MSD, Ionis trumpet lipid-lowering drug data

 Two pharma companies developing lipid-lowering drugs, MSD and Ionis, have reported positive phase 3 data that open the way for regulatory filings in the coming months.

First up, MSD, which chalked up its third positive phase 3 trial for oral PCSK9 inhibitor enlicitide decanoate (formerly MK-0616), in a wider patient population than its two earlier studies in the CORALreef programme.

The CORALreef Lipids trial in patients with elevated cholesterol (hypercholesterolaemia) at risk of atherosclerotic cardiovascular disease showed that enlicitide achieved a statistically significant and "clinically meaningful" reduction in LDL-cholesterol compared to placebo at 24 weeks, its primary endpoint.

That was backed up by significant reductions in secondary risk factors for heart disease, including non-HDL-cholesterol, ApoB, and LP(a), according to lead investigator Ann Marie Navar of UT Southwestern Medical Center.

MSD – known as Merck & Co in the US and Canada – previously reported two positive phase 3 trials, one in inherited disorder heterogeneous familial hypercholesterolaemia (CORALreef HeFH) and another comparing enlicitide to other oral therapies as additional therapy for people with hypercholesterolaemia who are struggling to meet their treatment targets with statin therapy alone (CORALreef AddOn).

The third study encompassed a much broader group of patients, including those who had been treated with stable cholesterol-lowering therapies, including at least a statin, or who had documented statin intolerance.

Armed with the data, MSD now intends to start discussions with regulators with a view to filing enlicitide for approval, putting it firmly in the lead among drugmakers developing oral drugs against PCSK9, ahead of nearest rival AstraZeneca, whose AZD0780 started phase 3 testing earlier this year.

Currently available PCSK9-targeting therapies are Amgen's Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab), both antibodies dosed monthly, and Novartis' small interfering RNA therapy Leqvio (inclisiran), which can be given twice a year.

"Enlicitide, designed to deliver antibody-like efficacy, is the first oral macrocyclic peptide PCSK9 inhibitor with clinically meaningful and statistically significant LDL-cholesterol lowering in phase 3 trials," said MSD's head of R&D, Dean Li.

"If approved, it has the potential to change the way we think about managing LDL levels, giving patients the possibility of a new option to help them meet their treatment goals."

Tryngolza triumph

Ionis, meanwhile, is looking at expanding the eligible patient population for already-approved apoC-III inhibitor Tryngolza (olezarsen) with new data in people living with severe hypertriglyceridaemia (sHTG).

Topline results from the pivotal Phase 3 CORE and CORE2 studies showed that Tryngolza achieved statistically significant reductions of up to 72% in fasting triglycerides in sHTG patients, as well as an 85% reduction in pancreatitis, one of the main complications of excessive triglyceride levels in the blood.

Last December, Tryngolza became the first FDA-approved drug therapy for familial chylomicronaemia syndrome (FCS), an ultra-rare disease causing high triglyceride levels that affects fewer than 5,00 people in the US. For comparison, around three million people are living with sHTG in the US, including more than a million who are considered high risk.

The company has previously suggested that approval for both FCS and sHTG could lead to Tryngolza achieving $1 billion-plus in annual sales, while analysts at Jefferies said that the strength of the CORE data had prompted them to raise their peak sales forecasts by $1 billion to $2.5 billion.

"These data are groundbreaking, demonstrating that olezarsen is the first therapy for sHTG to significantly reduce acute pancreatitis events," said Ionis' head of cardiovascular development, Sam Tsimikas.

The company has said it intends to file for the new indication for olezarsen, which has a list price of $595,000 a year in FCS, before the end of this year.

https://pharmaphorum.com/news/msd-ionis-trumpet-lipid-lowering-drug-data

''Brainwave' test raises hopes of early dementia diagnosis'

 A three-minute test could play a role in diagnosing people at risk of developing dementia, spotting signs of cognitive decline years before other approaches, say researchers from the UK.

The Fastball test asks people to remember a stream of images viewed on a screen whilst wearing an electroencephalogram (EEG) headset, and analyses the brain's ability to differentiate between images based on previous exposure.

The team from the Universities of Bath and Bristol – led by Bath cognitive neuroscientist Dr George Stothart – have carried out a small clinical study of Fastball that suggests it can reliably identify memory problems in people with mild cognitive impairment (MCI) that precedes Alzheimer's.

The scientists have previously shown that it can spot memory problems in people with established dementia, but now – for the first time – have demonstrated that it can be administered in people's homes, outside of a clinical environment.

Their study – published in the journal Brain Communications and funded by BRACE Dementia Research – enrolled 33 people with memory deficits, 20 people with deficits in other cognitive domains, and 54 people without cognitive deficits.

They found that subjects with amnestic MCI, which largely affects a person's memory for objects, exhibited markedly reduced responses to the test compared with healthy adults and those with non-amnestic MCI.

As people with amnestic MCI are much more likely to go on to develop Alzheimer's, the hope is that it could allow earlier intervention with an emerging generation of potentially disease-modifying drugs, such as Eisai/Biogen's Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab) – both targeting the amyloid plaques that characterise the disease.

"We're missing the first 10 to 20 years of Alzheimer's with current diagnostic tools," said Stothart. "Fastball offers a way to change that – detecting memory decline far earlier and more objectively, using a quick and passive test."

While acknowledging that much more testing will be needed before it can be used routinely in health settings, the authors of the paper said it has the potential to deliver wider screening and monitoring and could be scaled for use in GP surgeries, memory clinics, or at home.

Commenting on the results, Prof Vladimir Litvak of UCL Queen Square Institute of Neurology – who was not involved in the study – said that it represents an early step towards developing a clinically useful test, but it does not yet demonstrate such a tool.

"The study found a clear difference in EEG responses between patients with and without amnesia. However, the ability to classify individual patients using this effect, including estimates of error rates, was not assessed," said Litvak.

"Furthermore, all patients tested were already symptomatic," he added. " A crucial next step would be a prospective study to determine whether this effect can predict an individual's clinical trajectory and support patient stratification for treatment. This is yet to be done."

Earlier this year, the FDA approved the first blood test to aid in diagnosing Alzheimer's, with reports suggesting this has already led to an uptick in usage of anti-amyloid therapies.

Other experimental approaches to detecting individuals who may go on to develop this form of dementia include AI-powered eye examinations, virtual reality navigation assessments, tests based on smell, typing, handwriting, and driving patterns, and applying AI to the standard cognitive assessments carried out by doctors.

https://pharmaphorum.com/news/brainwave-test-raises-hopes-early-dementia-diagnosis

Roche Makes Preclinical IBD Play in $420M+ OMass Pact

 

The OMass partnership will boost Roche’s strategy in inflammatory bowel diseases, currently led by afimkibart, an anti-TL1A therapy the pharma obtained from its $7.1 billion acquisition of Telavant in 2023.

Roche’s subsidiary Genentech is fronting $20 million to partner with England-based biotech OMass Therapeutics and advance the British company’s preclinical small-molecule program for inflammatory bowel diseases.

Genentech is also pledging more than $400 million in preclinical, development, commercial and net sales milestone payments. OMasswill also be eligible to receive tiered royalties on net sales, as per Tuesday’s release. The biotech will continue to lead preclinical development of the IBD program and see it through to candidate selection, after which Genentech will assume leadership and be responsible for clinical studies, regulatory activities and commercialization.

In exchange for its investment, Genentech will have the exclusive right over the program developed using OMass’ proprietary OdyssION drug discovery platform.

The companies did not disclose in their announcement on Tuesday what specific targets they plan to go after, nor did they provide a timeline for when they expect clinical development to start.

Roche’s IBD efforts are anchored by the anti-TL1A antibody RVT-3101, which the pharma obtained in October 2023 when it acquired the Roivant subsidiary Telavant for $7.1 billion. The pharma has since renamed the molecule afimkibart and has taken it into Phase III development for Crohn’s disease and ulcerative colitis. Roche anticipates a regulatory filing for ulcerative colitis in 2027 and for Crohn’s disease around 2028, as per its second-quarter earnings report in July.

For Roche, the OMass deal follows other partnerships that it has inked this year, including a $5.3 billion agreement with Zealand Pharma in March for the biotech’s obesity candidate petrelinitide. In May, the pharma put more than $2 billion on the line in a molecular glue deal with Orionis Biosciences, while in July, Tokyo-based Chugai Pharmaceuticals—which is majority owned by Roche—partnered with AI-focused Gero for over $1 billion to target age-related diseases.

Other industry heavy-hitters are also working on IBD, including Merck, which in April 2023 dropped $10.8 billion to buy Prometheus Biosciences,gaining ownership of PRA023, an anti-TL1A monoclonal antibody. The molecule is now called tulisokibart and is in late-stage development for Crohn’s disease and ulcerative colitis. Joining Roche and Merck is Sanofi, which in October 2023 bet $1.5 billion to partner with Teva and advance their own TL1A program for IBD.

https://www.biospace.com/business/roche-makes-preclinical-ibd-play-in-420m-omass-pact

Data Scientist Fourth Fastest-Growing U.S. Job, Says BLS

 

Data scientist employment is expected to grow 33.5% from 2024 to 2034 due in part to a growing demand for data analysis, according to new U.S. Bureau Labor of Statistics findings. Biopharma hotspots were among the top 10 states for employment and pay for this role in 2024.

Employment for data scientists—who’ve become increasingly important at biopharmas—is expected to increase 33.5% from 2024 to 2034, the U.S. Bureau of Labor Statistics (BLS) recently reported. The projected jump from 245,900 to 328,300 employees makes this role the economy’s fourth fastest-growing occupation, according to the agency.

In its Aug. 28 announcement, BLS noted that the growing demand to build artificial intelligence (AI) models, conduct data analysis and integrate applications into business practices is behind the expected increase. It also shared in its related occupational outlook handbook that about 23,400 openings are projected for each year, on average, from 2024 to 2034. The agency noted that many of those positions will be available due to employers’ need to replace workers who move into different occupations or exit the labor force for reasons such as retirement.

Data scientists’ value to the economy over the next several years is further underscored by findings from Coherent Market Insights, a global market intelligence and consulting organization. Coherent estimates that the global data science platform market will grow from $13.6 billion in 2025 to $57.1 billion by 2032. It attributes that increase to widespread adoption of data-driven decision making across various industries.

Highest Employment, Salaries Found in Biopharma Hotspots

Several of the top 10 states BLS identified for the highest data scientist employment in 2024 have a strong, established biopharma presence. Those states include the two biggest biopharma locations: California, which ranked first (36,850), and Massachusetts, which ranked sixth (9,990).

Several of the states with the highest pay also have a strong, established biopharma presence, with California ($136,800) and Massachusetts ($132,250) landing third and fourth, respectively.

The annual median wage for all U.S. data scientists in 2024 was $112,590, according to BLS. It was slightly higher—$120,090—for those working in scientific research and development services.

What Employers Want in Data Scientists

For those looking to move into data science, the BLS occupational outlook handbook noted that people entering this occupation typically need at least a bachelor’s degree in math, statistics, computer science or a related field. However, the agency added, some employers require or prefer that applicants have a master’s or doctoral degree.

BLS identified analytical, computer, communication, logical-thinking, math and problem-solving skills as important qualities for data scientists to perform their duties.

For a look at what biopharma employers, specifically, want in data scientists, job seekers can visit the data scientist job listings on the BioSpace website. Companies that recently posted openings include Amgen, Eli Lilly, Formation Bio, InVitro Cell Research, Takeda and Terray. Eli Lilly, for example, has multiple positions available, including data scientist (R4-R6) and genomics data scientist.

https://www.biospace.com/job-trends/data-scientist-fourth-fastest-growing-u-s-job-says-bls

Google won't be forced to sell Chrome as judge rules divestment 'poor fit' in landmark antitrust case

 Google (GOOG, GOOGL) won't be forced to sell Chrome after a federal district judge ruled divestment a "poor fit" in a landmark antitrust case, but it will have to share data that helped it hold on to its search monopoly.

The ruling from District of Columbia judge Amit Mehta sent Google's stock gaining by almost 6% in premarket trading on Wednesday.

As part of the decision, Mehta ruled that Google can continue to make payments to "distribution partners for preloading or placement of Google Search, Chrome, or GenAI products." That allows for Google to continue to make its $20 billion per year payments to Apple in exchange for the iPhone maker using Google Search as the default search engine in its Safari browser and Siri.

https://finance.yahoo.com/news/google-wont-be-forced-to-sell-chrome-after-judge-rules-divestment-a-poor-fit-in-landmark-antitrust-case-210218257.html

Trump to Review Approval of Massachusetts Offshore Wind Farm

 

The Trump administration plans to reconsider a permit issued to a large wind farm off the coast of Massachusetts, the latest move in its targeted campaign against the clean energy resource.

The US Interior Department intends to review the project’s approval issued in the waning days of the Biden administration, according to a filing by the Justice Department on Friday. The agency asked a federal court to pause the city of Nantucket’s challenge of the SouthCoast Wind development since the Trump administration intends to ask that the matter be sent back to the Interior Department for further action later this month.

https://www.bloomberg.com/news/articles/2025-09-02/trump-to-review-approval-of-wind-farm-off-massachusetts-coast

Appeals court overturns ruling halting EPA clawback of climate funds

 A federal appeals court has overturned a lower court’s ruling that prevented the Trump administration from clawing back billions of dollars in climate spending.

The 2-1 decision from a federal appeals court in Washington, D.C., vacated a lower court ruling that would have prevented the Environmental Protection Agency (EPA) from recouping billions issued for climate-friendly projects under the Biden administration.

The decision, from President Trump appointees Neomi Rao and Gregory Katsas, is expected to enable the administration to rescind unspent funding from the $20 billion program.

The funds in question are part of a $20 billion “Green Bank” program that passed as part of the Democrats’ 2022 Inflation Reduction Act.

Last year, under that law, the Biden administration doled out money to eight organizations, which were tasked with sub-awarding it to projects that reduce planet-warming emissions and/or air pollution, including renewable energy endeavors.

https://thehill.com/policy/energy-environment/5481883-appeals-court-trump-epa-climate-funds/