine’ such as reflexology, acupuncture and other homeopathic remedies. RESULTS: Lack of common outcome measures prevented a formal meta-analysis. Three studies on the effects of spirulina in allergy, rhinitis and immunomodulation were found. One was a double-blind, placebo, randomised, controlled trial (RCT) of patients with allergic rhinitis, demonstrating positive effects in patients fed spirulina for 12 weeks. The other two studies, although non-randomised, also reported a positive role for spirulina in mucosal immunity. Regarding the use of Ginkgo biloba in tinnitus, a Cochrane review published in 2004 showed no evidence for this. The one double-blind, placebo-controlled trial that followed confirmed this finding. Regarding the use of Vertigoheel in vertigo, two double-blind RCTs and a meta-analysis were identified. The first RCT suggested that Vertigoheel was equally effective in reducing the severity, duration and frequency of vertigo compared with betahistine. The second RCT suggested that Vertigoheel was a suitable alternative to G. biloba in the treatment of atherosclerosis-related vertigo. A meta-analysis of only four clinical trials confirms that Vertigoheel was equally effective compared with betahistine, G. biloba and dimenhydrinate. Regarding multivitamins and sinusitis, two small paediatric pilot studies reported a positive response for chronic sinusitis and otitis media following a course of multivitamins and cod liver oil. Regarding bromelain (pineapple enzyme) and sinusitis, one randomised, multicentre trial including 116 children compared bromelain monotherapy to bromelain with standard therapy and standard therapy alone, for the treatment of acute sinusitis. The bromelain monotherapy group showed a faster recovery compared with the other groups. CONCLUSION: The positive effects of spirulina in allergic rhinitis and of Vertigoheel in vertigo are based on good levels of evidence, but larger trials are required. There is overwhelming evidence that G. biloba may play no role in tinnitus. There is limited evidence for the use of multivitamins in sinus symptoms, and larger randomised trials are required.

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FluMist Gets CDC Nod for Use in Toddlers

Wednesday, April 25th, 2007

ATLANTA, Oct. 25 — Children as young as two can be safely given the intranasal influenza vaccine FluMist, the CDC’s Advisory Committee on Immunization Practices (ACIP) has affirmed.

The CDC recommends that all children ages six months to five years receive a vaccination against influenza. Yet, according to the Sept. 20 Morbidity and Mortality Weekly Report, only 31.9% of children under two received at least one dose of influenza vaccine in the 2005-2006 influenza season and only 20.6% were fully vaccinated.

Last month, the FDA expanded the indications for FluMist to include children ages two to five, but ACIP is the advisory body charged with developing written recommendations for the routine administration of vaccines to children and adults, including age for administration, number of doses and dosing interval, precautions, and contraindications.

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Hopes Dashed Again for HIV Preventive Vaccine

Tuesday, April 24th, 2007

SAN FRANCISCO, Sept. 24 — In another setback to the effort to create a preventive vaccine against HIV, a key trial has been halted because of a lack of efficacy, according to Merck and the HIV Vaccine Trials Network.Action Points
Explain to interested patients that many authorities believe that a key element in halting the HIV pandemic will be a vaccine that prevents new infections.

Add that HIV vaccines have proven difficult to develop because of the extreme changeability of the virus.

Note that this trial showed that a vaccine aimed at cell-mediated immunity had no apparent effect and was stopped for that reason.

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Epigallocatechin gallate affects human dendritic cell differentiation and maturation.

Sunday, April 22nd, 2007

Epigallocatechin gallate affects human dendritic cell differentiation and maturation.: J Allergy Clin Immunol. 2007 Oct 10; Authors: Yoneyama S, Kawai K, Tsuno NH, Okaji Y, Asakage M, Tsuchiya T, Yamada J, Sunami E, Osada T, Kitayama J, Takahashi K, Nagawa H

BACKGROUND: Epigallocatechin gallate (EGCG), a component of green tea catechin with the strongest biological activity, has been focused in recent years because of its anti-inflammatory and immunomodulatory activities. Dendritic cells (DCs) are professional antigen-presenting cells, capable of priming naive T cells, and play the key roles in the activation of T-cell-mediated immune responses. OBJECTIVE: We aimed to investigate the effect of EGCG on human monocyte-derived DCs (MODCs) and, consequently, on the T-cell-mediated immune response. METHODS: The induction of apoptosis, and the detailed phenotypic and functional changes of MODCs, generated by culture of peripheral blood monocytes in the presence of GM-CSF and IL-4, induced by EGCG was investigated and compared with the effects of dexamethasone. RESULTS: Epigallocatechin gallate induced apoptosis and affected the phenotype of the developing DCs. The expressions of CD83, CD80, CD11c, and MHC class II, which are molecules essential for antigen presentation by DCs, were downregulated by EGCG. EGCG also suppressed the endocytotic ability of immature DCs, whereas dexamethasone-treated DCs had higher endocytotic ability than control DCs. Most importantly, mature DCs treated with EGCG inhibited stimulatory activity toward allogeneic T cells while secreting high amounts of IL-10. CONCLUSION: Epigallocatechin gallate induces immunosuppressive alterations on human MODCs, both by induction of apoptosis and suppression of cell surface molecules and antigen presentation. CLINICAL IMPLICATIONS: These alterations should be considered promising new immunosuppressive and anti-inflammatory agents to treat autoimmune and allergic diseases and to prevent the graft rejection in organ transplantation.

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Survey: Does Health Care Reform Mandate a Single-Payer System?

Sunday, April 22nd, 2007

BRUSSELS, Belgium, Sept. 21 — New guidelines offer a more conservative — and pricey — take on formula choices for infants who have an allergy to cow’s milk.

Allergic infants should be given only extensively hydrolyzed formula or an amino-acid based formula rather than a soy-based product as a first line substitute for cow’s milk, said Yvan Vandenplas, M.D., Ph.D., of Vrije Universiteit Brussel here, and colleagues in the October issue of the Archives of Disease in Childhood.Action Points
Explain to interested patients that more than one organization has developed guidelines for the feeding of infants who have an allergy to cow’s milk.
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