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Tuesday, June 28, 2022

Why Endo International Stock Is Soaring

 Endo International Plc 

 shares continue to trade higher Tuesday in possible reaction to a recent U.S. Supreme Court ruling, which overturned the Roe v. Wade decision.

Endo International subsidiary Paladin Labs has a group of brands, including Plan-B, that it has acquired or licensed for use in Canada. Plan-B is a type of emergency birth control, often referred to as "the morning-after pill."

In 1973, the Roe v. Wade ruling established the constitutional right to abortion. Nearly 50 years later, that right has been eliminated. The court’s controversial decision will allow individual states to make their own abortion laws.

"The Constitution does not confer a right to abortion; Roe and Casey are overruled; and the authority to regulate abortion is returned to the people and their elected representatives," the Supreme Court syllabus said.

https://www.benzinga.com/markets/penny-stocks/22/06/27885571/why-endo-international-stock-is-soaring-today

Class I Recall For GE Healthcare CARESCAPE Ventilator

 The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.

https://medtech.pharmaintelligence.informa.com/MT145565/Class-I-Recall-For-GE-Healthcare-CARESCAPE-Ventilator

Amazon limits how many Plan B pills you can buy

 Amazon has limited sales of emergency contraceptive pills as demand spikes following last week’s U.S. Supreme Court ruling overturning Roe v. Wade and ending the constitutional right to have an abortion.

The company has placed a temporary quantity limit of three units per week on emergency contraceptive pills, Amazon confirmed to CNBC.

A review of emergency contraceptive pills sold on Amazon showed varying quantity limits. A listing for Plan B, a popular brand of the drug Levonorgestrel, showed purchases were capped at three products per shopper. Meanwhile, one listing for a generic version of the drug, called My Choice, allowed users to purchase up to 30 units.

Amazon is the latest retailer to place limits on purchases of the pills. CVS said Monday it was temporarily capping purchases of Plan B pills. The company has since removed those restrictions, saying demand has returned to normal levels.

Walmart said many of the chain’s products have online purchase limits that can change “during times of fluctuating demand.” Walgreens said purchases of emergency contraceptive pills were not being limited.

Emergency contraceptive pills, often referred to as “morning after pills” and sold under the Plan B brand, can be purchased over-the-counter and without an ID or prescription.

They typically work by stopping the release of an egg from the ovaries, preventing a sperm from fertilizing an egg, or, if fertilization has already occurred, stopping a fertilized egg from attaching to the womb. They’re designed to be taken up to three days after unprotected sex.

Morning-after contraception pills are distinct from abortion pills, which require a prescription and can be used in the first 10 weeks of pregnancy to terminate it.

The Supreme Court on Friday overturned the landmark 1973 Roe v. Wade ruling that established the constitutional right to abortion across the U.S. Numerous states have started to impose partial or full bans on the procedure.

In response, many people have urged others to stock up on Plan B in anticipation of possible restrictions on contraceptive pills. Others said potential shortages could impact those most in need and urged people to instead fund organizations that help distribute the pills to keep it available.

https://www.cnbc.com/2022/06/28/amazon-limits-plan-b-pill-purchases-as-demand-surges.html

CDC activates Emergency Operations Center for monkeypox

 The US Centers for Disease Control and Prevention announced on Tuesday the activation of its Emergency Operations Center (EOC) to respond to the US monkeypox outbreak.

The activation of the EOC "allows the agency to further increase operational support for the response to meet the outbreak's evolving challenges," the agency said in a news release.

    This facility is currently activated for Covid-19 and is where experts monitor information on other public health emergencies, such as hurricanes, earthquakes and oil spills.
    According to CDC's webpage, the center works to outline a structure of response from the government and alongside non-government actors in emergency response.
      Most recent data from the CDC show at least 244 probable or confirmed cases of monkeypox in the US.

      VBI: New Long-Term Follow-Up Clinical Data for Hepatitis B Vaccine

       -VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that new data from a follow-up analysis of a subset of participants from the pivotal Phase 3 study (PROTECT) of the Company’s 3-antigen prophylactic hepatitis B (HBV) vaccine, were presented in an oral presentation at The International Liver Congress™ 2022 (ILC), the Annual Meeting of the European Association for the Study of the Liver (EASL), which took place on June 26, 2022.

      Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, and principal investigator of the PROTECT and CONSTANT Phase 3 clinical studies of VBI’s 3-antigen HBV vaccine, highlighted data from his investigator-initiated analysis that evaluated duration of immune response approximately 2.5 years after completion of vaccination. Immunogenicity was assessed using frozen sera samples from a subset of participants (n=465) who had been enrolled at five clinical sites in Finland as part of PROTECT. In the follow-up analysis, participants in PROTECT who received VBI’s 3-antigen HBV vaccine had 5.5-fold higher mean anti-HBs titers (GMC: 1382.9 mIU/mL vs. 251.4 mIU/mL) and a higher seroprotection rate (SPR: 88.1% vs. 72.4%) compared to those who received Engerix-B. Additionally, 72.9% of participants who received VBI’s 3-antigen HBV vaccine retained anti-HBs titers ≥ 100 mIU/mL compared to 32.6% of those who received Engerix-B.

      https://finance.yahoo.com/news/vbi-vaccines-announces-long-term-120000228.html

      Verrica Holds Type A Meeting with FDA for Skin Condition Med

       Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced that the Company held a Type A meeting with the U.S. Food and Drug Administration (FDA) on June 27, 2022 regarding the path forward for the resubmission and potential approval of the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum).

      “We are pleased with our communications with the FDA leading up to and during yesterday’s Type A meeting,” said Ted White, Verrica’s President and Chief Executive Officer. “In particular, we are encouraged by the FDA’s willingness to work collaboratively with us on the amount of stability data required from an alternative contract manufacturing organization (CMO) for our bulk solution at the time of resubmission as well as our options for post-approval use of bulk solution previously manufactured. We remain confident in VP-102 as the potential first FDA-approved treatment option for molluscum, and we continue to be encouraged by the overwhelming support from caregivers and the medical community.”

      https://finance.yahoo.com/news/verrica-pharmaceuticals-holds-type-meeting-113000582.html

      Reckitt weighs shelving $7 bln infant nutrition sale

       Britain's Reckitt Benckiser Group RKT.L is considering if it should shelve the sale of its infant nutrition unit, as high-profile deals have fallen through due to a worsening financing market, Bloomberg News reported on Tuesday.

      Talks between the Enfamil baby formula maker and potential buyers have stalled in recent weeks, the report said, citing people familiar with the matter.

      https://www.nasdaq.com/articles/reckitt-weighs-shelving-%247-bln-infant-nutrition-sale-bloomberg-news