Top news
* AstraZeneca PLC and Merck & Co. Inc. said a late-stage study showed Lynparza, or olaparib, when added to standard-of-care bevacizumab and used as an initial maintenance treatment, significantly extended the lives of certain women with ovarian cancer while keeping their disease at bay. The phase 3 trial, dubbed Paola-1, evaluated women with advanced ovarian cancer, with or without mutations in the BRCA1 and BRCA2 genes.
* Canadian health officials and various stakeholders launched an effort this week to devise a strategy to protect the nation's drug supply from being depleted by Americans seeking cheaper prescription medicines if two importation pathways conceived by the Trump administration are ever implemented.
Health Minister Ginette Petitpas Taylor said she convened a roundtable discussion in Ottawa on Aug. 12 with a broad coalition of players, including pharmacists, patients, physicians, industry representatives and policy experts, to mull over ideas for addressing U.S. President Donald Trump's plans to import drugs.
"Participants expressed their appreciation to the minister for swiftly convening the group and shared their perspectives on the importance of consistent patient access to prescription drugs, as well as their concerns about anything that could lead to or worsen drug shortages in Canada," Alexander Cohen, press secretary for Petitpas Taylor, told S&P Global Market Intelligence in an emailed statement.
* At least three healthcare companies have delayed or canceled plans to list on the Hong Kong Stock Exchange in the past five months amid rising market uncertainty. Financial market sentiment is being weighed down mainly by an escalation in U.S.-China trade tensions, slowing economic growth and volatile exchange rates, experts said. Local protests that started in June against a controversial bill permitting extraditions to China are also making investors wary about capital markets, S&P Global Market Intelligence reports.
On the policy front
* The U.S. Preventive Services Task Force, an independent panel of experts in disease prevention and evidence-based medicine, recommended screening for illicit drug use, including opioid painkillers, in all adults age 18 years or older regardless of risk factors. In its draft statement, the task force said screening should be implemented when services for accurate diagnosis, effective treatment and appropriate care can be offered or referred. The recommendation does not cover adolescents due to insufficient data to assess whether screening is beneficial for this age group.
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* Drug companies are feeling the pinch as Congress attempts to close the Medicare prescription drug coverage gap, known to industry insiders as the "doughnut hole." The 2018 U.S. congressional budget increased discounts that are paid by drug manufacturers in order to reduce certain patients' out-of-pocket payments.
Executives at several of the largest pharmaceutical companies in the world said during their second-quarter earnings calls that the change in the Medicare payment paradigm requiring they provide heftier discounts has led to lost profits and slower growth. The section of Medicare that covers branded prescription drugs is called Part D.
Drug and product pipeline
* Deciphera Pharmaceuticals Inc.'s stock price jumped Aug. 13 after the company said it will seek U.S. approval of its cancer medicine ripretinib based on the results of a clinical trial released the same day. The application is based on a phase 3 trial, called Invictus, in which ripretinib significantly extended survival in patients with advanced gastrointestinal stromal tumors without their disease worsening.
Operational activity
* Coloplast A/S said its pretax profit for the fiscal third quarter rose 12.5% year over year and confirmed its revenue outlook for the fiscal year. Pretax profit totaled 1.39 billion Danish kroner, up from 1.23 billion kroner in the year-earlier period. EPS came in at 5.02 kroner, a gain of 12.3% from 4.47 kroner in the prior-year period.
* South African drugmaker Aspen Pharmacare Holdings Ltd. agreed to pay £8 million to the U.K.'s National Health Service following a probe by the U.K. Competition and Markets Authority into suspected anti-competitive practices that raised the cost of life-saving fludrocortisone acetate tablets, used for treating Addison's disease. The investigation found that Aspen reached a deal with two rival companies to remain the sole supplier of fludrocortisone and increase the drug's prices.
* Elanco Animal Health Inc. posted a 3% increase in core revenue growth to $754 million in its fourth quarter as an independent entity, led by new product launches and recent pipeline-expanding deals across the companion animal and livestock categories. Amid rumors that Elanco is eyeing a purchase of Bayer AG's animal health unit, executives declined to confirm a deal during an Aug. 13 earnings call.
* CSL Ltd.'s net profit after tax for the fiscal year ended June 30 was about US$1.92 billion on a reported basis, or US$4.24 per share, up from US$1.73 billion, or US$3.82 per share, in the year-ago period. For the fiscal year 2020, the Australia-based biotechnology company expects its net profit after tax to be in the range of US$2.05 billion to US$2.11 billion.
* Novartis AG sold the rights to CDZ173 — which is being developed in the late stage to treat activated phosphoinositide 3-kinase delta syndrome, a rare, genetic immunodeficiency disease — to Pharming Group NV for $20 million up front. If approved, the drug is expected to reach the market in the second half of 2021 or the first half of 2022.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng ticked 0.08% higher to 25,302.28, while the Nikkei 225 gained 0.98% to 20,655.13.
In Europe, around midday, the FTSE 100 fell 0.97% to 7,180.47, and the Euronext 100 dropped 1.25% to 1,028.66.
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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