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First annual U.S.-African Union high level bilateral meetings start in Washington

Representatives of the African Union (AU) on Wednesday began meeting with members of the Obama administration in Washington, as part of the first Annual U.S.-African Union High Level Bilateral Meetings, United Press International reports (4/21).

23 Apr 2010

Opinions: New U.S.-backed global food, agriculture program; Foreign aid to Africa; Medicines in Africa

In a Wall Street Journal opinion piece, U.S. Secretary of the Treasury Timothy Geithner and Bill Gates, co-chair of the Bill & Melinda Gates Foundation, announce the launch of the Global Agriculture and Food Security Program, a fund "to help the world's poorest farmers grow more food and earn more than they do now so they can lift themselves out of hunger and poverty."

23 Apr 2010

Physio-Control decides to perform voluntary correction of LIFEPAK 15 monitor/defibrillators

Physio-Control, Inc., a wholly-owned subsidiary of Medtronic, Inc., (NYSE: MDT), announced today the U.S. Food and Drug Administration has classified the company's decision to perform a voluntary correction of LIFEPAK 15 monitor/defibrillators manufactured prior to December 16, 2009 as a Class I recall.

23 Apr 2010

Nicotine poisoning linked to weight gain

A new study links nicotine poisoning with weight gain, and concludes tha active smokers, not only those who stop, put on more weight than non-smokers. After four years of analysis in the University of Navarra, those who put on least weight were those who had never smoked.

23 Apr 2010

Report recommends increasing investment in small-scale farms run by women to achieve hunger MDG

An ActionAid report released on Wednesday recommends that major aid donors increase their support of small-scale farms run by women in developing countries to maximize the chance of meeting the U.N. Millennium Development Goal of halving hunger by 2015, Reuters reports.

23 Apr 2010

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

Genentech, Inc., a wholly owned member of the Roche Group, announced today that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Herceptin® (trastuzumab) plus chemotherapy in people with advanced, HER2-positive adenocarcinoma of the stomach, including gastroesophageal junction cancer.

23 Apr 2010

FDA rejects experimental painkiller Acurox

In a new development King Pharmaceuticals Inc. and Acura Pharmaceuticals Inc. have failed to win the approval of a US panel for marketing an experimental painkiller called Acurox.

23 Apr 2010

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration had granted tentative approval of adenosine injection, USP, the generic equivalent of Astellas Pharmaceuticals' Adenoscan®, in 60 mg per 20 mL and 90 mg per 30 mL vials. IMS data indicate that the 2009 U.S. innovator market for these adenosine presentations approximated $124 million. The Company plans to launch the product upon expiry of applicable innovator patents.

23 Apr 2010

Gelesis presents Attiva data at AACE 19th Annual Meeting & Clinical Congress

Boston-based medical technology firm Gelesis, Inc. unveiled its capsulated device Attiva™, and presented data showing that Attiva™ significantly increased the post-meal feeling of satiety and reduced hunger between meals in obese patients. This data was presented today at the American Association of Clinical Endocrinologists (AACE) 19th Annual Meeting & Clinical Congress.

23 Apr 2010

FDA Advisory Committees vote against approval of Acurox NDA

Acura Pharmaceuticals, Inc. and King Pharmaceuticals®, Inc. today announced that the U.S. Food and Drug Administration's (FDA) Anesthetic and Life Support Drugs and Drug Safety and Risk Management Committees voted that they do not have enough evidence to support the approval of the New Drug Application (NDA) for Acurox® (oxycodone HCl and niacin) Tablets for the treatment of moderate to severe pain, considering the deterrent effects of niacin as well as the potential deterrent effects of the other features specific to Acurox®.

23 Apr 2010

Celator Pharmaceuticals presents data on CPX-351 Liposome Injection and HDPN formulation

Celator Pharmaceuticals today announced data from animal studies demonstrating the superior bone marrow uptake of CPX-351 (Cytarabine:Daunorubicin) Liposome Injection, its lead clinical-stage program, as well as the enhanced circulation kinetics and efficacy of its preclinical hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation were presented at the 101st Annual Meeting of the American Association for Cancer Research in Washington, DC (Abstracts 3698 and 5534).

23 Apr 2010

FDA grants conditional approval for first approved Total Spine Arthroplasty system clinical study

Flexuspine, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted conditional approval to begin the initial phase of the Investigational Device Exemption (IDE) for a feasibility study of its FSU device. This is the first approved clinical study for a Total Spine Arthroplasty system in the U.S.

23 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Website launched to track aid to Haiti from 'pledge to impact'

Agence France-Presse reports that the U.N. has launched "a new website to track the estimated 9.9 billion dollars in aid pledged to Haiti by the international community in the wake of a devastating January 12 earthquake." The website is a joint project of the Haitian government and the U.N. Development Programme.

23 Apr 2010

Baxter International's global sales for first-quarter advances by 11% to $3.1 billion

Baxter International Inc. today reported first quarter net income of $525 million, an increase of 2 percent from $516 million reported in the first quarter of 2009. Earnings per diluted share of $0.86 increased 4 percent from $0.83 per diluted share reported in the prior-year period. Baxter's first quarter financial results included a one-time, non-cash special charge of $39 million (or $0.07 per diluted share) related to a change in the tax treatment of post-retirement prescription drug benefits under recent U.S. healthcare reform legislation.

From Baxter International Inc. 22 Apr 2010

FDA announces draft guidance expanding transparency, disclosure in conflict of interest waivers

The U.S. Food and Drug Administration today announced draft guidance that would expand transparency and disclosure when the agency grants a conflict of interest waiver to permit an individual's participation at an FDA advisory committee meeting.

22 Apr 2010

Actelion Pharmaceuticals launches Epoprostenol for Injection for treatment of primary pulmonary hypertension

Actelion Pharmaceuticals US, Inc. today announced the commercial availability of Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, for the treatment of primary pulmonary hypertension and pulmonary hypertension associated with scleroderma spectrum of disease in NYHA Class III and Class IV patients.

22 Apr 2010

New campaign highlights dangers of carrying excess weight around waist

Cancer Research UK has joined forces with the British Heart Foundation and Diabetes UK to launch a new campaign to raise awareness of the dangers of carrying excess weight around the waist.

22 Apr 2010

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter ended March 31, 2010.

22 Apr 2010

Study uses new BL-DMAC method to measure PAC levels in cranberry products

Natural compounds in cranberries are linked to the prevention of urinary tract infections (UTIs) but inconsistencies in methods currently used commercially to measure levels can result in the over- or under-estimation of potency levels, leaving product manufacturers and consumers without good data. A study published today in the Journal of the Science of Food and Agriculture outlines a new, commercially viable method of measuring these compounds.

22 Apr 2010

Food News and Research

First annual U.S.-African Union high level bilateral meetings start in Washington

Opinions: New U.S.-backed global food, agriculture program; Foreign aid to Africa; Medicines in Africa

Physio-Control decides to perform voluntary correction of LIFEPAK 15 monitor/defibrillators

Nicotine poisoning linked to weight gain

Report recommends increasing investment in small-scale farms run by women to achieve hunger MDG

Genentech submits sBLA for Herceptin plus chemotherapy for advanced HER2-positive stomach cancer

FDA rejects experimental painkiller Acurox

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Gelesis presents Attiva data at AACE 19th Annual Meeting & Clinical Congress

FDA Advisory Committees vote against approval of Acurox NDA

Celator Pharmaceuticals presents data on CPX-351 Liposome Injection and HDPN formulation

FDA grants conditional approval for first approved Total Spine Arthroplasty system clinical study

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Website launched to track aid to Haiti from 'pledge to impact'

Baxter International's global sales for first-quarter advances by 11% to $3.1 billion

FDA announces draft guidance expanding transparency, disclosure in conflict of interest waivers

Actelion Pharmaceuticals launches Epoprostenol for Injection for treatment of primary pulmonary hypertension

New campaign highlights dangers of carrying excess weight around waist

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Study uses new BL-DMAC method to measure PAC levels in cranberry products

The future is bioengineered: Synthetic biology and global sustainability eBook

Bringing real-time analytics to downstream bioprocess monitoring

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

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