Top news
* Alex Azar, secretary of Health and Human Services, led U.S. health officials and infectious disease experts in urging Americans to get their annual flu shots, emphasizing that the virus kills tens of thousands of people across the nation every year.
A new National Foundation for Infectious Diseases-sponsored survey showed that only 52% of U.S. adults plan to get a flu shot this season, despite 60% responding that they thought the vaccine was the best way to prevent hospitalizations and deaths from the virus.
The medical community must figure out how to get more Americans to take the flu seriously and get vaccinated against the seasonal virus so that the innovations the infectious disease community is working on to produce pandemic and universal influenza vaccines can best be utilized, NFID President-Elect Patricia Whitley-Williams told S&P Global Market Intelligence.
* China's National Medical Products Administration approved Merck KGaA's Erbitux as an initial treatment for colorectal cancer patients whose disease has spread to other parts of the body and exhibits the RAS wild-type gene. The therapy is to be used in combination with chemotherapy drugs Folfox or Folfiri, or with cancer medicine irinotecan, for those who are resistant or have not responded to irinotecan-based chemotherapy.
Germany's Merck KGaA licensed Erbitux, or cetuximab, outside the U.S. and Canada from Indianapolis-based Eli Lilly and Co.
* U.S. pricing watchdog Institute for Clinical and Economic Review said AbbVie Inc.'s rheumatoid arthritis drug Rinvoq provides marginal clinical benefit compared to the company's own blockbuster immunosuppressive therapy Humira, but at a higher cost. Rinvoq's high price may not be justified for the marginal benefit it offers, ICER said in a draft evidence report.
* Dana-Farber Cancer Institute President and CEO Laurie Glimcher spoke with S&P Global Market Intelligence about ongoing work at the nonprofit treatment and research center, the challenges of running successful cancer programs and the future of treatment in the space.
* U.S. District Judge Dan Polster in Cleveland denied the request of several pharmacy chains and drug distributors to recuse himself from the opioid litigation, Reuters reported. Companies including AmerisourceBergen Corp., Cardinal Health Inc., Henry Schein Inc. and McKesson Corp., along with retailers CVS Health Corp., Rite Aid Corp., Walgreens Boots Alliance Inc. and Walmart Inc., previously asked Polster to step down from the litigation, claiming the judge was biased against the defendants and focused primarily on reaching settlements.
The judge is presiding over the hearings for more than 2,000 lawsuits by state and local municipalities seeking compensation for the costs incurred in combating the U.S. opioid painkiller addiction crisis.
* Despite the government's effort to build up stockpiles of medicines, there is still "significant work" needed to ensure the steady flow of health and social care supplies in a no deal-Brexit, a report by the U.K.'s National Audit Office said. A survey of suppliers showed that they had at least six weeks' stock for 72% of medicine product lines as of Sept. 20, the report noted.
On the policy front
* The Centers for Medicare and Medicaid Services issued two finalized rules Sept. 26. The first rule revises patient discharge requirements for home health agencies and multiple hospital types that want to participate in Medicare and Medicaid. The rule will also allow patients to be more involved in the discharge process.
The second rule finalizes provisions that the agency outlined in three separate proposed rules. The rule aims to reduce what the agency called unnecessary or obsolete regulatory burdens for multiple facility types. CMS projects the finalized rule will save providers $800 million annually.
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* Total enrollment in Medicaid and the Children's Health Insurance Program, or CHIP, declined by approximately 1.9 million people between May 2017 and May 2019, according to the Medicaid and CHIP Payment and Access Commission.
The congressional Medicaid adviser presented data that showed enrollment in Medicaid and CHIP declined by almost 930,000 children and about 787,000 adults over the two-year period.
* The National Health Law Program filed a lawsuit Sept. 23 in the U.S. District Court for the District of Columbia challenging Indiana's Medicaid work requirements policy, putting the controversial policy supported by the Trump administration before the court for the fifth time.
Much like the previous lawsuits, the court document claims that the U.S. Department of Health and Human Services does not have the authority to approve the policy and that work requirements harm Medicaid recipients.
M&A and capital markets
* Bankrupt INSYS Therapeutics Inc. is selling all strengths, doses and formulations of its controversial opioid painkiller Subsys and some related assets to Pharmbio Korea Inc. for $1.2 million.
Drug and product pipeline
* The U.S. Food and Drug Administration approved the expanded use of Genmab A/S and Johnson & Johnson's Darzalex in combination with dexamethasone, thalidomide and chemotherapy drug bortezomib to treat newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant. Multiple myeloma is an incurable blood cancer that forms in plasma cells, which are responsible for producing antibodies.
* Montreal-based Theratechnologies Inc. said the European Commission granted marketing authorization for its HIV drug Trogarzo to treat adult patients with multidrug-resistant infection.
* AbbVie said the FDA approved a shortened treatment duration for its chronic hepatitis C medicine Mavyret in adults and children older than 12 years who have not received any prior therapy for the infection.
Mavyret, which is a combination of glecaprevir and pibrentasvir, is the first 8-week treatment approved for all six major types of the disease. Previously, the standard treatment length for the treatment-naïve group and certain children was 12 weeks or more.
Operational activity
* The U.S. Patent Office's Patent Trial and Appeal Board will review Sandoz Inc.'s challenge for one of AbbVie's patents on the blood cancer drug Imbruvica. Sandoz, Novartis AG's biosimilar and generic-drug development arm, filed a petition arguing against the validity of AbbVie's '604 patent on Imbruvica, or ibrutinib, in March.
* Gene sequencing company Illumina Inc. laid off 58 employees including technical writers, scientists and engineers in September, CNBC reported. A document from California's Employment Development Department showed that the terminated employees were from the company's offices in San Mateo and San Diego.
The day ahead
Early morning futures indicators pointed to a higher opening for the U.S. market.
In Asia, the Hang Seng declined 0.33% to 25,954.81, and the Nikkei 225 dropped 0.77% to 21,878.90.
In Europe, around midday, the FTSE 100 was up 1.12% to 7,433.37, and the Euronext 100 was up 0.38% to 1,093.52.
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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