Abbvie Inc., of North Chicago, said the FDA approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. The approval marks the 10th approval in the U.S. for Humira in immune-mediated diseases.

Aeterna Zentaris Inc., of Charleston, S.C., said it will collect an up-front payment of undisclosed value for licensing its lead oncology candidate, Zoptrex (zoptarelin doxorubicin), to Orient Europharma Co. Ltd. affiliate Cyntec Co., of Taiwan. The exclusive license covers the initial indication of endometrial cancer for Taiwan and nine countries in Southeast Asia. Zoptrex, a synthetic peptide carrier linked to doxorubicin as a new chemical entity, is being tested in a fully enrolled phase III trial in endometrial cancer. Cyntec will potentially pay Aeterna additional regulatory and commercial milestone payment plus royalties on future net sales of Zoptrex. It will also be responsible for the development, registration, reimbursement and commercialization of the product in the territory. Shares of Aeterna (NASDAQ:AEZS) rose 35 cents, or 10.7 percent, to close at $3.61 on Friday.

Allergan plc, of Dublin, said it received a positive opinion from the Swedish Medical Products Agency (MPA) for Belkyra (deoxycholic acid) for the treatment of moderate to severe convexity or fullness associated with submental fat (often called double chin) in adults when the presence of submental fat has a psychological impact for the patient. The drug is already licensed in Canada, as well as in the U.S., where it is marketed as Kybella. It is being evaluated through the decentralized procedure, with the Swedish MPA acting as the reference member state for 20 other countries in the EU, as well as Iceland and Norway. During European studies of the drug, 44.6 percent of people treated with Belkyra reported improvement in the psychological impact due to their double chin vs. 18 percent of people treated with placebo during the same time period.

Arena Pharmaceuticals Inc., of San Diego, is reducing its U.S. work force by about 100 employees, or 73 percent, primarily in areas of research, manufacturing and G&A as the company seeks to reduce its annualized cash expenditures. It will also implement additional cost control measures at its Swiss manufacturing facility. The company expects to incur restructuring charges, primarily in the second quarter, of about $6.1 million. Going forward, the company said it is focused on advancing its clinical programs, including the phase II S1P1 receptor modulator APD334 (etrasimod) for ulcerative colitis and other potential indications; the phase I cannabinoid-2 receptor agonist APD371 for pain indications; and the phase II prostacyclin receptor agonist APD811 (ralinepag) for pulmonary arterial hypertension. It will also continue supporting collaborators in various programs, such as Ingelheim-Germany-based Boehringer Ingelheim International GmbH, with which it struck a $262 million G protein-coupled receptor-focused collaboration in January.

Array Biopharma Inc., of Boulder, Colo., submitted a new drug application (NDA) seeking approval to market the MEK inhibitor binimetinib for treatment of patients with advanced NRAS-mutant melanoma. The submission, Array's first NDA, is based on results of the pivotal phase III Nemo study, which found binimetinib extended median progression-free survival at 2.8 months vs. 1.5 months observed with the chemotherapy dacarbazine (p<0.001) in patients with advanced NRAS-mutant melanoma. In a pre-specified subset of patients who received prior treatment with immunotherapy, including Yervoy (ipilimumab, Bristol-Myers Squibb Co.), Opdivo (nivolumab, Bristol-Myers Squibb Co.) or Keytruda (pembrolizumab, Merck & Co. Inc.), those who received binimetinib experienced 5.5 months of median PFS, compared with 1.6 months for those receiving treatment with dacarbazine. However, Array CEO Ron Squarer cautioned at the time that "interpretation beyond overall consistency with the primary result should be made with care." (See BioWorld Today, Dec. 17, 2015.)

Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, said the National Institute for Health and Care Excellence (NICE) has recommended Firmagon (degarelix) for men with advanced hormone-dependent prostate cancer who have spinal metastases. Firmagon was first approved by the EMA for men with advanced hormone-dependent prostate cancer in 2009, and has been available in the U.K. since 2010. But Ferring said that ongoing changes to NICE's guidance since then have resulted in great variations in access to the therapy across the U.K., and between regions in England and Northern Ireland.

Helsinn Healthcare SA, of Lugano, Switzerland, and Vifor Pharma, of Villars-sur-Glane, Switzerland, signed an exclusive promotion and distribution agreement for Aloxi, a therapeutic used to help prevent symptoms of chemotherapy-induced nausea and vomiting (CINV), in Spain. The agreement builds on an existing agreement with Vifor for the promotion and distribution of Akynzeo, an oral fixed combination of netupitant and palonosetron, developed for the prevention of CINV, in Spain, France, Switzerland, Portugal and the Benelux region. Previously, Aloxi was distributed in Spain by Italfarmaco SpA, of Milan, Italy; however, due to "portfolio synergies" with Vifor in other European countries, that agreement was terminated. Under the terms of the new agreement with Vifor, Helsinn retains rights to all clinical development, international regulatory activities and the manufacturing and supply of Aloxi. Financial terms were not disclosed.

Ligand Pharmaceuticals Inc., of La Jolla, Calif., said two recent events relating to its Omniab platform generated $4 million in combined payments. One payment arose from a current Omniab licensee exercising its option to expand access to the Omniab platform. The second event arose from Shanghai-based Wuxi Apptec sublicensing Chinese rights to an IND-ready antibody it discovered with the Omniab platform. Ligand said that, including those payments, it anticipates total revenue for the second quarter to be about $19 million.

Mesoblast Ltd., of Melbourne, Australia, disclosed plans for an early data readout on its phase III chronic heart failure trial, materially reduced projections for annualized cash burn and said it established an equity facility to provide funding at the company's discretion for up to three years. About 240 patients have been enrolled in the trial, the primary endpoint of which is a comparison of recurrent adverse cardiovascular events in high-risk heart failure patients receiving either Mesoblast's product candidate MPC-150-IM or control.

Northwest Biotherapeutics Inc., of Bethesda, Md., said it is considering "a range of available options" for regaining compliance with a Nasdaq share listing standard following receipt of a deficiency notice June 24. The company could remedy the deficiency through a reverse stock split, it noted, but it currently plans to regain compliance by focusing on progress in its multiple operational programs, it said. Company shares (NASDAQ:NWBO) closed at 60 cents Friday, up 2 cents.

Orasure Technologies Inc., of Bethlehem, Pa. and North Chicago-based Abbvie Inc. mutually agreed to an early termination of an agreement under which the companies have been co-promoting Orasure's Oraquick hepatitis C virus (HCV) rapid antibody test in the U.S. The agreement was originally scheduled to continue through Dec. 31, 2019, and will now end on Dec. 31, 2016. Orasure had granted exclusive rights to Abbvie to co-promote the test in certain U.S. markets and provided additional services in support of HCV testing in exchange for up to $75 million in exclusivity payments over the term of the agreement. As a result of the shortened term, only a portion of that money will be received by Orasure. The deal's end means Abbvie gets out of co-promotion obligations, while Orasure is relieved of compensating Abbvie for detailing.

Pain Therapeutics Inc., of Austin, Texas, said an FDA advisory committee meeting for Remoxy (oxycodone), which had been tentatively scheduled for Aug. 5, will not be held. The FDA also advised that the regulatory review of the Remoxy NDA remains active and on-going. The PDUFA date is unchanged, at Sept. 25. Pain Therapeutics is partnered with Durect Corp., of Cupertino, Calif., which in 2002 licensed to Pain Therapeutics the right to develop and commercialize Remoxy and other oral sustained-release drug candidates that use its Oradur technology.

Sprint Bioscience AB, of Stockholm, signed an agreement with the Center for Hematology and Regenerative Medicine (HERM) at the Karolinska Institute under which the parties will evaluate Sprint drug candidates for the treatment of acute myeloid leukemia. The partnership intends to enable early stage identification of groups of patients who may benefit from a future drug. The work will be conducted at HERM´s and Sprint's respective research laboratories at Novum in Huddinge, Sweden. Financial terms of the arrangement were not disclosed.

Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, and Los Altos, Calif.-based Altos Therapeutics LLC agreed to further develop Altos's sole compound, the oral dopamine D2/D3 receptor antagonist ATC-1906. The agreement includes an exclusive option for Takeda to acquire Altos through the completion of ongoing phase I studies of ATC-1906. The parties envision future development of ATC-1906 for the treatment of gastroparesis and its symptoms. Financial terms were not disclosed.

Vectura Group plc, of Chippenham, U.K., confirmed the lease of its manufacturing facility and oral product business in Saint-Quentin-Fallavier, Lyon, France, to contract manufacturer Aenova France SAS expired on June 30. The facility transferred back to Vectura upon the lease's expiration. The company said it is looking forward to working with existing and new partners.

Vivus Inc., of Mountain View, Calif. extended the termination date of a license agreement with Endo International plc subsidiary Auxilium Pharmaceuticals Inc., of Horsham, Pa., for Stendra (avanafil) U.S. and Canadian commercial rights through Aug. 31. In December 2015, Auxilium notified Vivus of its intention to return the U.S. and Canadian commercial rights for Stendra. Vivus said it expects to make a decision in the near term on whether it will commercialize Stendra on its own or with a third party. (See BioWorld Today, Oct. 14, 2013.)