GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...In other news, closed its initial public offering (IPO) of 3.5 million American depository shares (ADSs) at $8.90 per share...PM01183 is designed to bind covalently to the minor groove of DNA to induce a specific degradation in tumor cells of RNA

Prior to the approval of Nymalize, nimodipine was available only in gel capsule form...The company expects to complete the trial in the first half of 2014. (See BioWorld Today, Dec. 20, 2012...distribution rights to the drug, a next-generation micellar diblock co-polymeric paclitaxel formulation, from Samyang

Even after the news broke Monday – and the Theravance share price (NASDAQ:THRX) gained more than 14 percent to hit $40 – the entire company was still only valued at $3.94 billion...Editor's note: To obtain a CD of the webinar, "Royalty Financing for Biotech and Medical Device Companies: How to Determine Eligibility and Take Advantage of this Unique Financing Opportunity" or for a deeper dive, BioWorld's Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking, call 800-477-6307

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease...Valeant Pharmaceuticals International Inc., of Laval, Quebec, has provided additional information related to the proposal to continue

Even after the news broke Monday – and the Theravance share price (NASDAQ:THRX) gained more than 14 percent to hit $40 – the entire company was still only valued at $3.94 billion...Editor's note: To obtain a CD of the webinar, "Royalty Financing for Biotech and Medical Device Companies: How to Determine Eligibility and Take Advantage of this Unique Financing Opportunity" or for a deeper dive, BioWorld's Biopharmaceutical Royalty Rates Analysis: Essential Benchmarks for Dealmaking, call 800-477-6307

We note that an acquisition of Warner could potentially offer a tax strategy as Warner has a lower tax rate...Regeneron waived its right to opt in on canakinumab and, instead, is entitled to sales royalties

rights to market Pertzye (pancrelipase) for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis...The board is recommending that shareholders approve the arrangement resolution, which is intended, among other goals, to improve Mirati's ability to attract funding in the larger U.S

Under the terms, Adaptive will use its immune profiling assay, immunoSEQ, to identify potential biomarkers that may inform about drug response

Merck expects the review for this BLA, as well as a BLA for its Timothy grass pollen (Phleum pretense) sublingual allergy immunotherapy tablet, to be completed in the first half of 2014

To date, 130 laboratory-confirmed cases of human infection with the H7N9 virus, resulting in 31 deaths, have been reported to the World Health Organization...To date the company is known for its biodegradable and low toxicity DNA and RNA delivery reagents for cell-based research and therapeutics

In other news, Addex said dipraglurant demonstrated dose-dependent mGlu5 receptor occupancy in a nonhuman primate positron emission tomography study, showing the correlation between the plasma concentration of dipraglurant and occupancy of dipraglurant on mGlu5 receptors in the brain...The goal is to validate emerging epigenetic targets for oncology indications and to demonstrate the eligibility of selected target families for drug formalations

GW Pharmaceuticals plc, of Porton Down, UK, received commercial approval for lead cannabinoid product Sativex in Italy for moderate to severe spasticity in multiple sclerosis patients who have not responded adequately to other anti-spasticity medications...The technology is being developed to aid in understanding the biology critical to cardiac tissue engineering, for applications in regenerative cell therapy for heart disease and for predictive use in vitro assays for drug rescue and development

Eisai Inc., of Woodcliff Lake, N.J., said the European Commission granted orphan drug designation to multityrosine kinase inhibitor lenvatinib for the treatment of follicular and papillary thyroid cancer...In separate news, Eisai said it filed a Type II variation application with the European Medicines Agency for Halaven (eribuln), requesting an indication extension to include treatment of earlier-line metastatic breast cancer patients

Sagent expects to close the transaction over the next several months...Addition of Vaxfectin to the influenza vaccines substantially increased both antibody and T-cell responses compared with nonadjuvanted vaccines in mice and guinea pigs, according to Vical

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

Bristol-Myers Squibb Co., of New York, said the FDA approved a supplemental new drug application for the HIV-1 therapy Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5 kg...Inc., of Whitehouse Station, N.J., said the FDA has approved Liptruzet (ezetimibe and atorvastatin) tablets to treat elevated low-density lipoprotein cholesterol in patients with primary or mixed hyperlipidemia as adjunctive

Allergan licensed rights to the Darpin technology from Molecular Partners AG for development in AMD and other eye diseases. (See BioWorld Today, Aug. 22, 2012.) And Eylea has fared well so far against Roche AG's Lucentis (ranibizumab), due to its lower cost and a label that calls for less frequent dosing, and even to cancer drug Avastin (bevacizumab), a cheaper, off-label alternative

In separate news, Hyperion said it exercised its option to acquire Buphenyl (sodium phenylbutyrate) tablets and powder, an FDA-approved therapy for the chronic management of the most prevalent UCDs, and Ammonul (sodium phenylacetate and sodium benzoate) injection, a hospital-based product used to treat UCD patients in hyperammonemic crisis, from Valeant Pharmaceuticals International Inc., of Montreal...According to a March 2012 agreement between Hyperion and Medicis Pharmaceutical Corp. (later

ChemRar Ventures, of Moscow, said it signed a scouting agreement, for a period of 18 months, with Sanofi SA to source a venture investment in Russia...In granting the motion, the judge ruled that the plaintiffs failed to offer any reliable evidence that Mr. Cooper's disease was caused by Actos (pioglitazone HC1)," said Kenneth D. Greisman, senior vice president, general counsel, Takeda Pharmaceuticals U.S.A. Inc...Actos is prescribed for use with diet and exercise to improve blood sugar control in