Recent news on Omalizumab

Tanox Reports 2007 First Quarter Results  -  May 10, 2007
PharmaLive.com (press release),Net royalty revenue from sales of Xolair(R) (omalizumab) was $11.0 million for the first quarter of 2007, compared to net Xolair royalty revenue of $8.8

Asthma Medication Could Stop You Cold  -  Apr 21, 2007
Lawyers and Settlements,XOLAIR, which is the trade name for omalizumab, was approved by the FDA in 2003 to treat adults and adolescents 12 years of age and over with moderate to

Genentech earnings soar but Lucentis sales slow down slightly  -  Apr 12, 2007
Pharma Times (subscription),The arthritis and non-Hodgkin's lymphoma drug Rituxan (rituximab) posted a 12% gain to $535 million, while Xolair (omalizumab) for severe asthma was up 17%

Genentech Q1 Profit, Revenue Top Consensus; Sees FY07 EPS Growth ...  -  Apr 11, 2007
Trading Markets,Xolair also known as Omalizumab was approved by the FDA in June 2003 to treat adults and adolescents with moderate to severe allergy-related asthma,

Aerovance Tops Off Series C By Garnering $32M Payout  -  Mar 27, 2007
BioWorld Online,And while asthma drug Xolair (omalizumab, Genentech Inc. and Novartis AG) inhibits IgE and must be injected, Aerovant inhibits upstream targets IL-4 and

Pharma Sector: Few Newsmakers Of The Week - Basilea Glaxo ...  -  25 Feb 2007
Trading Markets,Xolair also known as Omalizumab was approved by the FDA in June 2003 to treat adults and adolescents (12 years and older) with moderate to severe

FDA Orders Black Box Anaphylaxis Warning for Omalizumab (Xolair)  -  Feb 21, 2007
MedPage Today,21 -- Anaphylaxis reports associated with the asthma drug omalizumab (Xolair) led the FDA today to order Genentech to add a black box warning to the agent's

FDA wants warning label on omalizumab (Xolair)  -  Feb 21, 2007
News-Medical.net,The Food and Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab,

FDA MedWatch: Xolair (omalizumab) New Reports of Serious and Life ...  -  Feb 21, 2007
PharmaLive.com (press release),FDA has received new reports of serious and life-threatening allergic reactions (anaphylaxis) in patients after treatment with Xolair (omalizumab).

Xolair Linked to Risk for Delayed-Onset Anaphylaxis  -  Feb 22, 2007
Medscape (subscription)Although most cases (71%) have occurred within 2 hours of omalizumab injection, some (13%) delayed-onset cases have been reported after 2 to more than 24

FDA Warns About Asthma Drug, Xolair  -  Feb 21, 2007
WebMDFDA Alert: "Omalizumab (marketed as Xolair) Information." FDA Alert: "Information for Healthcare Professionals, Omalizumab (for Subcutaneous Use) (marketed

Proposed Boxed Warning for Xolair  -  Feb 22, 2007
Facts and Comparisons,...reactions (anaphylaxis) after Xolair (omalizumab) treatment, including delayed anaphylaxis (2 to 24 hours or longer after receiving Xolair treatment).

FDA orders stronger label warning for injected asthma drug  -  Feb 21, 2007
SouthCoastToday.com,The risk of anaphylaxis was known when Xolair, also called omalizumab, was approved as an asthma treatment in 2003. But the Food and Drug Administration

Asthma wonder jab could kill, warn the Americans  -  Feb 21, 2007
This is London,The drug, also called omalizumab, is recommended for patients who have severe problems, such as reduced lung function, despite using highdose inhaled

UPDATE 2-US seeks tough warning on Genentech asthma drug  -  Feb 21, 2007
Reuters...said anaphylaxis -- a severe allergic reaction -- occurs in about one in a thousand patients taking the medication, also known as omalizumab.

FDA Orders Strengthened Warning for Biologic Asthma Drug Xolair  -  Feb 21, 2007
Biologic Drug Report,21st announced that it had ordered Genentech to add a stronger warning to the label for injected biologic drug Xolair (omalizumab) emphasizing that the drug

FDA orders warnings for Xolair  -  Feb 21, 2007
Therapeutics Daily (subscription) (press release),The FDA said the boxed warning should emphasize Xolair (omalizumab) might cause anaphylaxis, including trouble breathing, chest tightness, dizziness,

US seeks tough warning on Genentech asthma drug  -  Feb 21, 2007
Reuters AlertNet,...said anaphylaxis -- a severe allergic reaction -- could occur as late as 24 hours after patients take any amount of the drug, also known as omalizumab.

FDA Orders Stronger Asthma Drug Warning  -  Feb 21, 2007
Business Portal 24 (press release),The risk of anaphylaxis was known when Xolair, also called omalizumab, was approved as an asthma treatment in 2003. But the Food and Drug

FDA asks for tough warning on asthma drug  -  Feb 21, 2007
Reuters.uk,The Food and Drug Administration said anaphylaxis could be delayed up to 24 hours after patients take the drug, also known as omalizumab.

FDA Issues New Warning About Asthma Drug Xolair  -  Feb 22, 2007
Newsinferno.com,Citing reports of severe, potentially fatal allergic reactions, the US Food and Drug Administration (FDA) has issued a new warning about omalizumab,

FDA Mandates Stronger Warning on Asthma Drug Xolair  -  Feb 22, 2007
HealthCentral.com,The new alert for Xolair (omalizumab), marketed by Genentech Inc., draws attention to anaphylaxis as a potential side effect of the medication.

FDA proposes to strengthen label warning for Xolair  -  Feb 21, 2007
People's Daily Online,...(FDA) announced on Wednesday that it has requested Genentech, Inc. to add a boxed warning to the product label for omalizumab, marketed as Xolair.

US orders warnings on ADHD drug labels  -  Feb 21, 2007
Louisville Courier-Journal,Xolair, manufactured by Genentech Inc., is also called omalizumab. A patient experiencing anaphylaxis might have trouble breathing, feel tight in the chest,

National briefs: Wednesday  -  Feb 21, 2007
Albuquerque Tribune,Xolair, also called omalizumab, was approved as an asthma treatment in 2003. WASHINGTON - Five weeks and 19 witnesses into the CIA leak trial,

FDA Proposes to Strengthen Label Warning for Xolair  -  Feb 21, 2007
PharmaLive.com (press release),Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab, marketed as Xolair.

FDA Proposes to Strengthen Label Warning for Xolair  -  Feb 21, 2007
FDA.govToday the Food and Drug Administration (FDA) announced that it has requested Genentech, Inc. add a boxed warning to the product label for omalizumab,

Genentech and Tanox Receive 'Second Request' from the Federal ...  -  Jan 29, 2007
PR Newswire (press release),Tanox's first-approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma.

Genentech and Tanox Receive "Second Request" from the Federal ...  -  Jan 29, 2007
PharmaLive.com (press release),Tanox's first-approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma.

Asthma campaigners vow to fight for drug  -  Jan 16, 2007
Glasgow Evening Times,The SMC said the economic case for the drug - which would cost up to £20000 per year for each patient and is also known as omalizumab - "had not been

Strong Lucentis sales help Genentech earnings soar  -  Jan 11, 2007
Pharma Times (subscription),...arthritis and non-Hodgkin's lymphoma drug Rituxan (rituximab) posted a 16% gain to $560 million, while Xolair (omalizumab) for severe asthma advanced

Tanox, Inc. Stockholders Approve Merger with Genentech, Inc.  -  Jan 17, 2007
American Venture Magazine (press release),Tanox’s first-approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma.

Clinical Trials Update: Dec. 27, 2006  -  Dec 27, 2006
Atlanta Journal Constitution (subscription),...have active lung disease other than asthma, any significant illness, or prior treatment with omalizumab and/or any beta blocker medication.

Tanox, Inc. Stockholders Approve Merger With Genentech, Inc.  -  Jan 15, 2007
PharmaLive.com (press release),Tanox's first-approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma.

Asthmatics to be denied life-changing drug twice  -  Jan 13, 2007
Sunday Herald,Xolair, which is also known as omalizumab, is given as an injection every two to four weeks for asthma which is severe, persistent and allergic.

Genentech puts muscle behind blood drug  -  Jan 10, 2007
DrugResearcher.com,Genentech and Tanox had been working in collaboration with Novartis for 10 years to develop and commercialise Xolair (omalizumab), an anti-IgE monoclonal

Research Summary: Allergy Therapy  -  Dec 14, 2006
abc7news.com,The study shows people who were given the anti-IGE drug omalizumab before receiving rush immunotherapy had a five-times lower chance of having a reaction

Treatment May Leave You Allergy-Free  -  Dec 13, 2006
abc7news.com,In this new study, patients were pre-medicated with the anti-allergy drug Omalizumab before starting the immunotherapy.

Genentech Announces Agreement to Acquire Tanox for $20 Per Share  09 Nov 2006
Tanox's first-approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma. ... -Yahoo! News (press release) Allergy and Immunology on the Cusp of Major Breakthroughs  09 Nov 2006
Anti-IgE (Omalizumab) is a humanized monoclonal antibody and the only therapy which targets IgE, the root cause of allergic asthma. ... -Newswise (press release) Tanox Reports 2006 Third Quarter Results  Nov 2, 2006
Net royalty revenue from sales of Xolair® (omalizumab) was $10.2 million for the third quarter of 2006, compared to net Xolair royalty revenue of $7.7 million ... -Yahoo! News (press release) Tanox Reports 2006 Third Quarter Results  Nov 2, 2006
Net royalty revenue from sales of Xolair(R) (omalizumab) was $10.2 million for the third quarter of 2006, compared to net Xolair royalty revenue of $7.7 ... -Earthtimes.org Tanox Initiates Phase 1 Clinical Trial Evaluating TNX-650 For ...  Oct 26, 2006
Tanox's first-approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... -Medical News Today (press release), Tanox Initiates Phase 1 Clinical Trial Evaluating TNX-650 for ...  Oct 26, 2006
Tanox’s first-approved drug, Xolair® (omalizumab), is the first anti-immunoglobulin E (anti-IgE) antibody to be brought to market. ... -PipelineReview.com (press release), Genentech Earnings: Lucentis Strong, Oncology Weakening  Oct 11, 2006
Products posting higher US sales than in the previous quarter included Xolair (omalizumab) at $107 million, Raptiva (efalizumab) at $23 million and Avastin ... -BioWorld Online, UT Southwestern tests new asthma medicine targeting vulnerable ...  Oct 23, 2006
...children at each site. It will evaluate Xolair (omalizumab), a drug that binds to and inactivates IgE antibodies. "Xolair 'sops up ... -innovations report, Genentech Announces Third Quarter 2006 Results  Oct 10, 2006
...million. -- US sales of Xolair® (Omalizumab) increased 30 percent to $107 million, from $82 million in the third quarter of 2005. ... -Yahoo! News (press release) New Asthma Medicine Targeting Vulnerable Inner-City Children ...  Oct 23, 2006
...involves about 50 children at each site. It will evaluate Xolair (omalizumab), a drug that binds to and inactivates IgE antibodies. -MedIndia, Genentech Announces Third Quarter 2006 Results  Oct 10, 2006
...million. US sales of Xolair® (Omalizumab) increased 30 percent to $107 million, from $82 million in the third quarter of 2005. ... -PharmaLive.com (press release), Benefit From Omalizumab Seen Across IgE Levels in Patients With ...  Sep 13, 2006
MUNICH, GERMANY -- September 13, 2006 -- Patients with severe asthma that has an allergic component seem to benefit from omalizumab (Xolair) across a variety ... -DG News

Fast relief for allergies  Sep 7, 2006
...for all. Rush immunotherapy and omalizumab are FDA-approved, although the combination of the two has not yet been. Immunotherapy ... -News 8 Austin

Weapons to fight asthma get better  Sep 15, 2006
...limited. Changing IgE levels is not the primary aim of kissing. Not so with one of the newer asthma drugs, Xolair (omalizumab). Xolair ... -The Australian

Tanox to Present at UBS Global Life Sciences Conference  Sep 14, 2006
Tanox's first-approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma. ... -Yahoo! News

Allergy Antidotes  Aug 30, 2006
...reactions. In this new study, patients were pre-medicated with the anti-allergy drug omalizumab, better know by it's brand name, Zolair. ... -ABC7Chicago.com

A revolutionary remedy that may be a breath of fresh air  Sep 7, 2006
...to be limited. Changing IgE levels is not the primary aim of kissing. Not so with a new drug, Xolair (omalizumab). Xolair is a preparation ... -Times Online

NICE Welcomes Referral Of New Work Programme Topics, UK  Aug 31, 2006
...head and neck cancer (subject to licensing); atrasentan (Xinlay) for hormone refractory prostate cancer (subject to licensing); omalizumab (Xolair) for asthma ... -Medical News Today

Omalizumab Improves Symptoms and Pulmonary Function in Adolescents ...  -  Nov 15, 2006
DG NewsPHILADELPHIA, PA -- November 15, 2006 -- The benefit of omalizumab in patients with moderate to severe IgE-mediated asthma may be most pronounced among

Omalizumab May Be Treatment Alternative for Patients With Atopic ...  -  Nov 13, 2006
DG NewsIn addition, evaluation of the Scoring Atopic Dermatitis (SCORAD) index for quality of life suggested clinical improvement on omalizumab, she added.

Allergy And Immunology On The Cusp Of Major Breakthroughs  -  Nov 13, 2006
Medical News Today (press release),Anti-IgE (Omalizumab) is a humanized monoclonal antibody and the only therapy which targets IgE, the root cause of allergic asthma.

No More Allergies!  Aug 16, 2006
...time. In this new study, patients were pre-medicated with the anti-allergy drug omalizumab before starting the immunotherapy. That ... -KTBS

Rush Treatment for Allergies  Aug 2, 2006
In a new University of Wisconsin study, patients were pre-medicated with the anti-allergy drug Omalizumab before starting the immunotherapy. ... -abc7.com

Asthma in Children and Adolescents  Jul 26, 2006
Omalizumab (Xolair) is now FDA approved for patients age 12 and older who have moderate to severe persistent allergic asthma. The ... -About - News & Issues

Tanox Reports 2006 Second Quarter Results  Aug 8, 2006
Net royalty revenue from sales of Xolair® (omalizumab) was $9.9 million for the second quarter of 2006, compared to Xolair royalty revenue of $7.3 million for ... -Yahoo! News

New Data Confirm Durable Response Of TNX-355 Regimens Through 48 ...  Aug 18, 2006
Tanox's first-approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... -Medical News Today

New Data Confirm Durable Response of TNX-355 Regimens Through 48 ...  Aug 18, 2006
Tanox’s first-approved drug, Xolair® (omalizumab), is the first anti-immunoglobulin E (anti-IgE) antibody to be brought to market. ... -PipelineReview.com

HealthFirst-Rush immunotherapy  Aug 11, 2006
...time. In this new study, patients were pre-medicated with the anti-allergy drug omalizumab before starting the immunotherapy. "They ... -ABC12.com

Tanox Conducts Meeting With Food and Drug Administration Regarding ...  Aug 3, 2006
Tanox's first-approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... -Yahoo! News

Omalizumab for Asthma  Jun 21, 2006
...range for age, 6 to 97). The patient is referred to a specialist, who recommends treatment with omalizumab. Asthma is a disease that ... -New England Journal of Medicine (subscription)

Tanox to Report Second Quarter 2006 Financial Results, Host ...  Jul 18, 2006
Tanox's first- approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... -PR Newswire

Genentech Announces Second Quarter 2006 Results  Jul 11, 2006
2005. -- US sales of Xolair® (Omalizumab) increased 31 percent to $105 million, from $80 million in the second quarter of 2005. ... -Yahoo! News

Genentech Announces Second Quarter 2006 Results  Jul 11, 2006
2005. -- US sales of Xolair(R) (Omalizumab) increased 31 percent to $105 million, from $80 million in the second quarter of 2005. ... -PR Newswire

Novartis submits Xolair for approval in Japan for severe asthma  Jun 25, 2006
ZURICH (AFX) - Novartis AG said it has has submitted an application to Japanese health authorities for the approval of Xolair (omalizumab) as first-in-class ... -Forbes

Research Summary: Allergies & Asthma  Jul 4, 2006
...prescribed. One new FDA-approved medication called Xolair (omalizumab) is unique, however, in that it can affect the allergy antibody IgE. ... -abc7news.com

Novartis Japan Files New Drug Application for Agent for Treating ...  Jun 26, 2006
A recombinant humanized monoclonal anti-IgE antibody, Xolair (omalizumab) can exert beneficial effects with a once- or twice-per-month administration. ... -Japan Corporate News

AUDIO SUMMARY  Jun 21, 2006
...in atrial fibrillation, bioterror and bioart, and on TGF-Β signaling, vascular remodeling, and hypertension; a review article on omalizumab for asthma; a case ... -New England Journal of Medicine (subscription)

Novartis submits Xolair® for approval in Japan as first-in-class ...  Jun 26, 2006
BASEL, Switzerland | Jun 26, 2006 | Novartis has submitted an application to the Japanese health authorities for the approval of Xolair® (omalizumab), a novel ... -PipelineReview.com

Novartis Files Xolair In Japan To Treat Severe Asthma -2-  Jun 25, 2006
Xolair, also known under its generic name omalizumab, is a novel therapy which targets a root cause of allergic disease and offers an entirely new approach to ... -Therapeutics Daily (subscription)



Tanox Reports 2006 First Quarter Results  May 2, 2006
Net royalty revenue from sales of Xolair(R) (omalizumab) was $8.8 million for the first quarter of 2006, compared to Xolair royalty revenue of $5.9 million for ... - MSN Money

New drug offers relief for those with allergic asthma  May 10, 2006
...much-needed relief. Unlike other meds, Xolair (omalizumab) is injected and doesn't just control asthma's symptoms. It actually shuts ... - News 14 Carolina

Allergic asthma  May 10, 2006
Unlike other meds, Xolair (omalizumab) is injected and doesn't just control asthma's symptoms. It actually shuts off the allergic ... - News 14 Carolina

The facts about asthma  May 2, 2006
...of asthma. A recent breakthrough has been the omalizumab jab, which is effective for those with the most severe symptoms. For asthma ... - Daily Mail - UK

Tanox Reports 48-Week Results From TNX-355 Phase 2 Clinical Trial  May 2, 2006
Tanox's first- approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed, allergic asthma. ... - Yahoo! News

(PRN) Tanox to Present at Two Investor Conferences in May  Apr 17, 2006
Tanox's first- approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... - Houston Chronicle

Fibrogen, Astellas Anemia Deal: $300M, Plus $465M In Milestones  Apr 28, 2006
...three-way collaboration with Basel, Switzerland-based Novartis AG and Genentech Inc., of South San Francisco, for the asthma drug Xolair (omalizumab) and other ... - BioWorld Online (subscription)





Tanox to Report First Quarter 2006 Financial Results, Host ...  11 Apr 2006
Tanox's first- approved drug, Xolair® (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... - Yahoo! News

Genentech Announces Vice President Appointments in Commercial ...  11 Apr 2006
...this role, Anderson will be responsible for leading the sales and marketing activities for RAPTIVA® (efalizumab), Xolair® (Omalizumab), Rituxan ® (Rituximab ... - Yahoo! News

'NHS refuses a cure for my agony'  Mar 16, 2006
Omalizumab has been tested in America over the last 10 years and demonstrated its effectiveness for patients like Mr Tomlin, who has had asthma since birth. ... - icBerkshire

Genentech Provides Updates at Annual Investment Meeting  Mar 17, 2006
Genentech also announced that the US Food and Drug Administration approved in January 2006 the production of Xolair® (Omalizumab) bulk drug substance at ... - Yahoo! News



(PRN) Tanox to Report 2005 Fourth Quarter and Full Year Results ...  Feb 8, 2006
Tanox's first-approved drug, Xolair(R) (omalizumab), is the first antibody approved to treat moderate-to-severe confirmed allergic asthma. ... - Houston Chronicle,

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