CEO Daniel Gold told BioWorld Today that MEI Pharma Inc. will fiddle with dosing and schedules in a new phase II study with pracinostat for myelodysplastic syndromes (MDS) as Helsinn Group starts a phase III trial testing the histone deacetylase (HDAC) inhibitor against acute myeloid leukemia (AML) under the terms of a deal worth up to $464 million. Read More

Thrombogenics NV, of Leuven, Belgium, said results from its two-year OASIS phase IIIb study of Jetrea (ocriplasmin) were published in Ophthalmology and demonstrate the long-term efficacy and safety of the drug, a recombinant protease with activity against fibronectin and laminin, in vitreomacular adhesion (VMA). Read More

Merck & Co. Inc., of Kenilworth, N.J., said the FDA expanded the label for Keytruda (pembrolizumab), in a fixed dose of 200 mg every three weeks, to treat patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Read More

Pixarbio Corp., of Cambridge, Mass., said it is planning a private investment in a public entity (PIPE) financing. In connection with the financing it has secured, and currently merging, with a public entity and they expect to be publicly traded on the OTC-QB by the end of the month and then up-list to the Nasdaq early next year. Read More

Allergan plc, of Dublin, reported total net revenues of $3.7 billion for its second quarter 2016 financial, a 2 percent increase vs. the prior year quarter. The company said its results were impacted by the loss of exclusivity on Namenda IR, offset by strong performance in key brands such as Botox and Restasis and new product launches. GAAP operating loss from continuing operations in the second quarter 2016 was $488 million. Cash flow from operations was $1.4 billion. As of June 30, the company had cash and marketable securities of $507 million and outstanding indebtedness of $39.6 billion. Allergan announced it plans to begin a $5 billion share repurchase program over the remainder of the year. Read More

Pfenex Inc. learned late Friday that it was regaining rights to PF582, its biosimilar candidate to Lucentis (ranibizumab, Genentech Inc./Roche AG), according to Paul Wagner, the company's chief financial officer. The decision resulted from a re-prioritization of biosimilar assets by Pfizer Inc. following its acquisition of Pfenex partner, Hospira Inc. Read More

The big data revolution is all around us, from politics to power plants, manufacturing to multimedia content, Wall street to Main Street. Small wonder that big data also is driving radical change in health care and therapeutic development. Read More

Precision medicine is designed to target diagnostic, treatment and prevention strategies to individuals based on their biological and clinical profile. A number of companies are integrating data from multiple sources such as tissue samples, epidemiological and biochemical data, and genomics sequencing, and then using specific mining tools to analyze trends and patterns in the collective data. Turning those data from big to informative and useful can lead to more effective disease prevention, prognosis, diagnostics and therapeutics. Read More

The NIH has a serious problem, and it's not alone. Even as big datasets driving new threads of biomedical progress proliferate, a critical shortfall is showing up in another realm: "There is a desperate need for individuals who can develop creative approaches to bioinformatics problems." the NIH told members of the National Science and Technology Council last year. Read More

Researchers this week reported both progress in their ability to study long-term mechanical ventilation, and in understanding how its negative consequences might be blunted. Read More

LONDON – The U.K. is expanding the scope of its biosimilars adoption program as experience of using them grows, more products come onto the market and use begins to expand beyond hospital settings and into primary care. Read More

Cleave Biosciences Inc. has completed a $37 million series B financing to support further development of CB-5083, its lead oncology candidate for hematological and solid tumor malignancies and discovery efforts related to its AAA ATPase platform over the next 18 months. Read More

India's Central Drugs Standard Control Organization (CDSCO) is opening its online portal SUGAM to clinical trial applications. To help sponsors prepare for the new application process, CDSCO will hold a stakeholder meeting Wednesday at FDA Bhawan in New Delhi. The first phase of SUGAM launched late last year, providing for the online filing of applications for import and registration of drugs and medical devices. Read More