Arena Pharmaceuticals, Inc.’s (ARNA) fourth quarter fiscal 2009 net loss per share came in at 38 cents (excluding special items), wider than the Zacks Consensus Estimate of a loss of 30 cents. The year-ago loss was 84 cents. For 2009, the company reported a loss per share of $1.81 (excluding special items) compared to a loss of $3.21 (excluding special items) in 2008.

Revenue in the reported quarter was flat at approximately $2.7 million. Manufacturing services revenue fell slightly to $1.92 million from $1.97 million in the year-ago quarter. Revenue from collaborative agreements climbed to $766,000 from $725,000 in the fourth quarter of 2008. Revenue for fiscal 2009 was $10.39 million, versus $9.81 million in 2008.

Total operating expenses in the reported quarter fell 51.5% to $31.33 million from $64.64 million in the year-ago quarter because of lower research and development (R&D) expenses. R&D expenses plummeted 60% year-over-year to $21.2 million.

The

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Medtronic Inc. (MDT) has received several complaints from the U.S. Food and Drug Administration (FDA) regarding the company’s study of a new pacemaker that can be used in a Magnetic Resonance Imaging (MRI) machine. The FDA has raised concerns over the small population size and missing data in the study.   The study involved more than 500 patients with pacemakers, half of whom were randomly assigned to receive an MRI scan. However, Medtronic failed to provide a detailed follow-up on many patients who were enrolled in the study.   It is seen that patients implanted with pacemakers are generally discouraged from going through MRI scans as the radio waves could interfere with the functioning of their device. Medtronic’s REVO Surescan pacemaker claims to be the first device of its kind that can ...

Medical device maker Vycor Medical Inc. today announced it has started the registration process for State Food and Drug Administration (SFDA) in the People’s Republic of China (PRC) in collaboration with recently appointed exclusive distribution partner Devon Medical Inc., a manufacturer and distributor of creative, safe, and cost-effective medical devices.

The two companies will jointly distribute Vycor’s VBAS (ViewSite™ Brain Access System), a new approach to brain retraction, in China and South Korea, leveraged by the PRC government’s plans to spend USD$125 billion in addition to its usual healthcare budget over the next three years.

According to the China Business Review, China’s medical device market is estimated to be between USD$8 billion – UDS$10 billion in 2008, and forecast that the market could grow to USD$16 billion USD by the end of this year.

Dr. John A. Bennett, CEO of Devon Medical agrees.

“Devon Medical believes that the Chinese medical device

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Cadence Pharmaceuticals, Inc.’s (CADX) fourth quarter fiscal 2009 net loss per share came in at 30 cents, wider than the Zacks Consensus Estimate by a penny. The year-ago loss was 37 cents.   Quarterly Results   The company reported no revenues for the quarter. Operating expenses for the reported quarter climbed to $15.1 million from $13.5 million in the year-ago quarter due to the rise in sales and marketing expenses.

This can be attributed to the establishment of infrastructure in preparation for the launch of Ofirmev on approval. Ofirmev is an intravenous drug for the treatment of pain and fever for which the company is seeking approval.

The rise in sales and marketing expenses was partially offset by a reduction in the research and development spend in the quarter because of the completion of the clinical development program for Ofirmev in early 2009 in addition to the discontinuation of the

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A drug containing low aspirin and esomeprazole magnesium has been developed by AstraZeneca (NYSE:AZN), a major pharmaceutical company in the United States, over the last few years. Now the company is planning to bring thris drug into the market. For this purpose, a new drug application (NDA) was submitted to the Food and Drug Administration (FDA) on May 4, 2009. It usually takes the FDA 10 months to review a submitted NDA. So, the Prescription Drug User Fee Act (PDUFA) date of this drug – that is, the date on which the FDA will inform the company about whether it has accepted the NDA or not – is expected to be in March.

Meanwhile, the company also sent a variation of the NDA – called the supplemental new drug application (sNDA) to the FDA. This sNDA was submiited to get the regulator’s approval for

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We have recently downgraded our recommendation on Bayer (BAYRY) to Underperform from Neutral. During the fourth quarter of 2009, the company’s core earnings per share came in at €0.90 surpassing €0.71 reported in the year-ago period.  Bayer has been shifting its focus towards its HealthCare segment over the past few years in order to maintain solid growth in the long run. While we are pleased with the growth recorded by the HealthCare segment, we remain concerned about the disappointing performance of the Material Science segment.   The global economic crisis leading to weaker demand in the relevant customer industries is primarily responsible for the disappointing performance of this segment since 2005. Although sales during the fourth quarter of 2009 have stablized to some extent, the segment recorded €7,520 million in annual revenues in 2009, down 22.8% from €9,738 million in 2008 due to a decline in selling ...

APF530 is a drug that has been developed by A.P. Pharma Inc. (Nasdaq:APPA) using its “Biochronomer™ polymer-based drug delivery technology”. By far, it is the most important pharmaceutical product developed by this medium-sized specialty pharmaceutical company. Last year, the company finished the Phase 3 trial that measured the safety and the effectiveness of the drug in preventing chemotherapy-induced nausea and vomiting (CINV). Afterwards, on May 18, 2009, the company submitted a new drug application (NDA) to the United States of America’s Food and Drug Administration in order to get the regulator’s approval for bringing the APF530 into the market. On July 30, 2009, A.P. Pharma disclosed to its stakeholders that the FDA has found the NDA to contain all the information that would allow a thorough review of APF30 – that is, the NDA was accepted for review. The regulator has also given the company a Prescription

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Duratech™ BioRegeneration Matrix is a medical device that has been devekioed by Osteotech, Inc (Nasdaq:OSTE). Now the company wants to bring this product into the market. However, it needs the approval from the United States of America’s toughest regulator – the Food and Drug Administration (FDA). For this reason, Osteotech submitted a 510(K) application to the FDA on December 17, 2009.It usually takes the FDA about 90 days to review a 510(K) submission, so the company expects to get response from the FDA on March 17, 2010. However, the FDA may not announce its decision on this date and there is no way to find out when it will, since the FDA is not bound by law to notify about decision dates for any submission, such as 510(K), related to medical devices.

According to the company, the Duratech™ BioRegeneration Matrix, which has been developed using Osteotech’s

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BEMA Granisetron is a product candidate that has been developed by BioDelivery Services International, Inc. (Nasdaq:BDSI). According to the company, this product can reduce vomiting and nausea. The company is planning to start the Phase 1 trial of this product as early April 2010. The trial would measure the safety and the effectiveness of BEMA Granisetron in reducing vomiting and nausea. However, before starting the trial, it must get approval from the Food and Drug Administration (FDA) of the United States of America, where it plans to conduct the trial. For this purpose, the company is planning to submit an investigational New Drug (IND) application to the FDA. In order to make sure that the IND application contains all the relevant information and that the Phase 1 trial is conducted properly, the company wants to hold a meeting with officials from the FDA. At present, the FDA

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Exenatide is a drug that has been co-developed by Amylin Pharmaceuticals, Inc, (Nasdaq:AMLN), Alkermes, Inc. (Nasdaq: ALKS) and Eli Lilly and Company (NYSE:LLY). Exenatide is currently available in the market as BYETTA® injections. However, now the three companies want to use exenatide as a drug given once per week to treat people suffering from type 2 diabetes (by controlling the glycemic level in the body). For this purpose, they submitted a new drug application (NDA) to the United States of America’s Food and Drug Administration (FDA) to get the regulator’s approval for bringing exenatide once weekly into the market. The NDA was submitted on May 5, 2009. And in June 2009, the FDA announced that the NDA contains all the information that would allow it to make a thorough review on exenatide – that is, the NDA was accepted for review. The FDA also handed the company a

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