Hypersensitivity News and Research

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

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

ZymoGenetics, Inc., today announced the publication of pooled safety and immunogenicity observations from eight clinical trials of RECOTHROM in the February issue of the Journal of the American College of Surgeons. The authors concluded that RECOTHROM is a well-tolerated topical hemostatic agent in numerous surgical settings and has a low rate of anti-product antibody formation. In the pooled data from all trials, less than one percent of treated patients developed product-specific antibodies. None of the antibodies neutralized native coagulation proteins.

2 Feb 2010

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Romark Laboratories announced that it has initiated enrollment of patients in a clinical trial of Alinia® (nitazoxanide) for treating acute uncomplicated influenza including illness caused by the currently circulating H1N1 strain.

1 Feb 2010

Clinical results of MedImmune's pivotal trial for motavizumab published

MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics.

30 Jan 2010

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using TYKERB® (lapatinib) as a first-line, all-oral treatment for women with metastatic breast cancer.

29 Jan 2010

Onset Therapeutics expands its sales force to create nationwide presence

Onset Therapeutics LLC, a specialty pharmaceutical company focused in dermatology, today announced that the Company’s recent growth and future opportunities have facilitated an expansion of its field sales organization to cover more than twenty-five additional major metropolitan areas.

28 Jan 2010

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Patients with gastrointestinal stromal tumours (GIST) can now take action at an earlier stage of this rare form of cancer to reduce the risk of their disease returning following surgery. Novartis Pharmaceuticals Canada announced today that Gleevec* (imatinib mesylate) has received conditional approval by Health Canada for the adjuvant (post-surgical) treatment of adult patients who are at intermediate to high risk of disease recurrence following the surgical removal of GIST.

27 Jan 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

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

24 Jan 2010

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

Poniard Pharmaceuticals, Inc., a biopharmaceutical company focused on innovative oncology therapies, today announced final data from a randomized, controlled Phase 2 trial of picoplatin in metastatic colorectal cancer (CRC) patients.

24 Jan 2010

BrainTrust Canada and CSPS partner to distribute Concussion Cards to all CSPS ski patrollers

During this week - National Learn to Ski & Snowboard Week - BrainTrust Canada and the Canadian Ski Patrol System (CSPS) have launched a partnership which includes the distribution of Concussion Cards as a prevention and management tool to all 5,000 CSPS ski patrollers across the country.

20 Jan 2010

Health Canada approves Novartis' Afinitor to treat patients with mRCC

Novartis Pharmaceuticals Canada Inc. (Novartis) announced today that Afinitor(R) (everolimus), a once-daily oral cancer treatment, has been approved by Health Canada for patients with metastatic renal cell carcinoma (mRCC), also known as advanced kidney cancer, after failure of initial treatment with VEGF-receptor targeted therapies Sutent(R) (sunitinib) or Nexavar(R) (sorafenib).

20 Jan 2010

Antibiotic drops are safe and effective for treating swimmer's ear

When treating the pain and inflammation of swimmer's ear, antibiotic drops are the most effective — and safest - therapy, finds a new review of studies.

20 Jan 2010

FDA grants orphan drug exclusivity approval for Octapharma AG's wilate

Octapharma AG, one of the largest manufacturers of plasma products in the world, today announced that it has received orphan drug exclusivity approval for wilate® from the U.S. Food and Drug Administration (FDA).

18 Jan 2010

First sulfite-free rectal suspension for UC

sfRowasa™ (mesalamine) Rectal Suspension 4g/60mL –Sulfite-Free Formulation, is the first sulfite-free rectal suspension available for Ulcerative colitis (UC). According to a study published in The American Journal of Gastroenterology, products containing sulfites may exacerbate natural sulfide levels in the colon and may increase inflammation in UC patients. With its sulfite-free preparation, sfRowasa™ offers a new treatment option for the treatment of active, mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis.

13 Jan 2010

Cardene I.V. more effective than intravenous labetalol for BP management in acute stroke patients

EKR Therapeutics, Inc., a specialty pharmaceutical company commercializing acute-care hospital products, today said that interim study data1 demonstrate that Cardene® I.V. (nicardipine hydrochloride) is significantly more effective than intravenous labetalol for the management of blood pressure (BP) in stroke patients.

12 Jan 2010

ViroPharma signs agreement with Sanquin Blood Supply Foundation to develop and commercialize Cinryze

ViroPharma Incorporated today announced that it has signed an agreement with Sanquin Blood Supply Foundation for rights to develop, file regulatory dossiers, and commercialize Cinryze(TM) (C1 esterase inhibitor [human]) for hereditary angioedema (HAE) as well as for potential new indications in certain European and rest of world (ROW) territories.

12 Jan 2010

AMAG Pharmaceuticals provides update on the commercial launch of Feraheme Injection

AMAG Pharmaceuticals, Inc. today provided an update on the commercial launch of Feraheme® (ferumoxytol) Injection for intravenous (IV) use, including preliminary fourth quarter 2009 Feraheme net product revenues estimates, as well as an update on the Company’s international and label expansion efforts.

10 Jan 2010

Genentech's ACTEMRA approved to treat RA

Genentech, Inc., a wholly owned member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.

8 Jan 2010

3Sbio submits registrational clinical trial application for Feraheme injection

3SBio Inc., a leading biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products primarily in China, today announced that it has submitted its application for a registrational clinical trial to the Chinese State Food and Drug Administration ("SFDA") for Feraheme (ferumoxytol) Injection for intravenous use.

8 Jan 2010

Rituximab treatment reduces patients' response to pneumonia vaccine

Researchers from Johns Hopkins University determined that immune responses to the tetanus vaccine were not changed when rituximab in combination with methotrexate (MTX) was compared with MTX alone in patients with rheumatoid arthritis (RA).

7 Jan 2010

VELCADE sNDA receives FDA approval

Millennium: The Takeda Oncology Company today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VELCADE, which expands the label to include long-term (median follow-up 36.7 months) overall survival (OS) data from the landmark VISTA trial and provides specific dosing recommendations for patients with hepatic impairment. The VISTA trial examined the use of VELCADE based therapy in patients with previously untreated multiple myeloma (MM).

5 Jan 2010

Hypersensitivity News and Research

RECOTHROM topical hemostat exhibits low rate of anti-product antibody formation

Romark Laboratories commences enrollment in Alinia clinical trial for acute uncomplicated influenza

Clinical results of MedImmune's pivotal trial for motavizumab published

FDA grants accelerated approval for GlaxoSmithKline's TYKERB

Onset Therapeutics expands its sales force to create nationwide presence

Health Canada approves first post-surgical treatment for patients with gastrointestinal stromal tumours

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Final data from Poniard Pharmaceuticals' randomized Phase 2 trial of picoplatin announced

BrainTrust Canada and CSPS partner to distribute Concussion Cards to all CSPS ski patrollers

Health Canada approves Novartis' Afinitor to treat patients with mRCC

Antibiotic drops are safe and effective for treating swimmer's ear

FDA grants orphan drug exclusivity approval for Octapharma AG's wilate

First sulfite-free rectal suspension for UC

Cardene I.V. more effective than intravenous labetalol for BP management in acute stroke patients

ViroPharma signs agreement with Sanquin Blood Supply Foundation to develop and commercialize Cinryze

AMAG Pharmaceuticals provides update on the commercial launch of Feraheme Injection

Genentech's ACTEMRA approved to treat RA

3Sbio submits registrational clinical trial application for Feraheme injection

Rituximab treatment reduces patients' response to pneumonia vaccine

VELCADE sNDA receives FDA approval

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How ELRIG Is Helping Mid-Career Scientists Navigate Leadership, Career Change and Redundancy

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