FDA Approves World’s Costliest Drug For SMA

Saudi air defenses intercept two Houthi drones: Saudi press agency

(Reuters) – Saudi air defenses intercepted two Houthi drones, one of them targeting a residential area in the southern city of Abha, the Saudi press agency said on Tuesday, citing the Saudi-led coalition.

Al Masirah TV, citing a military spokesman, said on Monday the Houthis launched drone attacks on Abha airport.

The Houthis have launched several strikes at Abha since last week, when a missile attack on the airport wounded 26 people.

WarnerMedia reportedly near $500 million deal with J.J. Abrams

AT&T’s T, -0.15% WarnerMedia is close to a deal worth around $500 million with Hollywood hit maker J.J. Abrams, the New York Times reported Monday. Abrams’ Bad Robot Productions has been behind popular TV shows such as "Lost," "Alias" and "Westworld," and blockbuster movies such as "Star Trek: Beyond" and "Mission: Impossible — Rogue Nation." Abrams also directed the Walt Disney Co.’s DIS, -0.48% "Star Wars: The Force Awakens" and the upcoming "Star Wars: The Rise of Skywalker." Under the deal, WarnerMedia would reportedly get the right of first refusal for Abrams’ future productions. It is unclear if Abrams will still be able to direct films for other studios. WarnerMedia is expected to launch a streaming service later this year, and is seeking content creators for future competition with Netflix Inc. NFLX, +3.21% and Disney Plus, among others.

Steel Dynamics Sees Q2 Profit Below View

Steel Dynamics Inc. (STLD) expects earnings for the second quarter 2019 to be in the range of $0.86 to $0.90 per share, compared to $1.53 per share reported last year. Analysts polled by Thomson Reuters expect the company to report earnings of $0.99 per share for the second-quarter. Analysts’ estimates typically exclude special items.

STLD closed Monday’s regular trading at $26.23, down $0.20 or 0.76 percent. In the after-hours trade, the stock further dropped $0.52 or 1.98 percent.

The company expects second quarter earnings from its steel operations to decrease in comparison to sequential first quarter results, primarily related to lower profitability from the company’s long product steel operations, as shipments and metal spread declined in the quarter.

Second quarter 2019 profitability for the company’s metals recycling platform is expected to decrease when compared to sequential first quarter results, principally based on reduced ferrous metal spread as average pricing declined through the quarter.

Quarterly earnings from the company’s steel fabrication business are expected to improve from sequential first quarter results, due to both higher shipments and metal spread expansion, as demand remains strong and steel input costs decline.

In Pictures: Sneak peek at some of the best gardens at Bloom 2019

ICE to remove ‘millions of illegal aliens’ in US, Trump says, scant on details

Is Mexico doing more than Congress to help with the crisis at the border?

National Border Patrol Council President Brandon Judd says Mexico understands that they have to do something in order to avoid economic crippling tariffs.

President Donald Trump late Monday announced on Twitter that U.S. Immigration and Customs Enforcement will begin the process of “removing the millions of illegal aliens who have illicitly found their way into the U.S.,” but did not elaborate on what new measures will be taken.

“They will be removed as fast as they come,” Trump said.

Mike Morgan, the director of the agency, did not announce any new initiatives during his stop in Louisville on Sunday, where he spoke about the humanitarian and national security crisis at the border.

ICE did not immediately respond to an email from Fox News for comment.

Earlier this month, Trump announced that the U.S. reached a deal with Mexico that includes plans to return migrants seeking asylum to Mexico, where they will remain until they can be processed.

Trump praised Mexico in the tweet, saying the country has been doing a very good job at stopping those trying to gain access to the U.S. border.

FDA Approves World’s Costliest Drug For SMA

Spinal muscular atrophy or SMA is a genetic disease affecting the part of the nervous system that controls voluntary muscle movement.

The most common form of SMA is caused by a defect in the SMN1 gene that leads to deficiency of a motor neuron protein called SMN, which is necessary for normal motor neuron function.

The FDA approved Zolgensma, developed by Novartis (NVS), on May 24, 2019, for the treatment of spinal muscular atrophy (SMA) in children less than two years of age.

Zolgensma (onasemnogene abeparvovec-xioi) is an adeno-associated virus vector-based gene therapy that targets the cause of SMA by delivering a copy of human SMN gene into the target motor neuron cells.

Novartis priced the drug at $2.125 million, making it the most expensive medicine in the world. Analysts estimate peak annual sales of between $1.8 billion and $2.6 billion for the drug.

Zolgensma will compete with Biogen’s Spinraza (nusinersen), which was approved in December 2016, for the treatment of SMA in pediatric and adult patients.

Zolgensma, the first and only gene therapy approved by the FDA, is a one-time treatment whereas Spinraza has to be administerd multiple times. Spinraza, priced at $750,000 for the first year, and $350,000 afterwards, brought in revenue of $1.724 billion in 2018.

Novartis expects to get approval for Zolgensma in Europian Union and Japan this year.

Zolgensma has a boxed warning for acute liver injury.

Now, let’s take a look at the new drugs that won FDA approval in May.