Top news
* Novartis AG said new interim data from a late-stage study showed that Zolgensma, the $2.1 million controversial gene therapy under investigation, did not cause toxic or treatment-related brain damage that led to the death of a British baby with the rare genetic disease spinal muscular atrophy. Novartis and its unit AveXis Inc. are being investigated by the U.S. Food and Drug Administration for allegedly falsifying preclinical data of Zolgensma. The situation has even drawn the attention of Capitol Hill, where a group of senators has asked the FDA to ensure that the Swiss pharmaceutical giant is held accountable.
* China Biologic Products Holdings Inc. said its board received a preliminary nonbinding proposal to take the company private in a deal that values the company at $4.59 billion. A consortium, which includes investment firms Citic Capital China Partners IV LP and PW Medtech Group Ltd., offered to buy all of the outstanding ordinary shares of China Biologic Products it does not already own for US$120 per share in cash.
* Americans carry the burden of high medicine costs since the U.S. government does not negotiate prices, arguing that doing so would ward off investment in innovative therapies, the Financial Times highlighted in a report. According to the Organisation for Economic Co-operation and Development, the U.S. in 2018 spent about 47% and 160% more per capita on prescription medicines than Canada and the U.K., respectively.
* Research published in the journal GeoHealth said Superstorm Sandy and nine other events related to climate change in 2012 cost the U.S. healthcare system about $10 billion. The estimate only accounted for the mental health impact of Sandy, which wreaked havoc along the Atlantic Seaboard in 2012, and did not include "all possible sources of variability," researchers from environmental advocacy group Natural Resources Defense Council and University of California, San Francisco, noted.
* Researchers have identified a receptor on the spinal cord of mice that could be targeted to stop chronic itch, which affects millions of people and occurs in many medical conditions and as a result of some medication. Meanwhile, U.S. researchers looking at problems with brain circuits that control speech have identified mutations in genes linked to stuttering, which play a role in intracellular trafficking — the process of transporting substances needed for functioning around the cell.
On the policy front
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* U.S. lawmakers led by Senator Amy Klobuchar, D-Minn., sent a letter urging Federal Trade Commission Chairman Joseph Simons to closely review pharmaceutical mergers that may lessen competition, increase drug prices and reduce patient access to essential medicines.
The letter highlighted multibillion-dollar M&A transactions in the pharma sector, including AbbVie Inc.'s $63 billion deal to acquire Botox-maker Allergan PLC and Bristol-Myers Squibb Co.'s $74 billion bid for Celgene Corp.
* Judge Rosemary Collyer for the U.S. District Court for the District of Columbia ruled Sept. 17 that the Centers for Medicare and Medicaid Services did not have the authority to lower Medicare rates for evaluation and management services at certain off-campus outpatient facilities. The judge did not issue a court order on whether CMS is required to pay back any payments that were withheld due to the rule change, which was requested by the hospital groups.
* As many as 84 million prescriptions, or 3.45% of total claims, were declined by health insurance companies that cater to Medicare's Part D, which covers medicines for seniors and disabled Americans at the pharmacy counter. In a report by the U.S. Department of Health and Human Services, the Office of Inspector General recommended that CMS enhance electronic communication between Part D sponsors and prescribers to reduce claim rejections.
M&A and capital markets
* IGM Biosciences Inc. priced and upsized its IPO on Nasdaq. It is now looking to raise about $175 million by selling 10,937,500 of its shares at $16 each.
Drug and product pipeline
* Novartis' generics unit Sandoz is ceasing distribution of products that contain the stomach medication ranitidine as U.S. and EU regulators investigate whether they contain a cancer-causing chemical called N-nitrosodimethylamine. "A precautionary distribution stop of all Sandoz ranitidine-containing medicines in all our markets will remain in place under further clarification, this includes capsules in the USA," a spokesperson from Novartis said in an email.
Sandoz's capsules are a generic version of Sanofi's Zantac brand, and generic ranitidine is marketed by dozens of companies globally, including Teva Pharmaceutical Industries Ltd. and Mylan NV.
* Biogen Inc. halted a mid-stage study of its idiopathic pulmonary fibrosis drug dubbed BG00011 due to safety concerns, according to information from the National Institutes of Health's ClinicalTrials.gov. A representative from the company told S&P Global Market Intelligence on Sept. 18 that "Biogen determined that the benefit-risk profile of BG00011, a therapeutic candidate for IPF, no longer met the criteria to continue the clinical trial."
* Johnson & Johnson secured an additional U.S. Food and Drug Administration approval for prostate cancer drug Erleada, providing a boost for the pharmaceutical giant that is facing pressure from generic drug competition. Erleada can now be used to treat metastatic castration-sensitive prostate cancer, a type that has spread to other parts of the body despite responding to hormone therapy.
Operational activity
* Purdue Pharma LP asked U.S. Bankruptcy Judge Robert Drain to stop opioid litigations against the drugmaker for about nine months, Reuters reported, citing court documents. The Stamford, Conn.-based OxyContin manufacturer's request also seeks protection for its founders, the Sackler family, from related opioid cases.
Purdue Pharma and the Sackler family are facing more than 2,600 lawsuits for allegedly fueling the U.S. opioid epidemic.
* Google, a unit of Alphabet Inc., absorbed the health division of DeepMind, years after it acquired the artificial intelligence company. In 2016, Deepmind Health came under the spotlight for having access to private medical files of up to 1.6 million patients of the National Health Service, Britain's publicly funded national healthcare system.
Additionally, Google has signed agreements with five NHS trusts allowing the tech giant to process confidential patient data, which includes medical history, diagnoses, treatment dates and ethnic origin, the FT wrote.
* Switzerland's Competition Commission launched an investigation into manufacturers and distributors of scopolamine butylbromide, an active pharmaceutical ingredient used in stomach pain therapies, such as Boehringer Ingelheim's Buscopan. The Swiss watchdog has not named any company involved in its probe, which was prompted by unlawful price and market sharing agreements.
* Ironwood Pharmaceuticals Inc. fully sold the Chinese rights to Linzess — approved in China earlier in 2019 to treat irritable bowel syndrome — to AstraZeneca PLC. The companies had been jointly developing the medicine for the Chinese market since 2012 on a cost-sharing basis.
The day ahead
Early morning futures indicators pointed to a lower opening for the U.S. market.
In Asia, the Hang Seng dropped 1.07% to 26,468.95, and the Nikkei 225 rose 0.38% to 22,044.45
In Europe, around midday, the FTSE 100 was up 0.59% to 7,357.54, and the Euronext 100 climbed 0.25% to 1,091.33.
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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