* Drugmakers need to come to terms with the Trump administration's plan to merge the separate ways the U.S. federal government pays for pills versus the more expensive injectable medicines and come up with solutions on lowering prices or the industry will be forced to do so, Health and Human Services Secretary Alex Azar said during an address at the American Enterprise Institute in Washington, D.C.
* Ahead of the American Society of Clinical Oncology, or ASCO, meeting, Swiss drugmaker Roche Holding AG said its combination of Tecentriq and Avastin plus chemotherapy helped certain lung cancer patients live longer when compared to treatment with just Avastin and chemotherapy under a phase 3 study. The trial evaluated the combination in patients with nonsquamous non-small cell lung cancer, or NSCLC, that had spread to other parts of the body and who have not previously had or undergone chemotherapy.
Meanwhile, Roche's Alecensa helped people with anaplastic lymphoma kinase-positive metastatic NSCLC live longer by almost two years compared to Pfizer Inc.'s Xalkori, according to follow-up data from a phase 3 study.
* Regeneron Pharmaceuticals Inc. and Sanofi's cemiplimab produced a reduction in tumor size in 29% of advanced NSCLC patients in a phase 1 trial. The companies are developing cemiplimab under a global collaboration agreement.
* Germany's Merck KGaA, Morris Plains, N.J.-based Immunomedics Inc. and Waltham, Mass.-based ImmunoGen Inc. also released abstracts ahead of ASCO. Merck said two of its cancer drugs, fusion protein M7824 and tepotinib, are showing favorable outcomes in early stage trials for treating NSCLC. Immunomedics's sacituzumab govitecan reduced tumor size in patients with a certain type of breast cancer who had been previously treated. ImmunoGen said a combination of its experimental cancer drug IMGN853, in combination with Roche's Avastin, showed positive results in an early stage study for patients with folate receptor alpha-positive ovarian cancer.
On the policy front
* The World Health Organization said the Ebola virus disease has spread into an urban region of the Democratic Republic of the Congo, with a confirmed case reported in Mbandaka, a city with a population of 1.2 million. Earlier cases in this most recent outbreak had been reported in a rural area about 150 kilometers away from Mbandaka. As of May 15, 44 Ebola cases have been reported: three confirmed, 20 probable and 21 suspected.
* The U.S. Food & Drug Administration said it has identified inaccuracies in certain data, including information on opioid drug sales, provided by the healthcare research company IQVIA Holdings Inc. The inaccuracies, which resulted from a unit conversion error, would not affect the company's widely used data on projected global and U.S. drug sales, IQVIA told Reuters.
M&A and capital markets
* The Dublin-based maker of generic drugs Perrigo Co. PLC and Reckitt Benckiser Group PLC are interested in acquiring South Africa-based Aspen Pharmacare Holdings Ltd.'s infant formula business, Bloomberg News reported. The unit could fetch about $1 billion to $1.5 billion in a potential deal.
Drug and product pipeline
* Evolus Inc. said the U.S. Food and Drug Administration rejected the application for its wrinkle treatment prabotulinumtoxinA. The Irvine, Calif.-based company’s therapy is expected to compete with Allergan PLC's wrinkle therapy Botox.
* The European Commission, or EC, expanded the approval of Amgen Inc.'s cholesterol drug Repatha to prevent heart attack and stroke in adults with certain forms of cardiovascular disease.
* The EC also granted approval for Ipsen SA's drug Cabometyx as a first-line treatment for adults with intermediate or poor-risk advanced renal cell carcinoma. In 2016, Ipsen entered a deal with Exelixis Inc. for the exclusive rights for the commercialization and development of Cabometyx outside the U.S. and Japan.
* The U.S. Food and Drug Administration approved US WorldMeds, LLC's Lucemyra as the first nonopioid treatment for managing opioid withdrawal symptoms in adults. Lucemyra is only approved for treatment for up to 14 days and may lessen the severity of withdrawal symptoms but not completely prevent them, according to the U.S. regulator.
* AstraZeneca PLC declined to comment on reports that it is considering the sale of its former blockbuster cholesterol drug Crestor just over a week after announcing the disposal of another former blockbuster, Seroquel.
* Walgreens Boots Alliance Inc.'s Walgreen Co., Kroger Co., Albertsons Cos. Inc. and HEB Grocery Company, LP are suing Allergan for allegedly violating antitrust laws by trying to stop rivals from selling generic copies of its dry-eye drug Restasis.
* Eiger BioPharmaceuticals Inc. and Merck & Co. Inc. expanded their agreement to include the development of lonafarnib, a potential treatment for Hutchinson-Gilford progeria syndrome, a rare and fatal condition characterized by rapid aging in children.
* Lung cancer screenings can potentially save lives of thousands of smokers every year, but less than 2% of heavy smokers are undergoing testing, Bloomberg News wrote in a feature, citing a study by the University of Louisville's cancer center in Kentucky.
* Women with early stage breast cancer may soon be prescribed to take Roche's Herceptin for a shorter period of time compared to current standards of a year or more, The New York Times wrote, citing a study paid for by the British government. The study showed that less exposure to Herceptin minimizes adverse events without sacrificing the drug's efficacy.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng fell 0.54% to 30,942.15, and the Nikkei 225 rose 0.53% to 22,838.37.
In Europe, as of midday, the FTSE 100 was up 0.17% to 7,747.06, and the Euronext 100 was up 0.36% to 1,077.41.
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