Rigel Pharmaceuticals announced that the FDA approved TAVALISSE™ (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. https://www.prnewswire.com/news-releases/rigel-announces-fda-approval-of-tavalisse-fostamatinib-disodium-hexahydrate-for-chronic-immune-thrombocytopenia-itp-in-adult-patients-300631702.html
Ultragenyx and Kyowa Kirin announced FDA approval of Crysvita® (burosumab-twza) for the treatment of children and adults with X–Linked Hypophosphatemia http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-and-kyowa-kirin-announce-fda-approval-crysvitar
Bristol-Myers Squibb announced that Opdivo (nivolumab) plus Yervoy (ipilimumab) (injections for intravenous use) was approved by the FDA as the first Immuno-Oncology combination therapy for previously untreated patients with intermediate- and poor-risk advanced renal cell carcinoma. http://www.wlns.com/ap-top-news/us-food-and-drug-administration-approves-opdivo-nivolumab-yervoy-ipilimumab-combination-as/1125893981
In a related story, the FDA has also granted a priority review to BMS’s sBLA for Opdivo (nivolumab) for the treatment of patients with small cell lung cancer with disease progression following 2 or more lines of therapy. https://www.onclive.com/web-exclusives/fda-grants-nivolumab-priority-review-for-sclc
In a stunning about face, the FDA is now welcoming the NDA from Alkermes which it rejected two weeks ago. This comes after the company clarified certain aspects of the NDA submission while no additional data or analyses were submitted. https://endpts.com/in-a-stunning-about-face-the-fda-is-now-welcoming-the-new-drug-application-from-alkermes-it-rejected-2-weeks-ago/?utm
GW Pharmaceuticals’ lead cannabis-based drug picked up a clear endorsement from regulators at CDER. https://endpts.com/gw-pharmas-cannabis-based-drug-appears-poised-for-a-groundbreaking-fda-approval-as-internal-review-offers-a-clear-thumbs-up/?utm
Solid Bio has cleared a partial hold, but its Duchenne muscular dystrophy gene therapy trial is still on hold for safety concerns https://www.fiercebiotech.com/biotech/solid-bio-clears-partial-hold-but-dmd-gene-therapy-trial-still-hold
FDA Commissioner Scott Gottlieb told a House Appropriations subcommittee that the agency plans to “sharply increase” its release of disease-focused guidance documents to help drugmakers develop new treatments. https://endpts.com/fda-chief-scott-gottlieb-promises-to-streamline-drug-development-pathway-for-biopharma/?utm
In other news…
After weeks of rumors, Takeda has made an official $60 billion bid to acquire Shire which was rejected. Today Takeda announced an improved offer https://www.wsj.com/articles/takeda-returns-to-drug-rival-shire-with-fresh-takeover-proposal-1524233934
Shire announced an agreement to divest its oncology business to Servier for $2.4 billion in cash. http://www.firstwordpharma.com/node/1556968#axzz5Cpy43uHW
Arbutus Biopharma and Roivant Sciences announced that they have entered into an agreement to launch Genevant Sciences, a jointly-owned company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics. https://globenewswire.com/news-release/2018/04/11/1468874/0/en/Arbutus-and-Roivant-Launch-Genevant-Sciences-with-Industry-Leading-Platform-to-Develop-Broad-Range-of-RNA-Therapeutics-for-Genetic-Diseases.html
Seattle-based Kineta Chronic Pain signed a $359 million exclusive option and license deal with Genentech to develop Kineta’s alpha9/alpha10 nicotinic acetylcholine receptor antagonists. https://www.biospace.com/article/kineta-chronic-pain-inks-license-deal-with-genentech-for-over-359-million/?utm
With its lead “monoclonal microbial” about to be tested for the first time on a human, Evelo Biosciences believes that this is the right time to float a $100 million IPO. https://endpts.com/flagships-evelo-biosciences-pitches-100m-ipo-for-a-new-platform-of-monoclonal-microbials/?utm
Catabasis Pharmaceuticals is laying off 21 employees, or 42% of its staff, in a restructuring that will throw its resources behind its lead asset, the Duchenne muscular dystrophy drug edasalonexent. https://www.fiercebiotech.com/biotech/catabasis-slashes-42-staff-to-focus-resources-edasalonexent?mkt
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