FDA declines to approve Spero's urinary tract infection drug

 The U.S. Food and Drug Administration (FDA) declined to approve Spero Therapeutics Inc's SPRO.O oral antibiotic drug for the treatment of patients with complicated urinary tract infections, the company said on Monday.

In the complete response letter, the health regulator concluded that Spero's late-stage study testing the drug was insufficient and an additional study would be required, the drugmaker said.

Shares of Spero fell about 14% after the bell.

Spero had sought approval for its most advanced drug candidate, tebipenem, to treat the infections, including a type of kidney inflammation called pyelonephritis in adult patients with limited oral treatment options.

But the company suffered a setback in March when the agency found certain deficiencies in the drug's marketing application. Spero later suspended commercialization activities for tebipenem and slashed its workforce by about 75%, as the FDA's feedback suggested that the data on the drug could be insufficient to obtain approval.

The drugmaker said on Monday it intends to promptly request a meeting with the health regulator.

https://www.nasdaq.com/articles/u.s.-fda-declines-to-approve-speros-urinary-tract-infection-drug

U.S. appeals court vacates federal vaccine mandate pending additional hearing

 A U.S. appeals court panel said on Monday it would convene a full panel to reconsider President Joe Biden's executive order requiring civilian federal employees to be vaccinated against COVID-19, and set aside the order pending that hearing.

The U.S. Court of Appeals for the Fifth Circuit, which is based in New Orleans, had reinstated the vaccine order in April by a 2-1 vote after it was blocked by a district court judge in January. [L2N2W530Z]

The court said on Monday that it would reconsider the case en banc, which means it will be heard by a larger panel of judges. No date was given for the hearing. Pending that hearing, the court said it would vacate the April ruling, which means that Biden's order cannot be enforced.

Biden said in September he would require about 3.5 million government workers to get vaccinated by Nov. 22, barring a religious or medical accommodation, or face discipline or firing. Despite the legal fight, more than 90% of federal workers were vaccinated by December, the White House said last year.

The president's vaccine and mask mandates have faced stiff opposition, led by Republicans, which have turned public safety measures endorsed by disease experts into a political and legal battle in the United States.

The United States passed the milestone of 1 million dead from the coronavirus in May. More than 250 people still die of the disease daily, according to the U.S. Centers for Disease Control and Prevention.

https://news.yahoo.com/u-appeals-court-vacates-federal-202005262.html

Texas attorney general says judge's rule to continue early-term abortions 'wrong'

 Abortion rights advocates in Texas got a win on Tuesday, but there's no telling how long it will last. A judge temporarily ruled people can receive early-term abortions again, but the state's attorney general is promising to appeal the decision.

"The judge's decision is wrong. I'm immediately appealing." Those words came from Texas Attorney General Ken Paxton in a statement following a Harris County judge's decision to temporarily block a 1920s-era law prohibiting abortion in Texas.

"For right now, no one can file criminal charges against you. But, what happens in three weeks, or a month from now, when the Texas Supreme Court decides the trial judge made a mistake?" said Seth Chandler, a law professor at the University of Houston.

That uncertainty puts providers in a difficult position. Planned Parenthood is not offering abortion services currently, but Houston Women's Reproductive Services and The Houston Women's Clinic are.

"Can prosecutors go back and, basically, prosecute someone for an action that they thought was OK? That is not an easy question, and I suspect that's why you're seeing a mixed reaction (Tuesday) from abortion providers in Texas," said Chandler.

Whole Woman's Health is one of the providers that sued to seek Tuesday's temporary restraining order. Its president and CEO, Amy Hagstrom Miller, released the followings statement:

"Any day that we are able to provide the abortions Texans need and deserve is a good day! This TRO means that we now have the opportunity to open our doors in Texas before the trigger ban takes effect a month or two from now. When news of the TRO spread across the WWH and WWHA family, we immediately began calling the patients on our waiting lists and bringing our staff and providers back into the clinics in order to resume abortion care as soon as possible. Yes, we are reopening to provide care in our four Texas clinics. Keep in mind, Texas still enforces a two-visit requirement and a 24-hour waiting period, as well as the six-week ban and other restrictions. Even with these obstacles, our clinic staff are ready and eager to welcome patients back."

On the other hand, Paxton said, "Texas laws defending the unborn will win." However, he still needs an intermediate appellate court or the Texas Supreme Court to agree

"If Paxton can get one of those courts to act swiftly, the lifespan of that TRO may actually be less than two weeks," Chandler said.

As a result, uncertainty remains over how long some providers will offer abortion services, when we can expect the trigger ban outlawing the procedure almost completely to take effect, and what legal battles may wind up in the courts as a result. For now, abortion care for people up to six weeks pregnant is available in Texas again at a limited number of clinics where providers are pledging to help as many people as they can for as long as they can.

https://abc13.com/texas-judge-blocks-abortion-ban-law-blocked-2022-exceptions-new/12002422/

Santhera Updates on Ongoing NDA Submission for Vamorolone

 

Faces Delay in US FDA New Drug Submission For Duchenne Muscular Dystrophy Drug

https://www.marketscreener.com/quote/stock/SANTHERA-PHARMACEUTICALS-195471/news/Santhera-Updates-on-Ongoing-NDA-Submission-for-Vamorolone-40849711/

SK Bioscience Shares Advance on Covid-19 Vaccine Approval

 SK Bioscience Co. shares advanced Wednesday after its Covid-19 vaccine candidate secured final approval for use from local health authorities in South Korea.

Shares in the South Korean vaccine maker rose 5.6% to 114,000 won ($88.21) in early afternoon trading, when the broader market index Kospi fell 1.5%.

The Ministry of Food and Drug Safety's approval of the biotech company's SKYCovione jab made it the country's first homegrown Covid-19 vaccine.

SK Bioscience, formerly a contract manufacturer of AstraZeneca PLC's vaccine, said it is now seeking to get emergency-use approval for SKYCovione in other countries and from the World Health Organization.

The company said that clinical-trial data show that SKYCovione helped form about three times more neutralizing antibodies than AstraZeneca's vaccine.

The global Phase 3 clinical trial of SKYCovione involved 4,037 adults and the efficacy test group received two doses at four-week intervals, the company said.

https://www.marketscreener.com/quote/stock/SK-BIOSCIENCE-CO-LTD-120803076/news/SK-Bioscience-Shares-Advance-on-Covid-19-Vaccine-Approval-40850284/

EVOLENT HEALTH TO ACQUIRE IPG

 Expected to Accelerate Evolent Health's Position as a Leading Provider of Value-Based Specialty Care Solutions

- Expands Evolent's Value-Based Specialty Care Solutions Portfolio to Musculoskeletal Conditions
- Expected to be Immediately Accretive to Adjusted EBITDA Margins and Cash Flow
- Diversifies Customer Mix and Accelerates Entry into Commercial Line of Business

Evolent Health, Inc. ("Evolent" or "the Company") (NYSE: EVH) today announced that it has entered into a definitive agreement to acquire IPG, a leading technology and services company providing surgical management solutions for musculoskeletal conditions, from TPG Growth, the middle market and growth equity platform of alternative asset firm TPG, for $375 million plus additional contingent consideration of up to $87 million. Upon close the IPG team and platform will be integrated into New Century Health.

https://finance.yahoo.com/news/evolent-health-acquire-ipg-041800941.html

Analysts Believe Madrigal's Resmetirom Shows Impressive Overall Profile In Liver Fibrosis

 

• Madrigal Pharmaceuticals Inc 
  MDGL-4.61%+ Free Alerts
   presented multiple resmetirom abstracts at the European Association for the Study of the Liver's International Liver Congress.
• The data included new details on changes in FibroScan controlled attenuation parameter and liver stiffness measurement along with magnetic resonance elastography, which serves as critical non-invasive measures of liver stiffness and fibrosis. 
• Consistent with the previous top-line data, the most frequently reported adverse events were diarrhea and nausea, with no increase in the incidence of GI-related adverse events noted after the first 12 weeks of resmetirom treatment.
• Related: Madrigal Pharma's Kidney Disease Candidate Improves Liver, Cardiovascular Health.
• SVB Leerink views the presentations as incrementally de-risking for the program. 
• In a separate presentation, Madrigal also highlighted new results from a cohort of 105 NASH patients with compensated cirrhosis treated with resmetirom in an open-label portion of MAESTRO NAFLD-1.
• Resmetirom showed encouraging signals of efficacy. 
• SVB says that despite the limitations of this study, it views these results as encouraging regarding resmetirom's ability to impact a broad range of non-invasive measures positively.
• Ultimately, it views the histology results expected in 4Q from the MAESTRO-NASH study as an essential value-inflecting data catalyst for Madrigal shares. 
• JMP says that the key catalyst for MDGL shares, and the NASH field, remains the biopsy data from the Phase 3 MAESTRO-NASH study, which is on track for 4Q22.
• The analyst keeps the Market Outperform rating and the price target of $170.00.

https://www.benzinga.com/analyst-stock-ratings/analyst-color/22/06/27865213/analysts-believe-madrigals-resmetirom-shows-impressive-overall-profile-in-liver-fib