Allergan plc, of Dublin, said the FDA approved Allergan's supplemental NDA to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa and Haemophilus influenzae in patients 18 years of age or older. The expanded use is based on positive results from a pivotal phase III study in adult HABP/VABP. The drug first won clearance in 2015 for use in combination with metronidazole for complicated intra-abdominal infections. (See BioWorld Today, Feb. 27, 2015.)
Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said the FDA accepted for filing its NDA for patisiran, an investigational RNAi therapeutic targeting transthyretin for the treatment of hereditary ATTR amyloidosis. The FDA also granted the company's request for priority review and has set a PDUFA action date of Aug. 11. At this time, the FDA is not planning to hold an advisory committee meeting to discuss this application, Alnylam said.
Anika Therapeutics Inc., of Bedford, Mass., said it entered an agreement with the Institute of Integrative Biology at the University of Liverpool to collaborate on research to develop an injectable mesenchymal stem cell therapy for the treatment of osteoarthritis.
Astellas Pharma Inc., of Tokyo, and Pfizer Inc., of New York, are committing a total of $10 million in support to a new independent research project by the Breast Cancer Research Foundation to advance understanding of the role of the androgen receptor in breast cancer. The support from Astellas and Pfizer will enable preclinical and clinical independent research of the companies' androgen-receptor (AR) inhibitor in breast cancer. The drug is jointly developed by both companies. Last year, the foundation convened leading breast cancer experts from around the world for a think tank discussion of ARs.
Canbridge Life Sciences Inc., of Beijing, said it has licensed the exclusive rights to develop and commercialize Nerlynx (neratinib) in China, Taiwan, Hong Kong and Macao (collectively, greater China) from Puma Biotechnology Inc., of Los Angeles. The drug received FDA approval in July for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy. (See BioWorld, July 19, 2017.)
Celgene Corp., of Summit, N.J., said its wholly owned subsidiary, Blue Magpie Corp., has begun its tender offer for all outstanding shares of common stock of Juno Therapeutics Inc., of Seattle, for $87 per share. The tender offer is being made in connection with an agreement and plan of merger. Celgene is offering $9 billion to take over Juno. The tender offer is scheduled to expire at midnight ET on March 2, 2018, unless extended or earlier terminated. (See BioWorld, Jan 23, 2018.)
Novartis AG, of Basel, Switzerland, completed its $3.9 billion tender offer for Advanced Accelerator Applications SA, of Saint-Genis-Pouilly, France, a deal that adds EU-approved neuroendocrine tumor therapy Lutathera (lutetium [177Lu] oxodotreotide) to the company's portfolio, as well as a new technology platform that Novartis said has potential applications across a number of early oncology development programs. (See BioWorld, Oct. 31, 2017, and Jan. 29, 2018.)
Portage Biotech Inc., of Toronto, said its wholly owned subsidiary, Portage Pharmaceuticals Ltd., has formed a new joint venture company, Portage Glasgow Ltd. (PGL), incorporated in Scotland, to develop more effectively targeted drugs to treat chronic conditions, including cancer. Portage Pharmaceuticals is providing an undisclosed funding to the new business along with a limited license to its Cellporter peptide delivery technology. The University of Glasgow is providing therapeutic peptides and access to a therapeutic peptide discovery platform. PGL will focus on the commercialization of new therapies aimed at disrupting protein-protein interactions for therapeutic benefit. Candidate peptides and targets have already been identified from existing research at the university, the company said.
Scholar Rock Inc., of Cambridge, Mass., said preclinical research published in Scientific Reports by company researchers demonstrates that inhibiting the activation of the latent precursor form of myostatin using monoclonal antibodies offers a potentially superior approach to address that therapeutic target. SRK-015, its lead drug candidate, binds to the myostatin precursor and avoids binding to closely related protein growth factors. By binding with high affinity to the myostatin precursor, SRK-015 blocks activation of myostatin, thereby preventing atrophy and promoting increased muscle mass and strength in preclinical models. SRK-015 is initially being developed by the company for the improvement of muscle strength and function in patients with spinal muscular atrophy with the treatment of additional neuromuscular diseases to follow.
Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, said the EMA accepted its marketing authorization application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide antibody, for the prevention of episodic and chronic migraine in adults. The MAA includes data from the company's HALO trial program, which enrolled more than 2,000 patients with episodic migraine and chronic migraine. Fremanezumab is also being investigated for the prevention of chronic and episodic cluster headache.