Hypersensitivity News and Research

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Hypersensitivity is an exaggerated response by the immune system to a drug or other substance.

FDA approves Berinert for the treatment of hereditary angioedema

The U.S. Food and Drug Administration today approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with a rare and potentially life-threatening genetic disease called hereditary angioedema (HAE).

12 Oct 2009

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

BioDelivery Sciences International, Inc. announced that its commercial partner Meda will launch the FDA-approved ONSOLIS (fentanyl buccal soluble film) next week for the management of breakthrough pain (BTP) in patients with cancer, eighteen years of age and older, who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

8 Oct 2009

Schering-Plough receives FDA recommendation approval for PEGINTRON

Schering-Plough Corp. announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for PEGINTRON® (pegylated interferon alfa-2b) in the adjuvant treatment of patients with Stage III malignant melanoma.

6 Oct 2009

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Baxter International Inc. today announced the commercial launch of HYLENEX recombinant (hyaluronidase human injection) for use in pediatric rehydration at the 2009 American College of Emergency Physicians (ACEP) scientific assembly (Boston). HYLENEX, an enzyme, allows fluids to be administered under the skin (subcutaneously) rather than through a vein.

From Baxter International Inc. 5 Oct 2009

Cumberland to present clinical trial data of Caldolor at the AAPM annual meeting

Cumberland Pharmaceuticals Inc. announced today that data from two key clinical trials for Caldolor®, an intravenous formulation of ibuprofen approved for treatment of pain and fever in adults, will be presented at the American Academy of Pain Management's (AAPM) 20th Annual Clinical Meeting to be held in Phoenix, Ariz., on October 8-11, 2009.

5 Oct 2009

Interim results of Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine clinical trials announced

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today an interim analysis of data from clinical trials of the U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine in adults 18 years through 64 years of age and over the age of 65 years.

3 Oct 2009

First prescription foam formulation of benzoyl peroxide available

Onset Therapeutics, a specialty pharmaceutical company focused on dermatology, announced today the commercial availability of BenzEFoam (benzoyl peroxide) 5.3% Emollient Foam, the first prescription foam formulation of benzoyl peroxide.

1 Oct 2009

Januvia in combination with metformin or taken alone lowers blood sugar

A post-hoc analysis, presented at the 45th Annual Meeting of the European Association for the Study of Diabetes (EASD), of data pooled from studies of 104 weeks in duration showed ‘Januvia’ (sitagliptin), when taken alone or in combination with metformin, provided significant blood sugar lowering over two years.

29 Sep 2009

Heparin-induced skin lesions may indicate platelets deficit

Heparin, a commonly used anticoagulant, can cause skin lesions, reports a study http://www.cmaj.ca/press/cmaj081729.pdf in CMAJ (Canadian Medical Association Journal) www.cmaj.ca.

29 Sep 2009

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

Merck has thoroughly reviewed the safety data for sitagliptin, and sitagliptin was not associated with an increase in the incidence of pancreatitis in preclinical studies or in clinical trials of up to two years in duration with more than 6,000 patients.

28 Sep 2009

Quintiles Transnational enter into marketing agreement with Allergan for SANCTURA XR

Quintiles Transnational Corp. and Allergan, Inc. (NYSE: AGN) today announced an agreement under which Quintiles will co-promote Allergan's SANCTURA XR® (trospium chloride extended release capsules), an anticholinergic approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency, predominantly to primary care physicians in the United States.

28 Sep 2009

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme (MSD), has received a positive opinion from the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) for JANUVIA® tablets and JANUMET® tablets recommending their use as add-on to insulin for the treatment of type 2 diabetes.

26 Sep 2009

Merck, QIAGEN to collaborate to increase access to HPV vaccination and HPV DNA testing in developing countries

Merck & Co., Inc. and QIAGEN N.V. today announced their intent to collaborate on a new program to increase access to HPV vaccination and HPV DNA testing in some of the most resource-poor areas of the world.

From QIAGEN Manchester Limited 24 Sep 2009

Scientist reveals that selecting optimal radiation dosage for a patient is possible

An international group of scientists has taken the first step on the road to targeting radiotherapy dosage to individual patients by means of their genetic characteristics, a radiation oncologist told Europe's largest cancer congress, ECCO 15 - ESMO 34, in Berlin today (Thursday September 24). Professor Dirk de Ruysscher, from Maastricht University Medical Centre, Maastricht, The Netherlands, said that his team's work might provide the basis for personalised radiotherapy in which, with a simple blood test, doctors may be able to select the optimal radiation dose for a particular patient.

24 Sep 2009

EGFR-targeted therapy improves survival rates in metastatic colorectal cancer patients

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) demonstrated a significant improvement in overall survival (OS) when added to standard 1st-line chemotherapy for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors.

23 Sep 2009

Results of IES presented at ECCO

Pfizer Inc today announced new, longer-term data from the Intergroup Exemestane Study (IES) showing that women who switched to AROMASIN® (exemestane tablets) after taking tamoxifen for two to three years experienced a significant reduction (18%) in the risk of disease-free survival (DFS) events. In addition, IES showed that AROMASIN prolonged overall survival (OS) in the ER+/unknown population with a 14% reduction in the risk of dying. These results demonstrate that the benefits of treatment are maintained in long term follow-up. These results were presented at the joint ECCO 15/ESMO 34 meeting in Berlin, Germany.

23 Sep 2009

Sanofi Pasteur receives additional order H1N1 vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the company has received an additional order from the U.S. Department of Health and Human Services (HHS) to produce vaccine to help protect against the Influenza A (H1N1) 2009 virus. The new order is for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose.

22 Sep 2009

CSL Behring offers new dosage strength of Helixate FS in U.S.

Hemophilia A patients who require high doses of Helixate® FS, Antihemophilic Factor (Recombinant), can now benefit from greater convenience in administering their treatment, thanks to a new 3000 IU (international unit) dosage strength. CSL Behring announced today that this new dosage strength is available in the U.S., allowing many patients to reduce reconstitution time by eliminating the need to mix and pool multiple vials of Helixate FS.

22 Sep 2009

U.S. HHS orders for an additional 29 million doses of MedImmune's influenza vaccine

MedImmune announced today that the U.S. Department of Health and Human Services (HHS) has placed an order for an additional 29 million doses of its live attenuated influenza vaccine (LAIV) against the 2009 H1N1 influenza virus. This brings HHS orders to date to more than 40 million vaccine doses, with a total cumulative contract value of approximately $453 million.

22 Sep 2009

King Pharmaceuticals achieves milestone: Announces commercial availability of EMBEDA

King Pharmaceuticals(R), Inc. (NYSE: KG) today announced a true milestone as it marks the first commercial availability for EMBEDA(TM) (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules, a long-acting Schedule II opioid analgesic for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

21 Sep 2009

Hypersensitivity News and Research

FDA approves Berinert for the treatment of hereditary angioedema

BioDelivery Sciences' partner Meda to launch ONSOLIS for managing breakthrough pain

Schering-Plough receives FDA recommendation approval for PEGINTRON

Baxter launches HYLENEX recombinant for pediatric rehydration at the 2009 ACEP

Cumberland to present clinical trial data of Caldolor at the AAPM annual meeting

Interim results of Sanofi Pasteur's Influenza A (H1N1) 2009 Monovalent Vaccine clinical trials announced

First prescription foam formulation of benzoyl peroxide available

Januvia in combination with metformin or taken alone lowers blood sugar

Heparin-induced skin lesions may indicate platelets deficit

Safety profiles of JANUVIA and JANUMET drugs established through clinical development program

Quintiles Transnational enter into marketing agreement with Allergan for SANCTURA XR

European CHMP recommends Merck's JANUVIA and JANUMET as add-on to insulin

Merck, QIAGEN to collaborate to increase access to HPV vaccination and HPV DNA testing in developing countries

Scientist reveals that selecting optimal radiation dosage for a patient is possible

EGFR-targeted therapy improves survival rates in metastatic colorectal cancer patients

Results of IES presented at ECCO

Sanofi Pasteur receives additional order H1N1 vaccine

CSL Behring offers new dosage strength of Helixate FS in U.S.

U.S. HHS orders for an additional 29 million doses of MedImmune's influenza vaccine

King Pharmaceuticals achieves milestone: Announces commercial availability of EMBEDA

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

From Puberty to Menopause: Clue’s CEO, Audrey Tsang on the Power of Femtech

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