// Biotech and Pharma Therapeutics

Bicycle Health, Albertsons partner to boost access to opioid use disorder injections

September 5, 2023 / Bicycle Health / Albertsons / Opioids / Telehealth – 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. Read Full Article on Mobi Health News >>
Bayer bets big on Kerendia’s potential to treat heart failure
September 1, 2023 / Kerendia / Bayer / Heart Failure / Chronic Kidney Disease – 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. Read Full Article on Fierce Pharma >>
New Biomarker Tests Aid Quick, Accurate Diagnosis of Alzheimer’s Disease
September 5, 2023 / Biomarker Test / Alzheimer’s Disease / Eisai / Biogen – 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. Read Full Article on BioSpace >>
Coveted GLP-1 Drugs Show Early Promise in Alzheimer’s Disease
September 5, 2023 / GLP-1 Drugs / Alzheimer’s Disease / NAFLD / Cadiovascular – 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. Read Full Article on BioSpace >>
Gilead-backed study warns IRA price negotiations could hit R&D harder than expected
September 6, 2023 / Inflation Reduction Act / Medicare / Drug Prices / Small Molecules – 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. Read Full Article on Fierce Biotech >>

// 4th Industrial Revolution

Healthcare Organizations at Risk: BYOD and Mobile Devices are Increasing Cybersecurity Concerns
 September 7, 2023 / Healthcare / Organizations / Cybersecurity / Healthcare – 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. Read Full Article on Healthcare It Today >>
South Korea begins nationwide telemedicine pilot
 September 4, 2023 / South Korea / Telemedicine / Chronic Diseases – 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. Read Full Article on Healthcare IT News >>
Can virtual nursing combined with computer vision AI boost care quality?
 September 7, 2023 / AI / Healthcare – 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. Read Full Article on Healthcare IT News >>
Intelligent OMICS partners with Janssen on AI-driven research
 September 1, 2023 / OMICS Partners / Janssen / AI / New 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. Read Full Article on Pharma Times >>
How Will Generative AI Change the Role of Clinicians In the Next 10 Years?
September 4, 2023 / AI / Healthcare / Mayo Clinic – 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. Read Full Article on Med City News >>

// Business & Markets

Otsuka adopts new Mindset, dropping $59M to buy Canadian psychedelic biotech
September 1, 2023 / Otsuka Pharma / Psychedelic Drugs / M&A / Rexulti – NWith 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). Read Full Article on Fierce Biotech >>
Booming Demand in the Manufacturing Systems (MES) For Pharmaceutical Market: Worldwide Growth Prospects, Incredible Demand, and Business Strategies 2023-2030
September 4, 2023 / Pharma Market / Manufacturing – 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. Read Full Article on Digital Journal >>
Pharma firms to thrive in the US market boosted by new products and drug demand
September 5, 2023 / Pharma Firms / US Market / 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). Read Full Article on Business Today >>
Mark Cuban Vs. Big Pharma
September 7, 2023 / Mark Cuban / Big Pharma / Cost Plus Drugs – 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.” Read Full Article on Mens Health >>
NIA-Funded Small Business Spotlight: Juvena Therapeutics Unlocking the Secrets of Tissue Regeneration
September 6, 2023 / NIA / Small Business / 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. Read Full Article on National Institute on Aging >>

// 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
September 5, 2023 / Lawsuit / Drug Price / Novartis / White House / Medicare – 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. Read on Med City News >>
Novartis files suit against IRA after blockbuster Entresto makes CMS’ price negotiations list
September 5, 2023 / Novartis / Inflation Reduction Act / Entresto / Centers for Medicare & Medicaid Services – 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. Read Full Article on Fierce Pharma >>
Moderna, hoping for swift approval, shows updated COVID shot can defend against pirola variant
September 6, 2023 / Moderna / Covid-19 / Vaccines – 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. Read Full Article on Fierce Biotech >>
FTC Agreement Clears Amgen to Proceed with $27.8B Horizon Deal
September 1, 2023 / FTC / Amgen / Horizon – 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. Read on Biospace >>
Astellas withdraws lawsuit challenging Medicare drug price program
September 7, 2023 / Astellas / Lawsuit / Medicare / Drug Pricing / Drug Makers – 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. Read on Biopharma Dive >>
Krystal Biotech Announces Orphan Drug Designation Granted to KB408 for the Treatment of Alpha-1 Antitrypsin Deficiency
September 5, 2023 / Krystal Biotech / Orphan Drug / Alpha-1 Antitrypsin – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs, announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation for KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD). Read Full Article on Krystal Bio >>

// Research & Development

J&J sends blood pressure drug back to Idorsia
September 6, 2023 / Johnson & Johnson / Blood Pressure Drug / Idorsia / Actelion – 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. Read Full Article on Biopharma Dive >>
Recursion Vets Unveil Startup Noetik, Using AI to Unlock Tumor Biology
August 7, 2023 / Noetik / AI / 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. Read Full Article on Med City News >>
Wave readies clinical testing for first RNA editing therapy
September 5, 2023 / Wave / Clinical Testing / 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. Read Full Article on Biopharma Dive >>
Roche claims study success for targeted drug in early lung cancer
September 1, 2023 / Roche / 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. Read Full Article on Biopharma Dive >>
Nestle gives up on peanut allergy treatment after sluggish sales
September 5, 2023 / Nestle / Peanut Allergy / FDA – 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. Read Full Article on Biopharma Dive >>

// Politics

Amid Medicare negotiation battle, lawmakers push for answers on insulin prices and patent reform
August 31, 2023 / Sanofi / Novo Nordisk / FDA / Eli Lilly – 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. Read Full Article on Fierce Pharma >>
Bipartisan majorities support allowing Medicare to negotiate drug prices
September 6, 2023 / Bipartisan / Medicare / 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. Read Full Article on YouGov >>
Manchin pushes for review of opioid approval process
September 7, 2023 / Manchin / Opioid / Drug Approval – 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. Read Full Article on 12WBOY >>
Humana sues Biden admin to prevent Medicare payment clawbacks
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. Read Full Article on AXIOS >>