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Roche drug gets US nod for lung cancer; Gottlieb details FDA's funding demands

Top news

SNL Image
Scott Gottlieb
Source: U.S. Food and Drug
Administration

* Roche Holding AG said the U.S. Food and Drug Administration approved Tecentriq, combined with chemotherapy drugs carboplatin and etoposide, as a first-line treatment for adults with extensive-stage small cell lung cancer, a hard-to-treat type of the disease.

* Scott Gottlieb has laid out the U.S. FDA's funding demands to Congress for fiscal 2020 in greater detail, but with only weeks left as commissioner, he will not see whether any of the plans come to fruition. Gottlieb's temporary replacement, Ned Sharpless, the director of the U.S. National Cancer Institute, will guide the funding process for the FDA until a permanent commissioner is put in place — an action that may be several months away.

Gottlieb said the agency wants to spend the $6.1 billion the administration requested for the FDA to reduce the U.S. addiction crises — an epidemic that regulators' actions helped to spur. The FDA also plans to leverage innovation and competition for drugs and other medical treatments, empower consumers and patients to make better and more informed choices about their diets and health, and strengthen the agency's science and risk-based decision-making processes.

* The American College of Cardiology's annual scientific meeting, bringing together more than 16,600 attendees and 273 exhibitors, wrapped up March 18 following a weekend of cardiovascular results from studies around the world.

On the policy front

SNL Image

* The Medicare Payment Advisory Commission proposed that acute hospitals receive a 2.8% increase in payments for fiscal year 2020, with a portion of that payment rate increase going to a new quality program. Meanwhile, the Medicaid and CHIP Payment and Access Commission recommended that Congress slow down over $40 billion in payment reductions for disproportionate share hospitals, facilities that serve a large number of uninsured patients.

* In their March reports to Congress, a Medicare advisory group recommended a payment rate increase for acute care hospitals, and its counterpart on Medicaid recommended that lawmakers restructure billions of dollars in reimbursement reductions for hospitals with high amounts of uncompensated care.

* Ohio Attorney General Dave Yost filed charges alleging that UnitedHealth Group Inc. unit OptumRx overcharged the state nearly $16 million for medicines purchased by injured workers, who are insured under the Ohio Bureau of Workers' Compensation. Yost said the review into pharmacy benefit managers — the middlemen who negotiate drug prices for healthcare providers — is still ongoing. "These are the first raindrops, but there's a storm a-comin'."

M&A and capital markets

* China's CanSino Biologics Inc. plans to offer 57,248,600 H Shares as part of its Hong Kong IPO priced in the range of HK$21 to HK$22 per H share. The Tianjin-based vaccine developer expects to receive net proceeds of about HK$1.12 billion, assuming a per-share offer price of HK$21.50.

Drug and product pipeline

* AstraZeneca PLC said results from a sub-analysis of a late-stage trial of Farxiga, a medicine used to treat type 2 diabetes, showed it cut the likelihood of a cardiovascular event by 16% in high-risk patients and reduced the chances of hospitalization for heart failure in all patients with the disease.

* Building on results from September 2018, Amarin Corp. PLC's omega-3 fatty acid supplement Vascepa showed a reduction in the number of heart attacks in at-risk patients by 30%, based on new data from a clinical trial. Vascepa, which is derived from fish oil, is a prescription pill for heart disease patients with high levels of triglycerides who are already on statin therapy.

* Dermira Inc. said a mid-stage study of lebrikizumab met its main goal of treating skin among patients with atopic dermatitis, the most common and severe form of eczema. Dermira said it plans to move lebrikizumab to phase 3 clinical development by the end of 2019 following discussions with the U.S. FDA.

* Aerpio Pharmaceuticals Inc. said its medicine AKB-9778 did not improve the symptoms of diabetes-related vision loss, failing to meet the main goal of a mid-stage study. Aerpio evaluated AKB-9778 against placebo in 167 patients with moderate to severe nonproliferative diabetic retinopathy in a phase 2b trial dubbed Time-2b — the main goal of which was to see an improvement of two or more steps in the severity of the disease on a scoring system.

* Daiichi Sankyo Co. Ltd.'s Lixiana blood thinner showed low rates of clots and bleeding events in a late-stage clinical trial, meeting the main effectiveness and safety goals of the study. The phase 3b trial, dubbed Eliminate-AF, included about 600 European patients with atrial fibrillation — a condition in which the heart beats irregularly, raising the risk of deadly clots and stroke.

The day ahead

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

In Asia, the Hang Seng rose 0.19% to 29,466.28, while the Nikkei 225 fell 0.08% to 21,566.85.

In Europe, around midday, the FTSE 100 climbed 0.42% to 7,329.76, and the Euronext 100 lifted 0.66% to 1,055.98.

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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