ARIAD Announces U.S. Resumption of Marketing and Commercial Distribution of Iclusig (ponatinib) in Refractory Philadelphia-Positive Leukemias
ARIAD Pharmaceuticals, Inc. (ARIA) today announced that the U.S. Food and Drug Administration (FDA) has approved revised U.S. Prescribing Information (USPI) and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig® (ponatinib) that allows immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers.
Oramed Announces Successful Results from Ex-US Pharmacokinetic Study of its Oral Insulin for the Treatment of Type 1 Diabetes
Company Additionally Anticipates Results from Phase 2a FDA Study for Type 2 Diabetes in January
Oramed Pharmaceuticals Inc. (ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today successful results in a clinical trial testing the pharmacokinetic dose response of its oral insulin capsule (ORMD-0801) in type 1 diabetes patients.
Patients were treated with a different dose of oral insulin at each study visit; blood glucose and insulin levels were then monitored for the ensuing five hours. Patient responses positively correlated with administered doses, as did the duration of the effect.
Oxygen Biotherapeutics Provides a Business Review and Update in Conjunction with Filing of Second Quarter Fiscal Year 2014 Financials
Oxygen Biotherapeutics, Inc.,(“OBI”) (OXBT) a specialty pharmaceutical company focused on developing and commercializing a portfolio of products for the critical care market, today announced that it has filed its Quarterly Report on Form 10-Q for its second quarter fiscal year (FY) 2014 ended October 31, 2013. In connection with that filing, the company is providing a review of recent achievements and an update on business operations and future milestones.
Alimera Sciences and FDA Enter Into Labeling Discussions for ILUVIEN®, Agree Advisory Committee No Longer Necessary
Alimera Plans to Respond to October Complete Response Letter in First Quarter 2014
Alimera Sciences, Inc. (ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has entered into labeling discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN® and, as a result, reached an agreement with the FDA that Alimera's participation in the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary. Alimera will focus instead on drafting its response to the Complete Response Letter (CRL) received from the FDA in October 2013 with a goal of submitting the response in the first quarter of 2014.
FDA Grants Orphan Drug Designation to Omeros' OMS721 for Complement-Mediated Thrombotic Microangiopathies
-- Phase 2 Program Expected to Begin Next Quarter --
Omeros Corporation (OMER) today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for prevention of complement-mediated thrombotic microangiopathies (TMAs).
Depomed Acquires CAMBIA® (Diclofenac Potassium for Oral Solution) Migraine Medicine from Nautilus Neurosciences for $48.7 Million
Depomed, Inc. (DEPO) today announced that it has acquired the United States rights to CAMBIA® (diclofenac potassium for oral solution) from Nautilus Neurosciences for $48.7 million. In addition, Depomed may pay Nautilus up to an additional $5 million based on the achievement of certain annual net sales milestones. CAMBIA is a non-steroidal anti-inflammatory drug (NSAID) indicated for acute treatment of migraine attacks with or without aura in adults 18 years of age or older.
Navidea Biopharmaceuticals Submits Supplemental New Drug Application (sNDA) for Lymphoseek® for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer
- sNDA includes data from successful Phase 3 study in patients with head and neck cancer -
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that it has submitted a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node (SLN) detection in patients with head and neck cancer, an indication for which Lymphoseek was also granted Fast Track designation earlier this month. Lymphoseek is currently approved for use in lymphatic mapping procedures that are performed to aid in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
Neptune and Aker BioMarine Reach Patent Infringement Settlement and License Agreement
Neptune Technologies & Bioressources Inc. ("Neptune") (NEPT) (NTB.TO), Acasti Pharma Inc. ("Acasti") (ACST) (APO.V), a Neptune subsidiary, and Aker BioMarine AS, Aker BioMarine Antarctic AS and Aker BioMarine Antarctic USA (collectively "AKBM") jointly announce a settlement and license agreement that will result in the dismissal of all AKBM respondents from the on-going ITC investigation brought by Neptune and Acasti, as well as the dismissal of all current lawsuits brought by Neptune against AKBM and companies in its value chain.
BioLineRx Announces Promising Initial Phase 2 Results of Acute Myeloid Leukemia Treatment
- Initial results for BL-8040 show substantial mobilization of cancer cells and signs of robust cancer cell death (apoptosis) -
BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today promising initial results for its BL-8040 drug candidate in a Phase 2 clinical trial for patients with relapsed or refractory acute myeloid leukemia (AML). The early results show that BL-8040, as a stand-alone therapy and in combination with high-dose Cytarabine (Ara-C), is safe at all doses tested to date, and triggers substantial mobilization of cancer cells from the bone marrow to the peripheral blood, thereby increasing the vulnerability of the cells to chemotherapy treatment.
AcelRx and Grunenthal Announce Collaboration for EU Commercialization of ZALVISO™
- FDA establishes the PDUFA action date of July 27, 2014 for Zalviso -
AcelRx Pharmaceuticals, Inc. (ACRX) and Grunenthal GmbH announced today that they have entered into a commercial collaboration, covering the territory of the European Union, certain other European countries and Australia for ZALVISO™ (previously known as ARX-01) for potential use in pain treatment within or dispensed by a hospital, hospice, nursing home or other medically supervised setting. ZALVISO, a drug-device combination product utilizing the opioid agonist sufentanil formulated in a proprietary sublingual tablet formulation and delivered through a pre-programmed, non-invasive proprietary delivery device is AcelRx's lead program. AcelRx retains all rights in remaining countries, including the U.S. and Asia.
Positive Phase 2 Results from Agenus’ Brain Cancer Vaccine Published in Neuro-Oncology
Results Show Improved Survival Against Aggressive Brain Cancer; More Than 90% of Patients Alive After Six Months
Agenus Inc. (AGEN), a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, today announced results published from a Phase 2 study demonstrated that more than 90% of the patients treated with Prophage Series G-200 were alive at six months after surgery and 30% were alive at twelve months. Additionally, the median overall survival was approximately eleven months. This compares favorably to the expected median survival for recurrent Glioblastoma multiforme (GBM) patients of three to nine months1-7. The primary objective of this multi-center, single arm Phase 2 trial was to assess the survival rate at six months.
Valeant Pharmaceuticals Agrees to Acquire Solta Medical for $2.92 Per Share in Cash
Combination Creates a Global Leader in Aesthetics Transaction Values Solta at Approximately $250 Million Transaction Expected to Close in the First Quarter of 2014
Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) today announced that it has entered into a definitive agreement under which Valeant will acquire all of the outstanding common stock of Solta Medical, Inc. (SLTM) for $2.92 per share in cash, which represents a 40% premium to Solta's closing share price on December 13, 2013, the last trading day prior to announcement, or a transaction value of approximately $250 million. The transaction is expected to close in the first quarter of 2014 and Valeant expects the transaction, once completed, to be immediately accretive to Valeant's cash earnings per share.
Endo to Acquire Specialty Pharmaceutical Company NuPathe Accretive transaction furthers Endo's transformation into leading specialty healthcare company Builds on Endo's leadership in pain management through addition of ZECUITY® (sumatriptan iontophoretic transdermal system), the first and only FDA approved patch to treat migraine Proven Endo branded pharmaceuticals commercial team to execute ZECUITY launch, expected in first half 2014
Endo Health Solutions (ENDP) today announced it has entered into a definitive agreement under which Endo will acquire NuPathe Inc. (PATH) for $2.85 per share in cash, or approximately $105 million.
Celsion Corporation Announces Combined Clinical Data from Two Phase I Trials at the 2013 San Antonio Breast Cancer Conference
Combined Safety and Efficacy Results with ThermoDox® plus Hyperthermia for Recurrent Breast Cancer at the Chest Wall
Celsion Corporation (CLSN), an oncology drug development company, today announced the presentation of the combined clinical study results from the Company's Phase I DIGNITY study and the Duke University sponsored Phase I trial of ThermoDox® plus hyperthermia in Breast Cancer Recurrences at the Chest Wall (BCRCW) at the 2013 San Antonio Breast Cancer Conference during Poster Session #4 on Friday, December 13, 2013 between 7:30 am to 9:00 am (local time).
Coronado Biosciences Announces Presentation of Interim Data From Autism Study at Neuropsychopharmacology Meeting Study Investigator Eric Hollander, M.D., Reports Potential Benefits of TSO Immunotherapy in First 5 Patients Study Completion and Final Results Expected Mid-2014
Coronado Biosciences, Inc. (CNDO), a biopharmaceutical company developing novel immunotherapy agents for the treatment of autoimmune diseases and cancer, today announced that Dr. Eric Hollander, Clinical Professor of Psychiatry and Behavioral Sciences at Albert Einstein College of Medicine of Yeshiva University and Director of the Autism and Obsessive Compulsive Spectrum Program at Montefiore Medical Center and Einstein, presented interim data from his pilot study of oral TSO (Trichuris suis ova or CNDO-201) to treat autism at the American College of Neuropsychopharmacology Annual Meeting in Hollywood, Florida.
Cangene To Be Acquired By Emergent BioSolutions For US$222 Million
Cangene Shareholders to Receive US$3.24 Per Share (C$3.44 Per Share) in Cash
Readers are referred to the cautionary notes regarding Forward-looking Information and non-IFRS Financial Measures at the end of this release. Unless noted otherwise, all dollar amounts are in U.S. dollars.
Cangene Corporation ("Cangene") (TSX:CNJ.TO - News) today announced the signing of a definitive agreement under which Emergent BioSolutions ("Emergent") (NYSE:EBS - News) of Rockville, Maryland will acquire Cangene in an all-cash transaction valued at US$222 million (approximately C$236 million1).
Under the terms of the agreement, which has been approved by the Boards of Directors of both companies, Cangene shareholders will receive US$3.24 per share (C$3.44 per share) in cash.
Echo Therapeutics Announces Strategic Partnership with Medical Technologies Innovation Asia (MTIA)
Echo to receive a $10 million cash investment from MTIA and Platinum Partners Company will withdraw the offering identified in recent Form S-1 filing Echo Therapeutics, Inc. (ECTE) ("Echo"), a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that it entered into a strategic collaboration agreement with Medical Technologies Innovation Asia (MTIA), Ltd., Hong Kong, for a license arrangement and equity investment in Echo.
BG Medicine Welcomes Final Determination by CMS of 2014 Reimbursement for BGM Galectin-3(R) Test
BG Medicine, Inc. (BGMD) announced today that the Centers for Medicare and Medicaid Services (CMS) have published the final determination of the 2014 Medicare national limitation amount for the Company's galectin-3 blood test (analyte-specific CPT(R) Code 82777) at the amount of a crosswalked test (analyte-specific CPT(R) Code 84244) whose 2014 national limitation amount is $30.01. This national limitation amount will replace the galectin-3 blood test's national limitation amount of $17.80 that was effective in 2013.
"We are very pleased that CMS has finalized the previously announced preliminary determination of the Medicare reimbursement rate for our galectin-3 test," said Dr. Paul R. Sohmer, President and Chief Executive Officer of BG Medicine.
CytRx Reports Highly Statistically Significant Positive Results from its Global Phase 2b Clinical Trial
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced highly positive top-line efficacy results from a multicenter, randomized, open-label global Phase 2b clinical trial. The trial investigated the efficacy and safety of aldoxorubicin compared with doxorubicin in subjects with first-line metastatic, locally advanced or unresectable soft tissue sarcomas (STS). Aldoxorubicin combines the chemotherapeutic agent doxorubicin with a novel linker-molecule that binds specifically to albumin in the blood to allow for delivery of higher amounts of doxorubicin (3½ to 4 times) without the major dose-limiting toxicities seen with administration of doxorubicin alone.
FDA Grants Fast Track Designation to Navidea Biopharmaceuticals’ Lymphoseek® for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer
– Fast-Track designation may expedite supplemental New Drug Application (sNDA) approval process –
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer.