Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by methicillin-resistant Staphylococcus aureus, when other alternatives are not suitable...In other news, Elan said its Tysabri (natalizumab) restructuring transaction is

CMX001 is a broad-spectrum, oral nucleotide analogue lipid-conjugate designed to block the replication of double-stranded DNA viruses...Leica Biosystems, of Newcastle-upon-Tyne, UK, and Synthon Biopharmaceuticals, a subsidiary of specialty pharma firm Synthon BV, of Nijmegen, the Netherlands, inked a deal to develop and commercialize a companion diagnostic test using Leica's BOND system paired with one of Synthon's antibody-drug conjugates, with the aim of enhancing the treatment of solid tumors

and other affiliates he controls, proposing to acquire outstanding shares not currently owned by the group for $9.56 per American Depositary Share (ADS) or $4.78 per ordinary shares in cash...Simcere's board formed a special committee of independent directors to evaluate the offer

Toxicity experiments conducted to date revealed best-in-class potential with a greatly improved therapeutic index compared to other armed antibodies, due to an impressive safety profile, according to the company, which has opened a manufacturing facility in Nijmegen for the production of ADCs up to Phase III trials and early launches

Celtic Therapeutics Management LLLP, of New York, changed its name to Auven Therapeutics Management LLLP to overcome confusion related to other Celtic entities...Clinigen Group plc, of Burton-on-Trent, UK, and Theravance Inc., of South San Francisco, entered an exclusive commercialization agreement in the European Union and certain other countries located in Europe for Vibativ (telavancin) in nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by

Astellas Pharma Inc., of Tokyo, said its Canadian subsidiary won Health Canada approval of Myrbetriq (mirabegron, extended-release tablets) for overactive bladder with symptoms of urgency, urgency incontinence and urinary frequency...Eisai Inc., of Woodcliff Lake, N.J., reported that the German Federal Joint Committee said it considers the additional benefit of Fycompa (perampanel) unproven when compared to two other treatments...Eisai said it believes the committee "failed to adequately interpret

The company has also submitted new drug applications to the FDA for canagliflozin and for the fixed-dose combination therapy...The companies will expand their existing collaboration to include joint promotion of Abilify in Denmark, Finland, Germany, Italy, Spain, Sweden and the U.K. Lundbeck will promote Abilify in Austria, Belgium, Ireland, Netherlands, Poland, Portugal and Romania...Under the agreement, Lundbeck will have the right to promote all formulations of Abilify currently marketed, sold or

to develop, manufacture and supply commercial quantities of Ofirmev (acetaminophen) injection in flexible plastic bags...PolyTherics Ltd., of London, received an undisclosed milestone payment from Celtic Pharma Holdings LP, also of London, triggered by further progress on their hematology alliance to produce longer-acting versions of blood factor proteins...Sorrento Therapeutics Inc., of San Diego, signed an exclusive option to acquire Igdrasol Inc., of Fountain Valley, Calif., a private company

As part of the agreement, the company pleaded guilty to a misdemeanor, entered a five-year corporate integrity agreement and agreed to dismiss its lawsuit challenging FDA regulations that criminalize truthful speech about approved drug uses. (See BioWorld Today, Oct. 24, 2011...Roche will provide R&D funding and scientific expertise to BioLamina

The application requests approval to expand the indication beyond the treatment of iron deficiency anemia in adults with chronic kidney disease to also include adults with iron deficiency anemia who have failed or could not take oral iron treatment...Last month, Royalty Pharma made an $11-per-share takeover bid for Elan, an offer that values the firm at about $6.6 billion. (See BioWorld Today, Feb. 26, 2013

Janssen said it is evaluating the letter and will respond to the agency's questions

Iroko Pharmaceuticals LLC, of Philadelphia, said the FDA accepted for review the new drug application (NDA) for lower-dose submicron diclofenac, a nonsteroidal anti-inflammatory drug, with a proposed indication of treatment of mild to moderate acute pain in adults...Relmada Therapeutics Inc., of Blue Bell, Pa., said an application for a clinical trial authorization (CTA) that was submitted with the UK's Medicine and Health Regulatory Agency (MHRA) to conduct a Phase I pharmacokinetic study with the

Cardiome Pharma Corp., of Vancouver, British Columbia, made its final payment of $13 million to Whitehouse Station, N.J.-based Merck & Co...materials to support ongoing commercialization of Brinavess, and oral API is expected to be sufficient for clinical trials

The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities...Actavis said it may be a first applicant to file an ANDA for the generic version of Fortesta and, should its ANDA be approved, may be entitled to 180 days of generic

CSL Behring, of King of Prussia, Pa., said the FDA approved an expansion of the indication for Corifact (Factor XIII concentrate [human]) to include the perioperative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency...Reddy's and OctoPlus will jointly request NYSE Euronext Amsterdam to terminate the listing and trading of OctoPlus shares as soon as possible...Meda AB, of Goteborg, Sweden, said Acnex (clindamycin/tretinoin) received registration

BioAlliance Pharma SA, of Paris, said it inked a collaboration with an undisclosed vaccine company to develop a vaccine application of its Lauriad mucoadhesive technology...The marketing authorization applies to all 27 European Union member states

Novo Nordisk A/S, of Bagsvaerd, Denmark, said its Norditropin (somatropin [rDNA origin]) 15-mg dose received a label update, allowing it to be left at room temperature after initial use for up to 21 days...Ltd., of Tokyo, said it submitted an application for the approval of the manufacture and marketing of oral nucleoside antitumor agent TAS-102 (combination of trifluorothymidine and tipiracil hydrochloride) to Japanese regulators for use in unresectable, advanced, recurrent colorectal cancer

The companies will target development of drugs to treat topical ophthalmic diseases, including ocular allergy, dry eye and other inflammatory eye conditions...Araxes Pharma LLC, of San Diego, said it inked an exclusive arrangement with Janssen Biotech Inc., a unit of New Brunswick, N.J.-based Johnson & Johnson, to develop first-in-class therapeutics against a certain cancer target

Ltd., of Osaka, Japan, said the FDA approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause