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Tuesday, June 28, 2022

Uncertainty surrounds ‘abortion pill’ access and legality after SCOTUS ruling

 The pills used to perform medically induced abortions are shaping up to be at the center of the next fight in the U.S.

Several states have already banned and criminalized abortion following a U.S. Supreme Court ruling Friday that overturned Roe v. Wade. The landmark case had previously secured abortion as a constitutional right.

Now, as the decision falls back to the individual states, some worry about future access to the FDA-approved pills that can be used to induce abortion in a private setting.

“This is a very viable option,” said Monica Skoko, a former nurse for Planned Parenthood. “It is an incredibly safe option.”

Some opposed to abortion, however, want to see it outlawed.

“It’s no different than a surgical abortion,” said Florida Family Policy Council President John Stemberger. “It ends that unborn child’s life and we think that’s morally wrong, we think it should be legally wrong.”

A medical abortion requires taking two FDA-approved pills: mifepristone and misoprostol, according to the Mayo Clinic. Mifepristone blocks the hormone progesterone and keeps the embryo from staying implanted in the uterus. Misoprostol rids the embryo from the body.

The procedure is most effective during the first trimester of pregnancy, according to the Mayo Clinic.

The option has become increasingly more common in the U.S. and accounted for more than half of all abortions in 2020, according to the Guttmacher Institute, a group that researches and supports abortion access.

“You get to have that in the privacy of your own home,” Skoko said. “You get to kind of dictate and have that power.”

In 2020, the FDA lifted a requirement to get the pills in person. People in some states now can have the drugs mailed to them.

But other states are trying to restrict access to the medication.

Kentucky, Tennessee and South Dakota limit access to abortion medication by specifying that the pill cannot be mailed or requiring specific qualifications of the doctor providing the service.

Healthcare attorney Harry Nelson said it would be “almost impossible” for states to stop people from accessing abortion pills through telehealth or doctors in other states.

“We’ve been fighting a losing battle for over a decade trying to stop opioids and fentanyl from being mailed into the country and other places,” Nelson said. “There’s absolutely no way that these states are going to be able to do anything about medication being mailed from overseas or outside of the country, or frankly even from in the country, from advocacy groups.”

“States may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” Attorney General Merrick Garland said in a statement last week. He added that the Justice Department “will work tirelessly to protect and advance reproductive freedom.”

Garland also said that in addition to protecting providers and those seeking abortions in states where it remains legal, “we stand ready to work with other arms of the federal government that seek to use their lawful authorities to protect and preserve access to reproductive care.”

Some states, including Texas and Oklahoma, are taking a new approach by allowing bans to be enforced through private lawsuits. Under those laws, private citizens can sue abortion providers and anyone who aids an individual in obtaining an abortion.

https://thehill.com/homenews/wire/3538938-uncertainty-surrounds-abortion-pill-access-and-legality-after-scotus-ruling/

GSK Submits Shingrix Regulatory Application in Japan for Adults 18 and Older

 GSK PLC said Tuesday that Japan's Ministry of Health, Labour and Welfare has accepted its regulatory application for its shingles-prevention treatment, Shingrix, so that it is used in adults age 18 and older who are at increased risk.

The U.K. pharmaceutical company, formerly known as GlaxoSmithKline, said Shingrix has already been approved in the country for adults age 50 and older.

The company said Shingrix's application was based on six clinical trials in patients 18 and older who had undergone recent blood-forming cells (stem cell)transplantation, kidney transplant, or have blood cancer, solid tumors or HIV.

"Shingrix is also recommended in the U.S. by the U.S. Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices as the preferred vaccine for the prevention of shingles and related complications for immunocompetent adults aged 50 years and older," the company said.

https://www.marketscreener.com/quote/stock/GSK-PLC-9590199/news/GSK-Submits-Shingrix-Regulatory-Application-in-Japan-for-Adults-18-and-Older-40840029/

Basilea: positive results of phase 3 study with ceftobiprole in Staphylococcus aureus bacteremia

 

  • Ceftobiprole met primary and secondary efficacy endpoints
  • Basilea plans to submit a New Drug Application (NDA) in the U.S. around year end 2022

Astrellas, Sutro to Collaborate on Immunostimulatory Antibody-Drug Conjugates

 iADCs are a next-generation modality for treating cancer and designed to boost anti-cancer activity, offering potential new options for patients who do not respond to existing cancer immunotherapies -

- Sutro will receive an upfront payment of US$90 million to develop iADCs for three biological targets and may be eligible to receive up to an additional US$422.5 million USD in development, regulatory and commercial milestones for each product candidate, plus royalties -

https://finance.yahoo.com/news/astellas-sutro-biopharma-announce-worldwide-233100535.html

CVS, Walmart, Rite Aid limiting purchases of Plan B pills following SCOTUS ruling

 CVS, Walmart and Rite Aid announced they would be capping the number of purchases of emergency contraceptive pills due to a surge in demand stemming from the Supreme Court decision last week to overturn Roe v. Wade.

The pills were in short supply or out of stock on Monday morning on the retailers' websites, and now CVS and Rite Aid are limiting customers to three purchases of the product. 

Plan B morning after pill

Walmart is capping purchases of the pills this week at four or six. The retailer had some pills available without purchasing restrictions, but only for pills that would not ship until next month.

CVS said in a statement it had plenty of pills online and in stores, but that it wanted to ensure "equitable access and consistent supply on store shelves," according to the Wall Street Journal. Rite Aid said it was imposing limits due to the increase in demand. Walmart has not addressed reports of its limits on pills.

Walgreens' website initially said there would be limits on the pills as well, but the company later revealed that the restriction was an error.

The pills, also referred to as morning-after pills, are often sold over-the-counter under the Plan B brand without an ID or prescription. The pills are to be taken up to three days after a woman engages in unprotected sex. The medication mainly works by preventing ovulation and, failing that, may stop a fertilized egg from attaching to the uterus.

They work by preventing ovulation or preventing a fertilized egg from attaching to the uterus.

The pills are different from abortion pills, which require a prescription and involve administering different pills over several weeks to terminate a pregnancy.

This comes after the Supreme Court ruled on Friday to overturn Roe v. Wade, meaning states can now make their own laws regarding the legality of abortion.

In the days following the ruling, some social media users urged women to stockpile contraceptive pills, while others cautioned against the move in fear that those in immediate need would not have access. Planned Parenthood encouraged women not to stockpile the pills because they have a limited shelf life.

https://www.foxbusiness.com/retail/cvs-walmart-rite-aid-limiting-purchases-plan-b-scotus-ruling

Stocks Swing Higher as China Eases Quarantine Rules

 Asian shares swung into positive territory in afternoon trade on Tuesday, propelled by China's decision to ease some quarantine requirements for international arrivals, with Hong Kong stocks particularly supported.

MSCI's broadest index of Asia-Pacific shares outside Japan was up 0.5%, having spent most of the day in the red. The index has fallen 3.8% so far this month.

Health authorities said on Tuesday that China will halve to seven days its COVID-19 quarantine period for visitors from overseas, with a further three days spent at home.

Following the news, Hong Kong's Hang Seng index reversed its losses and jumped 0.85% in afternoon trade.

In China, the blue-chip CSI300 index was 1% higher, also having clawed back earlier losses.

The sharp change in mood looked set to last into the global day with the pan-region Euro Stoxx 50 futures up 0.31%, German DAX futures 0.2% higher and FTSE futures climbing 0.47%. U.S. stock futures rose 0.46%.

"With local new infections dropping further in June, and COVID curbs to ease more, we expect the (Chinese) economy to continue to recover," BofA said in its note. "That said, given soft domestic demand and lingering COVID uncertainties, the mending path is likely to be bumpy in the coming months."

Market sentiment was also boosted by an official's remarks that Beijing would roll out tools to cope with economic challenges as COVID-19 outbreaks and risks from the Ukraine war pose a threat to employment and price stability.

Australian shares were up 0.86%, while Japan's Nikkei stock index rose 0.66%.

U.S. stocks ended a volatile trading session slightly lower on Monday with few catalysts to sway investor sentiment as they approach the half-way point of a year in which equity markets have been slammed by heightened inflation worries and tightening Fed policy.

Interest rate sensitive megacaps such as Amazon.com Inc, Microsoft Corp and Alphabet Inc were the heaviest drags on the U.S. main indexes.

The Dow Jones Industrial Average fell 0.2%, the S&P 500 lost 0.30% and the Nasdaq Composite dropped 0.72%.

Oil continued to rise with investors still weighing worries about an economic slowdown against concerns over lost Russian supply amid sanctions related to the conflict in Ukraine.

U.S. crude ticked up 1.02% to $110.69 a barrel. Brent crude rose to $116.42 per barrel.

"A seam of tight supply news bolstered the (oil) market," said analysts at Commonwealth Bank of Australia. "Political unrest might curtail supply from a couple of second-tier producers, Ecuador and Libya. And then there's the G7's proposed price cap on Russian oil."

In bond markets, Treasury yields climbed on Monday following capital and durable goods orders data and as pending home sales surprised to the upside from the previous month.

The yield on benchmark 10-year Treasury notes last reached 3.1828% on Tuesday, compared with its U.S. close of 3.194% on Monday. The two-year yield, which rises with traders' expectations of higher Fed fund rates, touched 3.0934%.

Also, the dollar edged lower versus major rivals as investors weighed expectations on inflation and interest rate hikes. The dollar index, which tracks the greenback against a basket of currencies of other major trading partners, was down at 103.96.

Monday, June 27, 2022

Gilead Resubmits New Drug Application for Lenacapavir for HIV-1

 NDA Resubmission Addresses Issues Related to Vial Compatibility 

 If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly

https://finance.yahoo.com/news/gilead-resubmits-drug-application-u-203000139.html