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Roche snaps up Ignyta; Celgene's Revlimid fails cancer trial

Top News

* Roche Holding AG is acquiring San Diego-based oncology company Ignyta Inc. for $27 per share in an all-cash deal valued at $1.7 billion. The transaction is expected to close in the first half of 2018.

* Celgene Corp.'s Revlimid, in combination with rituximab, failed to meet its primary goal in a phase 3 trial in patients with follicular lymphoma, a cancer of the white blood cells. Rituximab is sold by Roche as Rituxan or MabThera for treating chronic lymphocytic leukemia and various types of non-Hodgkin's lymphoma.

* Novartis AG's Kymriah, intended for treating a certain form of leukemia, and Gilead Sciences Inc.'s Yescarta, a non-Hodgkin's lymphoma treatment, are cost-effective, despite their high prices, according to the U.S. Institute for Clinical and Economic Review.

On the policy front

* About 8.8 million Americans signed up for Affordable Care Act plans through the platform for 2018, according to the Centers for Medicare & Medicaid Services. The enrollment figures showed a 4.4% decline from the previous year — a "healthy number" considering political uncertainty about the ACA's future, said Karen Pollitz, senior fellow at the Kaiser Family Foundation, Bloomberg News noted.

* Senate Majority Leader Mitch McConnell, R-Ky., told The Wall Street Journal that he was unlikely to bring up changes to Medicare or Social Security next year unless Democrats support them. House Speaker Paul Ryan, R-Wis., was hoping to make changes to entitlement programs as part of efforts to rein in government spending.

* U.S. states that have expanded their Medicaid programs under the ACA saw an increase in the number of cancer diagnoses, particularly those at early stages, a new study showed. Research from Indiana University suggests that public health insurance may increase cancer detection, which can lead to fewer cancer deaths and better outcomes for patients.

M&A and capital markets

* Pfizer Inc. priced at €1,208.34 a tender offer to buy back the company's outstanding €2 billion 5.750% notes due 2021. The company said as of 5 p.m. ET Dec. 20, €834 million, or about 41.7%, of the principal amount of the outstanding notes were bought back.

Drug and product pipeline

* Biogen Inc. and Eisai Co. Ltd.'s experimental drug targeting Alzheimer's patients, BAN2401, failed to meet the criteria of success in a phase 2 study. The failure was largely expected by investors given the study never stopped at any of the interim analyses and Eisai recently opted into Biogen's aducanumab, Mizuho Biotech analyst Salim Syed said in a research note.

* Johnson & Johnson secured a priority review from the U.S. Food and Drug Administration for apalutamide to treat men with nonmetastatic castration-resistant prostate cancer. There are no FDA-approved treatments for the condition.

* The FDA also granted priority review designation to Novartis AG's Tafinlar, in combination with Mekinist, for treating patients with stage 3 melanoma — a type of skin cancer — whose tumors express mutations BRAF V600E or BRAF V600K, after complete surgical resection.

* Furthermore, the FDA awarded breakthrough therapy status to Merck KGaA and Pfizer's Bavencio, or avelumab, in combination with Inlyta to treat advanced kidney cancer.

* Meanwhile, the FDA approved removal of the boxed warning from the label of AstraZeneca PLC's asthma treatment Symbicort regarding risks of hospitalization, intubation or death. The FDA also allowed updating the labels of GlaxoSmithKline plc's Advair Diskus, Advair HFA and Breo Ellipta; Teva Pharmaceutical Industries Ltd.'s Advair generic Airduo Respiclick; and Merck & Co. Inc.'s Dulera.

Operational activity

* Johnson & Johnson unit Janssen Biotech Inc. agreed to collaborate with units of China-based Genscript Biotech Corp. to develop a CAR-T cell drug candidate. Legend Biotech USA Inc. and Legend Biotech Ireland Ltd. will grant Janssen a worldwide license to jointly develop and commercialize the drug candidate in multiple myeloma for an upfront payment of $350 million, plus additional milestone payments.

* The Supreme Court of California ruled that consumers could sue brand-name drugmakers for failing to warn users about the risks of generic versions of their medicines, Reuters reported. The court's decision comes as a father of twin children filed a lawsuit against Novartis after his twins were diagnosed with developmental delays and autism caused by a generic version of Novartis' premature labor drug Brethine.

* U.S. District Judge Brian Martinotti in Trenton, N.J., said former Valeant Pharmaceuticals International Inc. CEO Michael Pearson should arbitrate his claim that the company owes him more than 3 million shares, instead of pursuing the case in court, Reuters wrote.

* North Carolina sued INSYS Therapeutics Inc. over its alleged role in the opioid crisis, Reuters reported. The lawsuit, filed by North Carolina Attorney General Josh Stein, claims the drugmaker illegally pushed its opioid painkiller Subsys to make more profit.

Other features

* Bloomberg highlights the increasing competition in the already "crowded" diabetes market as the FDA continues to approve more diabetes therapies, the most recent of which was Pfizer and Merck & Co.'s Steglatro.

* Analysts said generic drugmakers should brace for more pricing woes next year, but executives from the sector have an optimistic outlook for the industry, FiercePharma wrote.

* Investors and analysts will be keeping a closer look on data from immuno-oncology studies in 2018, as they become more wary of trial failures, FiercePharma reported.

* FierceBiotech presents an outlook for the biotech industry next year, including the positive impact on the sector of potentially faster regulatory routes in the U.S.

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