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AstraZeneca cancer drug gets FDA nod; Gilead wins reversal of $2.54B verdict

Top news

* The U.S. Food and Drug Administration approved AstraZeneca PLC's Imfinzi, or durvalumab, as the first drug to reduce the risk of cancer progression among certain patients with stage 3 non-small cell lung cancer.

* A federal judge in Delaware ruled that Gilead Sciences Inc. no longer has to pay Merck & Co. Inc. a record $2.54 billion in damages, reversing a federal jury decision that said Gilead's blockbuster hepatitis C therapies Sovaldi and Harvoni infringed a Merck patent, Reuters reported.

M&A and capital markets

* Switzerland-based Novartis AG is planning to kick off an auction process for its U.S. generic pill business, Reuters reported, citing anonymous sources. The move could pave the way for a potential $1.6 billion sale of the unit, which has been struggling due to competition in pricing.

* Stada Arzneimittel AG is planning acquisitions of niche drug producers in central and eastern Europe in a bid to reduce costs and bolster regional sales growth, Ronald Seeliger, the company's regional chief, told Bloomberg News.

* Hybrigenics SA sold its Helixio genomic services unit to employees and managers in a management buyout, as part of the Paris-based biopharmaceutical company's strategic refocusing on biopharma research and development.

* German conglomerate Siemens AG said it expects to complete the planned IPO of its Healthineers unit on the Frankfurt Stock Exchange in the first half of the year, subject to market conditions.

* Arcus Biosciences Inc. plans to offer up to $100 million of its common shares in an IPO on the New York Stock Exchange.

Drug and product pipeline

* AbbVie Inc. reported additional positive data from two phase 3 studies of risankizumab in chronic plaque psoriasis, an inflammatory skin disorder.

* AbbVie also reported new positive data from a phase 2b study on upadacitinib in atopic dermatitis, a chronic inflammatory skin disease.

* Meanwhile, Celgene Corp. said Otezla reduced oral ulcers significantly better than placebo, meeting its main goal in a phase 3 trial in Behcet's disease — a rare, chronic, multi-system inflammatory syndrome.

Other features

* Newly minted Novartis CEO Vasant Narasimhan is facing "looming questions" about the Swiss pharmaceutical giant's Alcon eyecare unit and the U.S. arm of its Sandoz generics division, The Wall Street Journal wrote.

* Roche Holding AG announced acquisitions of three technology companies in the past eight months — the latest of which was the $1.9 billion deal for Flatiron Health Inc. — to gain access to patient databases and improve drug research, Bloomberg noted.

* Recent data from the U.S. Centers for Disease Control and Prevention showed that the percentage of Americans visiting a doctor for an influenza-like illness declined to 7.5% last week from a 7.7% rate in the week ending Feb. 3, marking the first week-by-week drop since the severe flu season started, STAT reported.

* FierceBiotech highlighted the challenge that researchers may face in using CRISPR technology to treat blood disorders, as a Rice University-led team repaired the sickle cell mutation in up to 40% of stem cells from affected individuals.

The day ahead

U.S. markets are closed for the President's Day holiday

In Asia, the Hang Seng was up 1.97% to 31,115.43. The Nikkei 225 climbed 1.97% to 22,149.21.

In Europe as of midday, the FTSE 100 slid 0.14% to 7,284.37, and the Euronext 100 was down 0.08% to 1,020.20.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.