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Allergan Receives Complete Response Letter For BOTOX(R) (Botulinum Toxin Type A) For Treatment Of Upper Limb Spasticity In Adults
Allergan, Inc. (NYSE:AGN) today announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company"s Supplemental Biologics License Application (sBLA) for BOTOX® (Botulinum Toxin Type A) to treat upper limb spasticity in post-stroke adults. Allergan submitted its sBLA for this indication in the third quarter of 2008.
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Novavax Announces Selection Of A Respiratory Syncytial Virus Vaccine Candidate For Advanced Preclinical Studies
Novavax, Inc. (Nasdaq: NVAX) announced final selection of a Respiratory Syncytial Virus (RSV) vaccine candidate that will be advanced into additional preclinical studies to support an Investigational New Drug (IND) application. As previously announced, Novavax has been evaluating a number of RSV vaccine candidates, all of which have successfully induced antibody responses in mice. Novavax scientists have now engineered a new vaccine candidate which has been shown to protect mice against RSV disease and can be produced at sufficient yields to allow commercial manufacture. This new candidate is directed against a protein on the surface of the virus, the "F" or "fusion" protein, which is the protein that the virus uses to infect and fuse with cells in the respiratory tract and cause disease.
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Tobira Therapeutics Inc. Announces Phase I Data Demonstrating Pharmacokinetic Properties Of TAK-652 For The Treatment Of HIV
Tobira Therapeutics Inc., a clinical stage biotechnology company committed to research and product discovery for the treatment of life-threatening and life-altering infectious diseases, today announced pharmacokinetic data and results from two Phase I pharmacokinetic studies for TAK-652, an investigational compound being developed for the treatment of HIV. These data suggest that TAK-652 is rapidly absorbed and demonstrate relatively good oral bioavailability (as shown by the plasma TBR-652 concentration data) and has a long plasma half-life of TBR-652 (approximate mean of 35 hours) supporting once-daily dosing. Mean TBR-652 plasma concentrations were well above the predicted target plasma concentration (2ng/mL) with or without food. In both studies TBR-652 was safe and well tolerated in this healthy subject population when administered over a dose range of 10 mg to 800 mg in 2 tablet formulations. "These two Phase I studies provide encouraging support for TAK-652 as a therapeutic option for the treatment of HIV. We look forward to results from our on-going proof-of-concept study," said James Sapirstein, CEO.
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TB-HIV Link Emphasised In Uganda Event

"I am stopping TB and controlling HIV" was the theme of an event marking World TB Day (24 March) in Uganda"s Masindi district. The Union Uganda Office participated in this event, which attracted representatives from both government and a wide variety of NGOs, as well as the public. World TB Day is a joint TB-HIV event in Masindi District, Uganda "I am stopping TB and controlling HIV" was the theme chosen by Uganda to commemorate World TB Day on Tuesday, 24 March 2009. The function was held at Boma grounds in the district of Masindi and was attended by a wide variety of organisations and government and district representatives working in TB and TB/HIV, as well as the general public. District leaders not only attended in large numbers, but they also made moving speeches that demonstrated their understanding of TB -- a credit to the mobilisation and sensitisation activities carried out by the district health team. During his speech, the National TB Programme manager noted that this was the first time he had seen the district political as well as technical leaders fully participate in the commemoration of the World TB Day. Thanks were given to the TB CAP (TB Control Assistance Program) for its financial support of the event. TB CAP is USAID"s centrally funded project supporting the implementation of the international Stop TB strategy, which is coordinated by The Union in Uganda. The Honorable Kabakumba Masiko, Minister for Information and National Guidance, was the event"s chief guest. She spoke with passion about the individual"s role in TB control and challenged those present to go and have free screening for TB if they have cough for two weeks or more. She also promised to champion the Stop TB campaign in cabinet and parliament. The chief guest then launched the new TB logo -- special signage to help patients easily identify TB diagnostic and treatment units -- and referral directories designed to help health workers identify the nearest health facilities where patients can receive TB and HIV services. She visited stalls, including that of The Union Uganda Office (TBCAP), and was happy to note that the documents displayed had been disseminated down to the implementers. WHO


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