BIO's Special 301 Submission encouraged the USTR to perform out-of-cycle reviews of patent systems in these countries. (See BioWorld Today, April 2, 2013...The company said it plans to file an investigational new drug application for ES414 next year...The team designed the vaccine to elicit antibodies against not only heroin, but also 6-acetylmorphine and morphine

The product, a small molecule that binds to S100A9, is the subject of a study across 37 countries in 1,245 metastatic castrate-resistant prostate cancer patients who have not yet received chemotherapy...Addex Therapeutics SA, of Geneva, said regulatory authorities in the Netherlands gave approval to start in the first half of this year a Phase I study of ADX71441, a GABA-B receptor positive allosteric modulator, for Charcot-Marie-Tooth1A (CMT1A) neuropathy and other disease indications

Celgene Corp., of Summit, N.J., said the European Committee for Medicinal Products for Human Use adopted a positive opinion for Revlimid (lenalidomide) for the treatment of patients with transfusion-dependent anemia due to low or intermediate-1 risk myelodsyplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate...One company, referred to as Royalty Management Co., will focus on managing all development and

However, there was some promising news to help give the sector a lift going into that meeting...According to Credit Suisse analyst Ravi Mehrotra writing in a research note, "We do not think that we are in a 'biotech bubble,' given that the drivers of the biotech sector's YTD performance are very different from those in '99/'00...Editor's Note: The BioWorld editorial team will be providing comprehensive coverage of BIO 2013 in the daily issues of BioWorld Today.

The products cover a broad array of treatments and disease states: Nilandron is used to treat prostate cancer...and, Kayexalate is prescribed to remove dangerously high levels of potassium in the blood

The trial will enroll up to 200 chemotherapy-naïve patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer...In other news, GSK recently agreed to a nonexclusive material transfer, patent and know-how license deal with the Health Protection Agency (HPA) for the development and manufacture of a next-generation polio vaccine

Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, presented data at the European Association of Urology 2013 annual meeting in Milan, Italy, showing that degarelix (Firmagon), a gonatropin-releasing hormone antagonist for prostate cancer, may be associated with a lower risk of a cardiovascular event or death compared to luteinizing hormone-releasing agonists...Oxford Gene Technology, of Oxford, UK, was granted a license by the Institute of Cancer Research, London, to further develop and

Oxford Gene Technology, of Oxford, UK, was granted a license by the Institute of Cancer Research, London, to further develop and commercialize a new panel of diagnostic and prognostic microRNA biomarkers for prostate cancer...That news "shocked the Street," according to Roth Capital Partners analyst Joseph Pantginis...Investors took the news hard, sending shares of Spectrum (NASDAQ:SPPI) falling $4.64, or 37.3 percent, to close Wednesday at $7.79

At all doses tested, ALX-0061 was well tolerated and the safety profile compared favorably to data reported for other biological DMARDs...To date, almost 50 percent of planned patients have been enrolled in about 30 European centers...In both studies the JE vaccine was shown to be highly immunogenic in children/adolescents age 2 months to younger than 18 years with a safety profile comparable to pediatric vaccines licensed for other diseases

Oramed Pharmaceuticals Inc., of Jerusalem, said the FDA responded to its investigational new drug (IND) application for oral insulin, requesting a sub study in a controlled inpatient setting...for the treatment of active, mild-to-moderate ulcerative colitis...On Thursday, United's shares (NASDAQ:UTHR) gained $2.29, to close at $56.10

The FDA advised the firm to apply for fast-track designation when it submits its IND, which is expected to come in the fourth quarter of 2013...MorphoSys may sublicense the targets to third parties, and is eligible to receive license fees, milestones and royalties on any Ylanthia antibody developed by Heptares

Breckenridge launched its abbreviated new drug application (ANDA) prior to patent expiration pursuant to a settlement of patent litigation with Osaka, Japan-based Takeda Pharmaceutical Co...and Takeda Pharmaceuticals North America Inc., which granted Breckenridge and Synthon a license to applicable patents to sell and distribute its ANDA

Diamyd Medical AB, of Stockholm, Sweden, said it's planning to start a new 60-patient study in February with diabetes vaccine Diamyd, testing it in combination with other drugs – relatively high doses of vitamin D and anti-inflammatory drug ibuprofen – to potentiate the effect of the vaccine's ability to help the body control blood sugar levels in newly diagnosed Type I diabetics

Endocyte expects to file an investigational new drug application by the end of 2013...A pivotal trial in prostate cancer is slated to start late this year, and the companies hope to file for approval under the 505(b)(2) pathway

In other news, Evotec said a compound identified and optimized in a research collaboration with Osaka, Japan-based Ono Pharmaceutical Co...In separate news, Janssen reported that the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 10-5 late Thursday to recommend approval of canaglifozin, a selective sodium glucose co-transporter 2 inhibitor, to treat Type II diabetes in adults

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved an extension for once-daily Zytiga (abiraterone acetate), expanding the indication to include its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated...In

The change is expected to allow the firm to explore various strategic options as it moves forward with its programs in oncology and immune-modulatory diseases...Terlipressin is designed to reduce portal vein pressure and increase mean arterial pressure in cirrhotic patients with splanchnic vasodilation

Public biopharmaceutical companies, which had a great year, by and large were not able to fully leverage their increased stock valuations, successful clinical results and product approvals into follow-on and other financings...The company paid $350 million in cash, with the remainder made up of milestones: $195 million related to the development and regulatory approval of Bruton's tyrosine kinase (Btk) inhibitor AVL-292, and up to $380 million in potential payments contingent upon the development

Public biopharmaceutical companies, which had a great year, by and large were not able to fully leverage their increased stock valuations, successful clinical results and product approvals into follow-on and other financings...Signs are pointing to plenty of room in the market for the "big three," as well as many other obesity candidates making progress through pipelines...Editor's note: This article is from BioWorld Insight, the in-depth analytical companion to BioWorld Today.