Top news
* Multinational and local companies are expected to cut drug prices as they seek to secure contracts to supply 33 off-patent medicines to public hospitals in China, Bloomberg News reported. China, the world's second-largest pharmaceuticals market, previously launched a drug procurement plan that requires drugmakers to slash prices of their products after negotiations with regulatory authorities in exchange for greater access to hospitals. The plan is part of China's efforts to lower healthcare costs in the country.
* Over four dozen economic and policy experts, as well as a number of groups representing insurers, hospitals and consumers, asked the U.S. Supreme Court to uphold the Affordable Care Act and expedite a review of a Republican lawsuit challenging the constitutionality of the decade-old law.
"Leaving the ACA in limbo for another year or more needlessly threatens injury to every kind of participant in the U.S. healthcare system — from insurers, to consumers, to providers, to states" — 56 economics, health policy and legal scholars said in an amicus brief filed with the Supreme Court.
* Listed prices of cancer treatments and services differ from the actual prices paid by patients or insurers, a study published in the medical journal JAMA Oncology found. The U.S. Centers for Medicare and Medicaid Services mandated hospitals in 2019 to post prices of their cancer therapies and services online to help patients identify a better deal when getting treatments.
* The FDA approved 32 innovative medical devices through its premarket approval, or PMA, process in 2019, a slight uptick from 31 in 2018. The U.S. regulator uses the PMA pathway to evaluate the safety and effectiveness of class III medical devices, which support or sustain human life, but could also potentially bring a risk of illness or injury. PMA is the most stringent type of device marketing application required by the regulator.
On the policy front
* The Medicare Payment Advisory Commission, or MedPAC, voted on nine separate 2021 payment recommendations during a Jan. 16 meeting, including an increase in 2021 Medicare payments for hospital services and payment decreases for home health agencies and inpatient rehabilitation facilities. The commission will also recommend to Congress payment freezes for hospice providers and ambulatory surgical centers.
M&A and capital markets
* I-Mab, a clinical-stage biopharmaceutical company with principal executive offices in China, priced its planned IPO of 7,407,400 American depositary shares at $14 apiece. The price is at the higher end of a previously disclosed range of between $12 and $15 per ADS.
* Merck & Co. Inc. completed its $2.7 billion acquisition of Burlington, Mass.-based precision medicine specialist ArQule Inc. At the close of the tender offer period, 75.3% of ArQule's outstanding common stock were validly tendered, with the remaining shares canceled and converted into a right to receive $20 apiece.
Drug and product pipeline
* Novo Nordisk A/S said the U.S. Food and Drug Administration approved the expanded use of its blockbuster drug Ozempic to include reducing the risk of major adverse cardiovascular events — including cardiovascular death, nonfatal heart attack or nonfatal stroke — in adults with type 2 diabetes and established cardiovascular disease.
Meanwhile, a Reuters report said Novo Nordisk's new diabetes pill Rybelsus will be covered by pharmacy benefit manager Express Scripts Holding Co., which will negotiate discounts on behalf of health insurers.
* The U.K.'s National Institute for Health and Care Excellence did not recommend Bayer AG and Loxo Oncology Inc.'s cancer treatment Vitrakvi for routine use in the National Health Service due to its cost. Vitrakvi, or larotrectinib, is a histology independent treatment — can be used for tumors that did not form in the blood or bone marrow — targeting solid tumors with a neurotrophic tyrosine receptor kinase, or NTRK, gene fusion.
NICE calculated that a 30-day supply of Vitrakvi costs £15,000, or almost twice the price of Roche Holding AG's Rozlytrek, another histology-independent treatment that costs about $17,050 per month.
* The FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 6-6 on the approval of Durect Corp.'s Posimir, a non-opioid painkiller for post-surgical pain. Posimir, or bupivacaine, is intended to be administered directly to a patient's surgical site for up to three days after surgery.
Operational activity
* Bankrupt opioid manufacturer Insys Therapeutics Inc. secured the court's approval for its proposed deal of dividing the company's cash among parties who claimed in lawsuits that it fueled the U.S. opioid crisis, The Wall Street Journal reported. Under the deal, trade suppliers and parties with drug damage claims will get at least four cents on the dollar, while creditors are estimated to be paid about eight cents on the dollar or less.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng rose 0.60% to 29,056.42, and the Nikkei 225 rose 0.45% to 24,041.26.
In Europe, around midday, the FTSE 100 was up 0.92% to 7,679.82, and the Euronext 100 was up 0.76% to 1,168.04.
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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