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FDA denies accelerated approval of Genentech's trastuzumab-DM1 (T-DM1) BLA for metastatic breast cancer

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.

27 Aug 2010

Afferent Pharmaceuticals' P2X3 receptor antagonist reduces bladder hyperactivity

Afferent Pharmaceuticals, a clinical-stage biopharmaceutical company developing first-in-class, small molecule compounds that target P2X3 receptors, today announced preclinical in vivo results demonstrating that an investigational P2X3 receptor antagonist reduced experimentally induced bladder hyperactivity.

26 Aug 2010

Diarrhea, skin diseases increase among children in flood-affected areas of Pakistan: Survey

World Vision says assessments conducted over the last few days near the towns of Muzaffar Garh and Kot Addo in Punjab paint a bleak picture of the impact of the flooding. The Christian humanitarian organization says its reports from Sukkur in the Sindh Province are equally dire. Contaminated water, cramped living conditions and a lack of sanitation are contributing to a rapid increase in cases of diarrhea and skin diseases in children.

25 Aug 2010

Celgene to enforce REVLIMID intellectual property rights following receipt of Paragraph IV notification letter

Celgene Corporation today announced that information was posted on the FDA Web site indicating that an Abbreviated New Drug Application (ANDA) has been received by the Office of Generic Drugs (OGD) containing a "Paragraph IV" patent certification, for REVLIMID (lenalidomide) 25 mg capsules. Celgene has not yet received the Paragraph IV notification letter identifying the filer.

25 Aug 2010

Department of Health to hold vaccination drive for whooping cough

With some areas of the state seeing an increase in whooping cough, known medically as pertussis, the Department of Health urges all Pennsylvanians to ensure they are protected against the vaccine-preventable disease.The department will soon hold public vaccination clinics in York and Delaware counties, where cases of pertussis have been rising.

24 Aug 2010

Baxter announces definitive agreement with Kamada for GLASSIA alpha1-proteinase inhibitor

Baxter International Inc. today announced a definitive agreement with Kamada Ltd. for exclusive commercial rights to GLASSIA™ [Alpha 1-Proteinase Inhibitor (Human)], the first and only liquid alpha1-proteinase inhibitor, in the United States, Australia, New Zealand and Canada.

From Baxter International Inc. 24 Aug 2010

Measles outbreak in northern NSW and Queensland

There is a confirmed measles outbreak just south of the Queensland border according to Queensland Health authorities. There have been seven cases of this highly infectious disease at Tweed Heads, NSW, including a person who reportedly visited a McDonald’s restaurant at Coolangatta over the weekend. Any residents who visited the fast food outlet between 8am and 1pm on Saturday are advised to check their vaccination status.

23 Aug 2010

Immunization rate increases among teens: NIS report

In light of today's report of the National Immunization Survey results, the Society for Adolescent Health and Medicine (SAHM) encourages increased efforts in fully immunizing all adolescents.

21 Aug 2010

Celgene receives Japan's MHLW approval for REVLIMID in deletion 5q myelodysplastic syndrome patients

Celgene International Sàrl announced that REVLIMID (lenalidomide) has been granted full marketing authorization by Japan's Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenic abnormality. REVLIMID was also approved in June 2010 in combination with dexamethasone, for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior standard therapy.

20 Aug 2010

Scientists suggest combination vaccine prevents pertussis

If you think you shouldn't be worried about your child's—or your—lingering, nagging cough, think again. Pertussis has reemerged on the scene. In what some public health officials are calling the worst outbreak in 50 years, pertussis, better known by its unique sound—whooping cough, has been found in six states with 1,500 cases reported, six of them fatal.

19 Aug 2010

Hospitals should inform patients about availability of insurance coverage for breast reconstruction: New law

While breast reconstruction after a mastectomy is covered by insurers in New York, many poor, minority, and less educated women do not seek out the procedure. Now, NY Gov. David A. Paterson has signed into law a bill that is aimed at reversing this trend.

18 Aug 2010

Pharmacists in all states authorized to administer influenza vaccines

The American Pharmacists Association (APhA) is encouraging consumers to get immunized against influenza and to consider their local pharmacy as the site to receive their vaccine. Pharmacists in all 50 states including the District of Columbia are authorized to administer influenza vaccines and, as of June 30, 2010, more than 120,000 U.S. pharmacists have been trained to administer immunizations.

18 Aug 2010

Air quality along US Gulf Coast improves after stoppage of oil leak

The oil spill along the United States Gulf Coast poses health risks to volunteers, fishermen, clean-up workers and members of coastal communities, according to a new commentary by UCSF researchers who spent time in the region and are among the first to look into health problems caused by the oil spill. The good news, the authors say, is that one of the risk factors, coastal air quality, is improving now that the oil leak has been stopped.

17 Aug 2010

August is National Immunization and Cataract Awareness Month

Childhood immunizations keep our children safe from a number of serious diseases. This is a good time of year to make sure your child is up-to-date on all of his/her immunizations. Continue reading to find out which vaccines the Centers for Disease Control and Prevention (CDC) recommend for children 6 and under.

16 Aug 2010

Heater replacement funding falters

Education Minister Verity Firth promised parents two weeks ago that 55,000 unflued gas heaters in the state's schools that could result in respiratory problems for children would be replaced. However the Government was unable to find $400 million for the project and parents and students need to wait before the heaters are actually replaced. The plan is now to take up a 10-year replacement program.

12 Aug 2010

Perrigo fourth-quarter fiscal 2010 net sales up 22%

Perrigo Company today announced results for its fourth quarter and full year ended June 26, 2010.

12 Aug 2010

FDA approves longer Valcyte therapy for CMV disease in adult kidney transplant patients

Genentech, Inc., a member of the Roche Group, announced today that the U.S. Food and Drug Administration (FDA) approved increasing the length of therapy with Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.

11 Aug 2010

Three-year efficacy data on STELARA for psoriasis presented at American Academy of Dermatology meeting

New study findings showed that a majority of patients with moderate to severe plaque psoriasis who had a previous response to STELARA® (ustekinumab) sustained a clinical response for up to three years with continued treatment regardless of their body weight. Investigators also presented findings from an integrated safety analysis that included data from one Phase 2 and three Phase 3 trials in which treatment with STELARA demonstrated a favorable benefit-risk profile for up to three years of treatment, consistent with previous analyses.

10 Aug 2010

Cornerstone announces ANDA filing for generic Tussionex

Cornerstone Therapeutics Inc., a specialty pharmaceutical company focused on acquiring, developing and commercializing significant products primarily for the respiratory and related markets, today announced that its product candidate CRTX-067 is an ANDA filing for a generic 10 mg chlorpheniramine polistirex/8 mg hydrocodone polistirex suspension product that will be a generic substitute for the product currently sold under the Tussionex brand name by UCB, Inc.

7 Aug 2010

Matrixx Initiatives first-quarter net loss reduces to $2.4 million

Matrixx Initiatives, Inc., an over-the-counter healthcare company that develops and markets Zicam® products, today announced financial results for its fiscal first quarter ended June 30, 2010.

4 Aug 2010