Is the police operation for climate change protests working?

On today’s podcast, we discuss how well police are coping with Extinction Rebellion demos as resources are diverted from other parts of the country.

We also examine renewed optimism as the Brexit deadline nears.

Meanwhile, Nazanin Zaghari-Ratcliffe’s young daughter is reunited with her father as she returns to the UK while her mother remains in an Iranian jail.

:: Listen to the Daily podcast on Apple Podcasts, Google Podcasts, Spotify, Spreaker

Poland's ruling party seen to keep power in parliamentary vote

Early official results show populist Law and Justice party set to win with 49.3 percent of vote.

Poland’s ruling nationalist party has declared victory in parliamentary elections.

Exit polls show the Law and Justice party is on course to win an even bigger majority.

Al Jazeera’s Andrew Simmons reports from Warsaw.

New Osteoarthritis Treatment Has to Wait Even Longer for FDA Approval

Flexion Therapeutics Inc. (NASDAQ: FLXN) has announced that the U.S. Food and Drug Administration (FDA) informed the company that it needs additional time to complete the review of the supplemental New Drug Application (sNDA) for Zilretta.

Note that the anticipated Prescription Drug User Fee Act (PDUFA) action date was today, October 14, 2019.

Although the FDA did not provide a new action date, the FDA informed the company that the review is expected to be completed in the coming weeks. The FDA has not asked for any additional clinical data, and the company has provided the FDA with all information requested to date.

In December 2018, the company filed the sNDA seeking to revise the Zilretta product label based on results from an open-label Phase 3b clinical trial, which evaluated repeat administration of Zilretta in patients with osteoarthritis knee pain.

The approval of Zilretta was based on the pivotal Phase 3 trial that demonstrated that this steroid significantly reduced knee pain for 12 weeks, with some people experiencing pain relief through week 16.

Shares of Flexion traded down about 5% in Monday’s premarket but were last seen up fractionally at $13.46, in a 52-week range of $8.76 to $19.82. The consensus price target is $25.78.

Stocks on course to snap three-day winning streak after U.S.-China deal comes under doubt

U.S. stocks fell slightly at the opening bell on Monday after reports suggested the trade deal struck between U.S. and Chinese negotiators last week had yet to be finalized. The S&P 500 SPX, -0.06% was down less than 0.1% to 2,969. The Dow Jones Industrial Average DJIA, +0.02% shed 19 points, or 0.1%, to 26,797. The Nasdaq Composite comp fell less than 0.1% to 8,054. Bloomberg News reported that Chinese officials desired further discussions to work out the remaining kinks in the so-called "phase 1" trade deal, which would delay tariff increases this week. But the agreement was not set out in writing, and only agreed in principle. In company news, shares of Boeing Co. BA, +0.17% were down after the company’s board said it had voted to separate the roles of chief executive and chairman.

FDA Approves Reyvow Tablets To Treat Migraine

The U.S. Food and Drug Administration or FDA approved Reyvow (lasmiditan) tablets of Eli Lilly and Co. as an oral medication for the acute treatment of migraine, with or without aura, in adults. However, Reyvow is not indicated for prevention of migraine.

Reyvow is a new oral treatment that binds to 5-HT1F receptors with high affinity. The approval of it is the the first new class of acute migraine treatment approved by the agency in more than two decades.

Migraine is a neurologic disease characterized by recurrent times of intense throbbing or pulsing pain in one area of the head, accompanied by nausea and/or vomiting and sensitivity to light and sound.

One in seven Americans or 30 million adults are affected by it – three times more women than men suffering from the disease.

The effectiveness of Reyvow was demonstrated in two randomized, double-blind, placebo-controlled trials conducted on a total of 3,177 adult patients with a history of migraine.

Both studies met the efficacy endpoints of pain freedom and freedom from most bothersome symptom such as nausea, light sensitivity, or sound sensitivity at two hours following administration of Reyvow in comparison to placebo.

The recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration (DEA). The approval is expected within 90 days of FDA approval, after which Reyvow will be available to patients in retail pharmacies.

Nike sportswear, Jordan brand drive upgrade at Bank of America

Nike Inc. NKE, +1.00% was upgraded to neutral from underperform at Bank of America Merrill Lynch based on a bullish outlook for the company’s sportswear business, especially for women and children, and the "democratization" of the Jordan brand. Bank of America raised its price target to $98 from $70. Analysts think items like the Air Force 1 classic shoe and Tech Fleece and growth of the "core" category, priced at less than $100, will offset continued challenges such as store closures and a resurgence at competitors like Adidas AG ADS, -0.25%. "Broadening the Air Jordan franchise well beyond performance and signature basketball footwear and apparel should remain a global growth driver for Nike (in addition to ‘sportswear’), especially in China where the launch of the Jordan flagship store on T-Mall (Aug. 2017) helped drive 20%+ FX-neutral growth for the last six quarters," analysts said. Nike stock, up 0.5% in early Monday trading, was among the top gainers on the Dow Jones Industrial Average DJIA, +0.05%. Shares are up 27.2% for the year to date, outpacing the 14.8% growth on the Dow.