// Biotech and Pharma Therapeutics

AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology
September 8, 2023 / AstraZeneca / AI / New Drug Targets / ALS – Launched in 2015, Verge has raised over $100 million from a variety of investors, including the asset management firm Blackrock and large pharmaceutical companies like Eli Lilly and Merck & Co. Rather than follow the typical path for identifying new drug targets, which often involves animal or cell models, Verge uses machine learning to analyze genomic data from human tissue samples. Read Full Article on Biopharma Dive >>
Tyneside biotech pioneer 3DBT launches new base in Hong Kong
September 11, 2023 / Tyneside / Hong Kong / 3D-Tissue – Newcastle-based 3D Bio-Tissues (3DBT) is seeking to revolutionise food, fashion and the pharmaceutical sector with its lab cultivated meat and skin, grown from a patent-protected supplement that removes the need for the use of animal serum. Read Full Article on Business
Live >>
Breast Cancer Treatment Drugs Market May See a Big Move
September 12, 2023 / Breast Cancer / Drug Manufacturer – The Latest Released Breast Cancer Treatment Drugs market study has evaluated the future growth potential of Breast Cancer Treatment Drugs market and provides information and useful stats on market structure and size. The report is intended to provide market intelligence and strategic insights to help decision-makers take sound investment decisions and identify potential gaps and growth opportunities. Read Full Article on Digital Journal >>
Big pharma’s blockbuster obesity drug battle is just getting started, and it’s headed for $100 billion
September 9, 2023 / Obesity Drug / Novo Nordisk / Eli Lilly – Beyond staggering sales figures for Novo’s Ozempic and Wegovy and Lilly’s Mounjaro, news of a study showing Wegovy can reduce the risk of heart disease and the anticipated approval of even more powerful prescription drugs to treat obesity will only strengthen the position of these venerable pharmaceutical giants, which have been in business for 100 years and 147 years, respectively. Read Full Article on CNBC >>
Moderna aims for the stars again with ambitious drug development plan
September 13, 2023 / Moderna / Drug Development / FDA – The company aims to launch as many as 15 new products in the next five years, including four by 2025. In 2027, Moderna expects $8 billion to $15 billion in respiratory product sales. And on Wednesday, it forecast another $10 billion to $15 billion in annual sales from new treatments for cancer and rare and latent diseases it hopes to introduce by 2028. Read Full Article on Biopharma Dive >>

// 4th Industrial Revolution

Google announces funding for AI-enabled digital health projects September 13, 2023 / AI / Google / Digital Health – Google announced that it is funding 15 AI-powered projects, including digital health initiatives to improve provider experience and patient access to care, via its commitment to advancing the United Nations Sustainable Development Goals. Read Full Article on Mobi Health News >>
AI Integration In Biotech & Pharma: Companies Positioned To Benefit
 September 11, 2023 / AI / Investors – The convergence of artificial intelligence (AI) with the biotech and pharmaceutical sectors is ushering in a new era of innovation. AI is catalyzing transformations from drug discovery to patient care. For investors keen on capturing this intersection’s potential, several publicly traded companies are making significant strides in embedding AI into their operations. Read Full Article on Investing.com >>
Notable Launches ChatGPT-Like Assistant for Patients
 September 7, 2023 / AI / Healthcare – Today, patients prefer to use digital tools for basic tasks like finding a doctor or scheduling an appointment. Notable research found that 70% of patients who tried online scheduling were redirected to a phone call. Tasks that should be simple quickly become cumbersome as patients are pushed to overloaded call centers. It doesn’t have to be this way. Read Full Article on HIT Consultant >>
How Meditech Plans to Integrate Google’s Generative AI Into Its EHR
 September 10, 2023 / Meditech / Google / AI / EHR – The EHR vendor has been partnered with Google Cloud for about five years. Over the past year, Meditech has deepened its relationship with the tech giant by exploring ways to embed Google’s generative AI into its EHR. But Meditech is not adding generative AI to its EHR capabilities just because that seems like the hot thing to do right now — the company is approaching its generative AI efforts in a steady, intentional way, COO Helen Waters said in an interview this week. Read Full Article on Med City News >>
New machine-learning algorithms can help optimize the next-generation of therapeutic antibodies
September 11, 2023 / Machine-learning / Antibody’s / Alzheimer’s / Parkinson’s – Antibody treatments may be able to activate the immune system to fight diseases like Parkinson’s, Alzheimer’s and colorectal cancer, but they are less effective when they bind with themselves and other molecules that aren’t markers of disease. Read Full Article on News Medical Life Sciences >>

// Business & Markets

Rocket boosted as FDA alignment on pivotal gene therapy trial design sends stock skyward
September 13, 2023 / FDA / Rocket Pharmaceuticals / Cell & Therapy / Emerging Biopharma – Rocket Pharmaceuticals has reached alignment with the FDA on the design of a pivotal phase 2 rare disease trial, positioning it to run a 12-patient study that could support accelerated approval of a gene therapy. Read Full Article on Fierce Biotech >>
Calidi goes public via SPAC with $70M lined up to push allogeneic cancer therapies into clinic
September 13, 2023 / Calidi Biotherapeutics / Special Purpose Acquisition Company / Emerging Biopharma / Allogeneic Cell Therapy / San Diego – The San Diego-based drug developer will debut on the Nasdaq this morning following a merger with SPAC First Light Acquisition Group yesterday. The combined company will continue to operate under the Calidi name and leadership team but now has about $28 million in gross proceeds as a result of the merger. However, around $18 million will be used to pay off transaction expenses and debts. Read Full Article on Fierce Biotech >>
Walgreens partners with value-based care platform Pearl Health
September 12, 2023 / Walgreens / Pearl Health / Digital Health – Pearl Health offers a technology platform for primary care providers participating in Medicare’s ACO REACH model. The platform includes data visualizations and recommendations that allow clinicians to see which patients may need extra support, such as those with multiple chronic conditions or those recently discharged from a hospital. Read Full Article on Mobi Health News >>
Ex-Johnson & Johnson CEO joins R.I. biotech company
September 13, 2023 / Johnson & Johnson / R.I. Biotech / Neurotech Pharma – Alex Gorsky, the former CEO and chairman of pharmaceutical giant Johnson & Johnson, was named lead director of Neurotech Pharmaceuticals Inc. on Wednesday. Gorsky left Johnson & Johnson in January 2022 after a decade as CEO for “family health concerns.” He initially joined the company as a sales associate in 1988. Read Full Article on Boston Globe >>
High-throughput Drug Screening Instrument Market Expected to Reach Tremendous Growth, Industry Insights, Market Size, Share, Factors, Forecast to 2029
September 11, 2023 / Drug Screening / Market Growth – Global “High-throughput Drug Screening Instrument Market” 2023-2029 covering historical and forecast data for the predefined timeframe. This Market report provide in depth analysis of the reports which is one of the key aspects for the growth of the market. The High-throughput Drug Screening Instrument market elaborates in all perspective of the market, from its historical growth through the future outlook. Read Full Article on Digital Journal >>

// Legal & Regulatory

FDA calls out eight companies for selling unapproved eye drugs
September 13, 2023 / FDA / Eye Drugs / Walgreens / CVS – The companies must respond with steps to correct violations within 15 days of receiving warnings. Failing to comply could lead to the FDA pursuing legal action, including product seizure and/or a court order to the company to stop unapproved product manufacturing and distribution. The FDA has already placed an import alert on some of the eight companies, stopping the entry of these drugs into the US. Read on Pharmaceutical Technology >>
Drug Supply Chain Security Act enforcement delayed until 2024
September 12, 2023 / Drug Supply Chain / FDA / Drug Makers / Stakeholders – The extension was well received by industry stakeholders, who have voiced concerns over the their readiness to comply with the law’s mandate that drug manufacturers provide distributors with unit-level serialized products to legally move items through their supply chains. Companies expressed worry that communication issues and technology shortcomings in their supply chains could inhibit their ability to move products. Read Full Article on Supply Chain Dive >>
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 >>
VA and Oracle eye new EHR deployment schedule by next summer
September 14, 2023 / VA / Oracle / EHR / Chicago – The Department of Veterans Affairs and leaders from Oracle provided an update on the paused electronic health record modernization project to the House Appropriations Committee this week, indicating progress and their expectations about when they will develop a new deployment schedule. Read on Healthcare IT News >>
New regulatory relief to benefit Europe’s pharma SMEs
September 13, 2023 / SMEs / Economic Climate / Europe – As small and medium-sized enterprises (SMEs) often face unfair competition when doing business in Europe, through the (SME) Relief Communication, the European Commission (EC) has proposed new measures to provide short-term relief, boost long-term competitiveness, and improve equality in the business environment across the Single Market in Europe. Read on European Pharmaceutical Review >>
Signal: Kroger to pay up to $1.4bn to settle opioid crisis lawsuits
September 5, 2023 / Krystal Biotech / Orphan Drug / Alpha-1 Antitrypsin – Up to $1.2bn will go to states and polities to aid in harm reduction efforts, as well as $36m to Native American tribes, who are disproportionately affected by the epidemic. Around $177m will cover legal fees. The news follows several other large pharmacy chains reaching similar deals last year. Read Full Article on Pharmaceutical Technology >>

// Research & Development

AbbVie’s Skyrizi Outperforms J&J’s Stelara in Late-Stage Crohn’s Disease Trial
September 13, 2023 / AbbVie / Crohn’s Diease / Johnson & Johnson – Topline data from the Phase III SEQUENCE trial showed that AbbVie’s Skyrizi (risankizumab) matched, and could potentially even outpace, Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease. Read Full Article on Biospace >>
After initial stumbles, Moderna finally gains clean phase 3 win for mRNA flu shot
August 13, 2023 / Moderna / Influenza Vaccine / Respiratory Syncytial Virus – After tweaking the formula behind an mRNA flu vaccine, Moderna has finally met all the goals needed for a successful shot in a phase 3 trial. Now, CEO Stéphane Bancel is eyeing a launch as early as 2024. Read Full Article on Fierce Biotech >>
New startup Arialys takes aim at the immune system, hoping to create neuropsychiatry drugs
September 12, 2023 / Startup / Neuropsychiatry / Immune System – Launched on Tuesday, Arialys Therapeutics says it was founded on recent scientific discoveries that point to the immune system as a main culprit behind some of these disorders. The biotech’s research focuses on “autoantibodies” — proteins created by the immune system that attack the body’s own tissues. Read Full Article on Biopharma Dive >>
Novadiscovery Announces Success of First-of-its-Kind Clinical Trial Simulation to Accurately Predict Findings of Phase III Clinical Study
September 12, 2023 / Novadiscovery / Clinical Trials – Novadiscovery, a life sciences company leading AI-driven in silico clinical trial simulation with its jinkō platform to inform and optimize the next-generation trial design, today announced the accurate, prospective prediction of results from AstraZeneca phase III FLAURA2 trial. Read Full Article on Biospace >>
Pig kidney works a record two months in donated body, raising hope for animal-human transplants
September 14, 2023 / animal-human transplants / Transplant – It marked the longest a genetically modified pig kidney has ever functioned inside a human, albeit a deceased one. And by pushing the boundaries of research with the dead, the scientists learned critical lessons they’re preparing to share with the Food and Drug Administration — in hopes of eventually testing pig kidneys in the living. Read Full Article on STAT >>

// Politics

Senators push back on DEA proposed telehealth rules, say they’d affect patient care
September 13, 2023 / Senators / DEA / Patient Care / Telehealth – U.S. Senators Mark Warner (D-Va.), John Thune (R-S.D.) and four of their colleagues expressed support for the Drug Enforcement Administration’s new engagement on a potential special registration for telehealth with this week’s listening sessions hosted by the DEA’s Drug Diversion Control Division, but said they had several concerns. Read Full Article on Healthcare It
News >>
California Bill to Decriminalize Natural Psychedelics Passes State Legislature on the Heels of Phase 2 Data Showing Safety, Efficacy of Psilocybin for MDD
September 11, 2023 / California Bill / Psychedelics – California is possibly on the verge of decriminalizing natural psychedelics after the bill SB58 passed the legislature. The bill would remove criminal penalties for those aged 21 years and older for the personal possession of natural psychedelics, such as psilocybin, psilocin, dimethyltryptamine, and mescaline. Once signed into law by Governor Gavin Newsom, SB58 will not go into effect until January 2025. Read Full Article on Pharmacy Times >>
The House China Select Committee issued its first ever subpoena as it investigates a Chinese-owned lab in California.
September 13, 2023 / China / California / House Committee – The House China Select Committee issued its first ever subpoena last week, as it took its investigation into a Chinese-owned lab in California to the next level. Read Full Article on Politico >>
Taking on big pharma’s patent abuse is the right next step for Congress to lower health care costs
September 14, 2023 / Congress / Healthcare Costs / Drug Costs – Senator Chuck Schumer has long been an advocate for lowering healthcare costs for New Yorkers, and—in his position as majority leader of the Senate—for Americans across the country. The Inflation Reduction Act, which Schumer helped usher through the Senate, included several critical policies that are already helping to lower prescription drug costs for many. However, one issue the Inflation Reduction Act did not address is the pharmaceutical industry’s abuse of the patent system. Read Full Article on Amsterdam News >>
With a pharmacare bill on the horizon, Big Pharma’s attack on single-payer drug coverage for Canadians needs a fact check
September 11, 2023 / Canada / Drug Coverage – Health Minister Mark Holland announced in August that the federal government intends to introduce pharmacare legislation in the fall. Now the battle lines are being drawn. Read Full Article on The Conversation >>