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US FDA, HHS plan 2 drug import pathways; Vertex Q2 net income rises 34% YOY

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US FDA, HHS plan 2 drug import pathways; Vertex Q2 net income rises 34% YOY

Top news

* The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration released an action plan that could allow states and pharmaceutical companies to import medicines from Canada and other countries. The action plan proposes two separate pathways: One could allow certain drugs to be imported only from Canada, while the other could allow companies to reimport any of their drugs from any country.

* Vertex Pharmaceuticals Inc.'s second-quarter non-GAAP net income totaled $327.0 million, or $1.26 per share, up 34% from $244.0 million, or 94 cents per share, in the year-ago period. Second-quarter revenue saw a 25% year-over-year increase to $940.0 million from $750.0 million.

* Healthcare companies are reporting results for the second quarter amid a flurry of megamergers, and Wall Street wants to know who is next. After all the M&A activity, few pharmaceutical executives have escaped their second-quarter earnings calls without being asked if they will execute the next megadeal. Unfortunately for the analysts searching for even a tiny hint as to who will be the next buyer or target, executives, including Eli Lilly and Co. CEO David Ricks and Merck & Co. Inc. CEO Ken Frazier, have so far stayed mum on the details.

* Goma, one of the Democratic Republic of Congo's densely populated cities, saw a second death due to Ebola after the patient sought delayed treatment, Reuters reported. The World Health Organization had already declared the Ebola crisis in the African country a public health emergency of international concern.

* A machine-learning algorithm developed by London-based DeepMind was able to predict the risk of acute kidney injury in patients about two days in advance, researchers said in a paper published in the journal Nature. The clinical data used in the study was collected by the U.S. Department of Veterans Affairs and transferred to DeepMind — a unit of Alphabet Inc., the parent company of Google LLC — in a de-identified format.

On the policy front

* The Centers for Medicare and Medicaid Services will increase Medicare payments to skilled nursing facilities for fiscal year 2020 by $851 million, or 2.4%. According to the July 30 finalized rule, the patient-driven payment model — a completely new payment system for nursing homes — will take effect Oct. 1. The finalized payment rate is slightly below the $887 million, or 2.5%, increase CMS proposed in April.

M&A and capital markets

* GlaxoSmithKline PLC and Pfizer Inc. completed the combination of their consumer health units, which is set to become the world's largest consumer health business. U.K.-based GSK will own about 68% of the combined entity, while the remaining 32% will be held by New York-based Pfizer.

* Chinese drugmaker Shenzhen Chipscreen Biosciences Co. Ltd. said its planned IPO on the STAR Market, Shanghai's new trading board, was oversubscribed by retail and individual investors, Reuters reported. The company has set the IPO price at 20.43 Chinese yuan per share.

Drug and product pipeline

* Aclaris Therapeutics Inc. medicine ATI-501 helped improve the severity of a hair loss disorder called alopecia areata and met the main goal of a phase 2 trial. However, the trial failed to meet some secondary goals.

Operational activity

* Takeda Pharmaceutical Co. Ltd. maintained an optimistic outlook for a type of plasma therapy known as Gammagard over the next quarter and highlighted the strong ongoing performance of cancer drug Ninlaro in China, after posting a loss for the fiscal first quarter ended June 30. Cancer and plasma treatments rank among the five main therapy areas for the Japanese drugmaker after acquiring Dublin-based Shire PLC.

* Germany's Bayer AG signed an agreement with Sensyne Health PLC to use the U.K.-based technology company's artificial intelligence platform to develop new treatments for cardiovascular disease.

* Sweden-based Alligator Bioscience AB (publ) will regain worldwide rights for ADC-1013, a cancer therapy it was developing in partnership with Johnson & Johnson's unit Janssen Biotech Inc. The companies terminated the 2015 agreement as Janssen Biotech decided to pursue other assets.

* Akorn Inc. will pay about $74 million to settle a class-action lawsuit, which, among other things, alleged that certain top executives of the company failed to disclose sooner the existence of investigations into data integrity at the company. Data integrity was an issue in the terminated acquisition of Akorn by German healthcare company Fresenius SE & Co. KGaA in 2018.

* Mylan NV, which is merging with Pfizer's unit Upjohn, had exercised an option in May to acquire a San Carlos, Calif.-based facility from Novartis AG that is engaged in manufacturing cystic fibrosis products, FiercePharma reported. Mylan received the option in 2018 when it bought certain cystic fibrosis assets from the Swiss drugmaker for about $463 million.

The day ahead

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

In Asia, the Hang Seng was down 1.31% to 27,777.75, and the Nikkei 225 fell 0.86% to 21,521.53.

In Europe, around midday, the FTSE 100 was down 0.60% to 7,601.13, and the Euronext 100 dipped 0.07% to 1,079.68.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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