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Roche's Tecentriq, Hemlibra win trials; Novartis, AbbVie drugs get NICE nods


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Roche's Tecentriq, Hemlibra win trials; Novartis, AbbVie drugs get NICE nods

Top news

* Roche Holding AG's lung cancer drug Tecentriq showed improved survival for lung cancer patients that had not already received previous treatments. The phase 3 trial, in which the drug was tested in combination with Avastin and chemotherapy, showed that previously untreated patients with advanced nonsquamous non-small cell lung cancer who received the combination had a 38% reduced risk of their disease worsening or death.

Roche's hemophilia drug Hemlibra also showed clinically meaningful control of bleeding when given as a preventive treatment once every four weeks under a phase 3 trial.

* The U.K.'s National Institute for Health and Care Excellence, or NICE, recommended Novartis AG's Zykadia to treat adults with a form of non-small cell lung cancer. The recommendation was granted after Novartis agreed with NICE on a confidential discounted price.

The regulator also recommended AbbVie Inc.'s Maviret for treating adults with chronic hepatitis C. NICE said the treatment is an additional option suitable for all genotypes, whether they exhibit liver scarring or not, and in people who are untreated or have been given an interferon-based treatment.

* The number of people living with dementia is expected to triple from 50 million to 152 million by 2050, according to a report from the World Health Organization. About 60% to 70% of dementia cases are caused by Alzheimer's disease, for which there is no known cure.

On the policy front

* U.S. healthcare spending grew 4.3% in 2016, a slowdown from the two previous years as insurance enrollment and retail prescription drug costs plateaued, according to an analysis from the Office of the Actuary at the Centers for Medicare and Medicaid Services.

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* Moody's forecasts a 1% to 2% rise in EBITDA for the global pharmaceutical industry in 2018, expecting the oncology market to be the largest growth contributor. The agency also said the outlook for the global healthcare industry for 2018 is stable, and it expects healthcare to represent a growing part in the GDP of most countries.

M&A and capital markets

* Novartis started a cash tender offer to buy all of the outstanding ordinary shares of Advanced Accelerator Applications SA for $41 per ordinary share and $82 per American depositary share. Advanced Accelerator's board previously approved Novartis' takeover bid.

* Denali Therapeutics Inc. tweaked its previously announced IPO and is now planning to offer 13,888,888 common shares at an estimated price of between $17 and $19 per share.

Drug and product pipeline

* The U.S. Food and Drug Administration issued draft guidelines to simplify the development of drugs for rare pediatric diseases. The proposal, developed in collaboration with the European Medicines Agency, details an approach that could eliminate the need for certain clinical studies and reduce the numbers of patients required for trials.

* The U.S. FDA accepted Insys Therapeutics Inc.'s new drug application for a buprenorphine spray for treating moderate to severe acute pain.

* The FDA also granted rare pediatric disease designation for CTD Holdings Inc.'s Trappsol Cyclo, a potential treatment for Niemann-Pick type C.

* Acorda Therapeutics Inc. resubmitted its new drug application for its Parkinson's disease treatment Inbrija. The company said it addressed the issues raised by the regulator after its previous submission.

Operational activity

* Amgen Inc. entered a drug discovery collaboration with Carmot Therapeutics Inc. to find novel leads for Parkinson's and other diseases.

Other features

* Breast cancer risk was found to persist in newer birth control pills that were previously thought to improve safety for women taking them, Bloomberg News reported, citing a study published in the New England Journal of Medicine.

* Positive clinical trial results for Roche's lung cancer drug Tecentriq has company CEO Severin Schwan aiming for the lead in cancer immunotherapies, Reuters reported.

The day ahead

Early morning futures indicators pointed to a mixed opening for the U.S. market.

In Asia, the Hang Seng rose 0.28% to 28,303.19, and the Nikkei 225 was up 1.45% to 22,498.03.

In Europe, as of midday, the FTSE 100 climbed 0.12% to 7,356.88, and the Euronext 100 rose 0.04% to 1,040.58.

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