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...for the Brisbane, Australia-based company's Diversity Scanning Array (DSA) and Versatile Assembly on Stable Templates (VAST) technologies in a deal worth up to $240 million in milestones, plus other payments

Merck will continue to retain rights to its existing portfolio of sitagliptin-containing products...The first suit pertains to a previously disclosed investigation into discounts and rebates to specialty pharmacies for Myfortic

Novartis has worldwide rights to the drug, along with certain backup compounds in all indications, with Incyte retaining a co-development option to INC280 in the U.S...Due to third-party manufacturing issues, distribution of Janssen Products LP's Caelyx in Europe has been intermittently disrupted since 2011

Pfizer Inc., of New York, said the European Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion for Xeljanz (tofacitnib citrate) for the treatment of adults with moderate to severe active rheumatoid arthritis

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 news also adds to the growing fear that biosimilar drug development will prove trickier – and, perhaps costlier – than previously envisioned...In the last year, for instance, some much-lauded big pharma biosimilar deals came to abrupt ends, such as Pfizer Inc.'s deal with Indian generics maker Biocon Ltd

Avilex Pharma ApS, of Copenhagen, Denmark, said it has received seed funding from Novo Seeds, the early stage financing arm of Novo A/S, which will be used to support the development of dimeric ligands targeting PDZ domains...In other news, GSK experienced manufacturing delays for manufacture and supply of Horizant (gabapentin enacarbil), partnered with XenoPort Inc., of Santa Clara, Calif., resulting in a stockout of the drug...The firms will aim to offer pharma and biotech companies a set of fully

Merck KGgA, of Darmstadt, Germany, reported that a collaboration agreement between its subsidiary, EMD Serono Inc., and Pfizer Inc., of New York, inked in July 2002 for the co-promotion of multiple sclerosis drug Rebif (interferon beta-1a) extends until Dec. 31, 2015, according to an appellate court ruling...In separate news, Merck Serono SA, of Geneva, a division of Merck KGgA, said it launched the EspeRare Foundation, a nonprofit organization set up by three Merck Serono employees in the

PeptiDream Inc., of Tokyo, and Ipsen SA, of Paris, entered a research collaboration and license option agreement to discover, evaluate, potentially develop and launch therapeutic peptides to treat serious medical conditions in areas of therapeutic focus for Ipsen...Pfizer Inc., of New York, said its palbociclib (PD-0332991), an oral and selective inhibitor of cyclin-dependent kinases 4 and 6, received breakthrough therapy designation by the FDA for the potential treatment of patients with breast

DFH Pharma Inc., of Gaithersburg, Md., said it entered a research and product development agreement with Hetero Group, a research-based pharmaceutical group headquartered in Hyderabad, India, to develop next-generation HIV maturation inhibitor drugs...Tris Pharma Inc., of Monmouth Junction, N.J., said the FDA approved its new drug application for Karbinal ER (carbinoxamine maleate) extended-release oral suspension, a sustained-release histamine receptor blocking agent indicated for the treatment of

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...Terms include certain milestones and tiered royalty payments to the HPA in return for technology transfer and other licensing rights

Pfizer Inc., of New York, said Japanese regulators approved Xeljanz (tofacitinib citrate) for the treatment of adults with rheumatoid arthritis who have had an inadequate response to existing therapies

With this new approval, Stivarga is intended to be used in patients whose GIST cancer cannot be removed by surgery or is metastatic and no longer responding to Gleevec (imatinib, Novartis AG) and Sutent (sunitinib, Pfizer Inc.), two other FDA-approved drugs to treat GIST...Lallemand Pharma, of Lugano Switzerland, partnered with Cipla Ltd., of Mumbai, India, to market and distribute PMBL tablets in India, under the name Pulmigen, for prevention of chronic bronchopulmonary infections

Pursuant to the terms, each of the company's ordinary shares, including shares represented by American depositary shares (ADS), will be cancelled in exchange for the right to receive $2.20 in each per share, or $15.40 per ADS...Due to the oversubscription, the closing unit price was set at NIS3.544 per unit

Isotechnika Pharma Inc., of Edmonton, Alberta, and privately held Aurinia Pharmaceuticals Inc., of Victoria, British Columbia, said they signed a binding term sheet for a merger to create a clinical-stage firm focused on the global nephrology market...The announcement was made in response to reports appearing in the Israeli press stating that the biotech was in talks to be acquired by New York-based Pfizer Inc

5,100,899 valid and infringed by Parsippany, N.Y.-based Actavis Inc.'s generic version of Pfizer Inc.'s Rapamune (sirolimus...The restricted stock units vest over three years, and each is subject to terms of the company's 2012 equity incentive plan...Valeant Pharmaceuticals International Inc., of Montreal, completed the acquisition of Russian specialty pharma company Natur Produkt International JSC for $163 million

Pfizer Inc., of New York, said the District Court of Delaware ruled that its patent covering a method for using sirolimus, the active ingredient in Rapamune, for the inhibition of organ transplant rejection is valid and infringed...The company brought patent infringement action in April 2010 against generic firm Watson Laboratories Inc., of Parsippany, N.Y., (now known as Actavis) after Watson applied to the FDA to market a generic version of Rapamune

Hanmi filed the application pursuant to the 505(b)(2) pathway with data showing comparative bioequivalence of its drug to Nexium (esomeprazole magnesium delayed-release capsules, AstraZeneca plc...Pfizer Inc., of New York, said the FDA approved expansion of its pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), in older children and adolescents 6 through 17 for active immunization against invasive disease caused by the 13 Streptococcus

The drug is expected to launch in Canada in the second quarter...Pfizer Inc., of New York, said the Committee for Medicinal Products for Human Use of the European Medicines Agency offered a positive opinion on the conditional marketing authorization of bosutinib in the European Union (EU) in chronic phase, accelerated phase and blast phase Philadelphia chromosome positive chronic myelogenous leukemia patients previously treated with one or more tyrosine kinase inhibitors and for whom imatinib