Abbvie Inc., of North Chicago, gained approval in Australia for Venclexta (venetoclax) to treat advanced forms of chronic lymphocytic leukemia. CLL is the most common type of leukemia in Australia, with 1,300 people diagnosed each year. Venclexta was approved for CLL patients with 17p deletion, a mutation that makes the disease resistant to standard treatment options, as well as for patients with relapsed or refractory CLL for whom on other options are available. The drug, a BCL-2 inhibitor, was discovered and developed at Abbvie and Genentech Inc., of South San Francisco, as part of a collaboration with the Walter and Eliza Hall Institute.

Amgen Inc., of Thousand Oaks, Calif., said it remains confident in the validity of its patents following the U.S. District Court of Delaware's denial of Paris-based Sanofi SA and Tarrytown, N.Y.-based Regeneron Inc.'s motion to stay the injunction pending the appeal in the ongoing PCSK9 patent litigation. By the ruling, the court has extended the time before the injunction will be imposed by 15 days to allow Sanofi and Regeneron to seek appellate review of the court's orders.

Bayer Corp., of Whippany, N.J., part of Bayer AG, and the University of Pittsburgh established a master collaboration agreement to advance research for heart, lung and blood disease indications. The collaboration spans from early research studies, to drug development and big data analysis including real-world evidence studies. Bayer also will support an independent investigator-initiated clinical trial in sickle cell disease. A joint steering committee composed of leaders from both Bayer and Pitt will manage the collaboration.

Chronos Therapeutics Ltd., of Oxford, U.K., partnered with a subsidiary of Aptuit Holdings LLC for services related to Chronos' program targeting the addictive behaviors of binge eating and alcohol use disorders. The companies will work to optimize Chronos' selective orexin 1 antagonists that have shown promise in treating addiction. All intellectual property, know-how, development and marketing rights for the program will belong to Chronos.

Cytori Therapeutics Inc., of San Diego, plans to broaden its investigation of the ECCS-50 formulation of Cytori Cell Therapy to include secondary Raynaud's phenomenon (RP) beyond scleroderma. Habeo Cell Therapy (formerly ECCS-50) is the new brand name of Cytori's hand therapy franchise. Pilot trial data suggest it may help address secondary RP symptoms and other autoimmune and inflammatory conditions of the hand.

Duchesnay Inc., of Blainville, Quebec, said Health Canada approved Mictoryl/Mictoryl Pediatric (propiverine hydrochloride) for symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in patients with overactive bladder. Duchesnay has marketing agreements with Germany-based Apogepha and its subsidiary Duchesnay USA.

Genervon Biopharmaceuticals LLC, of Pasadena, Calif., published a confidential list of genes associated with Parkinson's disease during the J.P. Morgan Healthcare Conference in San Francisco. This is the third list of genes the company has published. Two weeks ago, it published their confidential list of genes associated with amyotrophic lateral sclerosis and Alzheimer's disease. Genervon decided to share its research findings in hopes that neurological researchers will go beyond the single target drug development paradigm. Genervon researchers discovered a critical regulator of the human nervous system they called GM6, a small peptide delivered by injection. They spent more than 10 years developing it GM6, which demonstrated safety in preclinical studies, a phase I study and three phase II trials for ALS, Parkinson's disease and ischemic stroke.

Immune Pharmaceuticals Inc., of New York, intends to request a hearing before the Nasdaq listing qualifications staff panel to appeal a notification that Immune's securities are subject to delisting from the Nasdaq Capital Market. The company received a letter Jan. 4 stating its common stock has not maintained the $1 minimum bid requirement for continued listing. At the hearing, Immune will present its plan to regain compliance, and will commit to effect a reverse stock split, if necessary.

Ionis Pharmaceuticals Inc., of Carlsbad, Calif., and subsidiary Akcea Therapeutics, said they inked an exclusive, worldwide option and collaboration agreement with Novartis AG, of Basel, Switzerland, to develop and commercialize Akcea-APO(a)-LRx and Akcea-APOCIII-LRx. Under the terms, Ionis and Akcea are eligible to receive $225 million in near-term payments, including an immediate $75 million up-front option payment and a $100 million equity investment in Ionis, which equates to about 1.6 million shares at $61.30 per share. Ionis and Akcea are also eligible to receive a license fee as well as development, regulatory and commercial milestone payments as each drug advances. In addition, Ionis and Akcea are eligible to receive tiered royalties in the midteens to low 20 percent range on net sales of each drug. For each drug, upon option exercise, Novartis will pay Ionis and Akcea a $150 million license fee, will initiate a global phase III cardiovascular outcome study in a high-risk population and will be responsible for worldwide development and commercialization activities. Akcea retains the right to co-commercialize any successful drug through its specialty sales force. Ionis and Akcea are also eligible to receive up to $315 million and $265 million in development and regulatory milestone payments for Akcea-APO(a)-LRx and Akcea-APOCIII-LRx, respectively, as well as up to $285 million and $265 million in commercialization milestone payments, for each drug, respectively. Novartis has an obligation to make a further equity investment of $50 million in the next 18 months in either Ionis at the same premium as the initial investment or in Akcea. All told, the deal could exceed $1 billion.

Intas Pharmaceuticals Ltd., of Ahmedabad, India, through its wholly owned subsidiary Accord Healthcare Ltd., completed the deal to acquire Actavis UK Ltd. and Actavis Ireland Ltd. from Jerusalem-based Teva Pharmaceutical Industries Ltd., for £603 million (US$733.3 million) payable in cash. The transaction is part of the European Commission's anti-trust divestiture requirements arising from Teva's acquisition of Allergan's generics business.

Kite Pharma Inc., of Santa Monica, Calif., entered a strategic partnership with Daiichi Sankyo Co. Ltd., of Tokyo, for axicabtagene ciloleucel in Japan. The therapy uses a patient's T cells that are engineered to express a chimeric antigen receptor to target the antigen CD19, a protein expressed on the cell surface of B-cell lymphomas and leukemias, and redirect the T cells to kill cancer cells. Daiichi Sankyo will be responsible for development and commercialization in Japan, and will make a $50 million up-front payment, plus development and commercial milestone payments of up to $200 million. Kite also is eligible for low to mid double-digit sales royalties, and retains all development and commercialization rights outside of Japan. In separate news, Kite formed a joint venture with Chinese company Shanghai Fosun Pharmaceutical (Group) Co. Ltd. to form Fosun Pharma Kite Biotechnology Co. Ltd. to develop, manufacture and commercialize axicabtagene ciloleucel in China with the option to include additional products, including two T-cell receptor product candidates from Kite. The joint venture will be registered in Shanghai and owned equally between Kite and Fosun, which will provide $20 million in funding to support activities. They will share in profits with Kite receiving 40 percent and Fosun receiving 60 percent. Kite also will receive a $40 million up-front fee from the joint venture, plus regulatory and commercial milestones totaling $35 million and mid-single digit sales royalties.

Merck KGaA, of Darmstadt, Germany, is expanding its end-to-end biodevelopment centers to meet increasing customer demand for its portfolio of bioprocessing products, manufacturing capabilities and technological expertise. The expansion includes the opening of two new process development centers in the U.S. and China, close to Boston and Shanghai customers. They will provide cell line development services, upstream and downstream process development, as well as non-GMP clinical production.

Neurovive Pharmaceutical AB, of Lund, Sweden, signed a collaboration agreement with Karolinska Institutet in Stockholm regarding development of NV556 to treat mitochondrial myopathy. A team led by Håkan Westerblad at Karolinska will study Neurovive's cyclophilin inhibitor and its effects in experimental models. NV556 is expected to have higher specificity and tolerability than ciclosporin, another cyclophilin inhibitor studied by Karolinska researchers.

Novo Nordisk A/S, of Bagsværd, Denmark, said the EC approved marketing authorization in all 28 EU member states for Fiasp to treat diabetes in adults. Fiasp is a fast-acting mealtime insulin and will be available in vials, Penfill, and Flextouch pens. The company anticipates launching the product in the first European countries in the first half of this year.

Protea Biosciences Group Inc., of Morgantown, W. Va., said it inked a co-marketing agreement with Mattek Corp., of Ashland, Mass., which will permit Protea to use Mattek's human cell-based in vitro tissue models with Protea's molecular imaging services. Mattek is involved in tissue engineering and a producer of 3-D reconstructed human tissue models. The two companies said they plan to present data together at the Society for Investigative Dermatology conference in Portland, Ore., in April.

PTC Therapeutics Inc., of South Plainfield, N.J., said the EC has granted annual renewal of conditional marketing authorization for Translarna (ataluren). The decision was based on the Committee for Medicinal Products for Human Use's recommendation, and will allow PTC to market Translarna to treat nonsense mutation Duchenne muscular dystrophy in ambulatory patients 5 and older in all EU member states, plus Iceland, Liechtenstein and Norway.

Servier Canada Inc., of Laval, Quebec, part of the Servier Research Group, said Health Canada issued a notice of compliance for Lancora (ivabradine) as a treatment to reduce hospitalizations and mortality in those with chronic heart failure. The drug's approval was based Servier's development program, which includes the SHIFT trial, which studied 6,505 heart failure patients with elevated heart rate.

Viracyte LLC, of Houston, said Viralym-C, its T-cell immunotherapy for cytomegalovirus infections following stem cell transplants, has been given fast track designation by the FDA. The company presented data from a phase I study of Viralym-C to the American Society of Hematology Annual Meeting in December 2016.

Ziopharm Oncology Inc., of Boston, and Intrexon Corp., of Germantown, Md., reported that they signed a Cooperative Research and Development Agreement with the National Cancer Institute to develop genetically modified adoptive cell transfer-based immunotherapies via the Sleeping Beauty (SB) transposon-transposase system. The SB transposon-transposase is a platform that introduces genes encoding chimeric antigen receptors and TCRs into lymphocytes.