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Acton submits Manufacturing Supplement to FDA for AEROSPAN Inhalation Aerosol

Acton Pharmaceuticals, Inc. today announced that it has submitted to the U.S. Food and Drug Administration (FDA), a Manufacturing Supplement to the previously approved AEROSPAN Inhalation Aerosol NDA.

4 Nov 2010

Perrigo first quarter revenue increases 21% to record $641 million

Perrigo Company today announced results for its first quarter ended September 25, 2010.

2 Nov 2010

New REACT medical trial for early diagnosis of lung cancer

Physicians at El Camino Hospital are starting a medical trial called REACT that they hope may give doctors a new and cost-effective tool for early diagnosis of lung cancer, the deadliest of the common cancers.

2 Nov 2010

Gilead presents Phase IIa data for HCV therapy at The Liver Meeting 2010

Gilead Sciences, Inc. today announced data from a Phase IIa study showing that its investigational compounds GS 9190 and GS 9256, used in conjunction with current standard of care therapies, produced substantial suppression of the hepatitis C virus (HCV) within 28 days of treatment.

1 Nov 2010

FDA new approvals, antibiotic and neurological drugs

Two new drugs have gained approval from the US Food and Drug Administration (FDA) – one is an antibiotic from Forest Labs and the other a first-time treatment for a neurological disorder developed by Avanir Pharmaceuticals. Another waiting for approval is Biodel's fast-acting insulin Linjeta. On the other hand seven new drugs got rejected including a diabetes drug from Amylin Pharmaceuticals and weight-loss drugs from Arena Pharmaceuticals and Vivus, respectively.

31 Oct 2010

Rite Aid to host flu shot clinics at nationwide pharmacies

With the holidays getting closer, Rite Aid is reminding people to get a flu shot so that the only thing they are spreading this season is good cheer. According to The Centers for Disease Control and Prevention (CDC), it can take up to two weeks for flu shots to be effective and protect against the flu; those who get their flu shot now can help protect themselves by the time they sit down for Thanksgiving dinner.

30 Oct 2010

FDA approves Teflaro for treatment of community-acquired bacterial pneumonia

Forest Laboratories, Inc. announced today that Teflaro(ceftaroline fosamil), a broad-spectrum bactericidal cephalosporin with activity against both gram-positive and gram-negative microorganisms, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP), including cases caused by Streptococcus pneumoniae bacteremia, and acute bacterial skin and skin structure infection (ABSSSI), including cases caused by methicillin-resistant Staphylococcus aureus (MRSA).

30 Oct 2010

FDA approves NUEDEXTA capsules for pseudobulbar affect

AVANIR Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved NUEDEXTA (dextromethorphan hydrobromide and quinidine sulfate) capsules, as the first treatment for pseudobulbar affect.

30 Oct 2010

Coadministration of INTUNIV tablets with stimulant reduces ADHD symptoms

Shire plc the global specialty biopharmaceutical company, today presented research results of once-daily INTUNIV (guanfacine) Extended-Release Tablets, coadministered with stimulants in children and adolescents diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who had suboptimal response to treatment with a long-acting stimulant alone.

29 Oct 2010

SPRYCEL receives FDA approval for treating adult patients with Ph+ CML in chronic phase

After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.

29 Oct 2010

Forest, Almirall report topline results from aclidinium bromide comparative Phase III study in COPD

Forest Laboratories, Inc. and Almirall, S.A. today announced top-line results from ACCORD COPD II, a 12-week Phase III study comparing the efficacy and safety of inhaled aclidinium bromide, an investigative bronchodilator, to placebo in 544 patients with moderate to severe COPD.

29 Oct 2010

Sanofi-aventis to acquire BMP Sunstone

Sanofi-aventis and BMP Sunstone Corporation announced today that they have entered into a definitive agreement under which sanofi-aventis is to acquire all outstanding shares of BMP Sunstone for cash consideration of USD 10 per share, or a total of approximately USD 520.6 million on a fully diluted basis.

29 Oct 2010

Consumer groups still concerned as insurance rules are considered by HHS

The Wall Street Journal Health Blog: Consumer groups are already concerned that insurers might lobby HHS Secretary Kathleen Sebelius to weaken the medical-loss ratio rules suggested by the National Association of Insurance Commissioners last week. "Today, consumer representatives sent a letter to HHS Secretary Kathleen Sebelius to urge her not to tinker too much with what the NAIC came up with." The medical-loss ratio rules will determine "how much insurers pay out in health care compared with the total premiums they collect.

28 Oct 2010

Sandoz initiates voluntary recall of Methotrexate Injection

Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product ("methotrexate") to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots.

28 Oct 2010

Survey shows Americans are unaware about causes of lung cancer

Men and women worry about prostate and breast cancer, yet the number one cancer killer in the United States – lung cancer – isn't on their radar. According to a survey released today by the National Lung Cancer Partnership, Americans know little about lung cancer's causes, symptoms and the number of lives it takes compared to other cancers.

27 Oct 2010

Eye-gaze technology opens world of communication for Rett Syndrome children

Special eye-gaze technology now being used in the Department of Neurology at The Children's Hospital at Montefiore (CHAM) is revealing the hidden, inner world of children who have Rett Syndrome, a rare and severe autism spectrum disorder that primarily affects little girls. It is a neurological disease in which mobility and autonomic functions are severely impaired, seizures and orthopedic problems are common, and the children lose functional hand use and the ability to speak.

26 Oct 2010

Baxter announces launch of GLASSIA in the U.S.

Baxter International Inc. today announced the commercial launch of GLASSIATM [Alpha1-Proteinase Inhibitor (Human)] in the United States. GLASSIATM is the first available ready-to-use liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha-1 antitrypsin (AAT), an under-diagnosed hereditary condition characterized by a low level of alpha-1 protein in the blood.

From Baxter International Inc. 26 Oct 2010

Pharmaxis announces combined results of Bronchitol Phase III trial for cystic fibrosis

Pharmaceutical company Pharmaxis today announced significant results of pooled data from its two large scale six month Phase III trials of Bronchitol (inhaled mannitol) in people with cystic fibrosis.

25 Oct 2010

Study on H1N1 virus to be presented at IDSA annual meeting

The 2009/2010 Influenza A (H1N1) is one of several viruses responsible for respiratory-related infections. A new study from Rhode Island Hospital examined patients with viruses and found distinguishing characteristics of the H1N1 virus in how it affects respiratory illness. Their findings will be presented at the annual meeting of the Infectious Diseases Society of America to be held in Vancouver, Canada on Friday, Oct. 22.

25 Oct 2010

New multi-centre trial to treat cold and flu in children

Three Canadian research teams are trying to determine if a novel Canadian medicine approved by Health Canada for adults can help parents deal with the hacking coughs and runny noses their children suffer.

22 Oct 2010