* Roche Holding AG's newly approved lung cancer therapy Rozlytrek was priced at about $17,050 per month, nearly half the cost of Vitrakvi, a rival drug from Bayer AG and Eli Lilly and Co., Reuters reported. Rozlytrek is the third medicine to receive U.S. approval for treating non-small cell lung cancer after Vitrakvi and Merck & Co. Inc.'s blockbuster drug Keytruda.
* A Novartis AG executive sold CHF925,400 in shares less than three weeks before it was revealed that data on gene therapy Zolgensma was manipulated, Swiss newspaper SonntagsZeitung reported, citing a Swiss stock exchange filing dated July 19. The $2.1 million medicine — the most expensive in U.S. history — is used to treat children under 2 years old with a genetic neuromuscular disorder called spinal muscular atrophy.
The share sale was "thoroughly checked" before being approved, a Novartis spokesman told Reuters. "The person in question was not in possession of relevant material information."
* Senior civil servants warned that U.K. businesses are not ready for a no-deal Brexit and that the nation may experience shortages of fuel, food and medicine in such a situation. A government report marked as sensitive but obtained by The Sunday Times said ports along the English Channel could see major disruption that could go on for three months if the U.K. leaves the EU with no deal on Oct. 31, which looks increasingly likely.
On the policy front
* The American Medical Association, the largest professional group of doctors in the U.S., confirmed reports it has left a coalition of organizations that lobbies against proposals to move the nation to a single-payer system or provide a public option.
The AMA remains opposed to Medicare for All. "[M]issing in the recent debate was an ongoing discussion of practical solutions that will result in more affordable insurance options," the group's CEO, James Madara, told S&P Global Market Intelligence in a statement. The AMA decided to leave the coaltion to devote more time to policies addressing coverage gaps and dysfunction in the U.S. healthcare system, Madara said.
* Medicaid work requirements have been struck down by a federal court four times since June 2018. But Centers for Medicare and Medicaid Services Administrator Seema Verma once again defended the Medicaid policy and her agency's review process for states' work requirements waivers.
Verma told reporters Aug. 15 that the agency's approval and review process for states' work requirements waivers has slowed due to recent litigation. However, she said it is still a "strong priority" that states have the flexibility to implement policies they need to "help people rise out of poverty," which is Verma's and other supporters' standard defense of the rules.
M&A and capital markets
* Satsuma Pharmaceuticals Inc. filed for an IPO of up to about $86.3 million of its common stock. The South San Francisco, Calif.-based biopharmaceutical company, which is developing STS101 for treating migraine, applied to list on the Nasdaq Global Market under the symbol STSA.
* Monopar Therapeutics LLC filed for an IPO of its common shares to raise about $40.3 million. Monopar Therapeutics plans to use proceeds to advance Validive. The drug is being developed to treat a complication arising from chemotherapy or radiotherapy in patients receiving treatment for oropharyngeal cancer.
Drug and product pipeline
* AbbVie Inc.'s rheumatoid arthritis drug Rinvoq, which the pharma giant said could replace its own blockbuster immunosuppressive drug Humira, received U.S. FDA approval. It will launch in late August.
AbbVie set the price of Rinvoq at $59,000 annually, Reuters reported. Rinvoq will go against rival therapies Xeljanz, made by Pfizer Inc., and Lilly's Olumiant. AbbVie's shares closed in the green Aug. 16, up 2.30% to $64.43.
* Celgene Corp.'s life sciences arm Impact Biomedicines Inc. gained U.S. FDA approval for Inrebic to treat myelofibrosis, a rare bone marrow disorder. Inrebic, or fedratinib, is the second medicine approved for the indication, with Incyte Corp.'s Jakafi being the pioneer.
* CSPC Pharmaceutical Group Ltd. said profit attributable to shareholders surged 24.8% year over year to 1.88 billion yuan for the six months ended June 30. Basic earnings per share climbed to 30.13 yuan during the six-month period, up from 24.10 yuan from the same period a year ago.
* Novo Nordisk A/S said a number of its shareholders filed a lawsuit against the company in Denmark alleging that it issued misleading statements about the sales of its insulin products in the U.S. The shareholders, based on their trading and holding of shares between Feb. 3, 2015, and Feb. 2, 2017, have made a claim of 11.79 billion Danish kroner in the lawsuit.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng grew 2.17% to 26,291.84, and the Nikkei 225 was up 0.71% to 20,563.16.
In Europe, as of midday, the FTSE 100 was up 1% to 7,188.07, and Euronext 100 had climbed 1.11% to 1,042.75.
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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