Alexion Pharmaceuticals Inc., of New Haven, Conn., said the European Commission approved the extension of the indication for Soliris (eculizumab) to include treatment of refractory generalized myasthenia gravis in adults who are anti-acetylcholine receptor antibody-positive. The company said Soliris initially will be launched in the newly approved indication in Germany. A supplemental biologics license application for Soliris in the same indication is under review in the U.S., along with a supplemental new drug application in Japan. (See BioWorld Today, Feb. 17, 2017.)

Alk-Abello A/S, of Copenhagen, said the FDA completed the transfer to Alk of the biologics licenses for its tablet portfolio, including Grastek and Ragwitek along with the house dust mite SLIT-tablet branded Odactra (marketed as Acarizax in Europe). Alk said it will increase investment in its North American commercialization activities to accelerate the launch of the house dust mite tablet from mid-2018 to the fourth quarter of this year. Additionally, following dialogue with the FDA, Alk plans to include U.S. patients in a pivotal phase III trial designed to support approvals of Odactra/Acarizax in children with allergic asthma. The company expects to initiate that trial this year. The company also revised its full-year guidance to expect EBITDA of approximately DKK 225 million to DKK250 million (US$35.7 million to $39.7 million) from approximately DKK 300 million. Full-year revenue is still projected at DKK 2.8 billion to DKK 3.0 billion.

Alkermes plc, of Dublin, started its rolling NDA for ALKS-5461, a once-daily, oral drug for adjunctive treatment of major depressive disorder (MDD). The company expects to complete the submission by the end of the year for the fast-track-designated combination of samidorphan and buprenorphine, designed to rebalance brain function that is poorly regulated in MDD. At a pre-NDA interaction with FDA in July, the company and the agency agreed upon the proposed content and timing of the ALKS-5461 NDA submission, Alkermes said.

Ampliphi Biosciences Corp., of San Diego, said a case study highlighting the successful treatment of a critically ill patient with a multidrug-resistant (MDR) Acinetobacter baumannii infection was published online on Aug. 14, 2017, in the peer-reviewed journal Antimicrobial Agents and Chemotherapy. The case study involves a patient first diagnosed with an abdominal A. baumannii infection who was treated with multiple courses of antibiotics over a four-month period, during which time the bacteria became resistant to cephalosporins, meropenem, gentamicin, amikacin, trimethoprim/sulfamethoxazole, tetracycline, ciprofloxacin and colistin. The patient continued to deteriorate and eventually fell into a coma. Ampliphi was involved in a joint effort that included several academic institutions and the U.S. Navy laboratory, producing a customized bacteriophage therapy specifically targeted to the A. baumannii strain infecting the patient. In March 2016, therapy was initiated under an emergency investigational new drug application approved by the FDA. Shortly after phage therapy was started, the patient emerged from the coma and continued to improve under ongoing phage therapy until the infection was cleared. To date, the infection has not returned, Ampliphi said.

Cytrx Corp., of Los Angeles, filed a preliminary proxy statement with the SEC in connection with a planned special meeting of stockholders to authorize its board to affect a reverse split of the company's common stock, if deemed necessary. The move could help the company to regain compliance with Nasdaq's $1 minimum bid price requirement and maintain its listing on the Nasdaq Capital Market. Company shares (NASDAQ:CYTR) closed at 57 cents on Monday.

Ironwood Pharmaceuticals Inc., of Cambridge, Mass., gained FDA approval for Duzallo as a once-daily oral treatment for hyperuricemia associated with gout in patients who did not achieve target serum uric acid levels with daily allopurinol alone. The drug is the first to combine allopurinol with the most recent FDA-approved treatment for the gout, lesinurad, marketed on its own as Zurampic (Astrazeneca plc). Ironwood expects Duzallo to be available commercially early in the fourth quarter.

Sandoz Canada, part of Sandoz International GmbH and a subsidiary of Basel, Switzerland-based Novartis AG, said Erelzi (etanercept), a biosimilar of Enbrel (etanercept, Amgen Inc.), is available in Canada to treat moderately to severely active rheumatoid arthritis in adults with or without methotrexate, to reduce signs and symptoms of active ankylosing spondylitis and to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 4 to 17 years with an inadequate response to one or more disease-modifying antirheumatic drugs.

Syros Pharmaceuticals Inc., of Cambridge, Mass., said the FDA granted orphan drug designation to SY-1425 to treat acute myeloid leukemia (AML). Syros is currently testing SY-1425, an oral selective retinoic acid receptor alpha agonist, with and without Vidaza (azacitidine, Celgene Corp.), in a phase II trial in patients with AML or myelodysplastic syndrome whose malignant cells have high expression of RARA or IRF8. Initial data from the trial are expected in the fourth quarter.

Trovagene Inc., of San Diego, reported preclinical research combining PCM-075, a polo-like kinase 1 inhibitor, with a histone deacetylase (HDAC) inhibitor in non-Hodgkin lymphoma cell lines, producing synergy of up to 80 percent in aggressive double-hit B-cell lymphoma and mantle-cell lymphoma cell lines.