Hypersensitivity News and Research

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

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

FDA approves Supplemental New Drug Application for DOXIL

Centocor Ortho Biotech Products, L.P. today announced that it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) regarding its Supplemental New Drug Application (sNDA) for DOXIL (doxorubicin HCI liposome injection) in combination with docetaxel for the treatment of women with locally advanced and metastatic breast cancer.

10 Sep 2009

Merck's GARDASIL receives approval from FDA Advisory Committee

Merck & Co., Inc. announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee agreed that efficacy, immunogenicity and safety data from clinical trials in males support the use of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] in boys and men 9 through 26 years of age for the prevention of genital warts caused by human papillomavirus (HPV) types 6 and 11.

10 Sep 2009

Caldolor launched ahead of schedule in U.S. by Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has successfully implemented the U.S. launch of Caldolor((R)), an intravenous formulation of ibuprofen, designed primarily for use in the hospital setting.

9 Sep 2009

Shire receives FDA approval for INTUNIV extended release tablets

Shire plc, the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV(TM) (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years.

4 Sep 2009

Shire's INTUNIV (Guanfacine) approved by the FDA for treatment of Attention-Deficit/Hyperactivity Disorder

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV- (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

4 Sep 2009

SAFLUTAN launched in United Kingdom and Spain

Merck Sharp & Dohme (MSD) has launched SAFLUTAN (tafluprost) in the United Kingdom and Spain, and additional launches in other countries are expected over the next several months, pending regulatory approvals, the Company said today.

3 Sep 2009

Biogen Idec's MS franchise to present at the 25th Congress of ECTRIMS

Biogen Idec today announced more than 70 platform and poster presentations from the company’s multiple sclerosis (MS) franchise being presented during the 25th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Düsseldorf, Germany.

3 Sep 2009

CORD I phase III clinical trial results of XIAFLEX published

Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, today announced that The New England Journal of Medicine (NEJM) has published in its September 3rd edition, the Company's pivotal CORD I Phase III clinical trial of XIAFLEX (collagenase clostridium histolyticum) a novel, first-in-class, biologic for the nonsurgical treatment of Dupuytren's contracture.

3 Sep 2009

Millennium's sNDA to be reviewed by the FDA

The Takeda Oncology Company today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s supplemental new drug application (sNDA) based on long- term overall survival (OS) data from the landmark VISTA1 trial examining the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

3 Sep 2009

Cimzia approved for treating adult patients with rheumatoid arthritis

UCB Canada Inc. announced today that Health Canada has approved Cimzia, the only PEGylated anti-TNF (Tumor Necrosis Factor), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

1 Sep 2009