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Volunteers needed in worldwide study to help people breathe easier

Australian sufferers of chronic obstructive pulmonary disorder (COPD), one of the most important causes of breathlessness and difficulty performing tasks of normal daily life, have the opportunity to participate in a worldwide study, starting this month, assessing a potential new treatment.

26 Jul 2011

Baxter GAMMAGARD LIQUID for PI receives FDA approval for subcutaneous administration

Baxter International Inc. announced today that the U.S. Food and Drug Administration has approved the subcutaneous administration of GAMMAGARD LIQUID 10% [Immune Globulin Infusion (Human)] for patients with primary immunodeficiency.

From Baxter International Inc. 25 Jul 2011

Janssen receives FDA Complete Response letter for SIMPONI sBLA to treat RA

Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response letter for its supplemental Biologics License Application (sBLA) for SIMPONI.

25 Jul 2011

Effects of refusal and delay in childhood vaccination

Alison M. Buttenheim, PhD, MBA, assistant professor at Penn Nursing answers parents' questions about childhood vaccines. Dr. Buttenheim is a public health researcher and social demographer who studies parent behavior and child health.

22 Jul 2011

GIDAC recommends FDA approval of Janssen's REMICADE for treatment of pediatric UC

Janssen Biotech, Inc., formerly Centocor Ortho Biotech Inc., announced today that the Gastrointestinal Drugs Advisory Committee of the U.S. Food and Drug Administration recommended the approval of REMICADE for the treatment of moderately to severely active ulcerative colitis in pediatric patients who have had an inadequate response to conventional therapy.

22 Jul 2011

Millennium submits VELCADE sNDA to FDA to add OS data for previously untreated multiple myeloma

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration for VELCADE® (bortezomib) for injection to add overall survival data after a five-year follow up to the product label.

20 Jul 2011

Johnson & Johnson second quarter sales increase 8.3% to $16.6 billion

Johnson & Johnson today announced sales of $16.6 billion for the second quarter of 2011, an increase of 8.3% as compared to the second quarter of 2010.

19 Jul 2011

Peak of Australian flu season is imminent so take the necessary precautions now: Experts

The Influenza Specialist Group (ISG) is today warning that high rates of influenza outbreaks have been confirmed in QLD, SA and NSW, but there is still time for most Australians, especially those in at-risk groups, to protect themselves and those around them.

18 Jul 2011

Measles epidemic grips Kenya and Ethiopia

The UNICEF announced Friday that children in Kenya and Ethiopia are at risk of a measles epidemic. Ethiopia has had more than 17,584 cases of measles in 2011, with 114 deaths. The WHO urges measles vaccination of young children to combat the situation.

18 Jul 2011

Berks County's Department of Health advises public about possible measles exposure

The state Department of Health is advising the public of a possible case of measles exposure in Morgantown, Berks County.

15 Jul 2011

CLEOPATRA Phase III study on HER2-positive mBC meets primary endpoint

Genentech, a member of the Roche Group, today announced that CLEOPATRA, a pivotal Phase III study, met its primary endpoint.

15 Jul 2011

Eisai's DACOGEN sNDA for acute myeloid leukemia accepted by FDA for review

SuperGen, Inc., a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced that Eisai Inc. today released information that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

14 Jul 2011

FDA accepts Eisai's DACOGEN sNDA for review to treat acute myeloid leukemia

Eisai Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) seeking approval of DACOGEN (decitabine) for injection in the treatment of acute myeloid leukemia.

13 Jul 2011

GlaxoSmithKline's Boostrix receives FDA approval to prevent tetanus, diphtheria, and pertussis

The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.

11 Jul 2011

FDA approves BOOSTRIX to prevent tetanus, diphtheria and pertussis in older people

The U.S. Food and Drug Administration (FDA) has approved BOOSTRIX for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria and pertussis.

11 Jul 2011

Novartis Afinitor Phase III trial on tuberous sclerosis meets primary endpoint

Novartis Pharmaceuticals Corporation announced today Phase III trial results that showed more than one-third of patients taking Afinitor tablets experienced a 50% or greater reduction in the size of their subependymal giant cell astrocytomas, non-cancerous brain tumors associated with tuberous sclerosis complex.

8 Jul 2011

Majority of tonsil surgery in children performed during summer vacation

Scheduling tonsils to be removed figures into many parents' itineraries for their childrens' summer vacation, right up there with summer camp stays and family reunions. An estimated 500,000 children have the procedure each year.

6 Jul 2011

Maternal anxiety, depression may increase risk of asthma in children

Anxiety, stress and depression during pregnancy may lead to a greater risk of asthma for your child. Study results are published in the July issue of Annals of Allergy, Asthma & Immunology, the scientific journal of the American College of Allergy, Asthma and Immunology.

6 Jul 2011

Almirall, Forest Labs submit aclidinium bromide NDA to FDA for treatment of COPD

Forest Laboratories, Inc. and Almirall, S.A. announced they have recently submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for aclidinium bromide, a long-acting inhaled antimuscarinic agent developed for the treatment of COPD.

30 Jun 2011

Vaccines may be given in food in the near future

Soon children could be vaccinated with bacteria mixed in milk and people in the developing world given unprecedented access to immunisations under a scheme proposed by an Australian Nobel laureate, Barry Marshall.

29 Jun 2011