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Thursday, December 2, 2021

Roberts and Roe: Supreme Court considers narrow question on abortion

 Think big, go small. That seems to be Chief Justice John Roberts’s approach to Dobbs v. Jackson Women’s Health, the Supreme Court’s most consequential abortion case in a generation.

Mississippi’s regulation prohibits most abortions after the 15th week of pregnancy. Though that is well past the point where a woman is aware of her pregnancy, it is significantly earlier than fetal viability — the stage at which an unborn child can potentially live outside the mother’s womb. Current medical consensus is that viability occurs at 24 weeks of pregnancy. But note that critical word: current. Medical technology constantly improves, so viability will always be a capricious standard — not an objective moment of human gestation between conception and birth, but a constantly-changing metric of scientific proficiency.

Why does that matter? Because viability is the straw at which the Supreme Court grasped in Roe v. Wade (1973) to establish when the state begins to have a cognizable interest in the life of the unborn child. Only then may it intrude on the woman’s right to terminate the pregnancy, the putative right the Roe court manufactured in an act of imperious judicial legislating. Because a 15-week restriction would necessarily forbid abortions that would be permitted under the viability standard that Roe purported to divine from the Constitution, it stands to reason that the court must invalidate Roe to uphold Mississippi’s law.

Let’s not forget, moreover, that Roe was substantially overhauled by Planned Parenthood v. Casey (1992). Put aside Roe’s illiteracy as jurisprudence. By the time Casey was decided nearly 20 years later, Roe’s fatal flaws as policy were patent — in particular, its facile “trimester” architecture for balancing the competing interests of the pregnant woman and the unborn child. 

Rather than abort Roe, as fidelity to constitutional law would have dictated, the Casey court went political. That is the story of the court’s doleful half-century in the abortion thicket. Casey undertook to scrap the trimester formulation while continuing to hang Roe’s hat on viability, notwithstanding its manifest instability as a legal standard. The justices opaquely elaborated that, post-viability, states were at liberty to enact restrictions as long as they did not “unduly burden” a woman’s right to abortion. 

As we’ve noted, Mississippi’s ban on pre-viability abortions violates RoeA fortiori, it poses an “undue burden” under Casey. One would think that both precedents must go.

One of the most fascinating developments in Wednesday’s oral arguments was Chief Justice John Roberts’s demolition of viability as the linchpin of the Roe right — and with it, his powerful illustration of the overarching folly of judicial legislating. Digging through the published papers of Roe’s author, the late Justice Harry A. Blackmun, the chief justice spotlighted the concession that viability was an afterthought: It was not argued as a major issue in the case, and it was dicta in Blackmun’s opinion — i.e., not central to the court’s holding.

Yet, by the time Casey rolled around, the afterthought had become foundational, even as the rest of the Roe edifice was swept away. Viability is what the Biden administration and the rest of the pro-abortion opposition to Mississippi’s law contend is the framework of the liberty interest the court has erected. Roberts exposed it as an illusion.

Logic would make that Roe’s death knell, but this isn’t necessarily about logic. Roberts is clearly struggling to minimize the ramifications of eviscerating Roe’s underpinnings, fearful of the public reaction — meaning, the hysteria of the media-Democrat complex — if the court were to make the obvious explicit: Roe is such bad constitutional law that no one dares defend it as such (the arguments for preserving it are odes to stare decisis — the doctrine of respect for even wrongly decided precedent), but rest assured that a court renunciation of Roe and Casey would not ban abortion, it would leave the matter to the states and the democratic process.

The chief justice can’t do anything about Roe’s fatal flaws, but he might be able to constrict the lens through which the court assesses them. On Wednesday, he took pains to point out that the question the court agreed to review is a narrow one: Whether all pre-viability prohibitions on abortion are unconstitutional.

Interesting thing about that. Mississippi’s petition asked for three questions to be reviewed. Besides the one the court accepted, another asked for a searching analysis of Casey’s undue burden standard in light of Whole Woman’s Health v. Hellerstedt, which materially revised it in 2016 — effectively raising the bar for justifying state abortion restrictions. A third question would have probed third-party standing — i.e., whether abortion providers should be heard to complain about restrictions on a right that belongs not to them but to the woman seeking an abortion. As Justice Clarence Thomas pointed out in dissent at the time, the Hellerstedt majority permitted such claims, against the weight of court precedent.

The court did not agree to consider those two questions. Why did Roberts stress that fact? Probably because he hopes to sidestep a wholesale review and rejection of Roe and Casey, despite their infirmities. He may calculate that Roe need not be swept aside entirely to hold in Dobbs that the Constitution does not prohibit all pre-viability restrictions on abortion. That is, the only question before the court is whether a prohibition after 15 weeks is permissible. Answering that question in the affirmative would not necessarily require invalidating Roe if the court agrees to put blinders on and ignore the ultimate logic of that answer.

Okay, but what about 13 weeks … or seven … or none? Are there five votes on the Supreme Court for a go-slow strangulation of Roe that will keep it barely breathing, and keep both sides of this most divisive national debate fulminating, for years to come?

Former federal prosecutor Andrew C. McCarthy is a senior fellow at National Review Institute, a contributing editor at National Review, a Fox News contributor and the author of several books, including “Willful Blindness: A Memoir of the Jihad.” 

https://thehill.com/opinion/judiciary/583927-roberts-and-roe-the-supreme-court-considers-a-narrow-question-on-abortion

Codiak Engineered Exosomes Promote T Cell, Antibody Responses to SARS-CoV-2 in vivo

 Codiak BioSciences, Inc. (Nasdaq: CDAK), a clinical-stage biopharmaceutical company focused on pioneering the development of exosome-based therapeutics as a new class of medicines, today announced new preclinical data from its exoVACC™ exosome-based vaccine platform. The data describe for the first time the potential of Codiak’s novel vaccine candidate for SARS-CoV-2, the virus that causes COVID-19, to generate a comprehensive immune response conferring both antibody and T cell-mediated immunity. The study reported the generation of a neutralizing antibody response that showed evidence of activity against multiple SARS-CoV-2 variants. In addition, the ability of exoVACC to generate antigen-specific T cell responses against structurally conserved regions of multiple coronavirus variants provides evidence of a broad immune response to the candidate. The results are being presented today at the World Vaccine & Immunotherapy Congress (WVIC) 2021 in San Diego.

https://finance.yahoo.com/news/codiak-engineered-exosomes-promote-t-133000155.html

Humanigen: Peer-Reviewed Paper, Independent Expert Commentary on Positive Phase 3 Lenzilumab Results

 

  • Lenzilumab is a variant-agnostic therapeutic that targets the dysregulated host immune response, an approach which may be of greater value than targeting the virus in hospitalized patients1

  • Per the paper, the implication from all the available evidence is that "Lenzilumab significantly improved survival without invasive mechanical ventilation in hospitalised patients with COVID-19 who were treated concurrently with other available therapies"2

  • Results of the LIVE-AIR Phase 3 trial demonstrate treatment of hospitalized COVID-19 patients with lenzilumab results in a statistically significant 54% relative improvement in the likelihood of survival without the need for invasive mechanical ventilation ("SWOV")

Glaxo: Tests indicate antibody drug works against Omicron

 Laboratory analysis of the antibody-based COVID-19 therapy GlaxoSmithKline (GSK) is developing with U.S. partner Vir has indicated the drug is effective against the new Omicron variant, the British drugmaker said on Thursday.

A GSK statement said that lab tests and a study on hamsters have demonstrated the sotrovimab antibody cocktail to work against viruses that were bio-engineered to carry a number of hallmark mutations of the Omicron variant.

The tests are continuing to confirm the results against all of the Omicron mutations, with an update expected by the end of the year, it added.

The antibody is designed to latch on to the spike protein on the surface of the coronavirus, but Omicron has been found to have an unusually high amount of mutations on that protein.

“Sotrovimab was deliberately designed with a mutating virus in mind," said Vir Chief Executive George Scangos, adding that the drug was targeting a region of the spike protein that was highly unlikely to mutate.

Separately, Britain's drug regulator on Thursday approved sotrovimab, also known under the brand name Xevudy, for people with mild to moderate COVID-19 and who are at high risk of developing severe disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) recommended use of Xevudy as soon as possible and within five days of the onset of symptoms.

Sotrovimab is based on monoclonal antibodies, which are lab-made versions of the natural antibodies the body generates to fight off an infection. Similar products are offered or being developed by Eli Lilly, Regeneron and AstraZeneca.

Regeneron on Tuesday said that lab tests and computer modelling suggest that COVID-19 antibody drugs including Regeneron's would have reduced efficacy against the Omicron variant.

https://finance.yahoo.com/news/1-gsk-says-tests-show-075620812.html

Novartis expects new drugs to boost sales by at least 4% until 2026

 Novartis is confident of delivering annual revenue growth of 4% or higher until 2026, as it banks on multi-billion dollar sales of experimental and approved drugs including arthritis and psoriasis medicine Cosentyx.

Sales from these new products is expected to exceed and make up for a $9 billion hit from launches of copycat versions of its products in this period, the Swiss drugmaker on Thursday said in a presentation https://www.novartis.com/sites/novartis_com/files/novartis-r-d-day-2021.pdf ahead of an investor briefing.

The update comes weeks after Novartis said it would sell its stake in Roche to simplify its structure and focus on key offerings against diseases such as arthritis and cancer, following the launch of a review of its generic-drug unit Sandoz.

Novartis also expects core margins in innovative medicines to reach the high 30s by 2026, adding it had up to 20 assets in its pipeline that had blockbuster potential - meaning they could eventually yield annual sales of at least $1 billion.

The company said it was committed to maintain a strong and growing dividend in Swiss francs.

https://finance.yahoo.com/news/novartis-sees-annual-sales-growth-062924374.html

Dyne Submits IND Application to Initiate Trial for Duchenne Therapy

 - DYNE-251, Dyne’s First DMD Program, is Being Developed for Patients with Mutations Amenable to Skipping Exon 51 -

- DYNE-101 IND Submission in DM1 Expected in the First Quarter of 2022 -

- Initiation of Patient Dosing of DYNE-251 and DYNE-101 in Multiple Ascending Dose Clinical Trials Anticipated by Mid-2022 -

https://finance.yahoo.com/news/dyne-therapeutics-announces-submission-ind-133000648.html

Omeros to Sell OMIDRIA® Franchise for >$1B

 - Transaction to Lock in Ongoing Revenue Stream for Omeros and Focus the Company on its Complement Franchise of MASP-2 and MASP-3 Inhibitors –

-- Conference call today at 8:30 a.m. ET, 5:30 a.m. PT --

  • $125 million upfront payment and $200 million on achievement of commercial milestone

  • Royalties of 50% on U.S. net sales until the earlier of either January 1, 2025 or payment of the $200-million milestone, after which royalties adjust to 30% of U.S. net sales

  • Royalties of 15% on ex-U.S. net sales

  • OMIDRIA to become a premier product in Rayner’s ophthalmology franchise

  • In addition to acquiring the OMIDRIA commercial organization, including the current OMIDRIA sales force, Rayner plans to further expand its U.S. and ex-U.S. sales forces

  • Conference Call Details

    Omeros’ management will host a conference call to discuss today’s announcement. The call will be held today at 8:30 a.m. Eastern Time; 5:30 a.m. Pacific Time. To access the live conference call via phone, please dial (844) 831-4029 from the United States and Canada or (920) 663-6278 internationally. The participant passcode is 9080996. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9080996.

    To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at https://investor.omeros.com/upcoming-events.