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Tuesday, January 16, 2024

Medicare Patients: Part D Overhaul Caps Out-of-Pocket Drug Cost Limits

 Medicare Part D beneficiaries facing rising drug costs received welcome news as changes brought about by the 2022 Inflation Reduction Act cap their out-of-pocket expenses in 2024. 

The legislation dictates that individuals on Part D plans will now pay a maximum of around $3,300 annually for their prescription drugs, with variations depending on whether the medication is brand or generic. In 2025, this cap will be further reduced to a flat $2,000.

The key mechanism behind the relief involves the elimination of the 5% coinsurance that individuals had to pay after reaching the catastrophic spending threshold.

 Once patients spend roughly $3,300, they will no longer bear additional out-of-pocket expenses for the rest of the year.

While the cap signifies substantial savings for Medicare patients, potential downsides may include higher premiums and more complex paperwork, the Wall Street Journal noted

The shift in cost responsibility from patients to insurers and drugmakers is set to reshape the drug coverage landscape under Part D.

In 2025, Medicare recipients are advised to carefully review their plans and drug coverage, as insurers may implement strategies to promote cost-effective alternatives. 

The changes significantly overhaul the nearly two-decade-old Part D prescription drug benefit.

Cancer drugs in pill form can be a significant financial burden for individuals enrolled in Part D plans. 

According to a June 2022 article in the New England Journal of Medicine, patients using Bristol-Myers Squibb & Co’s 

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 Pomalyst for blood cancer or Pfizer Inc’s 
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 Ibrance for breast cancer may face out-of-pocket costs exceeding $14,000 and $10,000 per year, respectively. 

The report highlighted that a Medicare breast cancer patient with a median income could spend nearly half of her earnings on Ibrance alone. 

However, a 2023 Patients for Affordable Drugs report projected that over 60,000 individuals receiving brand-name cancer drugs through Part D plans could save an average of more than $7,500 annually by 2025, thanks to the out-of-pocket cap.

Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

https://www.benzinga.com/general/biotech/24/01/36641146/financial-relief-for-medicare-patients-part-d-overhaul-caps-out-of-pocket-drug-cost-limits

7 Deals Emerge During JPM Week in Strong Start to 2024

 The first major events of the biotech calendar, the J.P Morgan Healthcare Conference and co-located San Francisco healthcare meetings, have come and gone. And while Novartis is reportedly pulling back from buying cardiovascular biotech Cytokinetics, several pharma companies did successfully purchase smaller biotechs and their assets. With many in the biopharma industry having returned home—or stuck en route due to weather-related events—BioSpace recaps the significant deals secured in biotech last week.

1. Johnson & Johnson Buys Ambrx for $2 Billion

With the antibody-drug conjugate (ADC) market red hot, J&J kicked off JPM with big news, announcing the purchase of Ambrx. The $2 billion price tag includes an ADC currently in Phase I/II trials for advanced prostate cancer. This is not the first ADC-focused biotech with which J&J has done business. In February 2022, it paid $40 million upfront in a research and licensing deal with Mersana Therapeutics, potentially worth $1 billion. In December 2023, J&J bought the licensing rights for LegoChem Bioscience’s ADC for $100 million upfront and $1.7 billion in possible milestone payments.

2. Merck to Purchase Cancer Biotech Harpoon for $680 Million

Already heavily entrenched in cancer, Merck announced it would buy cancer drug developer Harpoon Therapeutics for an estimated $680 million. The deal is designed to serve as a boost to Merck’s immunotherapy and oncology pipeline. Harpoon has developed T-cell engager drugs and antibodies to kill cancer cells. One candidate, HPN328, is currently in Phase I/II trials for patients with advanced cancers associated with the expression of DLL3.

3. GSK Pumps $1 Billion into Its Asthma Pipeline 

GSK will acquire Aiolos Bio for $1 billion upfront and potentially another $400 million in regulatory milestones. The biotech’s main asset is AIO-001, a monoclonal antibody targeting the thymic stromal lymphopoietin cytokine, a “validated driver of inflammation," according to the company's website. The treatment, being developed for asthma, may only need to be taken twice a year.

4 and 5. Alphabet’s Isomorphic Labs Secures Two Partners

Novartis and Eli Lilly each partnered with Alphabet’s Isomorphic Labs to use its artificial intelligence platform to develop small molecule-based drugs. The platform was developed with Google’s DeepMind. The Lilly deal will give Isomorphic $45 million upfront and $1.7 billion in performance-based milestones and tiered royalties. Novartis’s contract will see Isomorphic receive $37.5 million upfront and $1.2 billion in milestones and royalties.

6 and 7. Novartis Strikes Deals Targeting Gastrointestinal, Cardio Conditions

Novartis also announced last week the acquisition of Dutch outfit and Merck Serono spinout Calypso Biotech for $250 million upfront, with another $175 million for Calypso's taking if certain milestones are hit. Calypso's lead asset, CALY-002, targets the IL-15 cytokine and has the potential to treat several gastrointestinal conditions. Novartis additionally inked license and collaboration agreements with China-based biotech Argo for two RNA interface candidates meant to go after cardiovascular diseases. Argo could see $4.165 billion plus royalties under the terms of the agreement.

https://www.biospace.com/article/seven-major-deals-inked-to-start-the-year-/

Alto, Kyverna Join Growing Number of Biotech IPO Filings in 2024

 The initial public offering market continues to grow in early 2024, with two new biotechs jumping into the arena—California-based Alto Neuroscience and CAR-T specialist Kyverna Therapeutics.

Neurology-focused Alto announced its IPO in an SEC filing late Friday. The biotech has not yet disclosed how many shares of its common stock will be up for sale, nor how much it expects to make. Alto is planning to close its IPO within the year, but has likewise not set a specific date yet.

Once the offering is complete, Alto will trade on the New York Stock Exchange under the symbol ANRO.

Alto will use the IPO’s proceeds to bolster its existing cash and cash equivalents and support the clinical development of its lead candidate ALTO-100, a small molecule drug that targets BDNF and is currently in Phase IIb for major depressive disorder and Phase IIa for post-traumatic stress disorder (PTSD).

Last year, Alto released two positive readouts from these two programs demonstrating significant improvements in depressive symptoms in January 2023 and reducing PTSD burden in September 2023. According to Alto’s SEC filing, ALTO-100 binds a receptor “not targeted by other [central nervous system] therapeutics, which would make it first-in-class if approved.”

Alto will also use the funds from its IPO to fund its other programs, including the depression candidate ALTO-300, the PDE4-targeting ALTO-101 and the histamin H3 receptor inverse agonist ALTO-203. The IPO will also support Alto’s general corporate operations as well as “potential additional clinical development” across its programs.

Following in Alto’s footsteps is Kyverna, which according to an exclusive report from Endpoints News posted late Friday, could file for an IPO as early as February 2024. According to a source, who requested anonymity, Kyverna could reveal its IPO plans as early as next week and make its offer early next month, though it remains possible that these plans could still change.

Kyverna is developing CAR-T therapeutics to target autoimmune diseases, for which it uses a next-generation anti-CD19 CAR-T construct, according to the biotech’s website. It has two programs—the autologous KYV-101 and the allogeneic KYV-201—which it is developing for B-cell driven autoimmune conditions.

KYV-101 is already in a clinical trial for lupus nephritis and was recently given the FDA’s clearance for testing in myasthenia gravis and multiple sclerosis.

Alto and Kyverna follow three other companies that have launched their IPOs this year. Leading the pack is CG Oncology, which revealed its plan in the first week of the year, putting up 44 million shares of its common stock up for sale. Metagenomi and ArriVent disclosed their respective plans days after, though neither revealed the specific financial targets for their IPOs.

https://www.biospace.com/article/alto-kyverna-join-growing-number-of-biotechs-filing-for-ipos-in-2024/

CNS disorder biotech Alto Neuroscience files for a $100 million IPO

 Alto Neuroscience, a Phase 2 biotech developing biomarker-focused therapies for depression and schizophrenia, filed on Friday with the SEC to raise up to $100 million in an initial public offering.


Alto Neuroscience is focused on leveraging neurobiology to develop personalized and highly effective treatment options. Through its proprietary Precision Psychiatry Platform, it aims to discover brain-based biomarkers to better identify which patients are more likely to respond to its novel product candidates. The company's current pipeline consists of five clinical-stage assets initially targeting major depressive disorder (MDD) and schizophrenia populations characterized by independent brain-based biomarkers. Its most advanced programs are being evaluated in ongoing Phase 2b trials in MDD patients characterized by cognitive or electroencephalography biomarkers. Topline data from these trials is expected between the 2H24 and the 1H25.

The Los Altos, CA-based company was founded in 2019 and plans to list on the NYSE under the symbol ANRO. Jefferies, TD Cowen, Stifel, William Blair, and Baird are the joint bookrunners on the deal. No pricing terms were disclosed.

Shell suspends all Red Sea shipments indefinitely amid Houthi attacks

 The British oil company Shell reportedly has suspended all shipments through the Red Sea indefinitely amid the ongoing Houthi attacks from Yemen on commercial vessels on the key global trade route. 

The suspension was first reported by The Wall Street Journal on Tuesday, citing unnamed sources. 

FOX Business reached out to Shell’s office for the Americas on Tuesday but did not immediately hear back, and the Journal report says the company declined to comment on the matter. 

The move comes after BP paused shipments through the Red Sea last week, as did Qatar Energy this week of its shipments of liquefied-natural-gas exports. 

Speaking to Reuters at the World Economic Forum in Davos, Switzerland, an executive from the port and freight operator DP World predicted that the prices of consumer goods will be "significantly higher" as a result of the Houthi attacks, specifically impacting Europeans’ pocketbooks.

Since November, Iranian-backed Houthi rebels in Yemen have launched dozens of missiles and drones at commercial vessels around the Red Sea. They are claiming to avenge the Israel counter-operation in Gaza against Hamas terrorists, though the Houthi attacks have grown increasingly indiscriminate and have even imperiled tankers and container ships moving sanctioned Russian oil. 

Houthis targeted a tanker by Shell on its way to carry Indian jet fuel through the Red Sea last month. 

The Journal noted that around 12% of total global seaborne oil trade passes through the Red Sea.

After the United States, with help from the United Kingdom, led airstrikes targeting Houthi positions on Friday and Saturday, the rebel forces fired a missile that struck the U.S.-owned Gibraltar Eagle off the coast of Yemen in the Gulf of Aden, sparking concern of a broader conflict in the corridor that leads to the Suez Canal, serving as the fastest trade route linking Asia to Europe. 

The militia group vowed on Monday to expand attacks on ships in response to the U.S. and U.K. strikes. 

The U.S. carried out another strike against Houthi targets in Yemen on Tuesday, a U.S. official confirmed to Fox News. 

Suez Canal shipments

The Suez Canal in Ismailia Province, Egypt, Jan. 13, 2024. (Ahmed Gomaa/Xinhua via / Getty Images)

The strike targeted and destroyed four Iran-provided Houthi anti-ship ballistic missiles in Yemen. These missiles were being prepared to target merchant vessels in the Red Sea and Gulf of Aden, a U.S. official told Fox News. 

Reuters reported Tuesday that another ship, a Malta-flagged, Greek-owned bulk carrier, was struck by a missile in the Red Sea off the coast of Yemen while sailing from Vietnam to Israel. 

Tanker owners who spoke to the Journal after the U.S.-led airstrikes over the weekend relayed that several captains of chartered vessels bound for Europe through the Suez Canal recently refused to enter the Red Sea, instead choosing to sail around Southern Africa. The Journal also reports that the Singapore ship registry and Intertanko, an industry lobby group, are warning vessels to avoid the waterway.

https://www.foxbusiness.com/economy/shell-suspends-all-red-sea-shipments-indefinitely-houthi-attacks-yemen-report

Taxpayers Pay Millions of Dollars for Child Sex-Change Surgeries

 Massachusetts taxpayers reimbursed Boston Children’s Hospital (BCH) $1.4 million for “gender transition services”—including physician’s services, inpatient and outpatient care, hospital services, surgical services, prescribed drugs, therapies, and so forth—to minors from January 2015 to May 2023, according to documents obtained by The Daily Caller.

BCH is one of the top medical centers in the United States encouraging life-altering gender procedures for minors, according to The Daily Caller.

The Daily Caller report states, “The hospital, which boasts of having the first pediatric transgender surgery center in the country, has performed hundreds of gender surgeries on children since 2017 and has offered phalloplasties for 18-year-old boys and vaginoplasties for girls as young as 17, according to scrubbed pages of its website.”

Obamacare Is to Blame

Taxpayer dollars are now paying for dangerous, life-altering operations on minors due to the fine print of President Obama’s signature health care reform law, the Affordable Care Act (ACA), said Chris Moritz, a policy expert and documentarian, who was interviewed by Tucker Carlson in October.

The ACA, known as Obamacare, passed in March 2010 and resulted in 20,000 pages of rules and regulations.

In the interview, Moritz told Carlson insurance companies were mandated to provide coverage for what is deemed to be “medically necessary gender-affirming care,” and as a result, between 2010 and 2016, there was a 50 percent increase in sex reassignment surgeries and a 25 percent increase in insurance coverage for transgender individuals. Then, at the very end of the Obama administration, the ACA was amended so that gender identity could no longer be a basis for denial of coverage by private insurance companies.

Moritz concluded in his interview with Carlson that as a result of these provisions of the ACA, from 2016 to 2017 there was a 150 percent increase in sex reassignment surgeries in the United States.

School Districts as Parents

In addition to the new mandates afforded by the ACA, “peer contagion” has also been a catalyst in the skyrocketing rise in the number of minors undergoing gender modification surgeries, says Larry Sand, president of the California Teachers Empowerment Network.

“Now, why wouldn’t a teen want to be LGBT?” asks Sand. “These days, it’s cool! In reality, the leap in numbers is largely due to social contagion. It’s the ‘in’ thing, like owning a hula hoop, lava lamp, or mood ring. These things may have cost a few bucks at one time but would not potentially damage anyone’s life.”

“Many school districts have decided to take over the traditional role of parents, and this is a very important factor in the alienation of the young,” said Sand. “It’s happening all over the country.”

The Escondido Union School District in California is all too typical, says Sand. Under the current policy, “teachers must refer to students by their preferred pronouns or gender-specific names during school hours but revert to biological pronouns and legal names when speaking with parents.”

After a teacher learns of a child’s social transitioning, he or she is obliged to ensure that parents do not discover this, says Sand.

‘Permanently Scarred and Damaged’

No one should be funding this type of dangerous experimentation on healthy children, says Kallie Fell, a registered nurse and executive director of the Center for Bioethics and Culture Network.

“During production of each of our documentary films on the gender industry, we interview many detransitioners and medical experts who all echo the same message: once a person decides to medically transition, they are lifelong patients, no matter what,” said Fell.

“Can a minor really understand and consent to this medicalization and the lifelong consequences of these decisions?” asked Fell. “We would argue that they cannot. They cannot know as a child what they are doing to their healthy bodies and what kind of regret, especially reproductive regret, they might face in the future.”

“We hope taxpayers wake up and realize no one should be funding this type of dangerous experimentation on healthy children,” said Fell. “What these children really need is to be provided evidence-based counseling and therapy and an opportunity to grow up protected from the dangerous ideology of gender ‘medicine.’ No child is born in the wrong body and no child should have their perfectly healthy bodies permanently scarred and damaged in the name of ‘gender medicine.’”

‘Juries Very Likely to Be Sympathetic’

In addition to the rise in transgender surgeries being performed on minors, there is also a new trend of detransitioners bringing lawsuits, says Merrill Matthews, Ph.D., a resident scholar with the Institute for Policy Innovation.

“Numerous physicians and health care centers are boasting about how many transgender surgeries they are performing on minors, but a small and growing number of people who were children when they received hormone treatment or surgery are now detransitioning and asserting that what they really needed was mental health care,” said Matthews.

“Their lives and their bodies have been changed forever, and they are seeking out law firms that will hold these doctors and health care facilities financially and professionally accountable for their actions,” said Matthews. “Juries hearing their horrific stories and seeing the lasting physical and mental scars are likely to conclude that doctors broke their very first vow, ‘to do no harm.’”

Florida is one state that has banned spending tax dollars on sex change procedures on any person, let alone minors. Last summer, after new laws were passed, the state fined five Medicaid providers, sanctioning one of them after an audit revealed Medicaid dollars funded such treatments.

https://heartlanddailynews.com/2023/12/taxpayers-pay-millions-of-dollars-for-child-sex-change-surgeries/