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

to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML...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...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

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

Maturation inhibitors are designed to block virus replication by interfering with the formation of infectious HIV virus...Captisol, a chemically modified cyclodextrin, is used to improve the solubility and stability of drugs and currently is incorporated in six marketed products...SionX is designed to enable high-density expression of recombinant human ion channels on the cell membranes of Tetrahymena thermophile

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 the European Commission granted conditional marketing authorization for Bosulif (bosutinib) for the treatment of adult patients with chronic phase, accelerated phase and blast phase Philadelphia chromosome-positive chronic myelogenous leukemia previously treated with one or more tyrosine kinase inhibitors and for whom Gleevec (imatinib

KineMed Inc., of Emeryville, Calif., said it renewed a nonexclusive research collaboration with Pfizer Inc., of New York, to advance approaches for treating metabolic disease, in particular Type II diabetes...Ltd., of Yokohama, Japan, to use its cell-loading system to support clinical studies and commercialize treatment of cancer patients...Themis plans to start Phase I for both vaccines before the end of this year

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

India's Ministry of Health & Family Welfare is asking for comment from drug developers and other interested parties on the plan to establish two committees that would "formulate...In 2012, 253 of 480 applications were granted to conduct trials of new drugs or vaccines, compared to 283 (out of 306) granted the year before, according to figures from the health ministry obtained by india.com, a Mumbai-based news source...Editor's note: For a copy of BioWorld's new biosimilars report, The Biosimilars Game

Pfizer Inc., of New York, and Protalix BioTherapeutics Inc., of Carmiel, Israel, said the Brazilian National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria, or ANVISA) granted regulatory approval to Uplyso (alfataliglicerase) as long-term enzyme replacement therapy for adults with a confirmed diagnosis of Type I Gaucher disease

India's Ministry of Health & Family Welfare is asking for comment from drug developers and other interested parties on the plan to establish two committees that would "formulate...In 2012, 253 of 480 applications were granted to conduct trials of new drugs or vaccines, compared to 283 (out of 306) granted the year before, according to figures from the health ministry obtained by india.com, a Mumbai-based news source...Editor's note: For a copy of BioWorld's new biosimilars report, The Biosimilars Game

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

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

That drug is designed to treat acute myeloid leukemia, with potential applications in other hematological and solid tumors...Tranzyme Inc., of Research Triangle Park, N.C., said its board decided to explore and evaluate strategic alternatives, including the possibility of a merger, sale or other form of business combination, or other transaction to maximize value to its stockholders