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Regeneron-Sanofi's Praluent gets EU nod; Apple Watch detects heart rate issues


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Regeneron-Sanofi's Praluent gets EU nod; Apple Watch detects heart rate issues

Top news

* Regeneron Pharmaceuticals Inc. and Sanofi's cholesterol drug Praluent received the European Commission's approval to reduce the risk of heart attacks and strokes in certain patients. The expanded approval allows Praluent to be used to reduce cardiovascular risk in patients with atherosclerotic cardiovascular disease by lowering low-density lipoprotein cholesterol levels — also known as bad cholesterol — one of the key factors responsible for cardiovascular disease.

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Apple Watch Series 3. Study participants used the Series 1, 2 or 3, while the Series 4 won U.S. Food and Drug Administration backing in September 2018.
Source: Apple

* Apple Inc.'s wearable technology can safely detect heart rate irregularities that could eventually lead to strokes, according to results from a trial funded by the tech giant. Preliminary findings from the Apple Heart Study — conducted by researchers from the Stanford University School of Medicine and including more than 400,000 participants — showed that the Apple Watch can identify irregular heartbeat that subsequent tests confirmed to be atrial fibrillation.

On the policy front

* Getting generic medicines to the U.S. market quicker was the sole topic at a March 13 hearing of the House Energy and Commerce Health Subcommittee, while Health and Human Services Secretary Alex Azar promoted the administration's efforts to lower drug prices as part of its fiscal 2020 budget plan during three other hearings. Among the administration's proposals is a plan to eliminate the safe harbor protections that allow pharmacy benefit managers to secure lucrative rebates from biopharmaceutical companies under secret deals.

Sen. Chuck Grassley, R-Iowa, chairman of the Senate Finance Committee, partnered with Sens. Mike Lee, R-Utah; Dick Durbin, D-Ill.; and Amy Klobuchar, D-Minn.; on bipartisan legislation that would permit the temporary importation of medicines when there is a drug shortage or if there are few competitors. The bill is also intended to prevent situations such as when Turing Pharmaceuticals LLC was the sole manufacturer of the toxoplasmosis medicine Daraprim, and it hiked the drug's price by more than 5,000%.

Meanwhile, a bipartisan cadre of more than 40 House members sent a letter last week to Azar urging him to withdraw the administration's proposal that would give private insurers that sell drug plans under the government's Medicare Part D program for seniors and disabled Americans the power to restrict coverage of medicines in the so-called six protected classes — anticonvulsants, antidepressants, antineoplastics, antipsychotics, antiretrovirals and immunosuppressants.

Also last week, top U.S. health officials updated lawmakers on the nation's role in trying to stop the spread of Ebola in the Democratic Republic of the Congo — the second largest outbreak of the virus in known history. More than 130 U.S. public health workers have been deployed to respond to the outbreak.

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* More than 6,000 Arkansans are at risk of losing their Medicaid eligibility at the end of the month due to the state's Medicaid work requirements policy, according to a report from the Arkansas Department of Human Services. A total of 6,472 people are at risk of losing their Medicaid coverage at the end of March, which would be the first group of people to lose coverage in 2019, according to the report.

The Centers for Medicare and Medicaid Services approved Ohio's Medicaid work requirements waiver March 15. Ohio is the ninth state to receive approval from the federal agency to implement the policy.

* The American College of Cardiology and American Heart Association changed its guidelines on using aspirin for preventing heart attacks or other heart diseases, noting that the risk of bleeding from routine use of the pain reliever outweighs its benefits, The Wall Street Journal reported. The health organizations said the low-dose version of the therapy should not be given routinely to prevent heart events in people 70 years old and up who are at an increased risk of bleeding.

* Michael Brady, who will serve as the U.K.'s first national adviser for LGBT+ as of April 1, said the planned release of a highly effective pre-exposure preventive pill against HIV could save the country's health authority hundreds of thousands of pounds, Reuters reported. Brady said preventing the disease would save the U.K. National Health Service about £300,000 on lifetime medical costs for each HIV patient.

* Olli Rehn, the governor of the Bank of Finland, said the country's social and healthcare systems still need a revamp to ensure that its public finances are sustainable, Reuters reported. Rehn's statement came days after Finland's government collapsed after Prime Minister Juha Sipilä struggled to gain approval for certain social and healthcare reforms.

M&A and capital markets

* Novartis AG's Alcon Inc. acquired U.S. medical device company PowerVision Inc. for $285 million. PowerVision is a privately held company focused on creating fluid-based intraocular lens implants, which restores the vision of people affected by cataracts and/or presbyopia, the eyes' inability to focus up close.

* Private equity giants KKR & Co. and CVC Capital Partners Ltd. are considering buying the animal-health unit of Bayer AG, pushing the German conglomerate to go through the planned sale, Bloomberg News reported, citing people with direct knowledge of the matter. Buyout groups such as Advent International Corp., Blackstone Group LP, EQT Partners AB and Permira Holdings Ltd., along with industry peers, are among other potential buyers for the business, which could sell for as much as €8 billion, the sources said.

Drug and product pipeline

* Bristol-Myers Squibb Co. and Pfizer Inc. said their blood thinner Eliquis showed favorable safety results in patients with non-valvular atrial fibrillation in a phase 4 trial. Under the 4,614-patient Augustus study, significantly fewer patients who were given Eliquis showed major or clinically relevant non-major bleeding after six months compared to those treated with a vitamin K antagonist.

* Allergy Therapeutics PLC said its adjuvanted birch allergoid product failed to meet the main goal of reducing the symptoms of patients with allergic rhinitis in a late-stage study, called B301. Allergic rhinitis, also known as hay fever, is a type of inflammation in the nose that occurs when the immune system overreacts to allergens in the air, such as pollen released from the birch tree.

Operational activity

* Gilead Sciences Inc.'s former CEO John Milligan — who stepped down at the end of last year — was paid $16.7 million in total approved compensation for 2018, excluding share-based incremental expense, a 2% increase compared to his total approved 2017 pay.

* Novo Nordisk A/S said it settled a patent dispute with Teva Pharmaceutical Industries Ltd. regarding the launch of a generic version of its diabetes drug Victoza. Under the settlement, the Danish drugmaker gave Israel-based generic drugmaker Teva a license to launch a generic version of Victoza as of Dec. 22, 2023.

The day ahead

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

In Asia, the Hang Seng rose 1.37% to 29,409.01, while the Nikkei 225 gained 0.62% to 21,584.50.

In Europe, around midday, the FTSE 100 increased 0.59% to 7,271.06, and the Euronext 100 lifted 0.10% to 1,048.25.

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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