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Tuesday, November 1, 2022

Stealth Bio: Data Updates and Orphan Drug Designation for ALS

 SBT-272 Phase 1 safety and tolerability data support further clinical development

SBT-272 was neuroprotective and reduced neuroinflammation in ALS preclinical model

SBT-272 Granted Orphan Drug Designation for Treatment of ALS

https://www.biospace.com/article/releases/stealth-biotherapeutics-announces-sbt-272-data-updates-and-orphan-drug-designation-for-the-treatment-of-amyotrophic-lateral-sclerosis-als-/

On Second Thought, Just Throw Plastic Away

 Even Greenpeace has finally acknowledged the truth: recycling plastic makes no sense.

This has been obvious for decades to anyone who crunched the numbers, but the fantasy of recycling plastic proved irresistible to generations of environmentalists and politicians. They preached it to children, mandated it for adults, and bludgeoned municipalities and virtue-signaling corporations into wasting vast sums—probably hundreds of billions of dollars worldwide—on an enterprise that has been harmful to the environment as well as to humanity.

Now Greenpeace has seen the light, or at least a glimmer of rationality. The group has issued a report accompanied by a press release headlined, “Plastic Recycling Is A Dead-End Street—Year After Year, Plastic Recycling Declines Even as Plastic Waste Increases.” The group’s overall policy remains delusional—the report proposes a far more harmful alternative to recycling—but it’s nonetheless encouraging to see environmentalists put aside their obsessions long enough to contemplate reality.

The Greenpeace report offers a wealth of statistics and an admirably succinct diagnosis: “Mechanical and chemical recycling of plastic waste has largely failed and will always fail because plastic waste is: (1) extremely difficult to collect, (2) virtually impossible to sort for recycling, (3) environmentally harmful to reprocess, (4) often made of and contaminated by toxic materials, and (5) not economical to recycle.” Greenpeace could have added a sixth reason: forcing people to sort and rinse their plastic garbage is a waste of everyone’s time. But then, making life more pleasant for humans has never been high on the green agenda.

These fatal flaws have been clear since the start of the recycling movement. When I wrote about it a quarter-century ago, experts were already warning that recycling plastic was hopelessly impractical because it was so complicated and labor-intensive, but municipal officials kept trying in the hope that somebody would eventually find it worthwhile to buy their plastic trash. Instead, they’ve had to pay dearly to get rid of it, typically by shipping it to Asian countries with cheaper labor and looser environmental rules. In New York City, recycling a ton of plastic costs at least six times more than sending it to a landfill, according to a 2020 Manhattan Institute study, which estimated that the city could save $340 million annually by sending all its trash to landfills.

The environmental price has also been high because the plastic in American recycling bins has gone to developing countries with primitive waste-handling systems. Much of it ends up illegally dumped, burned (spewing toxic fumes), or reprocessed at rudimentary facilities that leak some of the plastics into rivers. Virtually all the consumer plastics polluting the world’s oceans comes from “mismanaged waste” in developing countries. There’d be less plastic polluting the seas if Americans tossed their yogurt containers and water bottles into the trash, so that the plastic could be safely buried at the nearest landfill.

The Environmental Protection Agency has promoted recycling as a way to reduce carbon emissions, but its own figures show that the benefits are relatively small and come almost entirely from recycling paper products and metals, not plastic. I’ve calculated that to offset the greenhouse impact of one passenger’s round-trip transatlantic flight, you’d have to recycle 40,000 plastic bottles—and if you used hot water to rinse those bottles, the net effect could be more carbon in the atmosphere.

While finally admitting the futility of plastic recycling, Greenpeace is making no apologies for the long campaign to foist it on the public, and the group is unashamedly pushing a new strategy that’s even worse. It proposes finally to “end the age of plastic” by “phasing out single-use plastics” through a “Global Plastics Treaty.” This is a preposterous goal—imagine “phasing out” disposable syringes—and would be laughable except that environmentalists have already made some progress toward it. They’ve found yet another way to harm both the environment and humans, as demonstrated in the movement to ban single-use plastic bags.

Progressive activists may not care that these bans have added to the cost of groceries, inconvenienced shoppers, and caused new headaches for merchants. (After New Jersey forbade stores from offering disposable plastic or paper bags, supermarkets ran out of handheld shopping baskets because so many customers were stealing them.) But progressives also don’t seem to care about the implications for climate change and public health.

Banning single-use plastic grocery bags has added carbon to the atmosphere by forcing shoppers to use heavier paper bags and tote bags that require much more energy to manufacture and transport. The paper and cotton bags also take up more space in landfills and produce more greenhouse emissions as they decompose. The tote bags aren’t reused nearly often enough to offset their initial carbon footprint, and they’re breeding grounds for bacteria and viruses because they’re rarely washed properly. Researchers have repeatedly found these bags to be responsible for gastrointestinal infections, but the warnings got little attention until the Covid pandemic suddenly revived respect for disposable products.

As stores and coffee shops banned reusable bags and mugs during the pandemic, Americans relearned the lessons of the early twentieth century, when public-health authorities promoted Dixie cups and other disposable products to counter threats like tuberculosis and the Spanish flu. This marked the beginning of the “throwaway society,” and the term wasn’t originally used pejoratively. Americans welcomed plastic products and packages because they were so much better than the alternative. Cellophane was considered a marvel because it was both moisture-proof and transparent, keeping food fresher and enabling grocery shoppers to see what they were buying. Advertisements featured housewives rejoicing that disposable plates and glasses freed them from dishwashing chores.

Environmentalists’ zeal to ban plastic is far more destructive than their former passion to recycle it; it’s also harder to explain. Recycling, while impractical, at least offered emotional rewards to hoarders reluctant to put anything in the trash and to the many people who perform garbage-sorting as a ritual of atonement—a sacrament of the green religion. But why demonize plastic? Why ban products that are cheaper, sturdier, lighter, cleaner, healthier, and better for the environment? One reason: the plastic scare helps Greenpeace activists raise money and keep their jobs. Environmentalists need something to replace their failed recycling campaign.

But there’s more to it than just financial self-interest. The best explanation I’ve come up with is that plastic bans are a revival of the sumptuary laws formerly imposed on the lower classes by monarchs, nobles, and clergy. Those laws forbade commoners from owning certain kinds of clothes, jewelry, furnishings, and other products. The restrictions consistently failed to achieve their ostensible purpose of reducing “unnecessary” spending, but sumptuary laws endured until the Enlightenment because they reinforced ruling-class power and status. An English countess could display her superiority by wearing a dress with silver stripes that were illegal for women of lower rank. Spanish prelates and Portuguese monarchs proclaimed their moral virtue and political authority by forbidding the masses from owning clothes, curtains, and tablecloths made of silk.

Today’s rulers and moral guardians achieve the same purposes with their petty edicts on plastic. California’s law forbidding hotels from offering disposable plastic toiletries is a gratuitous annoyance for travelers who’d like a little bottle of shampoo, but it enables the state’s politicians and environmental groups to exercise power and pretend to be saviors of the planet. The pretense is so ridiculous that even Greenpeace will eventually abandon it—but once again, that could take a few decades. The rest of us can start today.

J&J to buy Abiomed in $16.6B deal to boost cardiovascular business

 Johnson & Johnson said on Tuesday it will acquire Abiomed Inc in a deal valued at $16.6 billion to boost the health care conglomerate's cardiovascular devices business.

The upfront payment of $380 per share represents a 50.7% premium to Abiomed's last closing price. Shares of Abiomed surged 48% in premarket trade.

Abiomed shareholders will also get a non-tradeable contingent value right entitling the holder to receive up to $35 per share in cash if certain commercial and clinical milestones are achieved.

The transaction broadens J&J's MedTech as a cardiovascular innovator, advancing the standard of care in one of healthcare's largest unmet need, heart failure and recovery, the company said.

The deal comes at a time when J&J is spinning off its consumer health business to focus on its pharmaceuticals and medical devices operations.

https://www.foxbusiness.com/markets/jj-buy-abiomed-16-6b-deal-boost-cardiovascular-business

Lilly cuts annual profit forecast on stronger dollar

 Eli Lilly and Co on Tuesday cut its annual profit forecast for the third time, as a stronger dollar piled more pressure on the drugmaker struggling with lower insulin prices and generic competition for its cancer drug.

The company now expects adjusted full-year earnings of $7.70 to $7.85 per share, compared to its prior forecast of $7.90 to $8.05.

The drugmaker said it took an additional $300 million hit from the stronger dollar.

Multinational companies such as Abbott Laboratories and Johnson & Johnson have been hit by the dollar's strength against a basket of currencies.

Sales of Mounjaro, Lilly's newly-approved diabetes drug, was $187.3 million, with over half coming from the United States

https://finance.yahoo.com/news/1-eli-lilly-cuts-annual-104521448.html

Pfizer RAISES 2022 OUTLOOK

  • Solid Third-Quarter 2022 Revenues of $22.6 Billion

    • Due to Exceptionally Strong Growth Achieved in the Prior-Year Quarter, Revenues Declined 2% Operationally

    • Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 2% Operationally

  • Third-Quarter 2022 Reported Diluted EPS(2) of $1.51, Reflecting 6% Growth Over Third-Quarter 2021, Including a $0.15 Incremental Benefit in the Current Period Related to Tax Resolutions for Multiple Years Impacting Both Reported(2) and Adjusted(3) Diluted EPS

  • Third-Quarter 2022 Adjusted Diluted EPS(3) of $1.78, Reflecting 40% Growth Over Third-Quarter 2021; Excluding Foreign Exchange Impacts, Adjusted Diluted EPS(3) Grew 44%

  • Raises Lower End of Full-Year 2022 Revenue Guidance(4) to a Range of $99.5 to $102.0 Billion, Reflecting an Improved Operational Outlook Combined with Incremental Unfavorable Foreign Exchange Impacts

    • Raises 2022 Revenue Guidance for Comirnaty(1) by $2 Billion to ~$34 Billion and Reaffirms Revenue Guidance for Paxlovid of ~$22 Billion, Despite Unfavorable Impacts from Foreign Exchange

  • Raises and Narrows Full-Year 2022 Adjusted Diluted EPS(3) Guidance from $6.30 to $6.45 to $6.40 to $6.50

  • Pipeline Programs That Have Achieved Positive Phase 3 Readouts Since Previous Earnings Release Include RSVpreF Vaccine in Older Adults & Maternal, Prevnar 20/Apexxnar in Pediatrics, Talzenna/Xtandi Combination in mCRPC and Pentavalent Meningococcal Vaccine in Adolescents and Young Adults

  • Pfizer to Host Analyst Event on December 12 in New York City, Where It Will Showcase Its Portfolio of Upcoming Product Launches and Other Pipeline Programs with High-Value Potential

Incyte guidance change, pipeline update

  Total net product revenues grew to $713 million (+20% Y/Y) as a result of strong Jakafi® (ruxolitinib) and Opzelura™ (ruxolitinib) cream net product revenues

– Jakafi net product revenues of $620 million in Q3’22 (+13% Y/Y); raising the bottom end of full year guidance to a new range of $2.38 to $2.40 billion

– Opzelura net product revenues of $38 million in Q3'22 driven by robust demand and broadening payer access; launch in vitiligo underway

– Pipeline progresses with positive povorcitinib data in hidradenitis suppurativa at EADV, oral PD-L1 update at SITC and the pending acquisition of Villaris Therapeutics and auremolimab, a novel anti-IL-15Rβ mAb

https://finance.yahoo.com/news/incyte-reports-2022-third-quarter-110000458.html

BioCryst Q3 update, coming milestones

 —$66.0 million in ORLADEYO Q3 2022 net revenue; on-track to more than double sales in 2022 vs 2021—

—Underlying patient trends remain strong with nine percent paid patient growth in Q3 2022—

—Company expands complement pipeline by advancing second oral Factor D inhibitor, BCX10013, into clinical development with goal of once-daily dosing, and adding discovery targets—

—BCX9930 patient screening underway, data expected from approximately 15 newly-enrolled patients in mid-2023—

https://finance.yahoo.com/news/biocryst-reports-third-quarter-2022-110000654.html