Hypersensitivity News and Research

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

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

Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Pfizer Oncology will present data from across its portfolio, including results from long-term follow-up of Aromasin® (exemestane tablets) in a study of early breast cancer, updated study results from a Phase 3 study of Sutent® (sunitinib malate) in pancreatic neuroendocrine tumors (NET), and early-stage research of investigational agents PF-02341066 and figitumumab (CP-751,871) in patients with non-small cell lung cancer (NSCLC).

19 Sep 2009

Millennium's sNDA for VELCADE granted priority review by the FDA

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has granted priority review to the Company’s supplemental new drug application (sNDA) for VELCADE. The sNDA contains long-term overall survival (OS) data from the landmark VISTA trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

19 Sep 2009

FDA approves sBLA for Influenza A (H1N1) 2009 Monovalent Vaccine

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of its Influenza A (H1N1) 2009 Monovalent Vaccine.

16 Sep 2009

Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Hyperion Therapeutics today announced that the first patient has been enrolled in a clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate) in children ages 6-17 with urea cycle disorders (UCD). The study will evaluate the safety, tolerability, and ammonia control of glycerol phenylbutyrate compared to BUPHENYL® (sodium phenylbutyrate).

15 Sep 2009

Phase III STARTMRK clinical study on ISENTRESS in comparison to efavirenz

ISENTRESS , an integrase inhibitor from Merck & Co., Inc., was studied in comparison to efavirenz in maintaining viral load suppression to undetectable levels (less than 50 copies/mL) and at improving CD4 cell counts in previously untreated (treatment-naïve) HIV-1-infected patients through 96 weeks in a Phase III study called STARTMRK.

14 Sep 2009

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) today announced data presented at the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showing the potential of TYSABRI® (natalizumab) to redefine successful multiple sclerosis (MS) therapy.

14 Sep 2009

Results further support the benefits of TYSABRI for multiple sclerosis patients

Biogen Idec and Elan Corporation, plc (NYSE: ELN) today announced six-month results of an ongoing, one-year longitudinal, observational, patient-reported outcomes study showing multiple sclerosis (MS) patients taking TYSABRI- (natalizumab) experienced an improvement in both their physical function and psychological well-being.

14 Sep 2009

Abstracts on Merck Serono oncology treatments to be presented at ECCO and ESMO

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, continues to drive the global effort to ensure patients receive personalized cancer therapies. A total of 17 abstracts concerning Merck Serono oncology treatments will be presented at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO), to be held in Berlin from 20-24 September 2009.

11 Sep 2009

Merck update on the status of telcagepant clinical development programs

Merck & Co., Inc. today updated the status of the clinical development programs for telcagepant (MK-0974) and MK-3207, the Company's investigational oral calcitonin gene-related peptide (CGRP) receptor antagonists for the intermittent treatment of acute migraine.

11 Sep 2009

Abbreviated New Drug Application for nateglinide tablets approved

Par Pharmaceutical Companies, Inc. today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for nateglinide tablets.

11 Sep 2009

Hypersensitivity News and Research

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

Pfizer Oncology to present early-stage research of investigational agents for cancer treatment

Millennium's sNDA for VELCADE granted priority review by the FDA

FDA approves sBLA for Influenza A (H1N1) 2009 Monovalent Vaccine

Hyperion enrolls first patient in HPN-100 investigational compound clinical trial

Phase III STARTMRK clinical study on ISENTRESS in comparison to efavirenz

Data from Phase III clinical trial of TYSABRI presented at ECTRIMS

Results further support the benefits of TYSABRI for multiple sclerosis patients

Abstracts on Merck Serono oncology treatments to be presented at ECCO and ESMO

Merck update on the status of telcagepant clinical development programs

Abbreviated New Drug Application for nateglinide tablets approved

Advancing Neuroscience Research Through Collaboration and Patient-Centered Innovation

The impact of vibration on microscopy

How Omics Technologies Are Transforming Biological Research and Drug Discovery

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