Navidea to seek approval for Lymphoseek in Europe

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 [...]

Roth upgrades Antares Pharma to buy

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 [...]

Navidea signs option to license PD imaging agent

Navidea Biopharmaceuticals (AMEX:NAVB), formerly Neoprobe,  has entered into a six-month option agreement with Alseres Pharmaceuticals to license [123I]-E-IAFCT Injection, also called Altropane, an Iodine-123 radio-labeled imaging agent, being developed as an aid in the diagnosis of Parkinson’s disease and movement disorders. “Should we exercise the option, [123I]-E-IAFCT would provide us not only with another strong [...]

TearLab Osmolarity System gets CLIA Waiver from FDA

The FDA has granted a waiver categorization under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the TearLab (NASDAQ:TEAR; TSX:TLB) Osmolarity System. The FDA took the action after reviewing and accepting labeling submitted to it by TearLab. “We believe that, with CLIA Waiver and Medicare reimbursement in place, and with the updated American Academy [...]

Alitair builds value without outside investors

Dr. William W. Howard likes to say there’s a lesson to be learned in how closely held Alitair Pharmaceuticals has spent the first couple years of its existence developing a portfolio of respiratory therapeutics and a drug safety technology: make some money first and then go out and get investors. “We’ve been able to develop [...]

CytoSorbents year-end letter to shareholders

In a letter to shareholders released today, CytoSorbents (OTCBB: CTSO) CEO Dr. Phillip Chan reviews the company’s major milestones for 2011, highlighted by the first-ever product revenue from the launch of its CytoSorb blood purification therapy to treat sepsis in Europe. Dr. Chan also outlines the company’s numerous opportunities and goals for 2012 and 2013, including [...]

Cynapsus readies first human data of sublingual strip for PD

Cynapsus Therapeutics (TSX-V:CTH) is set to release human proof-of-concept data of its sublingual thin film-strip as a treatment for motor fluctuations, or episodes of immobility, in patients with Parkinson’s disease. “This will represent an important de-risking event for the project,” CEO Anthony Giovinazzo says in an exclusive interview with BioTuesdays.com, referring to the company’s APL-130277 [...]

Cipher gets complete response for amended NDA

Cipher Pharmaceuticals’ (TSX:DND) amendment to its New Drug Application for CIP-Isotretinoin, a novel, patented formulation of the acne medication isotretinoin, has been accepted by the FDA as a complete, class 2 response. The FDA’s goal date under the Prescription Drug User Fee Act (PDUFA) is May 29, 2012. Cipher will receive a $1 million milestone [...]

Roth ups TearLab price target to $3

Roth Capital Partners has raised its price target on “buy-rated” TearLab (NASDAQ:TEAR; TSX:TLB) to $3 from $2.20, citing a decision by the FDA to grant the TearLab Osmolarity System a waiver under the Clinical Laboratory Improvement Amendments (CLIA). The stock was quoted at $1.19 Tuesday afternoon. “This milestone could represent a significant driver of TearLab [...]

Diamedica forms advisory group for diabetes products

Diamedica (TSX:DMA) has formed a development advisory group for its DM-199 and DM-204 products for the treatment of Type 1 and Type 2 diabetes, consisting of Dr. Joy Cavagnaro, Dr. Patrick Gearing and Larry Johnson. They are industry experts in the areas of pharmacology and toxicology, manufacturing and regulatory affairs. The new group brings together [...]

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