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Home » Newsletters » BioWorld

BioWorld

June 2, 2015

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Immunogen soars on early ovarian cancer data, big phase II plans

CHICAGO – Immunogen Inc. shares (NASDAQ:IMGN) shot up 72 percent to close at $15.44 Monday on news that about half of the heavily pre-treated patients in a phase I study of the company's single agent ovarian cancer therapy candidate demonstrated overall response (ORR), besting the 15 percent to 20 percent response rate typically seen in platinum-resistant ovarian cancer patients and giving the company confidence to plan a possible pivotal phase II trial for late 2015. Read More

MATCHing, 'linquing' just-right drugs to patients as research TAPURs to precision

CHICAGO – Vowing to make precision medicine more than a hackneyed phrase, researchers at the ASCO annual meeting disclosed the launch of three separate but complementary efforts in what amounts to the "expansion of an ongoing dream," said past ASCO president Clifford Hudis. Read More

Merck inks immunotherapy links with Dynavax, Tesaro during ASCO

CHICAGO – Merck & Co. Inc. and Dynavax Technologies Corp. have agreed to pursue dual trials investigating the potential for combining immunotherapies from both companies' pipelines to help patients with multiple cancers, an arrangement that could raise visibility for Dynavax at a time when it's also advancing SD-101 on its own. Read More

Neurovive walks the tightrope after its Ciclomulsion CIRCUS miss

Neurovive Pharmaceutical AB was dangling from the high wire after reporting a top-line analysis of the phase III CIRCUS study of Ciclomulsion, which indicated the study missed the primary clinical endpoint in patients with ST-segment elevation acute myocardial infarction (STEMI). Read More

Research is still stocking shelves at Target(ed) store

CHICAGO – Following up last March's investor-pleasing top-line phase III data from PERSIST-1, which tested the next-generation JAK2/FLT3 multikinase inhibitor pacritinib in myelofibrosis (MF), CTI Biopharma Corp. and partner Baxter International Inc. offered more results that better characterize the drug's position with regard to the marketed JAK2 inhibitor Jakafi (ruxolitinib), developed by Incyte Corp. and partner Novartis AG. Read More

Opdivo melanoma phase III beats Yervoy in combo and alone

CHICAGO – Bristol-Myers Squibb Co.'s programmed cell death-1 inhibitor Opdivo (nivolumab), cleared by the FDA late last year for melanoma and in March for squamous non-small-cell lung cancer (NSCLC), worked better than the firm's other approved melanoma drug Yervoy (ipilimumab) in patients with previously untreated cases of the deadly skin cancer not only when the two drugs were given together but also when Opdivo was administered by itself. Read More

Brain gains reign as Celldex reports data, WBRT risks made plain

CHICAGO – Brain cancer got plenty of buzz at the ASCO annual meeting, with a plenary talk about the risk/benefit tradeoff in whole-brain radiation therapy (WBRT) and the unveiling of detailed positive results from a 73-patient phase II trial by Celldex Therapeutics Inc. with Rintega (rindopepimut), an immunotherapy vaccine targeting epidermal growth factor variant III (EGFRvIII) in recurrent glioblastoma multiforme (GBM). Read More

Halozyme's combo drug to get last laugh in pancreatic cancer fight?

CHICAGO – Fresh off the FDA's April blessing of its plans to move the experimental metastatic pancreatic cancer therapy PEGPH20 into phase III early next year, Halozyme Therapeutics Inc. shared interim data from the ongoing second stage of its randomized phase II study of the drug at the ASCO meeting. Read More

NDA coming soon as Clovis unveils data in ovarian, NSCLC

CHICAGO – Clovis Oncology Inc. took a big step ahead in preparations for filing its new drug application (NDA) for the experimental non-small-cell lung cancer (NSCLC) therapy, rociletinib, showcasing data from an ongoing phase II study testing the drug in a group of heavily pre-treated patients, most of whom had developed resistance to current treatments. Read More

Stock movers

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Affibody imaging agent may supplant biopsy for some breast cancer patients

LONDON – A new non-invasive imaging agent has shown there can be unexpected changes in human epidermal growth factor receptor type 2 (HER2) status from primary breast cancer to metastatic disease, and that as a result some women are inappropriately being treated with HER2 positive-targeted drugs. Read More

Battling cancer drug access gaps, one policy change at a time

CHICAGO – Despite growing access to ever-better cancer therapies in major markets, underpinned by the many scientific advances presented at this year's ASCO annual meeting, low and middle-income countries are struggling to keep pace. Read More

Eisai's Halaven delivers precious months for sarcoma patients

CHICAGO – The first randomized phase III study to show an overall survival benefit in patients with the aggressive soft-tissue sarcomas was unveiled Saturday at the ASCO annual meeting. Read More

Regulatory front

The FTC has updated its endorsement guides, reflecting the growing influence of social media. The question-and-answer guides, which were last updated in 2009 when social media was still being called "new media," are filled with examples of how endorsements should be disclosed on blogs, chat rooms, Facebook, Pinterest, Twitter, YouTube and other social networks. The guides also reveal some gray areas, such as paid "likes" on Facebook. Read More

Financings

Biodelivery Sciences International Inc. (BDSI), of Raleigh, N.C., said it secured an additional $20.7 million in gross debt funding from Midcap Financial to bring their total outstanding debt with Midcap to $30 million in a single senior secured loan. Read More

Other news to note

Actavis plc, of Dublin, said it completed its acquisition of Auden Mckenzie Holdings Ltd., a fast growing company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the UK. Read More

In the clinic

Resverlogix Corp., of Calgary, Alberta, reported that new data on RVX-208 were presented at the ERA-EDTA Congress in London in a poster. Read More

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