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...Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said the European Committee

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

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...The agreement allows the HPA to contribute to global polio eradication, while securing a commitment from a major pharma firm to develop use of its technology

Astellas Pharma Inc., of Tokyo, said the European Commission approved expanded options for pre-treatment prior to use of Qutenza (8 percent capsaicin patch...Medigene's partner, Nordic Pharma Group, of Paris, is planning to launch Veregen in the Czech Republic, Poland, Hungary and Slovakia this year, upon conclusion of the reimbursable price-fixing procedure by the responsible authority...The IMODI project, which brings together big pharma firms including Paris-based Sanofi SA and Ipsen SA, along with

The IMODI project, which brings together big pharma firms including Paris-based Sanofi SA and Ipsen SA, along with biotechs such as Transgene SA, of Illkirch, France, is designed to make the selection of new effective treatments to combat eight cancer pathologies easier...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

OSE Pharma SA, of Paris, said the FDA granted orphan drug status to its lead candidate, OSE 2101, to treat non-small-cell lung cancer (NSCLC) in patients expressing HLA-A2

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

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

PharmaIN Corp., of Bothell, Wash., and LAT Pharma LLC, of Chicago, said the FDA granted orphan designation for terlipressin for the treatment of ascites due to all etiologies except for cancer...Terlipressin is designed to reduce portal vein pressure and increase mean arterial pressure in cirrhotic patients with splanchnic vasodilation...Tranzyme Pharma Inc., of Research Triangle Park, N.C., reported the successful completion of its chemistry-based drug discovery collaboration with New York-based

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

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 and approval of candidates generated from Avila's Avilomics platform. (See BioWorld Today, Jan. 27, 2012.) On the other side of the coin, Medicis was acquired by Canada's largest specialty pharma Valeant Pharmaceuticals

Algeta ASA, of Oslo, Norway, said partner Bayer AG, of Leverkusen, Germany, submitted a marketing authorization application to the European Medicines Agency for Alpharadin (radium-223 dichloride) for the treatment of castration-resistant prostate cancer patients with bone metastases...Galderma Pharma SA, of Lausanne, Switzerland, agreed to acquire Spirig Pharma AG, of Egerkingen, Switzerland

Distribution of Prothena ordinary shares in the demerger is conditioned upon, among other conditions to the demerger, a registration statement filed with the SEC, having been declared effective by the SEC and the affirmative vote of the Elan shareholders...Galderma Pharma SA, of Lausanne, Switzerland, and Valeant Pharmaceuticals International Inc., of Montreal, reached agreement on terms of a revised North American aesthetics arrangement, resolving Galderma's pending litigation related to Valeant's

GlaxoSmithKline plc, of London, and the Fred Hutchinson Cancer Research Center entered a partnership to develop therapeutics to treat an inherited form of muscular dystrophy...The goal of the agreement is to develop a small-molecule-based medicine to potentially reverse facioscapulohumeral muscular dystrophy by inhibiting the activity of a protein that is incorrectly expressed by the DUX4 gene in people with the disease

Reddy's Laboratories Ltd., of Hyderabad, India, acquired exclusive marketing and sales rights to Pamorelin LA (triptorelin) Depot, by Debiopharm Group, of Lausanne, Switzerland, in India for locally advanced or metastatic, hormone-dependent prostate cancer