Nearly 100 prosecutors sign pledge against criminalizing abortion

 A group of 83 prosecutors — including those in states where a “trigger ban” will take effect after Roe v. Wade was struck down by the U.S. Supreme Court — said they will not file charges against women seeking abortions and medical professionals who provide the procedures.

The prosecutors, along with the nonprofit group Fair and Just Prosecution, released the joint statement hours after the Supreme Court made its decision on Friday to overturn the landmark decision and restrict abortions in 26 states. 

“Not all of us agree on a personal or moral level on the issue of abortion,” according to the joint statement released by the 83 prosecutors. “But we stand together in our firm belief that prosecutors have a responsibility to refrain from using limited criminal legal system resources to criminalize personal medical decisions. As such, we decline to use our offices’ resources to criminalize reproductive health decisions and commit to exercise our well-settled discretion and refrain from prosecuting those who seek, provide, or support abortions.”

The prosecutors emphasized how the ban would disproportionately harm victims of human trafficking, rape, incest and domestic violence and force women to carry an unwanted pregnancy.

They added criminalizing abortion not only would end safe abortions, but also would impede medical professionals and law enforcement from performing their jobs and protecting victims.

Among the group of prosecutors who signed the pledge include Travis County District Attorney José Garza in Texas, who urged women to continue to seek medical help.

Texas is among 13 states that would automatically ban abortion in the first and second trimesters within 30 days of the Supreme Court’s decision. 

“While I am aware that our state’s ‘trigger law’ goes into effect in 30 days, making performing an abortion a felony, I will not force women into the shadows, especially when they need life-saving medical care,” Garza said in a statement. “No matter what the law says, I implore you: please, seek medical help if you need it. A prosecutor’s job is to protect public safety, and to enforce this law will not only fail to promote or protect public safety but will also lead to more harm.”

Six prosecutors in Michigan– Oakland County Prosecutor Karen McDonald, Wayne County  Prosecutor Kym Worthy, Ingham County Prosecutor Carol Siemon, Marquette County Prosecutor Matthew Wiese, Washtenaw County Prosecutor Eli Savit, Kalamazoo County Prosecutor Jeffrey Getting and Genesee County Prosecutor David Leyton– also signed the pledge.

Missouri Attorney General Eric Schmitt issued an opinion that led to Missouri becoming the first state in the country to ban abortion following the Supreme Court decision.

AP

“Michigan’s anti-abortion statutes were written and passed in 1931,” the Michigan prosecutors said in a joint statement. “There were no women serving in the Michigan legislature. Those archaic statutes are unconstitutionally and dangerously vague, leaving open the potential for criminalizing doctors, nurses, anesthetists, health care providers, office receptionists – virtually anyone who either performs or assists in performing these medical procedures. Even the patient herself could face criminal liability under these statutes.

“We believe those laws conflict with the oath we took to support the United States and Michigan Constitutions, and to act in the best interest of the health and safety of our communities. We cannot and will not support criminalizing reproductive freedom or creating unsafe, untenable situations for health care providers and those who seek abortions in our communities.”

Other states, however, moved quickly to enforce the ban.

Missouri Attorney General Eric Schmitt issued an opinion on Friday that “triggered” a house bill and became the first state in the country to effectively end abortion.

The signers of the pledge said criminalizing abortion would end safe abortions.

AFP via Getty Images

Under the house bill, no abortion can be performed in Missouri except in cases of medical emergencies. 

“My Office has been fighting to uphold the sanctity of life since I became attorney general, culminating in today’s momentous court ruling and attorney general opinion,” Schmitt said in a statement. “I will continue the fight to protect all life, born and unborn.”

https://nypost.com/2022/06/24/nearly-100-prosecutors-sign-pledge-against-criminalizing-abortion/

Merck, Seagen Talks Heat Up Under Cloud of Regulatory Scrutiny

 Talks between Merck and Seagen are heating up as the former looks to buy the latter, according to a report from The Wall Street Journal. If the merger-and-acquisition deal did go through, it would likely be a sizable one, since Seagen has a market cap above $32 billion.

This follows last week’s report published by WSJ that stated Merck was exploring purchasing the biotech company.

In September 2020, Merck and Seagen entered into an agreement to co-develop ladiratuzumab vedotincancer, a cancer treatment, with Merck pitching in $600 million upfront and acquiring 5 million shares of Seagen stock for $1 billion. They also have a licensing deal for Tukysa in countries outside the U.S., Canada and Europe, and Merck dropped $125 million upfront for that cancer drug.

Both companies are strong players in the oncology space. Merck’s lead product is its blockbuster anti-PD-1 checkpoint inhibitor Keytruda (pembrolizumab). The drug brought in $17.2 billion in 2021 alone. In the first quarter of this year, Keytruda brought in $4.7 billion, an increase of 23% from the previous year.

Seagen focuses on antibody-drug conjugates (ADCs). These drugs have onco-toxins attached to an antibody that delivers the drugs directly to the tumors. Its best-known drug is Adcetris.

On June 6, Seagen and Genmab announced interim data from the innovaTV 205 trial of Tivdak (tisotumab vedotin) in combination with Keytruda in patients with recurrent or metastatic cervical cancer who have not received previous systemic therapy. The interim data demonstrated a confirmed objective response rate (ORR) of 41% and median durability of response that was not achieved within almost 19 months of median follow-up.

Tivdak is an ADC made up of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Seagen’s ADC technology.

“With Genmab, we will continue to investigate tisotumab vedotin in combination with other therapies because there is still an unmet need for more effective first-line treatment for advanced cervical cancer patients,” Marjorie Green, M.D., senior vice president and head of late-stage development at Seagen, said in a statement. “We’re also researching innovative new tools to help increase awareness of the disparities and unmet needs that cervical cancer patients experience in order to better support this community in the future.”

Although Merck is a powerhouse in the oncology space, it doesn’t really focus on ADCs. It has a significantly larger market cap than Seagen, at about $233 billion. According to Seeking Alpha, Seagen's shares have risen considerably since the WSJ report, and Wells Fargo analyst Mohit Bansal wrote in a note that the value of a deal would be within the $200-$220/share range. 

"The real value to MRK is qualitative as SGEN adds durability and diversity to the company beyond Keytruda," Bansal said in the note obtained by Seeking Alpha. 

Although picking up Seagen would certainly beef up its already strong oncology portfolio, Merck is reportedly concerned that regulators might block the deal. The Securities and Exchange Commission has taken a close look at competing products with merging companies, sometimes forcing companies to divest drugs for the deals to go through. For example, in 2020, when AbbVie acquired Allergan, regulators required the companies to divest brazikumab and Zenpep (pancrelipase).

A recent report on the industry by PwC notes that one of the reasons M&A activity has been so slow this year is concern over increased regulatory scrutiny. On the other hand, a driving factor for M&A interest is an increasing number of patent expirations. Although Keytruda is still growing, its patents start to expire in 2028. Keytruda has been approved for a long list of cancer indications, both as a monotherapy and in combination with numerous other cancer drugs.

Amidst all of this, Seagen is undergoing some changes. In May, the company’s president, CEO and board member, Clay Siegall, resigned after domestic violence allegations, which had resulted in a leave of absence earlier in the month. The board is currently conducting a search for a replacement. Meanwhile, Roger Dansey, M.D., the company’s chief medical officer, is acting as interim CEO.

https://www.biospace.com/article/report-merck-seagen-talks-heat-up-under-cloud-of-regulatory-scrutiny/

2 Dozen States To Restrict Abortions After Supreme Court Decision

 by Jack Phillips via The Epoch Times,

More than two dozen states will move to restrict abortions following the Supreme Court’s Friday ruling that overturned Roe v. Wade and Planned Parenthood v. Casey.

The Guttmacher Institute, a research group, says that 13 states have “trigger laws” that bar most abortions that will take effect immediately after the ruling Friday.

They are Arkansas, Idaho, Kentucky, Louisiana, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, Utah, and Wyoming.

Five more states had respective bans on abortion from the time before the Roe v. Wade ruling in 1973.

They include Alabama, Arizona, Michigan, West Virginia, and Wisconsin.

Georgia, Iowa, Ohio, and South Carolina, according to the Institute, have laws that ban abortions after the 6-week mark. Those laws will be revisited after the overturning of Roe v. Wade.

Meanwhile, the legislatures of Florida, Indiana, Montana, and Nebraska appear likely to ban abortion based on previous and current efforts, the group says.

Overall, 26 of 50 U.S. states are likely or certain to ban abortion after the ruling was handed down Friday, the Institute says.

“Beyond the 26 states certain or likely to attempt to ban abortion immediately, other states have demonstrated hostility toward abortion by adopting multiple restrictions in the past, but are not likely to ban abortion in the near future. Notably, North Carolina has a pre-Roe abortion ban in place, but it is unclear if the state’s law would be implemented quickly. However, this analysis may change in the next few years,” according to the institute’s website.

The Center for Reproductive Rights, a pro-abortion group, estimates that 25 states are likely to ban abortion. That group believes that Montana, Iowa, and Florida will not—but that North Carolina and Pennsylvania will.

Supreme Court Justice Samuel Alito, in an opinion for the majority Friday, wrote that Roe and Planned Parenthood v. Casey, the 1992 decision that reaffirmed Roe, was incorrect on the day it was decided and must be overturned. The authority to regulate abortion doesn’t rest in the court system, he argued, adding that only legislatures have that power.

“We therefore hold that the Constitution does not confer a right to abortion. Roe and Casey must be overruled, and the authority to regulate abortion must be returned to the people and their elected representatives,” Alito wrote.

Justices Clarence Thomas, Neil Gorsuch, Brett Kavanaugh, and Amy Coney Barrett joined Alito. Chief Justice John Roberts wrote that he would have stopped short in ending Roe, adding that he would have upheld the Mississippi law at the heart of the case.

Justices Stephen Breyer, Elena Kagan, and Sonia Sotomayor dissented.

“With sorrow—for this Court, but more, for the many millions of American women who have today lost a fundamental constitutional protection—we dissent,” they said in their opinion.

https://www.zerohedge.com/political/2-dozen-states-restrict-abortions-after-supreme-court-decision

Federal appeals court pauses ban of Juul e-cigarettes

 A federal appeals court on Friday issued a temporary stay of a ban announced one day earlier by regulators, which would prohibit the sale of Juul electronic cigarettes nationwide, court records show.

In an order filed in court, the U.S. Court of Appeals for the D.C. Circuit stayed a marketing denial order issued one day earlier by the Food and Drug Administration. The FDA order required that Juul Labs Inc. stop selling and distributing its products in the U.S.

Judges noted Friday that the court’s order was aimed at giving it time to consider an emergency motion filed by Juul that aims to allow the vaping company to continue selling e-cigarettes. Friday’s order “should not be construed in any way as a ruling on the merits of that motion,” judges wrote.

On Thursday, FDA officials said they were barring the sale of Juul products after determining that there was not enough evidence to show that the products benefit public health, a requirement for companies that sell e-cigarettes, according to The Associated Press.

Regulators noted Thursday that they had “not received clinical information to suggest an immediate hazard associated with the use of the JUUL device or JUULpods.”

On Thursday, FDA Commissioner Robert Califf said the agency’s action showed “further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”

“The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market,” he said in a statement. “We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping.”

Juul petitioned Friday morning for relief from the FDA order, calling it extraordinary and unlawful, The Wall Street Journal reported. The company also questioned the handling of the announcement.

https://www.kiro7.com/news/trending/federal-appeals-court-pauses-ban-juul-e-cigarettes/SD4EE6JH5JCVFP7R65I5IXNVIE/

DC bridge shuts down after pro-abortion rights activist scales arch

 A bridge in Washington, D.C., has been shut down after a man climbed the bridge’s arch to protest the Supreme Court’s decision to overturn Roe v. Wade. 

The District Department of Transportation said in a release on Friday that the Frederick Douglass Memorial Bridge shut down for “safety concerns involved with protest activity” and will remain closed until further notice. The release states traffic enforcement officers are present to help direct traffic and motorists should use extra caution and expect moderate delays. 

The man, Guido Reichstadter, has posted multiple videos of himself from the top of the bridge, calling for people to go into the streets nonviolently to “shut down the government” until abortion rights are protected. 

Demonstrators rushed to the Supreme Court shortly after it issued its ruling to overturn Roe v. Wade, which guaranteed a federal right to abortion, and Planned Parenthood v. Casey, which upheld the right. The demonstrations are made up of both anti-abortion and pro-abortion rights demonstrators. 

Reichstadter said he is calling for “mass nonviolent civil resistance,” which he said is how people throughout the world protect their rights when “they’re under attack by unelected, unaccountable authoritarian governments.” 

“I’m a father — I got a 12-year-old daughter,” he said. “I’m willing to do anything it takes to fight for her rights.” 

Reichstadter also placed a green flag on the bridge, with the color representing abortion rights. 

“I’m at the top of the Frederick Douglass bridge in Washington DC right now & want to know why YOU aren’t in the streets nonviolently shutting down the gov day after day after day till Congress protects abortion rights? Rise Up my Friends!” Reichstadter posted on Twitter.

https://thehill.com/regulation/court-battles/3536331-dc-bridge-shuts-down-after-pro-abortion-rights-activist-scales-arch/

Adverum Gets EMA's Priority Medicines Status For Chronic Eye Remedy

The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to Adverum Biotechnologies’ 

ADVM-1.85%+ Free Alerts

  lead drug ADVM-022 for the treatment of wet age-related macular degeneration (wet AMD).

A Phase 2 study in wet AMD is planned to investigate ADVM-022, expects dosing the first patient in the third quarter of 2022.

Laurent Fischer, M.D., president and chief executive officer, said, “We are extremely pleased with EMA's decision to grant ADVM-022 PRIME designation. Following the encouraging results seen in the OPTIC trial in wet AMD, our PRIME designation recognizes the broad potential of ADVM-022 and is based in part on our trial subjects now having three-year sustained aflibercept expression with stable disease and maintained long-term central subfield thickness and visual acuity after a single IVT injection.”

PRIME is a program launched by the EMA to enhance support for research on and development of medicines that target a significant unmet medical need.

https://www.benzinga.com/general/biotech/22/06/27845039/adverum-biotech-receives-emas-priority-medicines-status-for-chronic-eye-disorder-candidate

DC police to back demonstrations through Tuesday following Roe overturn

 Washington, D.C., police are mobilizing to support demonstrations taking place in the District after the Supreme Court overturned Roe v. Wade on Friday. 

The Metropolitan Police Department (MPD) and D.C. Homeland Security and Emergency Management Agency (HSEMA) said in a release that MPD has “initiated full departmental activation” through Tuesday as demonstrations in favor and against the ruling continue throughout the weekend. Anti-abortion and pro-abortion rights demonstrators gathered outside the Supreme Court shortly after the ruling came out, with both sides showing strong emotions on the decision. 

“As the nation’s capital, we take seriously our responsibility to support First Amendment rights,” the statement reads. 

The release states D.C. Mayor Muriel Bowser (D) has been briefed on the situation and is “committed” to providing the resources to keep the local community safe. MPD and HSEMA are also closely monitoring the developments and are coordinating with federal partners. 

The D.C. National Guard tweeted that it has not received a request for assistance from the D.C. government or federal authorities but is ready to provide support if it receives a request for assistance that is approved by the Defense Department.

https://thehill.com/regulation/court-battles/3536052-dc-police-to-back-demonstrations-through-tuesday-following-roe-overturn/