Following preliminary discussions with several governmental authorities, Pluristem Therapeutics (NASDAQ:PSTI; TASE:PLTR) plans to expand its research and development efforts on an acute radiation exposure treatment.

Dr. Liat Flaishon, recently appointed as director of business development, will lead the company’s development efforts.

Pluristem’s placental 3D expanded cells have demonstrated efficacy as mitigators of the acute radiation syndrome following radiation exposure in animals that were given lethal doses of radiation and 24 hours later were treated with these cells. According to these studies’ findings, a statistically significant increased survival rate of three-to-fourfold was observed in those animals treated with Pluristem’s cells over the untreated control animals.

“Following announcement regarding our initial studies on radiation treatment, we have seen significant interest in our radiation product candidate”, CEO Zami Aberman said in a statement.

“Currently, there is an extensive search for an easily administered and effective product for radiation countermeasures,” he added. “We believe that our PLX cells have the potential to both extend the window of treatment for radiation victims and to become an off-the-shelf nuclear catastrophe countermeasure product.”

Rodman & Renshaw has raised its year-end price target for “market outperform-rated” Alnylam Pharmaceuticals (NASDAQ:ALNY) to $19 from $12, based on changes to the company’s business model and a sum-of-the-parts analysis.

Noting that Alnylam has made considerable progress in its clinical development programs in the past six months, analyst Michael King writes that he has been encouraged by the company’s “success in advancing a number of its programs, particularly the establishment of human proof-of-concept data with ALN-TTR01, the demonstration of robust, statistically significant efficacy with the company’s PCSK9 program in a Phase 1 trial, and the development of the GalNAc-conjugated delivery approach allowing subcutaneous delivery for the TTR programs, among others.”

Mr. King also gives the company high marks for prioritizing its resources in a recent restructuring, which should result in savings of about $20 million in 2012 operating expenses.

“We believe the company has made considerable progress in demonstrating the clinical potential of its pipeline programs, and hence the value of Alnylam’s platform and intellectual property has increased,” he said. “We continue to believe over the course of time the company’s value can multiply several-fold as its pipeline programs progress.”

Efri Argaman

Efri Argaman, CEO of D. Medical Industries (NASDAQ, TASE:DMED), was interviewed today by Sara Eisen on Bloomberg Television’s “InsideTrack.”

Mr. Argaman discussed a host of topics, ranging from the state of the U.S. diabetes market, regulatory oversight and D. Medical’s sales strategy in the U.S.

Instead of setting up a direct and costly U.S. sales force, D. Medical has chosen to use a handful of distributors for its Spring Universal Infusion Sets, which are compatible with most insulin pumps currently available on the market. Mr. Argaman pointed out that the sales strategy allows the company’s SG&A to be variable rather than fixed.

The interview may be accessed here.

Cipher Pharmaceuticals (TSX:DND) has reached a sales milestone for Lipofen, its fenofibrate product, triggering a $1 million payment from Kowa Pharmaceuticals America, the company’s U.S. marketing and distribution partner.

Lipofen® (fenofibrate capsules)

The one-time milestone, which is based on sales performance over a trailing 12-month period, reflects a steady increase in new prescriptions during the past quarter. Cipher’s 50% share of the milestone will be reflected in its financial results for the first quarter of fiscal 2012.

“We continue to be pleased with the solid performance of Lipofen under Kowa’s direction,” Cipher CEO Larry Andrews said in a statement. “This milestone will further strengthen our balance sheet to support future growth.”

GeneNews (TSX:GEN) has signed a memorandum of understanding with Shanghai Biochip, a leading Chinese engineering center for advanced microarray and gene expression profiling technologies, for a strategic alliance to establish the first Sentinel Centre for Personalized Medicine in China.

GeneNews and SBC would jointly establish and manage the Sentinel Centre for Personalized Medicine to co-develop and commercialize additional products based on GeneNews’ proprietary platform technology, the Sentinel Principle.

Sentinel Principle Illustration

In addition, the accord sets out criteria to be incorporated into definitive development, distribution and license terms to give Shanghai Biochip non-exclusive rights to market and sell GeneNews’ ColonSentry test in China. A formal agreement will be negotiated and executed before the end of the company’s third fiscal quarter.

“We are focused on bringing leading edge technologies to the people of China to improve healthcare outcomes,” Dr. Yuchen Chen, director of business development of Shanghai Biochip, said in a statement. “We are looking forward to working with GeneNews to establish the world’s first Sentinel Centre for Personalized Medicine to advance the development and commercialization of innovative, non-invasive tests targeted at early disease detection in China.”

Gailina Liew, president and COO of GeneNews, said Shanghai Biochip’s expertise in gene expression profiling platforms and well-established clinical network provide a “strong foundation for us to jointly establish a state-of-the-art research and development core capability in China that is aligned with our pipeline development and commercialization objectives. We look forward to building a successful strategic alliance with Shanghai Biochip.”

The Sentinel Principle is based on the concept that all clinical conditions and body states, including those resulting from disease or in response to treatment, generate characteristic gene expression signatures in the blood as a result of the constant and dynamic physiological interaction of blood with the cells, tissues and organs of the human body. This technology is the basis of GeneNews’ initial product, ColonSentry, the world’s first blood test for colorectal cancer, and the SentinelGx suite of services.

BioLineRx (NASDAQ, TASE:BLRX) has signed a worldwide, exclusive license agreement with Genoscience and RFS Pharma to develop and commercialize BL-8030, an orally candidate to treat Hepatitis C virus (HCV).

The agreement includes upfront license fees, milestones and royalties payable to both companies, which terms are consistent with BioLineRx’s standard in-license agreements.

Electron micrograph of hepatitis C virus

BL-8030 is a potent and selective second generation NS3 protease inhibitor, which is essential for the replication of the HCV and is an important target for HCV therapies. Pre-clinical studies have demonstrated a good toxicity profile and an improved resistance profile against common protease inhibitor mutants, resulting in a lower probability that the virus will develop resistance to treatment.

Two years ago, BioLineRx took a strategic decision to enter the rapidly growing field of Hepatitis C and since that time, has evaluated numerous projects in the field.

“A year ago, we identified and decided to focus on the in-licensing of the two most promising candidates: BL-8020, which we’ve recently licensed, and now BL-8030,” said Dr. Kinneret Savitsky, CEO of BioLineRx. “We will do our utmost to develop these promising drugs as swiftly as possible for the benefit of Hepatitis C infected individuals around the world.”

pSivida CEO Paul Ashton

pSivida (NASDAQ:PSDV; ASX:PVA) CEO Dr. Paul Ashton will participate today in a panel: New Horizons in Glaucoma Drug Delivery and IOP Monitoring during the Glaucoma 360 New Horizons forum at the Palace Hotel in San Francisco.

The conference is being presented by the Glaucoma Research Foundation in association with Ophthalmology Times to bring together leaders in medicine, science, business, venture capital, and philanthropy, all intent on transforming new ideas into new hope in the worldwide battle to beat glaucoma.”

pSivida is developing a product to treat glaucoma and occular hypertention in collaboration with Pfizer.

Rodman & Renshaw Capital Group (NASDAQ:RODM), via a new subsidiary, DirectMarkets, has unveiled an automated, state-of-the-art electronic transaction platform to directly link existing public company issuers and investors seeking to transact primary offerings of securities.

Both investors and issuers will benefit from 24/7 seamless access to DirectMarkets’ platform through a graphical user interface accessible via computer and mobile smart devices. The official launch will take place at the TradeTech 2012 Conference in New York City that begins on March 6, 2012.

The DirectMarkets platform will empower issuers to sell shares covered by a shelf registration directly into the secondary market and to complete funding transactions at a fraction of the current cost.

Using the same platform, investors will be able to directly contact issuers, with effective shelf registrations in place, to indicate their interest in buying that issuer’s stock, effectively gaining the ability to accumulate stock positions in a more cost-effective manner than through on-going open market purchases.

The DirectMarkets platform is designed to bring greater efficiency and cost savings to current methods that public companies use to effect financings, including follow-on offerings, Registered Directs, At-the-Markets, Confidentially Marketed Public Offerings and Private Investments in Public Equities. DirectMarkets also plans to adapt the platform across international markets.

Rodman has recruited Kevin Lupowitz as CEO of the DirectMarkets operating entity. Mr. Lupowitz was formerly chief information officer of FXall, an electronic foreign exchange platform.

“DirectMarkets will be a game-changer and with Kevin Lupowitz’s talent and experience at the helm, this new electronic transaction platform is the catalyst that will redefine Rodman as an innovative technology company, focusing on the financial services industry, while strengthening our legacy business,” Rodman CEO Edward Rubin said in a statement.

In conjunction with the launch of DirectMarkets, Rodman & Renshaw Capital Group intends to change its name to Direct Markets Holdings, subject to stockholder approval at the annual meeting on May 4, 2012. Rodman’s sales and trading, and investment banking operations will continue to be conducted by Rodman & Renshaw, LLC.

Navidea Biopharmaceuticals (AMEX:NAVB) intends to file a Marketing Authorization Application (MAA) in the EU for Lymphoseek, its radioactive diagnostic tracing agent, based on clinical data accumulated from completed pivotal studies and supporting clinical literature.

Navidea also has been advised by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use that it has adopted the advice of the Scientific Advice Working Party regarding the Lymphoseek development program and has determined that Lymphoseek is eligible for an MAA submission.

Lymphoseek® is a lymph node targeting agent intended for use in intraoperative lymphatic mapping (ILM)

As a result, the company has initiated regulatory activities to submit a MAA to the EMA for Lymphoseek by year-end 2012. The MAA will be similar in scope to Navidea’s New Drug Application submission with the FDA, which has given the company a PDUFA date of June 10, 2012.

Navidea will seek clearance to market Lymphoseek for use in Intraoperative Lymphatic Mapping and will also seek to include the use of Lymphoseek in Lymphoscintigraphy imaging procedures.

“We are pleased to receive the advice and feedback from the [committee and working party] as it provides Navidea with confirmation that our Phase 3 studies were well-designed and, with additional supportive information, provide a strong clinical basis for clearance to market Lymphoseek in the EU,” Rodger Brown, VP of regulatory affairs and quality assurance, said in a statement. “This milestone provides us with a clear pathway for the MAA submission.”

Thomas Tulip, EVP and chief business officer, said Navidea has already engaged a “number of well-known potential commercial partners in discussions and this development will stimulate even more interest in this important, innovative product. We look forward to completing a mutually beneficial arrangement with one or more of these high quality organizations in the coming months.””

CEO Mark Pykett added that the pending MAA submission reflects the company’s belief in the “widespread application and importance of Intraoperative Lymphatic Mapping innovation for those in the EU as a first step in the global registration process for Lymphoseek.”

Roth Capital Partners has upgraded Antares Pharma (AMEX:AIS) to “buy” from “neutral” and raised its 12-month price target to $3.50 from $2, saying the balance sheet is strong and the company could become cash flow positive this year.

“The solid financial position, platform opportunities, and potential for advancement of key products make the stock attractive at current levels,” writes analyst David Moskowitz. The closed at $2.56 on Tuesday.

In late December and January, Antares signed partnership deals with Pfizer and Daewoong Pharmaceuticals, receiving up-front cash from both transactions and royalties on sales of associated products. Antares licensed its overactive bladder gel formulation to Daewoong for sale in Korea and could begin collecting royalties in 2013.

“As a result, and with the potential for the announcement of a new proprietary product candidate later this year, we have increased our value for Antares’ platform and pipeline candidates to $70 million from $40 million,” Mr. Moskowitz said, adding that he believes more platform deals could be announced later this year.

Mr. Markowitz said that assuming Antares and its partner, Teva Pharmaceuticals, win a patent challenge on EpiPen and the FDA approves the company’s product, “we believe sales of branded EpiPen could quickly convert to the generic, and our revenue estimates to Antares could prove conservative.”

Teva continues to develop multiple products using Antares’ proprietary injection device technologies, and “as these candidates advance in development, the chance that Teva could acquire Antares increases,” he said.

In addition, the growth of TevTropin prescriptions is accelerating, “implying potential upside to our long-term expectations for this branded generic product,” he added.

Watson expects to launch its Gelnique line extension based on Antares’ oxybutynin formulation in the second quarter. “In our view, a strong launch could be a catalyst for Antares,” Mr. Markowitz said.