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9:28 AM, Sep 21, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

NICE waivers on end of life exception for DLBCL CAR Ts, says Kymriah doesn't meet criteria

Inconsistencies between appraisals by U.K.'s NICE of CAR T therapies emerged Sept. 19 after the committee released draft guidance that said Kymriah tisagenlecleucel from Novartis AG (NYSE:NVS; SIX:NOVN) does not qualify as a life-extending treatment...
9:27 AM, Sep 21, 2018  |  BC Week In Review | Company News  |  Deals

Qiagen gets ex-U.S. commercialization rights to NeuMoDx's PCR systems

NeuMoDx Molecular Inc. (Ann Arbor, Mich.) granted Qiagen N.V. (Xetra:QIA; NYSE:QGEN) rights to commercialize NeuMoDx 288 and 96 PCR automation systems outside of the U.S., where NeuMoDx will commercialize the products. Qiagen, which holds about...
9:26 AM, Sep 21, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA wants extra trial for Pharming's Ruconest as HAE Prophylactic

Pharming Group N.V. (Euronext:PHARM) said FDA requested another clinical trial of Ruconest conestat alfa as a prophylactic for hereditary angioedema in a complete response letter for an sBLA in the indication. Pharming, which fell €0.20 (20%)...
9:25 AM, Sep 21, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA: No new safety concerns for Acadia's PD psychosis drug

Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) rose $4.01 (27%) to $19.11 on Sept. 20, adding more than $500 million in market cap, after an FDA safety review of the company's Nuplazid pimavanserin found postmarketing safety data were...
9:24 AM, Sep 21, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

Sorrento's Scilex launching ZTlido in October

Scilex Pharmaceuticals Inc. (San Diego, Calif.), a subsidiary of Sorrento Therapeutics Inc. (NASDAQ:SRNE), expects to launch ZTlido 1.8% lidocaine patch in October at a wholesale acquisition cost (WAC) of $8.98 per patch. FDA approved the...
1:31 PM, Sep 14, 2018  |  BC Week In Review | Company News  |  Other News

Acorda loses Amprya appeal, reports Inbrija PDUFA delay

Acorda Therapeutics Inc. (NASDAQ:ACOR) fell $10.30 (37%) to $17.25 the week of Sept. 10 following setbacks related to multiple sclerosis drug Ampyra dalfampridine and Parkinson's disease candidate Inbrija levodopa inhalation powder (CVT-301). On Sept. 10,...
1:01 PM, Sep 14, 2018  |  BC Week In Review | Company News  |  Deals

Fate gets license to Gladstone's stem cell tech

Fate Therapeutics Inc. (NASDAQ:FATE) obtained an exclusive license to IP from the Gladstone Institutes covering the generation of induced pluripotent stem cells (iPS cells) using CRISPR-mediated gene activation. Gladstone will receive $100,000 up front and...
12:49 PM, Sep 14, 2018  |  BC Week In Review | Company News  |  Other News

Telo, GSK targeting TERT to halt glioblastoma cell immortality

Telo Therapeutics Inc. (San Francisco, Calif.) is exploiting a partnership with GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to discover small molecules against an isoform of GABPB1, first identified as a cancer immortality target in a paper published...
12:32 PM, Sep 14, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Celltrion NDA for rituxan biosimilar awaits FDA panel discussion

FDA's Oncologic Drugs Advisory Committee will meet on Oct. 10 to review a resubmitted BLA for CT-P10 from Celltrion Inc. (KRX:068270), the company's biosimilar of Rituxan/MabThera rituximab. Celltrion resubmitted the BLA in May, two months after...
12:16 PM, Sep 14, 2018  |  BC Week In Review | Financial News  |  Other Financial News

Oberland closes $800M healthcare fund

Oberland Capital Management LLC (New York, N.Y.) closed the Oberland Capital Healthcare II fund with $800 million. The royalty and credit opportunities fund plans to make investments of $20-$150 million in commercial or near-commercial stage...

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