// Biotech and Pharma Therapeutics

AbbVie sends SHP2 deal back to port, following Big Pharma peer in retreating from target
July 5, 2023 / Jacobio / AbbVie / Solid Tumor / Licensing Deals – China-headquartered Jacobio has announced the termination of a deal (PDF) with AbbVie that involved global development and commercialization of SHP2 inhibitors including solid tumor med JAB-3312, according to a regulatory document dated July 4. Financial details of the deal were not disclosed back in June 2020 when it was originally signed, but AbbVie snagged an exclusive license to develop Jacobio’s SHP2 portfolio. Read Full Article on Fierce Biotech >>
With new data, J&J steps forward in growing race for oral autoimmune drugs
July 5, 2023 / J&J / Autoimmune Disease / Oral Drug / Drugmakers – J&J’s disclosure is the latest salvo in a competitive race to use pills, rather than injectable medicines, to treat autoimmune conditions like psoriasis. Drugmakers are hoping these treatments can compare favorably with marketed injectable biologic medicines, but with the convenience of a pill.
Read Full Article on Biopharma Dive >>
First Round of Humira Biosimilar Launches in US
July 3, 2023 / Humira Biosimilar / AbbVie / Amgen – New, lower-price biosimilars to AbbVie’s Humira (adalimumab) have launched in the U.S. in the last couple of days, following in the steps of Amgen’s Amjevita (adalimumab-atto), which entered the country in January. Read Full Article on BioSpace >>
Volume and Cost of Clinical Lab Tests Expected to Rise in 2023
July 5, 2023 / Clinical Labs / Rise in Cost – More than 14 billion clinical laboratory tests are performed each year, making it the number one utilized medical benefit, and yet these diagnostics have the least management. Overall, lab tests drive 70% of medical treatment decisions, and have a disproportionate impact on spending throughout the care continuum. Avalon uses its specialized knowledge of lab science and breadth of data on how lab testing impacts other areas of medicine to identify trends in clinical testing. Read Full Article on HIT Consultant >>
‘Mixed’ results seed doubt about AstraZeneca, Daiichi’s next cancer drug
July 5, 2023 / AstraZeneca / Daiichi / Cancer Drug – The partnership between AstraZeneca and Daiichi is best known for Enhertu, a drug that’s now cleared for use in multiple cancer settings and became the first targeted therapy for what’s known as “HER2 low disease.” Analysts expect the drug to generate more than $4 billion in yearly revenue as its use grows with time. Read Full Article on Biopharma Dive >>

// 4th Industrial Revolution

Clarius & Usono to Bring Wireless, Wearable Ultrasound Imaging to Researchers
July 5, 2023 / Wireless Tech / Wearable Tech / New Tech / Clarius Mobile Health / Usono – Clarius Mobile Health, a leading provider of high-definition handheld ultrasound systems, and Usono, a developer of innovative ultrasound accessories unveils wireless and wearable ultrasound imaging solution for researchers studying the anatomy of people while they move. Clarius ultrasound tools for research provide access to raw data collected internally, gyroscope collection, a programable interface, and custom software for real-time analysis anywhere. Read Full Article on HIT Consultant >>
How Health Systems Can Transform Fragmented Data Into a Unified Patient Experience
July 5, 2023 / Patient / Health Systems / Healthcare – Imagine a giant clock where each single cog wheel contributes to displaying the time accurately. In this complex web of machinery, individual cogs can break, and the clock stops – rendering it useless. Healthcare organizations are at risk of facing a similar fate as they encounter fragmented IT infrastructures with disconnected data environments and silos. Failure to address this growing issue could have serious consequences, leading systems to falter sooner than anticipated. Read Full Article on HIT Consultant >>
Iodine Software Expands Partnership With OpenAI, Adds GPT-4 to Its Products
July 3, 2023 / Open AI / Chat GPT / Iodine Software – The Austin-based company — which sells technology designed to improve providers’ clinical documentation, coding accuracy and revenue cycle management — recently announced that it is expanding its relationship with OpenAI. By doing so, Iodine will integrate the latest GPT-4 language model into its existing AI technologies and datasets, specifically its AwareCDI product suite. Read Full Article on Med City News >>
AI-enabled brain imaging company icometrix receives CPT III code
July 3, 2023 / AI / Brain Imaging / FDA / Healthcare – icometrix AI-supported quantitative brain analysis software provides metrics for cerebral MRI scans to help clinicians diagnose, monitor and evaluate treatment responses in patients with neurological conditions, such as Alzheimer’s disease and dementia, multiple sclerosis, epilepsy, stroke and Parkinson’s disease. Read Full Article on Mobi Health News >>
Is 911 outdated and in need of a behavioral health transformation?
July 3, 2023 / 911 / First Responders / Healthcare – With Emergency Triage, Treat and Transport, the U.S. Centers for Medicare and Medicaid Services covers emergency medical response providers transporting patients to an alternative facility, such as a primary care office or community mental health center. ET3 also covers emergency responders to initiate treatment in place with a qualified healthcare partner – either at the scene or through telehealth. Read Full Article on Healthcare IT News >>

// Business & Markets

AstraZeneca stock slides as pivotal lung cancer readout on Daiichi-partnered ADC spooks investors
July 3, 2023 / AstraZeneca / Daiichi Sankyo / Antibody-drug conjugates / Non-small cell lung cancer – AstraZeneca and Daiichi Sankyo’s attempt to repeat the success of Enhertu has delivered its first phase 3 data. The antibody-drug conjugate (ADC) improved progression-free survival (PFS) in lung cancer patients but, with the partners yet to share numbers and “some” patients suffering fatal adverse events, shares in AstraZeneca fell almost 6% in early trading in London. Read Full Article on Fierce Biotech >>
Pfizer pours $25M investment into Caribou’s cell therapies
July 6, 2023 / Caribou Biosciences / Pfizer / Cell & Gene Therapy / Allogenic Cell Therapy – Pfizer is backing Caribou Biosciences with a $25 million equity investment, money the genome editing company will pour into its allogeneic CAR-T cell therapy for multiple myeloma. Read Full Article on Fierce Biotech >>
Moderna strikes deal worth up to $1B to develop, produce mRNA drugs in China: reports
July 5, 2023 / Moderna / China / mRNA / Vaccine Development – Despite political tensions between Washington and Beijing, foreign pharmaceutical investments are progressing in China. Now, as the commerce minister of the world’s second largest economy signals the potential for new development opportunities for Western firms in the country, mRNA wunderkind Moderna is getting in on the action. Read Full Article on Fierce Pharma >>
Cortexa Makes First Drug Order for Australian Commercial Market
July 4, 2023 / Cortexa / Australia / PharmaAla / Commercial Use – PharmAla Biotech Holdings Inc., a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is pleased to announce that Cortexa, its Joint Venture with Australian company Vitura Health (ASX:VIT) has executed its first purchase order for PharmAla’s GMP LaNeo MDMA, in both finished capsule and raw API forms. Cortexa will also be ordering an amount of GMP Psilocybin API. Read Full Article on BioSpace >>
Thermo Fisher Scientific to Acquire CorEvitas
July 6, 2023 / Thermo Fisher / CorEvitas / Healthcare – Real-world evidence is the collection and use of patient health outcomes data gathered through routine clinical care. This is a high growth market segment as pharmaceutical and biotechnology customers, as well as regulating bodies, are increasingly looking to monitor and evaluate the safety of approved therapies and examine their effectiveness and value in the post approval setting. Read Full Article on Biospace >>

// Legal & Regulatory

A Startup Wins the First FDA Approval of a Cell Therapy for Type 1 Diabetes
July 2, 2023 / Startup / FDA Approval / Type 1 Diabetes / Insulin – Insulin independence is a goal of type 1 diabetes drug research and cell therapy holds promise to achieve it. Several biopharmaceutical companies have programs in various stages of development for the autoimmune disorder. Read Full Article on Med City News >>
Gilead, Teva prevail in high-stakes trial over HIV drug pay-for-delay claims
July 5, 2023 / Gilead Sciences / Teva Pharmaceuticals / Pay for Delay Deals / Antitrust / California Court – Gilead and Teva have chalked up an important legal victory in a California court, defeating allegations that they created an anticompetitive scheme to delay generic competition to lucrative HIV treatments. Read Full Article on Fierce Pharma >>
Roche pulls a Gavreto approval before Blueprint severance, citing unfeasible trial
July 5, 2023 / Roche / Gavreto / Accelerated Approval / Blueprint Medicines – After speaking with the FDA, Roche’s Genentech unit has decided to withdraw Gavreto for the treatment of advanced RET-mutant medullary thyroid cancer. Blueprint Medicines, the drug’s original developer, revealed the news in a securities filing Friday. Read on Fierce Pharma >>
FDA Rejects Amneal’s Extended-Release Parkinson’s Drug
July 5, 2023 / FDA Rejections / Parkinson’s Drugs – The FDA has denied Amneal Pharmaceuticals’ application for IPX203, its investigational extended-release carbidopa/levodopa capsules, which was being proposed as a treatment for Parkinson’s disease, the company announced Monday. Read on Biospace >>
Abbott Receives FDA Approval for World’s First Dual Chamber Leadless Pacemaker
July 5, 2023 / Abbott / FDA Approval / Leadless Pacemaker –Unlike traditional pacemakers, leadless devices are implanted directly into the heart through a minimally invasive procedure and eliminate the need for cardiac leads. As a result, leadless pacemakers reduce people’s exposure to potential lead and infection-related complications and offer a less restrictive and shorter recovery period post-implantation. Read on Hit Consultant >>

// Research & Development

J&J Plans Phase 3 Trial to Keep Pace in the Chase for Oral Psoriasis Drugs
July 5, 2023 / J&J / Clinical Study / Oral Drug / Janssen / Psoriasis Drugs – Plaque psoriasis is already treatable with injectable biologic drugs, including two from Johnson & Johnson. Drugmakers are making headway with alternatives that offer efficacy comparable to biologics, but in pill formulations. J&J has one such drug in its pipeline and it now has mid-stage data that are keeping it in the mix of companies aiming to treat psoriasis with pills. Read Full Article on MedCity News >>
Moderna, chasing GSK and Pfizer, brings RSV vaccine to regulators
July 5, 2023 / Moderna / GSK / Pfizer / RSV Vaccine / AstraZeneca / Sanofi – After decades of fruitless efforts to find a vaccine for RSV, the market may soon be brimming with options. Bavarian Nordic is also developing an inoculation for older adults. And Sanofi and AstraZeneca recently won the backing of an FDA advisory committee for a preventive medicine for infants. Read Full Article on Biopharma Dive >>
First pediatric study to test neutralizing antibodies against HIV shows promise
July 5, 2023 / Pediatric Study / HIV / Early Stages – Details of the trial, documented in a study published Wednesday in Science Translational Medicine, show that broadly neutralizing antibodies can boost the protective effects of antiretroviral drugs. This suggests that antibody drugs can be used as supplements or even as alternative treatments for HIV in children. Read Full Article on STAT News >>
Protagonist, J&J oral psoriasis drug falls short of injectables but gets close enough to spur phase 3
July 4, 2023 / Protagonist Therapeutics / J&J / Oral Drug Delivery / Psoriasis – Protagonist Therapeutics has shared a closer look at midphase data on its Johnson & Johnson-partnered oral peptide psoriasis drug candidate. The efficacy fell short of the high bar set by injectable treatments, but, with the candidate offering the convenience of oral delivery, a phase 3 program is planned. Read Full Article on Fierce Biotech >>
Palisade Bio Announces Completion of Enrollment in LB1148 Dose Optimization Study
July 5, 2023 / Palisade Bio / Dose Optimization / San Diego Biotech – Palisade Bio, Inc. (Nasdaq: PALI) (the “Company”), a biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, today announced the completion of patient enrollment in its dose optimization study of LB1148. Read Full Article on BioSpace >>

// Politics

Government AI regulators won’t survive political pressures, but there’s a better way
July 1, 2023 / AI / Government Regulators / FDA / CDC – The FDA, CDC and NIH started as non-political, scientific entities focused on research and ensuring that new drugs are safe and effective. Now, a massive transformation has taken place, and not for the better. Read Full Article on The Hill >>
Biden promised a ‘war on cancer’ — but declared war on the cure instead
July 6, 2023 / Biden / Cancer / Vaccines – When then-Vice President Biden launched the Cancer Moonshot in 2016, there was reason to be optimistic. Decades of rigorous science had transformed many cancers from a death sentence to a manageable chronic disease. New treatment advances — including gene and cell therapies and immunotherapies — were showing stunning results. With support from the biopharmaceutical industry and the help of smart government policies, ending cancer was, and is, an achievable goal. Read Full Article on STAT News >>
Everything the government thinks it knows about the opioid crisis is wrong
July 1, 2023 / Opioid Crisis / CDC – I offer a short review of information extracted from 15 years of research in published medical literature and mass media. It is time for the Attorney General’s staff to read and understand the science — and for Congress to require changes in U.S. public health policy to reflect science rather than the prevailing anti-opioid hysteria. Read Full Article on KevinMD.com >>
Bernie Sanders proposes price caps on drugs developed with federal funds
July 6, 2023 / Bernie Sanders / Bill Cassidy / Insulin / BARDA – After becoming chairman of the powerful Senate Health, Education, Labor and Pensions Committee earlier this year, Sen. Bernie Sanders, I-Vermont—a longtime opponent of Big Pharma—has become even more ubiquitous in his efforts to reduce drug prices. Read Full Article on Fierce Pharma >>
GOP voters want free-market policies for American biotech to beat China’s
July 4, 2023 / GOP Voters / Free-market Policies / China – Over the last few years, in the face of withering attacks from the left and increasing government controls on our health care system, Republicans have put less emphasis on the importance of a strong U.S. biotech sector. Read Full Article on Washington Times >>