Target $28
Friday, June 24, 2022
Abortion banned in Missouri as trigger law takes effect, following SCOTUS ruling
Nearly all abortion is now banned in Missouri following the U.S. Supreme Court decision Friday ending the federal right to the procedure that marks the culmination of a decades-long campaign by Missouri abortion opponents to restrict – and one day eliminate – the lawful ability to end a pregnancy. The U.S. Supreme Court opinion overturns the federal right to abortion established by the 1973 Roe v. Wade decision. Missouri has a “trigger law” prohibiting abortions except those necessary because of medical emergencies in the event Roe is overturned. The sole clinic in the state offering surgical abortions — in St. Louis — is almost certain to immediately stop performing the procedure.
The decision is a historic moment not only for the country but for Missouri, ending nearly half a century of legal abortion in a state with deep anti-abortion roots. Missouri law barred abortion as early as 1825 – a prohibition that only ended with Roe 49 years ago. The opinion ushers in a new, chaotic era in the fight over reproductive rights in Missouri, as lawmakers clash over how far to go in eliminating the procedure and weigh whether they can punish those who help Missouri residents get abortions out of state.
Prosecutors, including Missouri Attorney General Eric Schmitt, will face new choices about whether to charge individuals with abortion-related crimes. The decision may not be the final word on abortion in Missouri. In the future, a ballot initiative could force a statewide vote on legalizing the procedure. A lawsuit could also be brought that argues the Missouri Constitution guarantees the right to an abortion.
“The battle is not over. It’s just that the battleground has shifted,” said Samuel Lee, a lobbyist for Campaign Life Missouri. “I expect lots more work for the pro-life movement over the coming years to protect the unborn and help women who are risk for abortions.”
Even before Friday’s decision, access to abortion was already very limited in Missouri. By 2020, fewer than 200 surgical abortions were performed, a drop of several thousand over the past two decades. In 2020,
Yamelsie RodrÃguez, president and CEO of Reproductive Health Services of Planned Parenthood of the St. Louis Region, said that “the reality is, abortion has essentially become a right in name only in Missouri.” Missouri residents often traveled to Kansas, where a clinic in Overland Park offers the procedure, or to a clinic in Fairview Heights, Illinois, near St. Louis. In 2021, for instance, 3,458 Missouri residents received abortions in Kansas — 44% of all abortions performed in Kansas that year.
Abortion is likely to remain legal in Illinois, but in Kansas, voters will decide in August whether to approve an amendment to their state constitution that would clear the way for state legislators to approve a ban. The one clinic in Missouri offering abortions, called Reproductive Health Services of PPSLR, will stop offering abortions. Instead, it will refer patients to a nearby clinic in Illinois
. “We will have to stop providing abortions at our clinic in St. Louis immediately,” Bonyen Lee-Gilmore, a spokesperson for Planned Parenthood of the Saint Louis Region (PPSLR), said in an interview on Tuesday. “It comes with criminal penalties.”
TRIGGER LAW SET STAGE FOR BAN
Republicans set the stage for halting legal abortion in Missouri three years ago, when lawmakers embedded a trigger ban in a 2019 anti-abortion bill signed by Republican Gov. Mike Parson. The law requires either Parson or Schmitt to issue statements that Roe has been overturned to implement the ban. Schmitt, a Republican running for U.S. Senate, had promised to immediately release the necessary document. Within minutes of the U.S. Supreme Court decision, his office announced he had signed a legal opinion implementing the abortion ban
. “Following the SCOTUS ruling overturning Roe v. Wade, Missouri has just become the first in the country to effectively end abortion with our AG opinion signed moments ago. This is a monumental day for the sanctity of life,” his office said. Parson soon followed, announcing he had signed a proclamation to trigger the ban.
“I’m a pro-life guy. I’m fine with that. That’s what I believe in, I’ve said that all along,” Parson said Thursday when asked about what the trigger law would mean for his legacy as governor. But Parson also said people would continue to have access to abortion.
“The one about it is, you’re not doing away with it, either. We may be in the state, but there’s other places to go if people want to do that in time,” Parson said. “But right now, this is something a lot of us have worked real hard for.”
At the time of the bill’s passage in 2019, the “trigger” provision was overshadowed by the legislation’s ban on abortion after the eighth week of pregnancy.
The law was blocked by a federal court before it could go into effect, however. For years, Missouri lawmakers, many of whom saw abortion as an evil akin to murder, chipped away at access to the procedure. They required women seeking an abortion to wait 72 hours and blocked the use of telemedicine in abortion. And again and again, they tried to stop Planned Parenthood from receiving public funds, even though federal law already prohibited the dollars from paying for abortions
. State Rep. Mary Elizabeth Coleman, an Arnold Republican and a staunch abortion opponent, has often described her goal as making abortion not just illegal, “but unthinkable.” Coleman this spring offered a preview into the possible next frontier of the anti-abortion movement, when she proposed allowing lawsuits against anyone helping Missouri women obtain abortions even if the procedure took place out of state. Her measure didn’t advance in the legislature.
“I am absolutely speechless. I haven’t even had a chance to process this,” Coleman said. “This is the day that the pro-life movement has been waiting for, for generations.” Abortion rights supporters have cast access to the procedure as a key element of health care for women. Ending a pregnancy, they often said, was such an important decision that it was best left to women themselves, in consultation with their doctor and possibly their clergy — and out of the hands of the government.
“Two hundred and fifty years ago, our country’s founders said, ‘All men are created equal.’ Today, the Supreme Court took the ‘men’ part literally, stripping rights from every woman in America,” Emily Wales, CEO of Planned Parenthood Great Plains, said in a statement.
If legal abortion isn’t an option in Missouri, abortion rights supporters may at the very least focus on persuading prosecutors not to go after doctors and others who help women obtain abortions. The 2019 trigger law doesn’t allow prosecutions of those who get an abortion. Some prosecutors have already made clear they won’t pursue abortion-related cases. Jackson County Prosecutor Jean Peters Baker released a statement in May calling the threat of criminal sanctions for reproductive health care “an injustice.” But Missouri law appears to give Schmitt at least some authority over abortion-related crimes, potentially setting up clashes between the Republican state official and local Democratic prosecutors.
https://www.kansascity.com/news/politics-government/article262796208
Bristol: Zeposia Analyses Show Benefits in Relapsing Multiple Sclerosis Treatment
Bristol Myers Squibb said Friday new analyses from two Phase 3 trials of Zeposia showed early use of the treatment demonstrated cognitive benefits in people with relapsing multiple sclerosis, a disease in which the immune system attacks the protective covering of nerves.
The biopharmaceutical product developer said the greatest effect from the demonstrated cognitive benefits were seen in people with high thalamic volume, supporting an association between preserved brain volume and improved long-term cognitive outcomes.
Zeposia was well tolerated with more than 80% of people who started the Phase 3 SUNBEAM trial remaining on continuous therapy through 48 months of the Phase 3 DAYBREAK OLE study, Bristol Myers Squibb said.
Bristol Myers must face $6.4 billion lawsuit over delayed cancer drug
A U.S. judge on Friday refused to dismiss a $6.4 billion lawsuit accusing Bristol Myers Squibb Co of delaying its Breyanzi cancer drug to avoid payments to shareholders of the former Celgene Corp, which the drugmaker bought for $80.3 billion in 2019.
U.S. District Judge Jesse Furman in Manhattan rejected Bristol Myers' claim that it was never properly notified about its alleged default on its merger obligations by UMB Bank NA, the trustee representing the former Celgene shareholders.
Bristol Myers and its lawyers did not immediately respond to requests for comment.
The case arose from the company's agreement to pay Celgene shareholders holding "contingent value rights" an extra $9 per share in cash if it won U.S. approval by specified deadlines for Breyanzi and two other Celgene drugs.
While two of the drugs were approved by the deadlines, UMB said the New York-based company failed to use the required "diligent efforts" to obtain approval for Breyanzi by Dec. 31, 2020, and reaped a "windfall" by avoiding the extra payout.
The trustee said Bristol Myers had delayed the submission of critical information to the U.S. Food and Drug Administration, and failed to prepare its manufacturing plants for inspections.
Bristol said the lawsuit must be dismissed because its agreement to pay the Celgene shareholders had expired.
But the judge said the agreement explicitly provided that UMB could sue, and that Bristol Myers was not excused from material breaches that predated the agreement's expiration.
"(Bristol Myers) cites no authority to support the proposition that a breach of a contract cannot, as a matter of law, 'continue' after termination of the contract," Furman wrote.
David Elsberg, a lawyer for UMB, said the trustee was "delighted" and looked forward to proving its case.
Bristol Myers won FDA approval for Breyanzi on Feb. 5, 2021, to treat non-Hodgkin's lymphoma. Its chemical name is lisocabtagene maraleucel.
The case is UMB Bank NA v Bristol-Myers Squibb Co et al, U.S. District Court, Southern District of New York, No. 21-04897.
'Abject failure': Abortion rights movement fractures over post-Roe future
Badly stung by the U.S. Supreme Court's decision to overturn Roe v. Wade on Friday, the abortion rights movement finds itself splintered, demoralized and faced with a startling landscape in which the procedure may be outlawed in half the country.
Angry grassroots activists are calling past efforts an "abject failure." They say national abortion rights advocacy groups were so consumed with winning federal elections they allowed conservatives to chip away at abortion rights through state-level legislation over decades.
At the same time, those groups have raised and funneled hundreds of millions of dollars to Democratic congressional and presidential candidates - largely for naught, the activists say.
Mini Timmaraju, president of NARAL/Pro-Choice America, one of the most powerful national abortion rights groups, said the movement should take a hard look at its tactics.
"As the right was being whittled away in the states, federal voices were still focused on protecting Roe," said Timmaraju, who was named to her post last year. "It would be malpractice not to investigate what happened."
NARAL and other abortion-rights mainstays, including Planned Parenthood and EMILY's List, say they are increasingly investing in state-level politics. But they insist a robust federal presence remains vital to ward off Republican attempts to pass an outright national abortion ban in Congress.
With Roe overturned, the divide within the abortion rights movement is widening along progressive and moderate lines, much like the current Democratic Party, grassroots activists say.
"The fight is in the states," says Kellie Copeland, executive director of Pro-Choice Ohio. "Washington has had their chance - and they failed."
Mainstream groups want to largely stay the course they have followed since the 1973 Roe v. Wade decision. They hope the Supreme Court ruling will galvanize voters in November's elections, perhaps helping Democrats retain control of Congress and boosting efforts to codify Roe's protections into federal law.
Progressive activists say it is time to turn the focus to ensuring women and people who seek abortions can obtain them no matter where they live.
BLAME GAME
The path toward the Supreme Court's decision begins with conservative Republicans, who for 40 years pushed to nominate federal judges hostile to Roe and worked at the state level to pass laws limiting abortion rights.
More than 1,330 restrictions on abortion have been passed by state legislatures since Roe became law, according to the Guttmacher Institute, which tracks abortion access. Some 44% of those restrictions passed in the last decade alone. The Friday ruling further empowers these state legislatures to determine the legality of abortion - potentially limiting access for millions of women nationwide.
Some longtime activists say the abortion rights movement underestimated conservatives' tenacity.
"The pro-choice movement made a grave error," said Merle Hoffman, who opened an abortion clinic in New York in the early 1970s. "They minimized the strength and the persistence of their opposition."
Experts and advocates point to various legal and political turning points in the battle over abortion rights: a 1992 Supreme Court decision that allowed states to start reducing abortion access; the 2010 midterms that resulted in huge Republican state-level gains; the success of Senate Republicans in keeping an Obama Supreme Court nominee off the court; and the unwillingness of Democratic presidents to make abortion rights and access a priority while they had party majority in Congress.
But several said the biggest sea change in the fight was cultural. Conservative activists were able to transform the right to have an abortion from a feminist principle to something that became a moral dilemma, aided by technology that allowed people to see images of fetuses.
Abortion became stigmatized, activists say. Democrats spoke of making it "safe, legal and rare," instead of speaking of it as a right.
Legal abortion has maintained broad public support. In a Reuters/Ipsos poll conducted last month, 71% of respondents, including 60% of Republicans, said they believed the decision to terminate a pregnancy should be left to a woman and her doctor.
Amelia Bonow, co-founder of Shout Your Abortion, a progressive advocacy group aimed at normalizing abortion, is part of a new wave of activists who have lost faith in the political process and the courts.
Instead, they want to utilize other tools - telemedicine, abortion pills, travel - to help women in need obtain abortions regardless of the state they live in.
"We are creating a world we can survive in," Bonow said, in the face of what she called "an abject failure."
Abortion rights supporters, Bonow said, should stop donating money to national organizations and instead donate to local abortion funds and advocacy groups to improve abortion access.
"We are no longer talking about rights," Bonow said. "We're talking about creating access in the absence of rights."
'LEFT BEHIND'
Mallory Schwarz, the executive director of Pro-Choice Missouri, watched with dismay in 2019 as Republican lawmakers in her state passed a sweeping anti-abortion bill that would ban the procedure if the high court gutted the federal protections.
Despite her pleas, she said, much-needed financial help from her parent organization, NARAL, never came.
"It's been really disappointing to be left behind while national groups make statements about the millions of dollars that they are going to throw away on a couple of Senate races," said Schwarz, whose group is no longer affiliated with NARAL.
NARAL said it decided to switch to an "integrated national structure" rather than relying on independent affiliates.
NARAL, Planned Parenthood and EMILY's List spent more than $190 million during the 2020 election cycle to elect abortion rights supporters, with the vast bulk of the spending on the federal level.
The mainstream abortion rights groups argue they still have a significant role to play, but said the funding of federal political campaigns ultimately failed to protect abortion rights.
"It would be foolish to think we can continue with business as usual," said Timmaraju. "There is an opportunity to do some innovative thinking."
Intellia and Regeneron's CRISPR ATTR Therapy Durable at 1-Year
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim data from an ongoing Phase I trial of NTLA-2001 for transthyretin (ATTR) amyloidosis. The data was presented at the European Association for the Study of the Liver (EASL) International Liver Congress 2022 in London.
The data included extended follow-up information from 15 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) receiving treatment in four single-ascending dose cohorts in Part 1 of the trial. The data demonstrated sustained durability of serum transthyretin (TTR) reduction through the last measured period in the ongoing observation. They support the therapy’s continued development.
Transthyretin amyloidosis (ATTR amyloidosis) is a rare, progressive and fatal illness. It is caused by mutations in the TTR gene, causing the liver to manufacture structurally abnormal transthyretin protein that tends to misfold. These damaged proteins build up as amyloid in the body, causing serious complications in the heart, nerves and digestive system. ATTRv amyloidosis typically occurs as polyneuropathy (ATTRv-PN), which can cause nerve damage, or cardiomyopathy (ATTRv-CM), which can cause heart failure.
NTLA-2001 utilizes CRISPR-Cas9 gene editing and is designed to be the first single-dose treatment for ATTR amyloidosis. It is dosed via a vein and edits genes inside the body using Intellia’s proprietary non-viral platform that deploys lipid nanoparticles to deliver a two-part genome editing system to the liver. The system includes guide RNA specific to the disease-causing gene and messenger RNA (mRNA) that encodes the Cas9 enzyme, which carries out the editing.
“Based on the interim data shared today, we believe NTLA-2001’s potential to be a transformational treatment for patients with ATTR amyloidosis is becoming clear,” John Leonard, M.D., president and CEO of Intellia, said in a statement. “The safety, depth of serum TTR reduction and durability profile demonstrated thus far highlights its potential for halting and reversing the disease after a single dose. These data further underscore the power of genomic medicines and bolster the probability of success across our broader in vivo genome editing platform. We look forward to progressing the clinical development of the first-ever systemically administered in vivo CRISPR investigational therapy.”
Big Week in the ATTR Space
It's been a big week for ATTR. Earlier this week, AstraZeneca and Ionis Pharmaceuticals announced that their NEURO-TTRansform Phase III trial in hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) hit its co-primary endpoints in a planned interim analysis at 35 weeks. The original partnership was inked in December to evaluate and develop eplontersen for ATTR-PN and amyloid transthyretin cardiomyopathy (ATTR-CM), with AstraZeneca paying Ionis $200 million upfront.
Eplontersen is a ligand-conjugated antisense drug, a very different type of technology from Intellia and Regeneron’s CRISPR in vivo gene-editing technology.
The interim analysis demonstrated the study hit its co-primary endpoints, meeting a statistically significant and clinically meaningful change from baseline for percent change in serum transthyretin (TTR) concentration, decreasing TTR protein production and change from baseline in the modified Neuropathy Impairment Score +7 (mNIS+7), a measurement of neuropathic disease progression.
“These encouraging data reinforce the safety profile of eplontersen and demonstrate clear evidence of its potential to provide much-needed therapeutic benefit to patients living with hereditary transthyretin-mediated amyloid polyneuropathy,” Teresa Coelho, M.D., a neurologist and neurophysiologist at Hospital Santo Antonio, Centro Hospitalar Universitario do Porto, Portugal, and an investigator for the NEURO-TTRansform trial, said.
The two companies plan to file a New Drug Application (NDA) with the U.S. Food and Drug Administration this year on the basis of the 35-week interim trial data.
The market for ATTR drugs appears to be getting crowded, although a one-time treatment or cure would be a lucrative one. Alnylam Pharmaceuticals received approval for Onpattro (patisiran) in 2018. That was the first RNA interference (RNAi) therapeutic to be approved by the FDA. Pfizer also has two ATTR cardiomyopathy drugs, Vyndaqel and Vyndamax, which brought in more than $2 billion in total sales last year, $909 million of it in the U.S. Last year, Novo Nordisk acquired Prothena Corp’s experimental AATR cardiomyopathy drug, PRX004, for $1.2 billion.
Ionis and its partner Akcea received approval for a first-generation drug for polyneuropathy of hereditary transthyretin-mediated amyloidosis, Tegsedi (inotersen), in 2018. The drug is linked to a risk of thrombocytopenia and glomerulonephritis, which requires significant monitoring for early detection and management, and is marketed with a Risk Evaluation and Mitigation Strategy (REMS).
At Intellia’s presentation of its CRISPR-based therapy data, Leonard said, “We’re excited to highlight the latest data from the study of NTLA-2001, our lead in vivo candidate being developed in collaboration with Regeneron Pharmaceuticals for the treatment of ATTR amyloidosis. At Intellia we are building a full-spectrum genome editing company by deploying the industry’s deepest and broadest toolbox. With each clinical data we’re demonstrating the immense power of CRISPR-based technologies which we believe has the potential to revolutionize the future of medicine.”
FDA Ups Ability to Pull Breakthrough Designation, Sets Neurodegenerative Action Plan
The U.S. Food and Drug Administration released new draft guidance that addresses Breakthrough Therapy designation.
Breakthrough Therapy designation is an important tool that expedites the development and review of a drug candidate that is believed to provide a substantial improvement to patients over available options.
The FDA noted some drug candidates that receive the Breakthrough Therapy designation during the early stages of development may not pan out during later-stage clinical trials. If the data no longer supports the designation, the FDA can rescind it. Not only can the designation be rescinded if clinical data no longer supports the necessary safety and efficacy, but the FDA also noted that it can revoke the designation if another drug is approved for that same unmet need for which the original drug received the designation.
An additional reason to revoke a Breakthrough Therapy designation is if the company that is developing the drug candidate no longer pursues the development of the drug for the indication that sparked the need for the designation.
“In assessing whether the criteria for BTD continue to be met, FDA typically gives greater weight to trials that are conducted in larger populations, use a well-understood and widely accepted, well-constructed clinical endpoint, and incorporate certain design features (e.g., randomization, blinding). Thus, the quality of evidence available may impact FDA’s decision-making,” the agency wrote in its six-page draft document.
The FDA also noted that it maintains the authority to not rescind the designation, even if clinical results appear to not support the award. The regulatory agency said if there are no “significant issues with the conduct and design of a subsequent study, the subsequent study may be given less weight in assessing whether the criteria for BTD are still met,” meaning the decision will be made on a case-by-case basis.
In addition to its guidance on Breakthrough Therapy designation, the FDA also released an action plan for rare, neurodegenerative diseases, including Amyotrophic Lateral Sclerosis (ALS). The new action plan is a five-year strategy aimed at improving the lives of people facing these often deadly diseases through the advancement of new treatments and medical devices.
In its announcement, the FDA said the plan focuses on the promotion of innovation for these neurodegenerative diseases through targeted activities, which include the establishment of the FDA Rare Neurodegenerative Diseases Task Force, as well as developing disease-specific strategies and bolstering public-private partnerships for rare neurodegenerative diseases.
“The action plan is a blueprint for how the agency will move forward in aggressively tackling challenges in drug development for rare neurodegenerative diseases, including ALS, in order to improve patients’ health. Specific actions include regulatory science initiatives, enhancements to existing programs and new policy initiatives,” the FDA said in its announcement.
With ALS, patients and patient advocates have been fighting for an improved regulatory process that will bring those experimental treatment options to them at a quicker pace due to the rapid deterioration the disease causes.
With the new action plan, the FDA said part of the focus is ALS-specific which provides a “forward-leaning framework” to assess the disease priorities. Amidst that framework is a plan that will facilitate patient access to new drugs when possible and also improve participation in clinical trials through decentralized trial structures. The FDA said it also wants to enhance the trial infrastructure and agility in order to “enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.”
https://www.biospace.com/article/fda-issues-new-guidance-for-breakthrough-therapy-designation/
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