Aldeyra Therapeutics Inc., of Lexington, Mass., said the FDA granted aldehyde trap ADX-102 orphan drug designation for the treatment of congenital ichthyosis, a severe skin disease characteristic of Sjögren-Larsson syndrome (SLS). There are no FDA-approved therapies specifically indicated for the treatment of SLS, and ADX-102 is believed to be the only potential SLS therapy in clinical development. A phase III trial is expected to begin this year.

Allergan plc, of Dublin, said it will collaborate with Target Pharmasolutions, a clinical data company focused on real-world evidence, on its Target-NASH study, a five-year longitudinal observational study that looks at patients with nonalcoholic fatty liver disease or nonalcoholic steatohepatitis (NASH). TARGET-NASH was launched in advance of related drug approvals in order to help facilitate a greater understanding of the impact of NASH and future treatment options. Target-NASH involves academia, industry, regulatory agencies and the NASH community. The first patient was enrolled last August and eventually 15,000 are expected to sign on. The study design is disease-focused, not drug-specific, allowing for continuous acquisition of natural history and outcomes data as new drugs enter the market and clinical treatment paradigms evolve.

Cellular Dynamics International Inc. (CDI), of Madison, Wis., signed a collaboration agreement with the Harvard Stem Cell Institute, which extends from the university to its affiliated hospitals and the biomedical industry. The objective of the new partnership is to increase the availability of induced pluripotent stem cells (iPS) and services to the institute's network and the research community at large. Under the terms of the agreement, CDI will collaborate with Harvard's iPS Core Facility by providing iPSC technology support to the stem cell community. CDI will offer critical iPSC technology elements, which may accelerate iPSC-based science, technology and applications. Further terms were not disclosed.

H3 Biomedicine Inc., of Cambridge, Mass., extended its multiyear collaboration with Foundation Medicine Inc., also of Cambridge, for the discovery and development of precision medicines in oncology, which was signed in February 2015. H3 and Foundation will continue to build upon the progress the two companies have made during the collaboration, interrogating the Foundation Core dataset, with the goal of expanding the translation of ongoing H3 programs and identifying new, actionable cancer drivers.

Immune Pharmaceuticals Inc., of New York, signed a letter of intent with Pint Pharma GmbH, of Vienna, which binds the parties to seek agreement regarding an exclusive license by Pint of the rights to commercialize Ceplene (histamine dihydrochloride) throughout Latin America, including Argentina, Brazil, Chile, Colombia and Mexico. Immune and Pint target closing a final agreement within 30 days. Pursuant to the anticipated final agreement, Pint will be responsible for registration of Ceplene in Latin American countries based on the existing European marketing authorization and will carry out the full commercialization of the licensed product in the territory, including Ceplene registration, pricing and reimbursement, and sales and marketing activities. In conjunction with the anticipated final agreement, Pint will make an investment of $4 million into Immune Pharma's oncology subsidiary, Cytovia Inc., of Irvine, Calif., to be used by Cytovia exclusively for oncology-related activities. Ceplene has been approved in Europe for the maintenance of first remission in patients with acute myeloid leukemia in combination with interleukin-2 . Shares of Immune (NASDAQ:IMNP) closed Thursday at $3.65, up $1.21, or 49.6 percent. (See BioWorld Today, June 22, 2016.)

Inventiva SA, of Daix, France, presented a poster on its lead drug candidate, IVA-337, at the International Liver Congress in Amsterdam. The poster discussed the effect of IVA-337 in two mechanistically different preclinical models of nonalcoholic steatohepatitis (NASH) and studied its effect on crucial pathways implicated in NASH and fibrosis development. The results further confirm the potential of IVA-337 as a treatment for NASH, the company said, showing that IVA-337 inhibits the development of NASH through the normalization of different metabolic parameters such as insulin resistance, through activation of fatty acid beta-oxidation, and inhibition of the inflammasome that's known to be a trigger of liver inflammation and fibrosis.

Mast Therapeutics Inc., of San Diego, said its stockholders are voting overwhelmingly in favor of the merger with Savara Pharmaceuticals Inc., of Austin, Texas, with the three required proposals – the merger, the reverse split and the name change – all exceeding 90 percent approval based on votes cast to date. However, a quorum for the special meeting of stockholders scheduled for Friday has yet to be obtained and the business of the meeting cannot be conducted if a quorum is not present. To achieve a quorum for the special meeting, stockholders of more than 50 percent of the company's outstanding shares as of the record date are required to vote and, as of April 19, about 44 percent of shares had voted. In the absence of a quorum or the necessary approvals of the proposals to be voted upon, Mast expects to adjourn the special meeting without conducting any business other than the adjournment to allow for the solicitation of additional votes. If adjourned, Mast expects to reconvene the special meeting next Thursday.

Merck KGaA, of Darmstadt, Germany, said Bioinvent International AB, of Lund, Sweden, which develops immuno-regulatory antibodies to treat cancer, is upgrading and expanding its drug manufacturing facility with a line of Merck's Mobius single-use bioreactors. That will allow the firm to meet production requirements for both its own antibody development projects and also those of its global customers.

Neurovive Pharmaceutical AB, of Lund, Sweden, said it presented positive preclinical results demonstrating antifibrotic effects with NV-556, a cyclophilin inhibitor, which is indicated for nonalcoholic steatohepatitis (NASH), in an additional well-validated experimental NASH model, at the International Liver Congress in Amsterdam. The data confirm earlier findings of similar antifibrotic effects in the experimental STAM NASH model. In addition, in the STAM model, where NASH is followed by liver cancer development, long-term treatment with NV-556 was well-tolerated and significantly reduced liver weight increase, indicating a reduced tumor burden. Furthermore, there was a trend that NV-556 reduced both the number and the size of tumors on the liver surface.

Oncbiomune Pharmaceuticals Inc., of Baton Rouge, La., said it signed a licensing agreement with Procaps SAS, of Barranquilla, Colombia, which grants rights to tretinoin, also known as all-trans retinoic acid (ATRA), an oral drug for the treatment of acute promyelocytic leukemia (APL), throughout Mexico, Central America and Latin America. Financial details of the transaction were not released.

Plx Pharma Inc., of Houston, said it completed its merger with Dipexium Pharmaceuticals Inc., of New York, with the combined company operating as Plx Pharma Inc. and trading on Nasdaq under the symbol PLXP. Going forward the company said it will initially focus on completion of manufacturing scale-up and label finalization for its FDA-approved Aspertec 325-mg aspirin dosage form, and filing of a supplemental new drug application for Aspertec 81-mg maintenance dose form. Aspertec is being developed to provide high-risk cardiovascular and stroke patients with more reliable and predictable antiplatelet efficacy as compared to enteric-coated aspirin, while also reducing the adverse gastric events common in an acute setting. Dipexium completed a 1-for-8 reverse stock split of its issued and outstanding shares of common stock in connection with the completion of the merger. The holders of shares of Plx common stock outstanding immediately prior to the merger received shares of common stock in the combined company, which represented 76.75 percent of its outstanding shares.

Preveceutical Medical Inc., of Vancouver, British Columbia, said it signed a research and option agreement with Uniquest Pty Ltd., the commercialization company for the University of Queensland, to conduct a research program for the development of scorpion venom-derived natural and synthetic peptides. Preveceutical said it has an interest in the preventive health sector and is developing products derived from Caribbean blue scorpion venom for the nutraceutical and eventual pharmaceutical market, which includes a CellB9 immune system booster. The proposed research program will last for up to 24 months and will encompass the identification of milked Caribbean blue scorpion venom-containing peptides, chemical synthesis of natural and synthetic peptide variants, followed by screening the peptides in various disease models of interest. Any intellectual property arising from the program (excluding any improvements to existing intellectual property used) will be owned by the company, which also has an option to negotiate a license to use Uniquest's IP for the commercialization of blue scorpion venom-derived products.

Prometic Life Sciences Inc., of Laval, Quebec, reported new preclinical results at the International Liver Congress in Amsterdam on the positive effects of PBI-4050 on reduction of nonalcoholic steatohepatitis (NASH) in a mouse model of obesity and metabolic syndrome. The study, the company said, enabled it to further characterize the effects of PBI-4050 on metabolic regulation and white adipose tissue and liver fibrosis induced in a high fat diet model. PBI-4050 effectively reduced liver damage and fibrosis, improved insulin resistance (HOMA-IR) and the pancreatic beta-cells function (HOMA-β). Pro-fibrotic and fibrotic gene expression in liver and in white adipose tissue were also reduced with the treatment. Those results strongly correlate with those seen in the company's phase II trials in diabetes associated with metabolic syndrome and Alström syndrome, Prometic said. (See BioWorld Today, April 20, 2017.)

Protein Sciences Corp., of Meriden, Conn., said a study published in PLOS One confirmed that a contaminating rhabdovirus previously reported in a related cell line is not present in SF+ cells. Those results demonstrate that not all cell lines are equal even if they are derived from the same parent cell line and highlight the high quality of the SF+ cell lineage. SF+ cells are used for the manufacture of multiple commercial products, including Protein Sciences' FDA-approved Flublok influenza vaccine.

Recordati Rare Diseases Canada Inc., of Toronto, part of Recordati SpA, said it acquired Canadian marketing rights to Cystadane (betaine anhydrous for oral solution), which is approved for use by Health Canada for the treatment of homocystinuria. Terms were not disclosed.

Saniona AB, of Ballerup, Denmark, said it reached the second research milestone for identifying candidates against Parkinson's disease under its grant from the Michael J. Fox Foundation for Parkinson's Research, releasing a payment of $119,487. Saniona was awarded the grant, for up to $590,000, to develop small-molecule modulators of nicotine receptors belonging to the alpha-6 subtype and to evaluate the feasibility of using those drug candidates for the treatment of Parkinson's.

Sawai Pharmaceutical Co. Ltd., of Tokyo, and Upsher-Smith Laboratories Inc., of Minneapolis, signed a deal for Sawai to purchase the generic pharma business of Upsher-Smith from its parent, Acova Inc. Under the terms, Sawai will purchase all the equity interest in the generic pharma business for consideration of $1.05 billion. The deal is set to close near the end of June.

Thrombogenics NV, of Leuven, Belgium, said it achieved a milestone in the advancing of preclinical development of THR-149, its plasma kallikrein inhibitor in development for diabetic macular edema. The company will now start pivotal toxicology studies, with clinical testing set to start in early 2018. THR-149 is a bicyclic peptide identified as a lead candidate in the alliance between Thrombogenics and Bicycle Therapeutics Ltd., of London.