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Anixa Bio teams up with Cleveland Clinic to investigate breast cancer vaccine

Anixa Biosciences (NASDAQ:ANIX) inks a strategic alliance and license agreement with Cleveland Clinic aimed at developing a vaccine against triple negative breast cancer (TNBC), its most aggressive and treatment-resistant form.

A Cleveland Clinic researcher, Dr. Vincent Tuohy, has identified a protein that he says becomes inactive after a women gives birth but reappears in many forms of cancer. Studies have shown that vaccinating against this protein completely prevents breast cancer in mice.

In November 2017, the U.S. Department of Defense awarded a $6.2M grant to Dr. Tuohy and Cleveland Clinic to fund preclinical studies and the completion of two Phase 1 trials in humans.

The company will host a conference call tomorrow, July 18, at 4:30 pm ET to discuss the agreement.

https://seekingalpha.com/news/3478366-anixa-bio-teams-cleveland-clinic-investigate-breast-cancer-vaccine

FDA OKs Merck’s triplet antibiotic

The FDA approves Merck’s (NYSE:MRK) RECARBRIO (imipenem, cilastatin, relebactam) for injection, 1.25 gm for the treatment of patients at least 18 years old with complicated urinary tract infections, including pyelonephritis, and complicated intra-abdominal infections caused by certain Gram-negative bacteria who have limited or no alternative treatment options.

The agency reviewed the application under Qualified Infectious Disease Product and Priority Review status.

Imipenem is a penem antibacterial drug, cilastatin sodium is renal dehydropeptidase inhibitor and relebactam is a beta lactamase inhibitor. Cilastatin limits the renal metabolism of imipenem and has no antibacterial activity. Relebactam has no intrinsic antibacterial activity either but protects imipenem from degradation by certain beta lactamase enzymes.

Market launch should commence later this year.

https://seekingalpha.com/news/3478339-fda-oks-mercks-triplet-antibiotic

Abbott Laboratories EPS beats by $0.02, misses on revenue

Abbott Laboratories (NYSE:ABT): Q2 Non-GAAP EPS of $0.82 beats by $0.02; GAAP EPS of $0.56 beats by $0.08.

Revenue of $7.98B (+2.7% Y/Y) misses by $20M.

Shares +0.65% PM.

Press Release

https://seekingalpha.com/news/3478347-abbott-laboratories-eps-beats-0_02-misses-revenue

Some states struggling to vet providers to prevent Medicaid fraud

Medicaid programs in several states fail to fully vet providers at high risk for fraud, according to a new report from the Office of Inspector General (OIG).

Beginning in July 2018, the Centers for Medicare & Medicaid Services (CMS) required that states conduct criminal background checks on high-risk providers before allowing them to receive Medicaid payments. However, OIG found that 18 states failed to comply with the requirement by that date.

Of those 18 states, 13 were not in compliance as of Jan.1, according to the report.

“An effective provider enrollment screening process is an important tool for preventing Medicaid fraud,” OIG wrote. “It plays a vital role in identifying unscrupulous providers and preventing them from enrolling in Medicaid.”

 

OIG previously studied states’ ability to implement these background checks in 2016 and found many were struggling to do so. However, failing to use a fingerprint-based check for these providers leaves those Medicaid programs open to fraud and abuse, OIG said.

The report found that five states had not collected fingerprints for any high-risk providers as of January, and these states reported several central challenges to the effort:

  1. A lack of authority: Three of these states said their Medicaid agencies did not have proper oversight power for these background checks and that legislative or executive action would be necessary.

  1. A lack of resources: One state reported that it did not have the staff necessary to implement the background checks.

  1. A lack of criteria to determine “high-risk providers”: One state said it was actively revising its criteria based on concerns from the provider community, delaying compliance.

There are two key loopholes that high-risk providers can abuse in Medicaid if a state isn’t vetting them effectively, according to the report. For one, some states enroll providers in Medicaid payments if they’re approved for Medicare payment—though Medicare may not have vetted them either.

In addition, some states rely on providers themselves to report relevant information, which can lead to inaccurate reporting, OIG said.

“States reported that even when they have fully implemented fingerprint-based criminal background checks, high-risk providers can enroll in Medicaid without undergoing the required criminal background checks,” OIG wrote.

The agency made three recommendations to CMS as a result of the findings: Ensure all states roll out the background check requirements; amend guidance to eliminate the loophole for Medicare enrollment; and compare Medicaid providers’ self-reported data to Medicare data to identify potential discrepancies.

CMS agreed to the first recommendation but not to the second or third.

https://www.fiercehealthcare.com/payer/oig-some-states-struggling-to-vet-providers-to-prevent-medicaid-fraud

Getinge AB reports Q2 results

Getinge AB (OTCPK:GNGBF): Q2 Non-GAAP EPS of SEK1.12; GAAP EPS of SEK0.38.

Revenue of SEK6.28B (+9.6% Y/Y)

Press Release

https://seekingalpha.com/news/3478299-getinge-ab-reports-q2-results

Recalls Issued For Select Ointments, Eye Drops Sold At CVS

There has been a national recall of over-the-counter eyedrops and ointments that are sold at CVS.

Altaire Pharmaceuticals, Inc. announced that it is voluntarily recalling a host of products that are sold at CVS Health as a precaution due to fears of the items not being sterile.

“As a precautionary measure, Altaire is voluntarily initiating the recall due to management concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility,” the company announced. “The FDA has determined these issues indicate a lack of sterility assurance. Administration of a non-sterile product intended to be sterile may result in serious and potentially life-threatening infections or death.”

There have been no reported adverse effects from consumers using any of the recalled items. The complete list of recalled items include:

* CVS Health Natural Tears Lubricant Eye Drops Preservative Free; Item number: 538397

* CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye; Item number: 317916

* CVS Health Lubricant Eye Drops for Mild to Moderate Dry Eye; Item number: 247887

* CVS Health Dry Eye Relief Eye Drops; Item number: 317914

* CVS Health Dry Eye Relief Eye Drops; Item number: 457802

* CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 495334

* CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 994883

* CVS Health Preservative-Free Lubricant Gel Drops Dry Eye Relief; Item number: 634634

* CVS Health Lubricating Gel Drops for Anytime Use; Item number: 563420

* CVS Health Overnight Lubricating Eye Ointment; Item number: 881532

* CVS Health Lubricant Eye Ointment; Item number: 247881

* CVS Health Extra Strength Lubricant Gel Drops; Item number: 799143

* CVS Health Extra Strength Lubricant Gel Drops Twin Pack; Item number: 258587

* CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy; Item number: 895160

* CVS Health Fast Acting Lubricant Eye Drops Dry Eye Therapy Twin Pack; Item number: 994881

* CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 495301

* CVS Health Preservative-Free Lubricant Eye Drops Sensitive Solution; Item number: 457791

* CVS Health Preservative-Free Lubricant Eye Drops Advanced Relief; Item number: 563442

* CVS Health Lubricant Eye Drops Advanced Relief; Item number: 563419

* CVS Health Fast Acting Lubricant Eye Drops Preservative Free; Item number: 994882

* CVS Health Preservative-Free Lubricant Eye Drops Fast Acting; Item number: 258625

* CVS Health Lubricant Gel Drops-Moderate to Severe Dry Eye Relief; Item number: 799145

* CVS Health Multi-Action Relief Drops; Item number: 694954

* CVS Health Lubricant Eye Drops Lasting Dry Eye Relief; Item number: 968210

* CVS Health Lubricant Eye Drops Lasting Dry Eye Relief Twin Pack; Item number: 495323

* CVS Health Maximum Redness Relief Eye Drops; Item number: 994880

* CVS Health Redness Relief; Item number: 317912

* CVS Health Redness Relief; Item number: 457799

* CVS Health Lubricant Eye Drops Multi-Symptom Eye Relief; Item number: 563431

* CVS Health Lubricant Eye Ointment Sensitive Formula; Item number: 247885

The products subject to recall were manufactured and labeled exclusively for CVS Health, and they were only shipped to CVS locations nationwide. Individual locations were notified of the recall on Wednesday, July 10, and the products have since been pulled from shelves.

https://www.marketscreener.com/CVS-HEALTH-CORPORATION-12230/news/CVS-Health-Recalls-Issued-For-Select-Ointments-Eye-Drops-Sold-At-CVS-28914890/

Reporting before open: Abbott

 

ABT
Abbott Laboratories
Q2 2019
Pre-Market
EPS:
REV:
0.73 A
7.767B A
 

0.80 E
8B E

 

https://www.benzinga.com/stock/ABT/earnings/