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Behind the US opioid epidemic's revolving door; backlash on ending ACA subsidy

Top news

* U.S. President Donald Trump's decision to stop cost-sharing reduction payments made under the Affordable Care Act that help eligible Americans cover their out-of-pocket costs for prescription drugs and doctor visits was met with public pushback and at least one multiparty lawsuit, with the threat of others to follow.

* The White House's decision has also drawn the ire of industry groups and companies, which said the cost-sharing subsidies are critical to keeping premiums low for consumers. The move sent shares of managed care companies with high participation on the state exchanges tumbling.

* While government officials from the White House to Capitol Hill have insisted they are trying to tackle the U.S. opioid epidemic, a news investigation revealed how former Drug Enforcement Administration agents and lawyers worked with industry and some members of Congress to weaken the agency's authority to rein in the problem. The report revealed that in recent years, 46 DEA investigators, attorneys and supervisors had left to work for the pharmaceutical industry or law firms that represent drug manufacturers or distributors — Washington's notorious revolving door.

* Meanwhile, Republican Sen. Susan Collins, who is best known in recent months for her opposition to Senate bills to repeal the ACA, said she is staying put on Capitol Hill. Collins said she had been mulling over a Maine gubernatorial run next year but decided against it to "continue to play a key role in advancing policies that…improve our healthcare system," among others — declaring the best place to do that is in the Senate.

* There is a rising concern of whether drugmakers could freely transfer product registration and drug testing across the U.K. and other EU states after Brexit, Alan Morrison, vice president of regulatory affairs international for Merck & Co. Inc., told Bloomberg News. David Boyd, AstraZeneca PLC's director of European government affairs, is also worried that medicines introduced by the company over the past seven years might be subject to tariffs if Brexit leaders decide to revert to the World Trade Organization's outdated list of drugs.

M&A and capital markets

* Genprex Inc. launched an IPO of between 2.5 million and 4.5 million common shares and priced the float at $5 per share. The biopharmaceutical company expects the offering to close on or around Nov. 6, after which its shares will trade on the Nasdaq Capital Market under the ticker GNPX.

* Fireman BV intends to list its common shares on the Nasdaq Global Market in an IPO of up to $86.3 million. The company will trade under the symbol IFRX.

* A consortium of investors completed the acquisition of SciClone Pharmaceuticals Inc. through Silver Biotech Investment Ltd. SciClone ceased to be a publicly traded company on the Nasdaq Global Select Market and became a subsidiary of Silver Biotech after the completion of the deal.

Drug and product pipeline

* Bristol-Myers Squibb Co. said Opdivo alone, or combined with Yervoy, exhibited encouraging response and survival rates in the phase 1/2 CheckMate -032 trial evaluating the drug in patients with a certain type of lung cancer.

* Takeda Pharmaceutical Co. Ltd. said the updated results from the pivotal phase 2 ALTA Trial of Alunbrigtm, or brigatinib, continue to support the efficacy and safety findings for the 180-milligram dosing regimen of the drug in patients whose lung cancer progressed on crizotinib.

* Hutchison China MediTech Ltd. said fruquintinib, in combination with Iressa, shows promising efficacy and an acceptable safety profile, according to preliminary data in an ongoing phase 2 study in patients with a type of non-small cell lung cancer.

* Medivir AB (publ) said the phase 2 trial of its remetinostat gel demonstrated efficacy and safety in patients with a type of skin cancer. According to data from the study, the drug was generally well-tolerated and reduced severity of the symptoms in patients with mycosis fungoides type early-stage cutaneous T-cell lymphoma.

* GlaxoSmithKline plc's Shingrix vaccine to prevent shingles in adults aged 50 and over received marketing approval from Health Canada. Shingrix contains Agenus Inc.'s proprietary immune adjuvant QS-21 Stimulon, an immune-potent adjuvant designed to help the body generate antibodies and T cells.

* The U.S. Food and Drug Administration approved an expanded indication for Johnson & Johnson unit Janssen Biotech Inc.'s Stelara to treat moderate to severe plaque psoriasis in patients aged 12 years or older who are candidates for phototherapy or systemic therapy.

Operational activity

* Roche Holding AG is scheduled to report a 6% rise in sales for the third quarter on Oct. 19, with all eyes on the performance of its immuno-oncology treatment, Tecentriq, which Barclays analysts forecast will have lost market share to Merck & Co. Inc.'s Keytruda in bladder cancer.

* Orexigen Therapeutics Inc.'s weight-loss therapy Contrave will continue to have market exclusivity after the U.S. District Court for the District of Delaware favored the company in its patent litigation lawsuit against Actavis Laboratories FL Inc.

Our features

With competition rising, biopharma looked to focus on core areas in Q3: With major patent expiries and acquisitions in the rearview mirror, the world's biggest biopharmaceutical companies are largely expected to report solid third-quarter revenue growth, but stakes are raised for future performance.

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Other features

* Bloomberg News highlights how GlaxoSmithKline uses supercomputers to trace the paths of previously failed potential medicines to help boost research and development efforts and lessen costs.

* The News Journal in Delaware has a feature on Incyte Corp.'s ongoing lawsuit against a former employee. The company is claiming that Jordan Fridman, a scientist who worked for the company for more than a decade, leaked company secrets to Flexus Biosciences, a Silicon Valley startup that was acquired by Bristol-Myers for $1.25 billion in 2015 for its preclinical IDO1 cancer drug, Endpoints News reported. In a lawsuit against Flexus' founders, Incyte alleged that Fridman had been demanding information on IDO1 from Incyte before he left for Flexus.

The day ahead

Early morning futures indicators pointed to a higher opening for the U.S. market.

In Asia, the Hang Seng was up 0.76% to 28692.80. The Nikkei 225 added 0.47% to 21,255.56.

In Europe as of midday, the FTSE 100 was up 0.06% to 7,540.06, and the Euronext 100 was up 0.06% to 1,048.84.

The Daily Dose is updated as of 6:30 a.m. ET. Some external links may require a subscription.