Consumers are frustrated with the pace of drug and medical device development, and they want more engagement with industry and regulators at every step of the process, from trial design to FDA review. Savvy biopharmas and medical device manufacturers would be wise to heed that call by incorporating input from patients at every stage of development and sharing that feedback with the FDA as part of regulatory filings. Read More
Xenoport Inc.'s guidance for even-higher sales of Horizant (gabapentin enacarbil) in postherpetic neuralgia and restless legs syndrome (RLS) sparked analyst speculation about potential specialty pharma interest in the compound and about the odds of phase II success for XP23829, due to report psoriasis data in the third quarter of this year. Read More
Early positive data supporting Celsion Corp.'s plans to further develop its interleukin-12 (IL-12)-producing immunotherapy, GEN-1, for the treatment of advanced platinum-resistant and recurrent ovarian cancer boosted shares (NASDAQ:CLSN) by 12.9 percent to $3.15 at Friday's close, providing early validation for its $14 million cash- and share-based acquisition of Huntsville, Ala.-based Egen Inc.'s nucleic acid-based therapeutic assets. Read More
DUBLIN – Pharmaceutical firms operating in Europe are breaching on a weekly basis their own voluntary code for regulating drug promotion, according to a recently published analysis, which calls for tougher financial penalties, stricter monitoring of drug companies' behavior and public naming and shaming of offenders. Read More
In a case that could limit the Federal Trade Commission's (FTC) reach in challenging pay-for-delay settlements, a federal appeals court Friday ruled that a lower court was correct in denying the commission access to documents about a co-promotion deal Boehringer Ingelheim Pharmaceuticals Inc. reached with Barr Laboratories Inc. as part of a patent settlement. Read More
HONG KONG — The results of a study by Japanese researchers from the University of Tokyo have helped to elucidate the previously unknown underlying mechanism whereby two commonly prescribed drugs in patients at risk for heart disease can adversely interact, a finding that could lead to improved clinical care of patients taking those medications. Read More
Massively parallel genetic sequencing systems offer much, but among the things they offer is large list of difficult questions, some of which were tackled in a Friday meeting on next-generation sequencing (NGS) systems. David Litwack, of the FDA's personalized medicine staff, ticked off a few concerns at the agency, including the fact that "we can't predefine what a test will find analytically." He said the biggest issue, in his view, is "the lack of a specific intended use" for such systems. Read More
Neurobiopharm Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., said it has completed a previously announced plan of arrangement providing for, among other things, the indirect acquisition by Neptune of all of its issued and outstanding shares and the issuance by Neptune of 116,714 class A shares to Neurobio shareholders. Read More
Bellerophon Therapeutics Inc., of Hampton, N.J., closed its IPO Feb. 19 after raising $60 million through the sale of 5 million shares priced at $12 each. Company shares, which began trading on Nasdaq under the ticker BLPH, closed at $9.42 on Friday. Read More
Chiesi Famaceutici SpA, of Parma, Italy, said the European Commission approved Holoclar, a medicine containing stem cells to treat a rare condition caused by burns to the eye, specifically limbal stem cell deficiency due to physical or chemical burns, which can cause blindness if untreated. The EMA issued a positive recommendation on the therapy in December. Read More
The National Institute of Allergy and Infectious Diseases (NIAID) is funding two new phase II trials to examine the safety and acceptability of long-acting, injectable antiretroviral drugs to protect against HIV infection. The HPTN 076 trial will evaluate the safety and acceptability of rilpivirine LA, a long-acting injectable form of the FDA-approved rilpivirine (Janssen Sciences Ireland UC), in 132 women, ages 18 to 45, who are not infected with HIV and who are considered at low-risk for HIV infection. Read More
Xenon Pharmaceuticals Inc., of Burnaby, British Columbia, said development and commercialization partner Teva Pharmaceutical Industries Ltd., of Jerusalem, plans to initiate a phase IIb trial of TV-45070 in patients with postherpetic neuralgia. The double-blind, placebo-controlled study will enroll approximately 330 patients to evaluate the efficacy and safety of TV-45070, with three treatment groups randomized to doses of 4 percent or 8 percent of TV-45070 or placebo, dosed twice daily. Read More
Novo Nordisk A/S, of Bagsvaerd, Denmark, said it completed the phase II trial for OG217SC, its oral formulation of long-acting GLP-1 analogue semaglutide. The study investigated dose range, escalation, efficacy and safety of once-daily oral semaglutide compared with oral placebo or once-weekly subcutaneously administered semaglutide in approximately 600 people with type 2 diabetes. Read More
Scientists from Stanford University and Pharmacyclics Inc. have found that in animal studies, Imbruvica (ibrutinib) synergized with cancer immunotherapies aimed at the interaction between PD-1 and its ligand, PD-L1. Approved drugs Keytruda (pembrolizumab, Merck & Co Inc.) and Opdivo (nivolumab, Bristol-Myers Squibb Co.) target the PD-1/PD-L1 interaction, allowing T cells to react to tumor cells. Imbruvica is a kinase inhibitor that targets, in addition to its main target BTK, the kinase ITK. Read More
