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Thursday, March 20, 2025

Windtree to Become Sourcing Partner for Biotech with FDA Approved Product

 Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating biotech and advancing early and late-stage innovative therapies for critical conditions and diseases, is pleased to announce that it has entered into a License and Supply Agreement to become the sourcing partner for Evofem Biosciences, Inc. (OTCQB: EVFM) for one of Evofem’s FDA-approved products -- PHEXXI® (lactic acid, citric acid and potassium bitartrate). The product is a first-in-class hormone-free, on-demand prescription contraceptive vaginal gel that women control. PHEXXI annual revenues have grown to more than $19 million with more than 96,000 boxes of 12 pre-filled applicators sold in full year 2024.

Windtree has manufacturing contacts that we believe are capable of reducing pharmaceutical product cost of goods for PHEXXI. Pursuant to the License and Supply Agreement, Windtree will serve as the sourcing partner to Evofem and aims to help generate profitable revenue by contracting with the manufacturer to produce PHEXXI at a cost that is significantly below current levels. Evofem will maintain ownership of the asset and continue to commercialize PHEXXI in the United States and internationally through strategic partnerships.

https://www.globenewswire.com/news-release/2025/03/20/3046178/0/en/Windtree-Announces-License-and-Supply-Agreement-to-Become-Sourcing-Partner-for-a-Small-Biotech-with-an-FDA-Approved-Product.html

Synchron, Nvidia showcase AI for brain-computer interfaces

 Brain-computer interface (BCI) specialist Synchron has previewed an artificial intelligence model that it believes will form the basis of a new generation of devices to allow individuals to control digital and physical environments with their minds.

The company gave a presentation on the 'cognitive AI', dubbed Chiral, at the GTC 2025 event hosted by Nvidia, its development partner for the technology, which is described as a "foundation model" for human cognition.

At the show, Synchron demonstrated how its Stentrode BCI, a stent-like device implanted via the neck into blood vessels near the brain's motor cortex, could work with Nvidia AI and an Apple Vision Pro headset to allow a patient to control various devices around his home.

Rodney Gorham, who has amyotrophic lateral sclerosis (ALS) and is paralysed and unable to talk, was able to adjust lighting, play music, turn on a fand and robotic vacuum, and activate an automated pet feeder using his thoughts.

While Gorham initially used a computer or smart device to control the technology around him, the addition of the Apple headset means he can now simply look at them and control them using drop-down menus.

The next stage in the development of the BCI will be expand the capabilities of the AI, moving from supervised to self-supervised learning, according to Synchron, which in time will make the implant quicker, more precise, and more responsive. That in turn could make it possible to control more complex operations.

"We are building a brain foundation model using generative pre-training techniques that learn directly from neural data – abstracting human cognition at its source – to create features that improve our user's lives," said Tom Oxley, chief executive and founder of Synchron.

"This is possible because of our ability to scale large datasets, by making BCI as common as a stent insertion," he added. In practice, that means drawing on data from a broad population of subjects, rather than just one user.

Future development of the AI will be aimed at allowing it to consider the environmental context in which commands are given, further improving its accuracy and ability to help users carry out tasks in real-world environments.

"Just as AI today is trained on vast datasets of text and images, the next step in AI evolution is training on neural signals," said Synchron and Nvidia in a statement.

"Chiral will evolve into a self-learning model of cognition, representing the next leap beyond generative AI and agentic AI into the era of cognitive AI."

https://pharmaphorum.com/news/synchron-nvidia-showcase-ai-brain-computer-interfaces

UK is becoming an 'outlier' for pharma, hitting investment

 The pharma industry in the UK has doubled down on its resistance to the increase in levies imposed on medicine sales, with a string of company leaders calling for an urgent rethink by the government.

They warn that, unless there are dramatic reforms to the voluntary rebate scheme (VPAG) – which this year will require companies to make payments of between a quarter and a third of revenues from the sale of branded medicines to the NHS – the UK's plan to make life sciences a pillar of its growth economy will fail.

Following the decision in December to set the VPAG rate at 22.9% for 2025, "global boardrooms are closely monitoring developments, concerned that the UK is further exacerbating its position as an international outlier," according to Russell Abberley, general manager of Amgen UK & Ireland.

It has already been speculated that AstraZeneca's termination of a plan to invest £450 million in a new vaccine manufacturing plant in the UK came about in part because of the big increase in the VPAG rate for newer medicines from around 15% in 2024 and mid-single digits in the pre-pandemic era.

The Association of the British Pharmaceutical Industry (ABPI) has estimated that will lead to the pharma industry paying around £3.4 billion ($4.41 billion) in rebates this year, at a rate that is far higher than is currently levied in other comparable European countries.

"Industry remains committed to working with government, at pace and with urgency, in the run-up to the scheme's Autumn review," said Abberley. "Together, we must identify solutions that bring the scheme back on track to meet its original objectives."

That sentiment was echoed by other UK industry leaders, including Biogen UK's managing director, Kyle Bromley, who said: "The size of the rebates and their unpredictability have had a major impact on our work in the UK and our investment here. We would love to celebrate the positive parts of the UK's life sciences ecosystem, but they are often overshadowed by the fact that we are a noticeable international outlier for the wrong reasons."

report (PDF) published by the ABPI links the challenges of operating in the UK and the cap on the branded market to a steady decline in NHS access to innovative treatments, with England having slipped from first to ninth on the availability of new medicines in the space of a decade.

It has also fallen from fourth to tenth place in the global rankings for the number of phase 3 trials it hosts, behind similar European countries, including Spain, Germany, and Italy, with the share of global R&D investment falling from 7.3% to 5.7% in the last three years.

Guy Oliver, general manager for Bristol Myers Squibb UK and Ireland, said the VPAG rate has already led to cuts to partnerships supporting the NHS and workforce reductions across the sector, "difficult decisions […] which contradict the government's ambition to collaborate with industry and foster growth."

The ABPI is calling for a move away from a hard growth cap in the voluntary scheme and towards a system that fairly shares the cost and benefits of growth in medicine spending between government and industry.

Last week, the pharma sector also slammed the decision by the government to hike the rate in the accompanying, but far less used, statutory scheme from 15.5% to 32.2% of companies' NHS sales in the second half of this year.

https://pharmaphorum.com/news/uk-becoming-outlier-pharma-hitting-investment

Optinose Cancels Fourth Quarter and Full Year 2024 Earnings Call

 Optinose (NASDAQ:OPTN), a pharmaceutical company specializing in ENT and allergy treatments, has announced the cancellation of its Q4 and full-year 2024 earnings conference call originally scheduled for March 20, 2025. The cancellation follows the company's earlier announcement of a definitive agreement to be acquired by Paratek Pharmaceuticals.

The acquisition deal is subject to shareholder approval and other customary closing conditions. Despite the earnings call cancellation, Optinose confirms it will still report its financial results for both the three-month and twelve-month periods ended December 31, 2024, in a timely manner.

https://www.stocktitan.net/news/OPTN/optinose-cancels-fourth-quarter-and-full-year-2024-earnings-9e5i9nige64s.html

'UnitedHealth To Overhaul Payment Model To Support Independent Pharmacies'

UnitedHealth Group Inc‘s 

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 Optum Rx will align payment models more closely to the costs pharmacies may face due to manufacturer pricing actions.

The company plans a full implementation by January 2028.

In February, President Donald Trump signed an executive order to strengthen price transparency regulations in the industry.

The order directs federal agencies, including the Departments of Treasury, Labor, and Health and Human Services, to enforce and expand a 2019 rule requiring hospitals and insurers to publicly disclose the actual costs of medical services.

This change will positively impact Optum Rx’s non-affiliated network pharmacies, including the more than 24,000 independent community pharmacies.

“Pharmacies and pharmacists provide important care to patients, and we recognize that increasing drug prices make it hard for them to afford needed medicines, especially independent and community pharmacies,” said Patrick Conway, CEO of Optum Rx. “This move will help correct imbalances in how pharmacies are paid for brand and generic drugs and will ensure greater access to medicines for patients across the country.”

Optum Rx will similarly transition client arrangements—such as employer and health plan customers—to ensure transparency and greater alignment with drug costs.

Optum Rx has been working to ensure pharmacies are paid fairly and offering solutions to improve operational efficiency and reduce administrative burden. Some of these efforts include:

  • Reimbursing pharmacists for connecting their underserved patients to services that address basic needs such as food, nutrition, transportation, housing, and baby supplies. Key areas of focus include maternal wellness and meeting health care needs in urban and rural communities with few pharmacies.
  • Supporting independent pharmacists by paying them for services such as counseling and medication management.
  • Enhancing pharmacy digital capabilities to easily access claims and payment data, ease administrative burdens, and manage revenue.
  • Removing retroactive recoupment (clawbacks) for pharmacies.
  • Offering predictive analytics and other tools.

On Wednesday, Optum Rx announced that it would eliminate up to 25% of reauthorizations, equal to more than 10% of overall pharmacy prior authorizations, to make prescription drugs more affordable and the pharmacy experience simpler.

The initiative focuses first on approximately 80 drugs, and Optum Rx will work with physicians and pharmacists to expand the list over time.

Optum Rx said that some reauthorizations are necessary for drugs with safety concerns, which need ongoing monitoring for dose adjustments, require additional tests, or may have alternative therapy considerations.

For example, new drugs developed for Alzheimer’s disease carry risks for the brain, and long-term effectiveness is not clear.

For these treatments, ongoing review is important for patients, payers and physicians. In contrast, once a genetic condition like cystic fibrosis is confirmed through testing, there is minimal additional value in reauthorizing an effective, lifelong treatment.

https://in.benzinga.com/25/03/44416313/unitedhealths-optum-rx-to-overhaul-payment-model-to-support-independent-pharmacies-soon-after-cutting-reauthorizations-on-80-drugs

Solventum reaffirms 2025 guidance, and announces long-range plan through 2028

 Solventum (NYSE: SOLV) today hosts its 2025 Investor Day and will outline strategic priorities for the Company, its business segments, and its long-range plan (LRP) to drive growth and value creation.

"Solventum has tremendous potential, with attractive businesses, large and growing markets, and highly regarded brands. We have undertaken a significant transformation to unlock the potential of our Medical Surgical, Dental Solutions, and Health Information Systems businesses, positioning the company to drive accelerated growth and create shareholder value," said Bryan Hanson, Chief Executive Officer of Solventum.

"Solventum has entered 2025 as a more focused company with an improving innovation engine and a purpose-built leadership team committed to realizing our mission of enabling better, smarter, safer healthcare to improve lives. The recently announced sale of our Purification & Filtration (P&F) business is a major milestone and will allow us to accelerate our plans and deliver for customers and shareholders. Our long-range plan demonstrates the progress we made in the last year and reflects our confidence in our ability to accelerate sales growth, expand margins, deliver EPS growth, and improve free cash flow," Hanson concluded.

Long-Range Plan and Financial Targets
Solventum today reaffirmed its fiscal year 2025 guidance, originally provided in connection with its Q4 earnings, and announced its LRP for 2025 through 2028:

  • Accelerate organic sales growth of 4% to 5% in 2028
  • Expand operating margins to be 23% to 25% in 2028 (inclusive of ~200bps 3M COGS increase)
  • Generate EPS CAGR of 10% over the 3-year period ending 2028
  • Drive free cash flow conversion of 80%+

The Company is also focused on delivering attractive ROIC and a solid investment grade credit rating and intends to use the proceeds from the P&F transaction primarily to pay down debt. Solventum will consider share repurchases and dividends over time.

Three-Phased Transformation Plan
The Company has been executing a three-phased transformation plan, and the LRP reflects the foundational improvements implemented over the last year to position the Company for success.

  • Capture hearts and minds and stabilize the business: The Company has taken action to drive mission and culture, refresh talent and harmonize the executive team, and enhance execution with a focus on relevant metrics for its business.
  • Enhance strategic focus: Solventum is executing a clear strategic plan to drive revenue growth, margin expansion, and cash flow improvement with a focus on high-potential markets where the Company has a path to leadership. Over the past year, the Company has carefully analyzed its markets to select key growth driver areas that will propel growth across the business segments.
  • Portfolio optimization: Solventum has identified organic and inorganic growth opportunities to maximize value and optimize its portfolio, including the recent sale of the P&F business, which frees up significant capital to invest for growth through M&A. The Company will continue to evaluate opportunities to enter or increase scale within the most attractive markets and submarkets, as well as invest in R&D and CapEx to support innovation and top-line growth.

2025 Investor Day Webcast
Solventum will host its 2025 Investor Day in New York City today starting at 1 p.m. Eastern Daylight Time. The event will also be accessible via webcast and can be found on the Company's investor relations site. A replay of the webcast and the presentation slides used will be available on the same site following the event.

What Recession? Initial Jobless Claims Hover Near Multi-Decade Lows

 The number of Americans filing for jobless benefits for the first time remains in 'strong labor market' mode with just 223k last week - a level it has oscillated around for three years now...

Moreover, this broad low level of initial jobless claims has not been seen since the late '60s...

Continuing claims remain around 1.9 million Americans...

For now, the effects of DOGE seem to be kept in line by the judiciary...

But continuing claims are definitely trending higher among the dominantly government-based-labor states...

...is there a surprise to come?

https://www.zerohedge.com/personal-finance/what-recession-initial-jobless-claims-hover-near-multi-decade-lows