Alimera Sciences Inc., of Atlanta, said the U.K.'s MHRA gave final approval to reduce the size of the Iluvien Registry Safety Study, or IRISS. The postmarketing study was originally designed to follow 800 Iluvien patients over five years; however, consistently positive real-world safety data from IRISS and other postmarketing studies led Alimera to seek a smaller sample size. Alimera enrolled the 550th patient in January of this year, making the anticipated last patient, last visit date in January 2020. Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg is a sustained-release intravitreal implant indicated in the EU to treat vision impairment associated with chronic diabetic macular edema considered insufficiently responsive to available therapies.

AMO Pharma Ltd., of London, and Numedicus Ltd., of Cambridge, U.K., entered a development and license agreement to advance the development of a glutamate modulator (AMO-04) and related compounds for the treatment of Rett syndrome and certain breathing disorders. The terms of the deal were not disclosed.

Astellas Pharma Inc., of Tokyo, said the FDA granted orphan drug designation to gilteritinib for patients with acute myeloid leukemia (AML). Astellas is investigating gilteritinib in various patient populations through several planned and already started phase III trials, including the registrational Admiral experiment in relapsed/refractory FLT3-positive AML.

Auris Medical Holding AG, of Zug, Switzerland, completed its acquisition of various assets related to intranasal betahistine from Otifex Therapeutics Ltd., of Melbourne, Australia. The assets, which comprise preclinical and clinical data as well as intellectual property rights, have been fully transferred to Auris with the closing of the transaction. They form the basis for the development of AM-125, an intranasal formulation of betahistine for the treatment of Meniere's disease and other vestibular disorders.

Braeburn Pharmaceuticals Inc., of Princeton, N.J., completed the rolling NDA submission to the FDA for the approval of the companies' weekly and monthly buprenorphine depots (CAM-2038) to treat opioid use disorder. Braeburn has also applied for priority review.

Cerulean Pharma Inc., of Waltham, Mass., and Dare Bioscience Operations Inc., of San Diego, said they closed the transactions inked March 19, with holders of Dare now owning about 51 percent of Cerulean capital stock and Dare becoming a wholly owned subsidiary of Cerulean. The company changed its name to Dare Bioscience Inc., effective July 20, and effected a 1-for-10 reverse stock split, with shares now trading on Nasdaq under DARE. Dare is focused on developing products for women's reproductive health.

Churchill Pharmaceuticals LLC, of King of Prussia, Pa., said the NDA for Yonsa (abiraterone acetate) ultramicrosize tablets has been accepted for filing by the FDA, with a PDUFA date of March 19, 2018. The drug is a CYP17 inhibitor being developed for the treatment of metastatic castration-resistant prostate cancer in combination with methylprednisolone.

CSL Behring, of King of Prussia, Pa., said the FDA accepted for review its BLA for Hizentra (immune globulin subcutaneous [human] 20 percent liquid) for the treatment of chronic inflammatory demyelinating polyneuropathy as a maintenance therapy to prevent relapse of neuromuscular disability and impairment.

Dompe Farmaceutici SpA, of Milan, Italy, said the European Commission granted approval of cenegermin eye drops for the treatment of moderate to severe neurotrophic keratitis, a rare and debilitating eye disease that can cause vision loss. Cenegermin is a recombinant version of human nerve growth factor and is designed to restore the normal healing processes of the eye and repair corneal damage. Dompe said it also has started the BLA submission process in the U.S. and has begun discussions with Japan's PMDA.

Essa Pharma Inc., of Vancouver, British Columbia, received written notification from Nasdaq that the company is not in compliance with the minimum bid price requirement set forth in Nasdaq rules for continued listing.

Evolus Inc., of Santa Barbara, Calif., said it received confirmation from the FDA that its BLA for DWP-450, a 900 kDa botulinum toxin type A, was accepted for review. The application is seeking approval to treat adults with glabellar lines, also known as frown lines between the eyebrows. In separate news, the company said the EMA accepted a marketing authorization application for DWP-450 for review.

Exelixis Inc., of South San Francisco, settled its dispute with Basel, Switzerland-based Roche Holding AG unit Genentech concerning the parties' collaboration for the development and commercialization of cobimetinib, which is marketed as Cotellic. Effective July 1, as part of the settlement the companies entered an amendment to the existing collaboration agreement, dated Dec. 22, 2006, to revise the revenue and cost-sharing arrangements for the collaboration. The amendment resolves the companies' dispute pursuant to the arbitration demand filed on June 3, 2016, and aligns both companies' interests in advancing cobimetinib as a therapy for patients with multiple forms of cancer. Exelixis said.

Gamida Cell Ltd., of Jerusalem, was awarded a grant of $3.5 million from the Israel Innovation Authority of the Israeli Ministry of Economy and Industry. The nondilutive funding, combined with a recent $40 million financing round, will support Gamida's ongoing research and development efforts, including its phase III registration study of Nicord for hematological malignancies such as leukemia and lymphoma, its trials of Cordin for sickle cell disease and thalassemia, and its NK cell therapy for blood and solid cancers.

Intra-Cellular Therapies Inc., of New York, said preclinical data presented at the Collegium Internationale Neuro-Psychopharmacologicum Thematic Meeting: Treatment Resistant Depression conference in Prague included data supporting the mechanism of action of lumateperone at the dopamine D2 receptor, as a presynaptic D2 partial agonist and a post-synaptic D2 antagonist. That finding is believed to form the basis of efficient modulation of dopamine, providing antipsychotic efficacy at relatively low striatal D2 receptor occupancy without the motoric disturbances associated with many current therapies. Additional data demonstrated that lumateperone, as a standalone agent, indirectly enhances glutamatergic neurotransmission through both AMPA and NMDA channels in the prefrontal cortex, mechanisms thought to predict potent and rapid antidepressant effects. Lumateperone is in phase III development in bipolar depression and agitation of dementia, including Alzheimer's disease.

Lentigen Technology Inc., a Gaithersburg, Md.-based subsidiary of Miltenyi Biotec GmbH, has acquired immunotherapy startup Living Pharma Inc., of Baltimore, for an undisclosed sum. Boro Dropulić, Lentigen's chief science officer and general manager, said Living Pharma's anti-tag-chimeric antigen receptor (AT-CAR) technology "is fundamental for the development of universal CAR T-cell therapeutics that couple a universal AT-CAR with tumor-targeting molecules, like an antibody, in the body."

Leo Pharma A/S, of Ballerup, Denmark, gained marketing authorization from the European Commission to sell Kyntheum (brodalumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The company has exclusive European rights to the interleukin-17-targeting fully human monoclonal antibody, which is sold under the name Siliq by Laval, Quebec-based Valeant Pharmaceuticals International Inc. in the U.S. and other territories. It is also approved in Japan, where it is additionally indicated for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. A postmarketing pharmacovigilance program will be run in Europe to catch any reports of safety events, such as suicidal ideation and behavior. (See BioWorld Today, Feb. 17, 2017.)

Marina Biotech Inc., of City of Industry, Calif., said it entered an agreement licensing rights to its Smarticles platform for the delivery of antisense DNA therapeutics to Oncotelic Inc., of Agoura Hills, Calif. Under the terms, Oncotelic will invest $250,000 in Marina at a share price of 51 cents. In addition, Marina may receive in certain circumstances a commercial license fee consummated by the sale to Oncotelic of shares of the common stock of Marina for an aggregate purchase price of $500,000, with the purchase price for each share of Marina common stock being the greater of 51 cents or the volume-weighted average price of the Marina common stock at the time of purchase, as well as sales milestones not exceeding $90 million. Further details were not disclosed.

Merck & Co Inc., of Kenilworth, N.J., said it has gained tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. The therapy is being developed by Merck with funding from Samsung Bioepis, of Incheon, South Korea. While the product has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, it remains subject to an automatic stay due to a lawsuit from Paris-based Sanofi SA claiming patent infringement.

Nivalis Therapeutics Inc., of Boulder, Colo., said during a July 19 special meeting, its stockholders approved a trio of proposals related to its merger with Alpine Immune Sciences Inc., of Seattle, including a reverse split of Nivalis' common stock. The merger is expected to close on July 24.

Ose Immunotherapeutics SA, of Nantes, France, said it will receive a €9.2 million (US$10.6 million) grant from the Projets de R&D Structurants Pour la Compétitivité of the Invest in the Future Program overseen by the General commissariat of investment and led by Bpifrance. Ose will lead the consortium collaborating on that project, named EFFI-CLIN, aimed at developing a new generation checkpoint inhibitor in cancer immunotherapy. The project will include product manufacturing compliant with pharmaceutical standards, translational studies conducted from tumor tissues to measure the presence of immunological targets including SIRP-alpha, and a clinical program planned up to phase II.

Pfizer Inc., of New York, and Basel, Switzerland-based Basilea Pharmaceutica Ltd. completed a $499 million licensing agreement under which Pfizer obtained exclusive commercialization rights in Europe to Cresemba (isavuconazole), an antifungal treatment for adults with diagnosed invasive aspergillosis and mucormycosis. (See BioWorld, June 16, 2017.)

Philogen SpA, of Siena, Italy, announced a collaboration and license agreement with Boehringer Ingelheim International GmbH, of Ingelheim, Germany, to discover and optimize small molecule-based therapeutics using its Encoded Self-Assembling Chemical, or ESAC, library technology platform. Financial details of the new agreement were not released. It is the second partnership between the companies. In October 2015, they agreed to work together on investigating new treatment approaches for acute myeloid leukemia.

Ra Pharmaceuticals Inc., of Cambridge, Mass., said in vitro and in vivo data published in the Proceedings of the National Academy of Sciences demonstrated that treatment of Escherichia coli sepsis with RA-101295, a macrocyclic peptide inhibitor of complement component 5, was associated with significant organ protection and markedly reduced mortality. In baboons receiving lethal doses of E. coli, treatment with RA-101295 blocked sepsis-induced inflammation, preserved endothelial cell function, decreased leukocyte activation and reduced overall mortality vs. placebo, while exhibiting no detrimental effects on the clearance of bacteria.

Recce Ltd., of Sydney, reported that its new automated manufacturing facility in Sydney is now producing its synthetic antibiotic synthetic antibiotic, Recce-327, at volumes suitable for trials in preparation for phase I and II studies.

Regenacy Pharmaceuticals LLC, of Boston, presented preclinical data at the Alzheimer's Association International Conference in London supporting the use of selective inhibition of HDAC 1,2 as a potential treatment approach for Alzheimer's disease (AD). Regenacy scientists used RCY-1305 as a tool compound in two mouse models of AD to explore the mechanism of HDAC inhibition in synaptic plasticity and neurodegeneration. The studies showed that chemical inhibition of HDAC1 and 2 in the brain improved performance in spatial learning tasks in normal and cognitively impaired mice.

Taiwan Liposome Co. Ltd., of Taipei, Taiwan, said TLC-178 received orphan designation from the FDA for soft tissue sarcoma. The drug, a liposomal-encapsulated formulation of vinorelbine, is in a phase I/IIa dose-escalation study at sites in the U.S. and Taiwan. It previously was designated a rare pediatric disease drug for rhabdomyosarcoma, a type of soft tissue sarcoma.

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Schrödinger Inc., of New York, formed a multitarget research collaboration using Schrödinger's in silico platform, with Takeda providing protein crystal structures, to design new chemical entities against diseases in Takeda's area of interest. Under the terms, Takeda will have the option to exclusively license the programs from Schrödinger later in discovery at established economic terms, including preclinical, clinical and commercial milestones of up to $170M per program, as well as royalties on future sales. Additional financial details are not being disclosed.

Teva Pharmaceutical Industries Ltd., of Jerusalem, said the National Institute for Health and Care Excellence has recommended use of Cinqaero (reslizumab) in the U.K.'s National Health Service as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. The recommendation took the form of a final appraisal determination. The European Commission granted marketing authorization for Cinqaero in August 2016. The drug won FDA approval in March 2016.