With Zejula (niraparib) well on its way to blockbuster status, Glaxosmithkline plc (GSK) paid a premium for the opportunity to pick up developer Tesaro Inc. in a deal valued at approximately $5.1 billion. But while Tesaro shares (NASDAQ:TSRO) spiked nearly to the proposed price of $75 per share – a 62 percent premium to Friday's closing price of $46.38 and a 110 percent premium to Tesaro's 30-day volume-weighted average price of $35.67 – GSK investors gave the transaction a chilly reception, pushing the stock (NYSE:GSK) down 7.8 percent to close at $38.61 for a loss of $3.26. Read More
DUBLIN – Shares in Argenx NV rose as much as 15 percent Monday on news of an oncology license agreement with the Cilag GmbH International arm of Johnson & Johnson involving its CD70-directed antibody cusatuzumab, in which it is receiving $300 million up front plus another $200 million as equity investment. Argenx could also receive up to $1.3 billion more in development, regulatory and sales milestones, while retaining the right to co-promote the drug in the U.S on a 50/50 basis. It would receive tiered double-digit royalties on ex-U.S. sales. Read More
Ocular Therapeutix Inc. said the therapeutic area has plenty of room for its newly approved Dextenza (dexamethasone ophthalmic insert) 0.4 mg for postoperative eye pain along with Eyepoint Pharmaceuticals Inc.'s single-dose, sustained-release, intracameral Dexycu (dexamethasone intraocular suspension) 9 percent, granted U.S. marketing clearance earlier this year for inflammation after surgery. Read More
LONDON – The EMA is continuing to work on the assumption of the U.K. being outside its regulatory ambit after Brexit on March 29, 2019, despite the EU and U.K. concluding negotiations on a withdrawal agreement that would open up a transition period until the end of 2020. Read More
SAN DIEGO – Results from the phase III randomized, double-blind, placebo-controlled BELIEVE and MEDALIST trials presented at the 60th American Society of Hematology (ASH) Annual Meeting over the weekend showed that the experimental red blood cell maturation drug luspatercept (Celgene Corp./Acceleron Pharma Inc.) reduced the need for transfusions in two different indications. Read More
SAN DIEGO – The dawn of regulator-approved chimeric antigen receptor (CAR) T-cell therapies such as Kymriah (tisagenlecleucel, Novartis AG) have provided doctors with important new options for treating people with several types of aggressive blood cancers. But how long the new therapies can help and whether their costs can be made sustainable remain open questions. New research presented at the American Society of Hematology (ASH) Annual Meeting and Exposition is shedding light on the duration question with what City of Hope's Joe Alvarnas called "practice-changing" results. Read More
SAN DIEGO – Imbruvica (ibrutinib) was first approved for second-line chronic lymphocytic leukemia (CLL) in 2014 by Janssen Biotech Inc. and Pharmacyclics Inc. based on overall response rate from a phase Ib/II study and then, later that year, with data from the phase III Resonate study where Imbruvica improved progression-free survival and overall survival compared to Arzerra (ofatumumab, Novartis AG). Read More
SAN DIEGO – Initial data from an ongoing phase I/II study of a CD19-directed CAR T-cell candidate under development at Celgene Corp. found that 81 percent of the 16 patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) treated so far responded to the medicine, with 43 percent of them demonstrating a complete response. The majority of patients evaluable for minimal residual disease (MRD), a measure that correlates with improved outcomes in the indication, achieved that state early on in their treatment. Read More
SAN DIEGO – Early data on an antibody-drug conjugate (ADC) under development at Immunogen Inc. drew attention during the American Society of Hematology (ASH) Annual Meeting and Exposition for its potential meaning to Jazz Pharmaceuticals plc, which has an option on the candidate and two other Immunogen ADC programs. Read More
SAN DIEGO – Incyte Corp.'s Jakafi (ruxolitinib), already approved for treating myelofibrosis (MF), polycythemia vera and thrombocythemia MF, could soon add steroid-refractory acute graft-vs.-host disease (GVHD) to its list of FDA-approved indications. If an upcoming FDA decision goes its way, it would be the first drug approved for acute GVHD in the U.S. The review, based on the phase II Reach1 study, is expected to yield a decision by Feb. 24. Read More
Allele Biotechnology and Pharmaceuticals Inc., of San Diego, is partnering with Scientist.com to develop nanoantibodies for therapeutic applications. Allele's recombinant, fully humanized, camelid single-domain heavy-chain only antibodies can be linked to produce multivalent new molecular entities. Read More
The EMA is revising its 12-year-old guideline on drug environmental risk assessments (ERAs), which are required to ensure that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken when specific risks are identified. Read More
Tactiva Therapeutics Inc., of Buffalo, N.Y., secured a $35 million series A financing and closed on the first tranche. Proceeds will be used to advance the clinical development of dual enhanced adoptive cell therapy (DEACT) platform for the treatment of multiple myeloma and several solid tumor type cancer indications. The financing was led by Panacea Ventures and included Vi Ventures and Efung Capital. Read More
