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Merck & Co. raises FY'18 outlook; AstraZeneca drops thyroid cancer drug trial

Top news

* Merck & Co. Inc., maker of the blockbuster cancer drug Keytruda, reported second-quarter non-GAAP net income $2.85 billion, or $1.06 per share, a year-over-year increase from $2.78 billion, or $1.01 per share. The Kenilworth, N.J.-based company raised its non-GAAP EPS guidance range for 2018, now expecting it to be between $4.22 and $4.30 compared to a range of $4.16 to $4.28 previously.

* AbbVie Inc. said second-quarter adjusted EPS rose year over year to $2.00 from $1.42. The biopharmaceutical company raised its guidance for full year 2018 and now expects EPS to be between $7.76 and $7.86 from the previous range of $7.66 to $7.76.

* AstraZeneca PLC said it was dropping a late-stage trial for its experimental cancer drug selumetinib as it did not meet the main goal in a thyroid cancer study. "Our ambition now with selumetinib is getting it approved in the unmet medical need of neurofibromatosis type 1," said Sean Bohen, chief medical officer and executive vice president of global medicines development, during the U.K. drugmaker's second-quarter earnings call.

* Outgoing HSBC Holdings Plc CFO Iain Mackay is leading the race to take over as GlaxoSmithKline PLC's new finance chief, Sky News reported. GSK CFO Simon Dingemans, who joined the British drugmaker in 2011 from Goldman Sachs, is set to step down in 2019.

* Amgen Inc. raised its EPS outlook for 2018 after its second-quarter earnings rose year over year to $2.53 billion, or $3.83 per share. The biotechnology company expects GAAP EPS for 2018 to be between $11.83 and $12.62, up from the previous outlook range of $11.30 to $12.28.

* Tokyo-based Astellas Pharma Inc. said its core profit for the first quarter ended June 30 grew 35.5% year over year to ¥70.35 billion.

On the policy front

* The European Medicines Agency is being asked to pay some £500 million in lease charges even as the drug regulator is set to transfer its headquarters to Amsterdam when the U.K. leaves the EU, Reuters reported. Property owner Canary Wharf T1 Ltd. is asking a court to enforce the lease, the contract of which spans a 25-year rent.

* The U.K. is allowing doctors to prescribe medical cannabis for the first time by the autumn, The Daily Telegraph wrote. Home Secretary Sajid Javid said the decision follows advice from the Chief Medical Officer and the Advisory Council on the Misuse of Drugs, prompted by the case of Billy Caldwell, a severely epileptic child, who made headlines and gained public support after being denied access to cannabis oil.

* In a speech at the conservative Heritage Foundation, U.S. Health and Human Services Secretary Alex Azar criticized backers of "Medicare for all" yesterday, saying Medicare is "running out of other people's money," The New York Times reported. Seema Verma, administrator of the Centers for Medicare and Medicaid Services, on Wednesday lambasted the campaign during a speech at the Commonwealth Club in San Francisco, saying offering Medicare to every American would "run the risk of depriving seniors of the coverage."

Meanwhile, Sen. Bernie Sanders of Vermont, the most prominent champion of "Medicare for all," dismissed the criticism, saying: "Medicare has worked extremely well for our nation's seniors and will work equally well for all Americans."

Drug and product pipeline

* 60° Pharmaceuticals LLC said the U.S. Food and Drug Administration's Antimicrobial Drugs Advisory Committee backed the company's malaria prevention medicine, tafenoquine. The drug will be sold as Arakoda.

Operational activity

* Amgen said its research and development head Sean Harper will retire and pursue opportunities in early stage biotechnology. Meanwhile, Anthony Hooper, the executive vice president of global commercial operations, will also be retiring.

* AstraZeneca is producing at full capacity its breast and prostate cancer therapy, Zoladex, as part of contingency plans ahead of Brexit, CEO Pascal Soriot told Bloomberg News.

* Speaking to reporters, Soriot said AstraZeneca is not raising its drug prices for the remainder of the year after U.S. President Donald Trump blasted drug manufacturers over the high cost of medicines, Reuters wrote.

* Amgen CEO Robert Bradway also pledged during the company's second-quarter earnings call that the company will maintain drug prices for the rest of the year, Reuters noted.

* Grifols SA said adjusted group profit for the first half grew 7.8% year over year to €355.9 million from €330.2 million. The Spanish biotechnology company, which produces plasma-derived medicines, booked net revenue of €2.12 billion, down from €2.19 billion a year ago.

* Celgene Corp. reported second-quarter adjusted net income of $1.59 billion, or $2.16 per share, compared to $1.51 billion, or $1.87 per share, a year earlier. For the full year 2018, the company expects adjusted EPS to be in the range of $8.70 to $8.75, compared to its previous guidance of about $8.45.

* Omeros Corp. resolved the last of a group of patent infringement lawsuits over its cataract surgery drug Omidria.

Our features

Roche lifts 2018 outlook as new medicines help to offset patent expiries in H1: Roche Holding AG raised full-year guidance on the back of strong sales for a swathe of its new medicines, which are helping to offset the impending patent cliff it faces when Herceptin loses exclusivity, starting in the second half of 2018 in Europe.

Bristol-Myers banks on Opdivo as EU regulators caution renal cancer application: Bristol-Myers Squibb Co. posted strong results owing to its immuno-oncology franchise during the quarter, even as European regulators gave pause over using the drug in combination to treat front-line renal cancer.

AstraZeneca CEO sees China leapfrogging Europe with strong drug sales growth: AstraZeneca forecast that China will overtake Europe as a pharmaceutical market, as the U.K. company continues to benefit from advancing sales in the region thanks to a combination of government investment and a faster regulatory process.

Amgen readies migraine drug launch ahead of copycat competition for Neulasta: The Thousand Oaks, Calif.-based drugmaker is offering free trials to provide a strong launch pad for its new migraine drug Aimovig as it prepares to compete with a copy of its blockbuster drug Neulasta.

Celgene CEO says M&A remains 'top priority,' updates drug pricing principles: CFO Peter Kellogg said the company continues to support growing its pipeline with M&A and business development investments and has deployed over $10 billion on M&A and business development year-to-date.

Allergan CEO: no 'fire sale' for women's health, infectious disease units: Allergan PLC is letting go of its women's health and infectious disease units to focus on its four core therapeutic areas — medical aesthetics, central nervous system, eye care and gastroenterology.

The day ahead

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

In Asia, the Hang Seng increased 0.08% to 28,804.28, and the Nikkei 225 rose 0.56% to 22,712.75.

In Europe, around midday, the FTSE 100 was up 0.58% to 7,707.50, and the Euronext 100 was up 0.24% to 1,078.64.

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