'<P>Mylan Inc. announced that it has received final approvals from the US FDA for Lamotrigine Tablets and Lamotrigine Tablets Chewable Dispersible (CD). The approvals were for 25 mg, 100 mg, 150 mg and 200 mg strengths of the generic version of GlaxoSmithKline's Lamictal® Tablets and 5 mg and 25 mg strengths of the generic version of Lamictal® CD Tablets. </P> <P>These products are indicated for treatments of epilepsy and for maintenance treatment of bipolar I disorder. </P>'

'<P>Decision Resources will follow AstraZeneca's zibotentan as its proprietary clinical gold standard by 2012. By the year 2017 this gold standard would be used for the treatment of metastatic hormone-refractory prostrate cancer also. Zibotentan&nbsp; has been chosen over the company’s current gold standard Sanofi-Aventis' Taxotere, due to formers advantages in overall efficacy, safety, tolerability and delivery measures. </P> <P>Natalia Reoutova, M.Sc., analyst at Decision Resources said, "Interviewed key opinion leaders' optimism for zibotentan's Phase II survival data combined with our survey results make zibotentan the most likely agent to supplant Sanofi-Aventis' Taxotere as our gold standard treatment for metastatic hormone-refractory prostate cancer patients." </P> <P>&nbsp;</P>'

'<P>Geron Corporation announced the receiving of the U.S. Food and Drug Administration (FDA) grant for the company’s Investigational New Drug (IND) applicant for the clinical trial of GRNOPC1 in patients suffering with acute spinal cord injury. With this study Geron has moved forward in the world’s first study of a human embryonic stem cell (hESC)-based therapy in man. GEron would initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with “complete” American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.</P> <P>“The FDA’s clearance of our GRNOPC1 IND is one of Geron’s most significant accomplishments to date,” commented Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “This marks the beginning of what is potentially a new chapter in medical therapeutics – one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord.”</P> <P>&nbsp;</P> <P>&nbsp;</P> <P>&nbsp;</P>'

'<P>3SBio Inc. announced the filing of approval for TPIAO label extension for the treatment of idiopathic thrombocytopenic purpura (ITP) with the Chinese State Food and Drug Administration (SFDA) on December 30, 2008.&nbsp; TPIAO for ITP will be the only treatment of its kind available in China, if the extension is approved. The aim of this filing is to extend the label of TPIAO for use in the treatment of ITP.</P> <P>Dr. Jing Lou, Chief Executive Officer of 3SBio, commented, "The filing of TPIAO for ITP successfully caps our development initiatives for 2008 and we now have three new product candidates in the approval pipeline. As with NuLeusin and high dosage EPIAO, TPIAO for ITP represents a logical extension of an existing product franchise, in-line with our therapeutic focus and growth strategy. The successful completion of our three Phase III trials demonstrates the strength of our research and development platform and highlights our operational excellence. Upon approval, TPIAO for ITP would provide a new treatment option for patients and will further enhance our footprint within China's growing pharmaceutical market."<BR></P>'

'<P>Abbott announced that it has opened a new pharmaceutical analytical research laboratory in Singapore's Biopolis research park. This new facility will conduct stability studies, including studies on active pharmaceutical ingredients and novel formulations, to support global regulatory requirements for new pharmaceutical products. The work done at the laboratory will enable Abbott to accelerate the development of innovative investigational medicines and potentially deliver new treatments to patients faster in areas such as neuroscience and cancer.</P> <P>"Abbott has continually increased its investment in R&amp;D over the last decade, resulting in a promising pipeline," said John M. Leonard, M.D., senior vice president, Pharmaceuticals, Research and Development, Abbott. "To realize the potential from the growth in Abbott's early stage pipeline requires the resources of a truly global R&amp;D organization and the scientific talent available in Singapore made it a logical choice for Abbott's expansion in the region."</P> <P>&nbsp;</P> <P>&nbsp;</P>'

'<P>Lupin Pharmaceutical announced the receiving of final approval from U.S. Food and Drug Administration (USFDA) for the company’s abbreviated new drug application (ANDA) for Levetiracetam Tablets 250mg, 500mg, 750mg and 1000mg. The company’s has began the commercial shipment of the product. <BR><BR>Levetiracetam tablets from Lupin Pharmaceutical are AB-rated generic equivalent of UCB Pharmaceuticals' Keppra(R) tablets. Levetiracetam tablets are indicated as adjunctive therapy in the treatment of certain types of seizures associated with epilepsy.<BR></P>'

'<P>TOPIGEN Pharmaceuticals Inc., reported results of Phase 2 fourteen day study of inhalable TPI ASM8 in patients with asthma. TPI ASM8 utilizes TOPIGEN's proprietary oligonucleotide technology. It inhibits multiple targets associated with inflammation in asthma thus providing a broader and specific , pharmacological activity with limited systemic availability and a favorable safety profile. </P> <P>"We believe that TPI ASM8 has a very compelling clinical profile for the treatment of moderate to severe asthma," said Mark Parry-Billings, Ph.D., Chief Executive Officer of TOPIGEN. "As an inhalable candidate with a well established safety profile, TPI ASM8 offers a significant advantage over other treatments in development for this patient population -- primarily injectable monoclonal antibodies. Importantly, TPI ASM8 inhibits multiple key inflammatory targets which are increasingly the focus of large pharma drug development pipelines. We plan to expand the TPI ASM8 program with the initiation of additional dose-finding studies in the first half of 2009 and we are optimistic that we will be able to define the potential role TPI ASM8 can play in providing much needed treatment options for patients with moderate to severe asthma who do not respond adequately to the current standard of care."</P> <P>&nbsp;</P>'

'<P>Halo Pharmaceutical, Inc., acquired the Whippany-NJ Manufacturing and Research facility from Abbott. Halo’s facility is over 200,000 square feet, and encompasses highly-diverse manufacturing and warehousing capabilities, including an impressive array of formulation services, operations for the aseptic filling of topical ointments, solid dosage forms (tablets and capsules), liquids, suppositories, associated packaging (tablet, powder, liquids and HUD) and ample laboratory space for formulation development, pre-clinical and clinical supplies and support of commercial operations.</P> <P>"We are extremely excited about the acquisition of this outstanding facility," said Douglas Kollmorgen, President of Halo Pharmaceutical. "The facility and the people, who are continuing on with Halo, have a long and proud history here. Under the management of Abbott, the Whippany facility has been an exemplary production operation. We welcome the opportunity to continue that tradition of excellence for our customers going forward."</P> <P>&nbsp;</P> <P>&nbsp;</P> <P>&nbsp;</P>'

'<P>U.S. Food &amp; Drug Administration (FDA) has&nbsp;approved the new drug application (NDA) for NEXTERONE® (amiodarone HCl) Injection, which is a novel, patent-protected, cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, as announced by Prism Pharmaceuticals.&nbsp; NEXTERONE® (amiodarone HCl) Injection was originally marketed in the US by Wyeth as Cordarone® Intravenous. NEXTERONE is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.</P> <P>Dr. Warren D. Cooper, President and CEO of Prism said, "Approval of our first product is an important corporate milestone and validates our accelerated development model, which allowed us to move NEXTERONE from licensing to FDA clearance in less than three years and ahead of the PDUFA target date.” He added, "We developed NEXTERONE to overcome solvent-based limitations of conventional intravenous amiodarone and to improve patient care and overall medication management in the setting of life-threatening cardiac arrhythmias."</P> <P>&nbsp;</P> <P>&nbsp;</P>'

'<P>Acura Pharmaceuticals, Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting a priority review for Acurox(r) (oxycodone HCl/niacin) Tablets, as&nbsp;announced by Acura Pharmaceuticals, Inc. and King Pharmaceuticals, Inc.&nbsp; The FDA will determine whether to accept the NDA for filing and consider the priority review request within 60 days. <BR><BR>Acura and King believe Acurox(r), if approved will be the first FDA approved immediate release opioid analgesic designed to deter swallowing excess quantities of tablets and other common methods of misuse and abuse. </P> <P>&nbsp;</P>'