// Biotech and Pharma Therapeutics
Bicycle Health, Albertsons partner to boost access to opioid use disorder injections
Virtual opioid use disorder treatment company Bicycle Health is partnering with supermarket chain Albertsons to allow the telehealth company’s providers to prescribe buprenorphine monthly injections for opioid use disorder that can be filled inside Albertsons pharmacies across 17 states.
Bayer bets big on Kerendia’s potential to treat heart failure
Approved two summers ago for chronic kidney disease (CKD) associated with type 2 diabetes, Bayer’s Kerendia (finerenone) isn’t off to the flying start expected of a potential blockbuster.
New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease
Prior to the approval of effective therapies for Alzheimer’s disease, there was little need for biomarker tests. Now, with Eisai and Biogen’s anti-amyloid drug Leqembi on the market and approval of Eli Lilly’s donanemab expected to follow soon, the pipeline of Alzheimer’s drugs is expanding and the development of tests to detect the disease is accelerating.
Coveted GLP-1 Drugs Show Early Promise in Alzheimer’s Disease
There may be no hotter trend in biopharma right now than GLP-1 receptor agonists. Currently approved to treat type 2 diabetes and obesity, this drug class has also shown potential in other indications, from nonalcoholic fatty liver disease and cardiovascular disease to addiction, and recent studies suggest it may help tackle another big target—Alzheimer’s disease.
Gilead-backed study warns IRA price negotiations could hit R&D harder than expected
The U.S. Congressional Budget Office (CBO) previously ran the numbers on the IRA, concluding that 15 out of 1,300 drugs would not come to market over the next 30 years. However, multiple analyses have called the CBO figures into question, with healthcare consulting firm Avalere, which received money from Gilead Sciences, finding the IRA could cut pharma revenues by $450 billion and another analysis suggesting between 24 and 49 currently available therapies wouldn’t have reached the market if the pricing provisions took effect in 2014.
// 4th Industrial Revolution
Healthcare Organizations at Risk: BYOD and Mobile Devices are Increasing Cybersecurity Concerns
The healthcare industry has been transforming radically over the past decade with the common goal of improving the way healthcare is delivered to patients. In the last few years alone, we’ve watched as healthcare organizations have quickly become mobile-powered businesses with the migration to electronic health records, patients increasingly using mobile apps to view test results, schedule appointments, contact their care provider, and even control their medical devices.
South Korea begins nationwide telemedicine pilot
Telemedicine is once again not allowed in South Korea after the country temporarily allowed its conduct during the pandemic as part of its emergency response. In June, the government downgraded its public health alert, which meant the end of the temporary conduct of telemedicine after three years.
Can virtual nursing combined with computer vision AI boost care quality?
We interviewed Singh to discuss why virtual nursing is getting so much attention, what computer vision AI is and why he thinks it needs to be integrated with virtual nursing technologies, what effective collaboration between virtual nurses and AI technology might look like, and how AI can improve care and boost the bottom line at hospitals and health systems.
Intelligent OMICS partners with Janssen on AI-driven research
Intelligent OMICS, a biotechnology company that applies artificial intelligence (AI) to accelerate drug discovery, has announced a target discovery collaboration with Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
How Will Generative AI Change the Role of Clinicians In the Next 10 Years?
AI is a bit of a buzzword in the healthcare world, so it’s sometimes difficult to tell how much of an impact this technology is going to end up having on the sector. This month, Citi released a report that sought to cut through the noise.
// Business & Markets
Otsuka adopts new Mindset, dropping $59M to buy Canadian psychedelic biotech
With the first crop of psychedelics inching closer to the FDA’s decision desk, Otsuka Pharmaceutical has decided to have some skin in the game, buying psychedelic biotech Mindset Pharma for $80 million Canadian dollars ($59 million).
Booming Demand in the Manufacturing Systems (MES) For Pharmaceutical Market: Worldwide Growth Prospects, Incredible Demand, and Business Strategies 2023-2030
The Manufacturing Systems (MES) For Pharmaceutical Market research study is a professional report with premium insights into the size of the business, current patterns, drivers, risks, potential outcomes, and major segments. The Industry Report forecasts the future growth of the market based on precise assumptions. Furthermore, based on input from industry experts, the report provides actionable insights into the Manufacturing Systems (MES) For Pharmaceutical market’s future growth to assist readers in developing effective strategies.
Pharma firms to thrive in the US market boosted by new products and drug demand
Pharmaceutical companies are expected to maintain their growth momentum and profitability in regulated markets, with the United States playing a pivotal role, according to India Ratings and Research (Ind-Ra).
Mark Cuban Vs. Big Pharma
Pharmaceuticals are Cuban’s: Cost Plus Drugs is tapping into a massive and desperate demographic. A 2021 poll by Gallup and West Health estimated that 7 percent of Americans, or 23 million, were unable to pay for at least one prescription in the preceding three months, and 10 percent skipped doses of medications in the past year to save money. “I’m used to people walking up to me and saying hi, taking pictures,” Cuban says. “Now I’m getting people walking up to me and hugging me and crying, telling me stories about how their mom or they saved $1,000 or $1,200 or $2,000 or $5,000 a month.”
NIA-Funded Small Business Spotlight: Juvena Therapeutics Unlocking the Secrets of Tissue Regeneration
With help from NIA, biotechnology company Juvena Therapeutics has begun unlocking the secrets of proteins for regenerative medicine. Juvena scientists are using a form of muscular dystrophy — myotonic dystrophy type 1 (DM-1) — as a model to sift through proteins that are produced by the body’s stem cells. These cells have the potential to become any type of cell in the body, from liver tissue to skin cells.
// Legal & Regulatory
HHS Will Likely Face More Lawsuits Against Drug Price Negotiation Now That It Has Named the First 10 Meds Included In the Plan
Last Friday, Novartis became the seventh drugmaker to legally challenge the White House’s Medicare drug pricing negotiation program. The company filed its lawsuit three days after HHS announced the first 10 drugs covered under Medicare Part D that were selected for the price negotiation program — Novartis’ heart failure medication Entresto was one on the list.
Novartis files suit against IRA after blockbuster Entresto makes CMS’ price negotiations list
The company filed its case Friday in New Jersey federal court, three days after the Centers for Medicare & Medicaid Services (CMS) revealed that Novartis’ heart failure treatment Entresto was among 10 drugs subject to price negotiations in 2026.
Moderna, hoping for swift approval, shows updated COVID shot can defend against pirola variant
Moderna is continuing to make the case for why its updated COVID-19 shot needs a speedy approval in time for the fall vaccination season, now pointing to its effectiveness against the so-called pirola variant.
FTC Agreement Clears Amgen to Proceed with $27.8B Horizon Deal
The biggest biotech deal of 2022 will move forward after the Federal Trade Commission announced Friday it has reached an agreement with Amgen to allow the $27.8 billion acquisition of Horizon Therapeutics to proceed.
Astellas withdraws lawsuit challenging Medicare drug price program
Astellas was one of a half dozen large drugmakers to preemptively sue the government over Medicare’s plan to negotiate the prices of select top-selling drugs — authority granted by last year’s Inflation Reduction Act.
// Research & Development
J&J sends blood pressure drug back to Idorsia
J&J’s decision to pull back from a medication so close to a potential approval is another in a series of setbacks for Idorsia, whose shares are trading at all-time lows. Earlier this year, Idorsia said a cardiovascular drug failed in a key clinical trial. A few months later, the company announced plans to lay off as many as 500 employees as it cut costs to conserve cash for operations.
Recursion Vets Unveil Startup Noetik, Using AI to Unlock Tumor Biology
Biotechnology research continues to churn out new drugs addressing genetic drivers of cancer. While that progress gives patients more treatment options, one limitation of this approach is it takes for granted that we know what target to drug, according to Ron Alfa, CEO of startup Noetik.
Wave readies clinical testing for first RNA editing therapy
Success in the clinic would boost the RNA editing field as well as Wave. Broadly speaking, the technology is designed to edit specific sites in an RNA transcript without making permanent changes to a person’s genome.
Roche claims study success for targeted drug in early lung cancer
Drugs that spur on the immune system have become standard for many patients with metastatic disease, extending survival in ways other drugs previously hadn’t. They’ve proved beneficial earlier in disease, too, becoming available for patients in the so-called neoadjuvant or adjuvant settings, before or after a tumor is removed surgically.
Nestle gives up on peanut allergy treatment after sluggish sales
Even before reaching market, Palforzia’s development journey was rocky. Originally submitted for FDA review in 2019, the therapy’s application was derailed by the partial shutdown of the federal government that year.
Amid Medicare negotiation battle, lawmakers push for answers on insulin prices and patent reform
It was a year ago this month that President Joe Biden signed the Inflation Reduction Act. While the landmark bill introduces several pricing measures, Democrats on Capitol Hill are still pursuing ways to rein in the pharma industry.
Bipartisan majorities support allowing Medicare to negotiate drug prices
Three-quarters of Americans (75%) believe people in the U.S. pay more than people in other wealthy countries for prescription drugs, and majorities favor several policies that aim to lower costs for some groups via government intervention.
Manchin pushes for review of opioid approval process
Studies have compared EERW, which excludes potential participants who are nonresponders or who cannot tolerate the experimental drug before random assignment, to nonenriched enrollment randomized withdrawal trials of opioids for chronic noncancer pain. One found that EERW did not appear to bias efficacy results, but did underestimate the adverse effects of the drug.
September 1, 2023 / Humana / Biden / Medicare
Studies show that the government has regularly overpaid private Medicare Advantage plans for care that isn’t supported by patient records. Medicare projected it would recoup $4.7 billion from insurers in the next decade under the policy it finalized earlier this year.