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Senate passes FDA, right-to-try bills; NICE backs Celgene's cancer drug


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Senate passes FDA, right-to-try bills; NICE backs Celgene's cancer drug

* The U.S. Senate approved a must-pass bill aimed at renewing the U.S. Food and Drug Administration's authority to collect user fees from drugmakers — funds the agency relies on for more than half its budget.

* The Senate also approved the "right-to-try" bill to allow terminally ill patients or those "with a life-threatening disease or condition" to use experimental treatments that have not yet received FDA approval, The Wall Street Journal wrote.

* Meanwhile, John Jenkins, the former head of the FDA's Office of New Drugs, criticized Janet Woodcock, chief of the FDA's Center for Drug Evaluation and Research, for potential bias in her decision to overrule the FDA review team and approve Sarepta Therapeutics Inc.'s Duchenne muscular dystrophy treatment eteplirsen in 2016, the Journal reported. Endpoints News also has a report.

M&A and capital markets

* Bristol-Myers Squibb Co. agreed to acquire IFM Therapeutics, a venture-backed biotech company focused on developing therapies to treat cancer, autoimmunity and inflammatory disorders. Bristol-Myers Squibb will pay $300 million upon closing of the deal.

* Lonza Group Ltd. acquired Switzerland-based Micro-Macinazione SA, a provider of micronization services and equipment for the pharmaceutical and fine chemical sectors. Financial details of the transaction were not disclosed.

* Spark Therapeutics Inc. priced an offering of 4,605,264 common shares at $76 apiece for expected net proceeds of about $330.8 million. The offering is expected to close Aug. 9.

Drug and product pipeline

* The U.K.'s National Institute for Health and Care Excellence recommended Celgene Corp.'s pancreatic cancer drug Abraxane for routine use in the National Health Service after the company agreed to give a confidential price discount and provided more evidence on the drug's effectiveness.

* A diabetes drug sold by AstraZeneca PLC may possess properties to change the course of Parkinson's disease and not just alleviate the symptoms, according to a study led by University College London and funded by The Michael J. Fox Foundation for Parkinson's Research.

* The U.S. FDA approved AbbVie Inc.'s Mavyret, a combination of glecaprevir and pibrentasvir, to treat all six major genotypes of chronic hepatitis C. Glecaprevir is being developed by AbbVie and Enanta Pharmaceuticals Inc.

* The U.S. FDA's Arthritis Advisory Committee recommends approval of Pfizer Inc.'s Xeljanz to treat adults with active psoriatic arthritis.

Operational activity

* Some of the biggest U.S. retail pharmacies, including Wal-Mart Stores Inc. and Walgreens Boots Alliance Inc., are deepening alliances with generic drug distributors, driving down costs at a faster pace. The partnerships will likely benefit the retail pharmacies more than their partner manufacturers and distributors, industry experts told Reuters.

* AbbVie Inc. filed a patent lawsuit alleging a potential biosimilar by Boehringer Ingelheim Corp. will infringe on its blockbuster drug Humira.

* GlaxoSmithKline plc is closing its Neuroscience R&D Center in Shanghai and moving key programs to its global R&D hub in Pennsylvania as a result of a portfolio review and prioritization, Endpoints News wrote. FierceBiotech also has a report.

* Moody's downgraded Teva Pharmaceutical Industries Ltd. by one notch, citing concerns over its U.S. generics business and the threat of generic competition for its multiple sclerosis treatment Copaxone. The company's senior unsecured rating now stands at Baa3.

The day ahead

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

In Asia, the Hang Seng increased 0.12% to 27,562.68, while the Nikkei 225 declined 0.38% to 19,952.33.

In Europe, around midday, the FTSE 100 was up 0.09% to 7,481.22, and the Euronext 100 was up 0.01% to 1,001.41.

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Shire is 'firing on all cylinders' says CEO as he mulls ADHD spinoff: Shire CEO Flemming Ørnskov said he may float the group's flagship neuroscience business, which is built on its attention deficit hyperactivity disorder franchise.

Teva's US generic business hit hard by buyer negotiations; shares drop: Teva Pharmaceutical Industries did not anticipate the pressure that consolidated U.S. generic drug buyers would exert this year, executives said on the company's second-quarter earnings call.

Regeneron buoyed by blindness drug as it pushes new product launches: Regeneron Pharmaceuticals' dominance in the age-related blindness market was maintained in the second quarter, balancing launch efforts and an uptake lag for newer drugs.

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