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Home » Newsletters » BioWorld

BioWorld

July 11, 2017

View Archived Issues

Genentech’s emicizumab hits marks in hemophilia A study while Shire lawyers up on safety claims

DUBLIN – Shire plc is challenging Roche Holding AG’s imminent disruption of the hemophilia A market by slapping a preliminary injunction on the Swiss pharma, alleging that the latter’s description of adverse events that occurred in a phase III trial of emicizumab is “inaccurate and misleading” and could compromise patient safety. Read More

In the clinic

Pluristem Therapeutics Inc., of Haifa, Israel, said Austria’s regulatory agency cleared the firm to begin enrollment for a pivotal phase III trial of PLX-PAD cell therapy in critical limb ischemia (CLI). Read More

News from ISTH

Alnylam Pharmaceuticals Inc., of Cambridge Mass., and Sanofi Genzyme, a unit of Paris-based Sanofi SA, reported data from an ongoing phase II open-label extension study testing fitusiran in 33 patients with hemophilia A and B, with or without inhibitors. Read More

Withdrawn antibody, CAR T and two biosimilars in ODAC lineup

The FDA’s Oncologic Drugs Advisory Committee (ODAC) will have a lot to consider this week in three days of back-to-back meetings in which it will be asked to weigh in on four different biologic candidates. Read More

G20 leaders form global hub in AMR as industry seeks reward mechanisms

LONDON – G20 leaders meeting in Hamburg, Germany, announced the formation of a global body to oversee the discovery and development of new antimicrobial drugs. Read More

Inotek looks past IOP after fixed-dose combo fails to impress in glaucoma

The next chapter in the tale of Inotek Pharmaceuticals Corp. is all about “something strategic,” David Southwell, president and CEO, said after the phase II fixed-dose combination (FDC) trial of lead candidate trabodenoson and standard-of-care therapy latanoprost failed to move the needle in treating glaucoma. Read More

Anaeropharma nets $13.2M for bacteria-based approach in cancer, ischemic disease

HONG KONG – With $13.2 million in new financing, Tokyo-based oncology drug developer Anaeropharma Science Inc. now plans to focus on research and development of drug candidates that target hypoxic microenvironments of tumors by using recombinant Bifidobacterium. Read More

Financings

Kala Pharmaceuticals Inc., of Waltham, Mass., has filed its form S1A to offer to sell 6 million shares of its common stock, priced between $14 and $16 per share, in an IPO. Read More

Other news to note

Inmed Pharmaceuticals Inc., of Vancouver, British Columbia, said it entered a research and development collaboration with Atera SAS, of France, a tissue engineering company specializing in the development of advanced human tissue models. Read More

Appointments and advancements

Flexion Therapeutics Inc., of Burlington, Mass., named Mark Levine senior vice president, general counsel and secretary. Read More

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