OPKO Health Inc. (OPK) on Tuesday agreed to acquire Canada-based Cytochroma Inc. whose two lead products - Replidea and Alpharen are in phase III trials.
Replidea is a vitamin D prohormone to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency, and Alpharen is a non-absorbed phosphate binder to treat hyperphosphatemia in dialysis patients.
The Medicines Co. (MDCO: Quote) announced positive results from a phase III trial of its investigational drug - Cangrelor, in the treatment of patients undergoing percutaneous coronary intervention, or PCI. The stock touched a new 52-week high of $29.45 on Tuesday before closing at $28.83.
Cangene Corp. (CNJ.TO: Quote) reached an important milestone in its history on Tuesday with the FDA approving VARIZIG to reduce the severity of chickenpox infections in high risk patient groups including immunocompromised children, newborns and pregnant women.
VARIZIG is approved in Canada and was previously made available in the United States under an investigational new drug Expanded Access Protocol.
NEXGENRX INC. (NXG.V: Quote) has appointed Barry Reiter to its board of directors. Barry Reiter is a partner with the law firm Bennett Jones LLP. Reiter is Chair of the Technology, Media and Entertainment Group for his firm. He is also the Bennett Jones leader of the Director Protection and Corporate Governance practice.
Paladin Labs Inc. (PLB.TO: Quote) on Tuesday acquired the distribution rights to Pollinex-R (modified ragweed tyrosine adsorbate), an allergy vaccine for the treatment of allergic rhinitis due to ragweed pollen in Canada, from Allergy Therapeutics plc (AGY.L). Paladin also received an option to acquire distribution rights to Pollinex-R in Sub-Saharan Africa. Financial terms of the agreement were not disclosed.
Theravance Inc.'s (THRX: Quote) investigational drug Velusetrag has advanced into a phase 2 proof-of-concept study for the treatment of patients with diabetic or idiopathic gastroparesis. The company has an agreement in place with Alfa Wassermann for the development and commercialization of Velusetrag for gastrointestinal motility disorders.
The stock has traded in a 52-week range of $15.69 to $31.87.
Titan Medical Inc. (TMD.V: Quote) secured one more patent from the United States Patent and Trademark Office on Tuesday covering aspects of its development of multi-articulating robotic instruments.
The company now has seven granted patents and ten patent applications filed in the U.S. or under the Patent Cooperation Treaty.
Savient Pharmaceuticals Inc.'s (SVNT: Quote) KRYSTEXXA on Tuesday received European Commission marketing authorization for the treatment of certain patients with chronic tophaceous gout. The product is expected to be launched in the European Union by mid-2013. KRYSTEXXA was launched in the U.S. in 2010.
With a phase II study in South Korea, which used umbilical cord blood as therapy for cerebral palsy demonstrating efficacy, Cryo-Cell International Inc. (CCEL.OB) said it is optimistic that an effective treatment may be on the horizon for this disability. The stock closed Tuesday's trading 0.49% higher at $2.05.
Baxter International Inc. (BAX: Quote) announced that in a pivotal phase III study evaluating prophylaxis treatment of FEIBA NF for hemophilia patients, the median annual bleed rate reduced from 28.7 during FEIBA NF on-demand treatment to 7.9 during FEIBA NF prophylactic treatment. The phase III study will form the basis of a biologics license application to be filed with the FDA in the first quarter of 2013.
Abbott Labs (ABT: Quote) has initiated a trial with the first-of-its-kind drug eluting bioresorbable vascular scaffold device namely Absorb in patients with coronary artery disease in the U.S. The study will compare the performance of Absorb to the company's XIENCE family of drug eluting stents. Data from this trial will support U.S. regulatory filings for Absorb.
Advanced Cell Technology Inc. (ACTC: Quote) said it has achieved a clinical milestone following evidence of engraftment of the transplanted human embryonic stem cell-derived retinal pigment epithelial cells and visual acuity gain in patients in its phase I/II clinical trials for Stargardt's macular dystrophy and dry age-related macular degeneration.
According to the company, engraftment of cells in the proper area, and recapitulation of normal retinal pigment epithelial, or RPE, cell layer structure is important to the ultimate efficacy of the RPE cells in the treatments. No safety issues were observed in the patients.
Medicure Inc. (MPH.V) has submitted a supplemental new drug application for high dose bolus dosing regimen of AGGRASTAT - an initial bolus of 25 mcg/kg and then continued at 0.15 mcg/kg/min. The current approved dosing regimen of AGGRASTAT is an initial rate of 0.4 mcg/kg/min for 30 minutes and then continued at 0.1 mcg/kg/min.
The company will receive up to $200,000 in grant funding from the Province of Manitoba Commercialization Support for Business Program to complete a renal study evaluating the AGGRASTAT high dose bolus regimen in patients with impaired kidney function.
Pfizer Inc. (PFE: Quote) has received European approval to expand the use of its pneumococcal conjugate vaccine, Prevenar 13, to older children and adolescents aged 6 To 17 years for the prevention of invasive disease, pneumonia and acute otitis media caused by vaccine-type Streptococcus pneumoniae.
Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide.
Acadia Healthcare Co. Inc. (ACHC: Quote) has acquired Greenleaf Center, a 50-bed acute inpatient psychiatric facility in Valdosta, Georgia from a Non-Profit Health System. Given the fact that the psychiatric facility has annual revenues of approximately $7 million, the acquisition is expected to have an accretive impact on Acadia Healthcare's 2013 earnings per share.
ACHC touched a new 52-week high of $ 25.76 on Tuesday before closing the day's trading at $24.94.
The FDA has granted fast track designation to GTx Inc.'s (GTXI: Quote) Enobosarm for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. The company's two definitive phase III clinical studies of Enobosarm are fully enrolled and top line data from these studies are expected this summer. In afterhours trading on Tuesday, the stock was up 4.64% to $4.74.
Sorrento Therapeutics (SRNE.OB) rose more than 37% to $0.22 on Tuesday after the company announced it has acquired rights to produce recombinant intravenous immunoglobulins. The company noted that with the acquisition of the proprietary rights to the rIVIG technology, it now has access to a multi-billion dollar market opportunity applying its G-MAB antibody libraries to address unmet medical needs.
Medistem Inc. (MEDS.PK) has elected John Chiplin to its Board of Directors, expanding the number of board members to six. Chiplin is currently CEO of Polynoma, a phase III cancer vaccine company.
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by RTT Staff Writer
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