Amgen submits evolocumab BLA
Amgen Inc. (NASDAQ:AMGN) submitted a BLA to FDA for evolocumab (AMG 145), a human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9), to treat high cholesterol. The application -- the first in the U.S. for a PCSK9 program -- includes data from 10 Phase III trials. Separately, Amgen said evolocumab plus a statin met the co-primary endpoints vs. placebo in the Japanese Phase III YUKAWA-2 trial, which enrolled 404 patients with high cardiovascular risk and high cholesterol. Amgen said it plans to submit a regulatory application in the EU this quarter, with a submission in Japan slated for next year.
NICE requests Jardiance cost effectiveness data
The U.K.'s NICE issued draft guidance concerning the cost effectiveness of Type II diabetes drug Jardiance empagliflozin (BI-10773) from partners Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (NYSE:LLY).
Luye buys majority stake in Beijing Jialin
Luye Pharma Group Ltd. (HKSE:2186) will acquire a 58% stake in Beijing Jialin Pharmaceutical Co. Ltd. from Beijing Jialin shareholders Mylin Holding Group Co. Ltd. (Beijing, China) and Beijing CITIC in a tranched RMB3.7 billion ($599 million) cash deal. Mylin will ask the other Beijing Jialin shareholders to sell Luye their remaining 42% interest.
China approves BTG's DC Bead
BTG plc (LSE:BTG) and SciClone Pharmaceuticals Inc. (NASDAQ:SCLN) said the China Food and Drug Administration (CFDA) approved BTG's DC Bead to treat patients with malignant hypervascularized tumors like hepatocellular carcinoma (HCC). DC Bead is a drug-eluting bead for controlled release of doxorubicin or irinotecan. SciClone has exclusive Chinese commercialization rights to the product.
Roche, Chugai amend licensing deal
Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said it and majority owner Roche (SIX:ROG; OTCQX:RHHBY) amended an agreement covering the geographic regions and timing of Roche's first refusal rights to Chugai compounds. Under the amended deal, Roche has worldwide first refusal rights to Chugai compounds, excluding Japan, South Korea and Taiwan. The pharma also will have first refusal rights to Chugai compounds at early proof of concept. The companies did not change Chugai's right of first refusal to Roche's products in Japan.
POLITICS & POLICY
NHS boosts U.K. cancer fund
NHS England said it will provide the Cancer Drugs Fund (CDF) with an additional L160 million ($265.1 million) over two years. The fund is intended to give patients access to drugs that would not otherwise be available on the NHS.
Court upholds HRSA's 340B Orphan interpretive rule
The U.S. District Court for the District of Columbia upheld an interpretive rule allowing discounts for Orphan drugs under Medicare's 340B program when used for non-Orphan indications. The Pharmaceutical Research and Manufacturers of America (PhRMA) had asked the court to vacate the rule, which was issued in July by HHS's Health Resources and Services Administration (HRSA).
PhRMA, BIO criticize FDA's journal guidance
The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization voiced concerns about FDA's June draft guidance on how companies can distribute journal articles that discuss new risk information for approved products.
Repros jumps on Phase III Androxal data
Repros Therapeutics Inc. (NASDAQ:RPRX) jumped $3.37 (19%) to $21.58 on Thursday after reporting data from the Phase III ZA-305 trial of Androxal enclomiphene to treat secondary hypogonadism. In the trial, 65.9% of patients receiving Androxal achieved a 24-hour average testosterone level in the normal range with a mean sperm concentration of 10 million/mL or greater -- a co-primary endpoint -- vs. 33.3% for AndroGel 1.62% testosterone gel from AbbVie Inc. (NYSE:ABBV) (p=0.0047) and 7.3% for placebo (p<0.0001).
GSK/NIAID Ebola vaccine gets grant for trials
The Wellcome Trust, the Medical Research Council and the U.K.'s Department for International Development provided a L2.8 million ($4.6 million) grant to fund trials of an Ebola vaccine candidate from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and NIH's National Institute of Allergy and Infectious Diseases (NIAID). The candidate is based on chimp adenovirus type 3 (ChAd3), an attenuated strain of chimpanzee cold virus.
FDA lifts partial hold on OncoMed's vantictumab
OncoMed Pharmaceuticals Inc. (NASDAQ:OMED) said FDA lifted a partial hold on the company's Phase Ib trials of vantictumab (OMP-18R5), a human HuCAL mAb targeting the Wnt signaling pathway. The agency placed the hold after the company halted the trial due to mild to moderate bone-related adverse events. According to OncoMed, FDA lifted the partial hold following a review of safety and efficacy data and revised study protocols submitted by the company with modified dosing regimens, risk mitigation measures, and modified enrollment criteria. OncoMed said FDA's partial hold of Fzd8-Fc (OMP-54F28), which also targets the Wnt pathway, is still in place.
Orexo raising private placement
Orexo AB (SSE:ORX; OTCQX:ORXOY) is raising an undisclosed amount in a private placement with Swedish and international institutional and strategic investors. Danske Bank is the sole lead manager and bookrunner.