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Home » Newsletters » BioWorld

BioWorld

Dec. 7, 2016

View Archived Issues

More than a B-cell story: Imbruvica shows benefit in chronic graft-vs.-host disease study

SAN DIEGO – Imbruvica (ibrutinib), the Bruton's tyrosine kinase (BTK) inhibitor that has racked up FDA approvals in B-cell cancers such as mantle cell lymphoma, chronic lymphocytic leukemia and Waldenström's macroglobulinemia has impressed in a non-oncology indication, chronic graft-vs.-host disease (cGVHD), with phase II data showing an overall response rate (ORR) of 67 percent. Read More

Getting out of the balkanized biomarker bargain basement

Precision medicine is one of those concepts that took 20 years to become an overnight sensation. Read More

PDCline Pharma raises cash for dendritic cell therapy with a twist

DUBLIN – Less than a week after Dendreon Corp. gained historic FDA approval, on April 29, 2010, for Provenge (sipuleucel-T) to treat prostate cancer, a group of scientists attached to Etablissement Français du Sang (EFS), the French blood transfusion service, and their collaborators published details of a cancer vaccine strategy based on a novel dendritic cell line derived from patients with a rare form of leukemia. Read More

Avid for post-gravid blues: FDA OKs Sage bid in PPD, may speed time to market

CEO Jeff Jonas told BioWorld Today the regulatory path OK'd by the FDA for Sage Therapeutics Inc.'s postpartum depression (PPD) drug SAGE-547 hurries the potential availability in a severe unmet need by at least a year, and "shows the strength of the data package" brought to gatekeepers who said yes to a plan that the company had in mind all along. Read More

Blood substitute passes its first acid test

SAN DIEGO – With much of the focus at the Annual Meeting of the American Society of Hematology (ASH) on blood disorders, it can be easy to forget that a large ongoing need is for something that can substitute for blood for short periods of time. Read More

Aussie firms could see faster approvals under proposed legislation

PERTH, Australia – Drug and device companies in Australia may soon be able to bring their products to market more quickly via a new priority review designation. Read More

Regulatory front

Interquim S.A., an API manufacturer based in Barcelona, Spain, received an FDA warning letter citing the potential for cross-contamination due to inadequate cleaning procedures and equipment issues. During a May inspection, an FDA investigator discovered drug residue on cleaned equipment. Read More

Financings

Tetra Bio-Pharma Inc., of Ottawa, Ontario, said it is conducting a non-brokered private placement with Aphria Inc. of 5 million units at $0.20 each for aggregate gross proceeds of $1 million. Read More

Appointments and advancements

Oncoceutics Pharmaceuticals Inc., of Philadelphia, named Lee Schalop chief operating officer. Read More

Other news to note

Azurrx Biopharma Inc., of Brooklyn, N.Y., said it reached an agreement in principle with Transchem Inc. to license its transition state chemistry technology for MTAN (methylthioadenosine/S-adenosylhomocysteine nucleosidase) inhibition, which plays a key role in bacterial quorum sensing. Read More

ASH 2016

Actinium Pharmaceuticals Inc., of New York, said an analysis of two trials with Actimab-A that enrolled 38 patients, 36 of whom were evaluable, validated its peripheral blast (PB) burden hypothesis, which suggests that patients below 200 blasts/µL have an increased response rate to Actimab-A while those above the threshold are unlikely to respond. Read More

In the clinic

Mast Therapeutics Inc., of San Diego, reported that the first patient has been enrolled in an investigator-sponsored phase II study of the company's lead product candidate, AIR001, for the treatment of heart failure with preserved ejection fraction (HFpEF). Read More

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