// Biotech and Pharma Therapeutics

Prothena raids pharmacy aisle for Alzheimer’s trial accelerant, teaming with Walgreens
April 13, 2023 / Alzheimer’s Disease / Prothena / Emerging Biopharma – Prothena has enlisted an ally to boost its pursuit of Biogen and Eisai in Alzheimer’s disease. Working with Walgreens, the biotech aims to accelerate enrollment in an early-phase clinical trial of a potential rival to Leqembi. Read Full Article on Fierce Biotech >>
Tiziana Life Sciences to Pursue Development of Intranasal Foralumab for the Treatment of Long COVID
April 13, 2023 / Tiziana / Covid-19 / Life Sciences – Tiziana Life Sciences Plc, a biotechnology company developing breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it plans to investigate intranasal foralumab for the treatment of Long COVID. Read Full Article on Biospace >>
RS BioTherapeutics Appoints Pharmaceutical Industry Veteran Dean Hart as Chief Executive Officer
April 10, 2023 / Cannabinoids / Dean Hart – Mr. Hart has 40 years of biopharmaceutical experience and has helped multiple well-known brands from pre-launch/early commercialization to achieving blockbuster status. Notable successes include Eisai Inc. where he created and built the U.S. sales force and successfully launched Eisai’s first product in the U.S., Aricept™, a blockbuster product for treating Alzheimer’s; and Takeda Pharmaceuticals North America where he led the sales force, sales operations, sales training, market access, pricing, and trade functions. Read Full Article on Biospace >>
AstraZeneca, Gilead get a new challenger as Pyramid deviates from TRK to bag antibody-drug conjugate
April 13, 2023 / Emerging Biopharma / Antibody-Drug Conjugates / Biotech Deals – Pyramid Biosciences’ current pipeline is built around the kinase TRK. But the biotech has now struck a deal that will take it down a new path, paying $20 million upfront and betting $1 billion in biobucks for the ex-greater China rights to a would-be challenger to Gilead’s antibody-drug conjugate (ADC) Trodelvy. Read Full Article on Fierce Biotech >>
Biogen, aiming for a better Alzheimer’s therapy, licenses a Denali program
April 13, 2023 / Biogen / Alzheimer’s / Denali program / Neuroscience – Neuroscience is widely considered one of the most difficult areas of drug development, in part because the blood-brain barrier can severely limit the effectiveness of certain therapies. Read Full Article on Biopharma Dive >>

// 4th Industrial Revolution

What Healthcare Organizations Should Know About Russian Hacking Gang KillNet
April 10, 2023 / Healthcare / Cybersecurity / Russia – Last week, the Health Sector Cybersecurity Coordination Center (HC3) issued a report letting healthcare organizations know that they are still being heavily targeted by KillNet, a Russian group of cybercriminals. Read Full Article on Medcity News >>
This biotech could one day make human eggs from scratch. But first, they’re trying to rethink IVF
April 8, 2023 / IVF / Women’s Health / Healthcare – Christian Kramme grew up in a big family, the youngest of seven kids raised in California’s Santa Clarita Valley. By the time he moved across the country to do a PhD in George Church’s lab at Harvard, his siblings were already trying to start families of their own. And some of them were struggling. So when Church, the legendary geneticist and cell engineer, asked Kramme what he wanted to work on, he decided to swing big; he wanted to make eggs. Human eggs. From scratch. Read Full Article on STAT News >>
How Digital Transformation is Moving Patient Care Forward and its Impact on Hospitals
April 10, 2023 / Digital Transformation / Patient Care / Healthcare – Digital transformation has become a popular buzzword, but it’s more complicated than just that. It’s the process of implementing emerging digital technologies to modify a company’s essential operations, processes, and services to ease the staff workload and enable the organization to withstand future challenges. Both aspects have become crucial since the beginning of the pandemic. Digital transformation is about more than just technology; it provides new ways to deliver value. Read Full Article on Healthcare IT Today >>
FDA & Cerner Enviza Collaborate to Develop AI Tools for Drug Safety
April 10, 2023 / FDA / Drug Safety / AI / New Tech – Cerner Enviza, an Oracle company, and FDA’s Sentinel Innovation Center are teaming up to develop AI tools to extract and assess clinical notes to better understand drug safety. Read Full Article on Hit Consultant >>
Google will let health care customers test its generative AI model, ramping up rivalry with GPT-4
April 13, 2023 / Google / Healthcare / AI / GPT-4 / Chat GBT – Accelerating medicine’s AI race, Google is releasing a version of its generative language model to health care customers who will begin testing its ability to perform specific tasks in medical and research settings, STAT has learned. Read Full Article on STAT >>

// Business & Markets

Novo boosts sales outlook on strong demand for obesity drug
April 13, 2023 / Novo / Obesity Drug – Novo is benefiting from higher demand for both Wegovy and Ozempic for their intended uses and off-label use of Ozempic for weight loss as well. The latter practice has become so commonplace that Jimmy Kimmel cracked a joke about it while hosting the Oscars last month. Read Full Article on Biopharma Dive >>
Biotech layoffs gather pace as industry downturn persists
April 10, 2023 / Biotech / Workforce – At least five dozen biotechnology companies have laid off employees so far this year in a sector-wide contraction that has reached large and small drugmakers alike. Read Full Article on Biopharma Dive >>
Alentis Therapeutics Lands $105M for Clinical Trials in Fibrosis and Cancer
April 13, 2023 / Clinical Trials / Fibrosis / Cancer / Alentis Therapeutics – Three months after Alentis Therapeutics’ lead program posted positive Phase 1 data, the biotech has raised cash to advance that program to mid-stage testing in fibrosis. The Series C financing will also support a cancer drug candidate ready to start human testing. Read Full Article on MedCity News >>
As FDA decision draws near, Sobi revamps RSV antibody deal with AstraZeneca, Sanofi
April 10, 2023 / RSV / AstraZeneca / Sanofi / Sobi – After an approval in Europe, AstraZeneca and Sanofi’s respiratory syncytial virus prevention antibody nirsevimab is on track for an FDA decision this year. Now, a third company wants to simplify its role with the pharma giants. Read Full Article on Fierce Pharma >>
Novo’s latest deal targets cell therapy for diabetes, obesity
April 12, 2023 / Novo / Diabetes / Obesity / Drugmakers – Novo, while historically not big on buyouts, has turned to acquisitions over the past couple years to expand its slate of technologies and research programs. In late 2021, it agreed to spend north of $3 billion on Dicerna Pharmaceuticals, a company specialized in so-called RNA interference. And in 2022, it picked up Forma Therapeutics in a $1 billion deal that provided an experimental drug for sickle cell disease in late-stage clinical testing. Read Full Article on Biopharma Dive>>

// Legal & Regulatory

Takeda hit with another pay-for-delay lawsuit, this time on gout drug Colcrys
April 12, 2023 / Takeda / Colcrys / Pay-for-delay / Antitrust – Takeda has already faced claims it used an illegal “pay-for-delay” deal to push back competition to constipation drug Amitiza. Now, a group of drug purchasers is going after the company, alleging illegal conduct on the gout medicine Colcrys. Read Full Article on Fierce Pharma >>
GSK throws counterpunch as ‘skinny’ label feud with Teva circles Supreme Court
April 13, 2023 / GSK / Teva Pharmaceutical / Coreg / Generic Drugs – In its “skinny label” legal saga with Teva, GSK has hit back following the U.S. solicitor general’s call for the Supreme Court to rehear the years-long case. Read Full Article on Fierce Pharma >>
Chasing Pfizer and Roche, Regenxbio benefits from FDA boost for DMD gene therapy
April 11, 2023 / REGENXBIO / Duchenne Muscular Dystrophy / Cell & Gene Therapy / Fast Track Designation – The FDA has boosted Regenxbio’s attempt to move five adeno-associated virus (AAV) drugs into pivotal trials or onto the market by 2025. The agency has given the company a fast-track designation that could accelerate its bid to muscle in on the Duchenne muscular dystrophy (DMD) sector. Read on Fierce Biotech >>
Moderna nabs a win in Arbutus patent case as appeals court upholds prior invalidation
April 12, 2023 / Arbutus Biopharma / Moderna Therapeutics / Patent Challenge – Back in 2018, Moderna challenged one of Arbutus’ lipid nanoparticle (LNP) technology patents at the U.S. Patent and Trademark office (PTO)’s Patent Trial and Appeal Board (PTAB). The patent, known as the ‘127 patent, was invalidated by the board the following year on the grounds that the company had already stated the invention in a prior patent (the ‘069 patent). Read on Fierce Pharma >>
AbbVie, J&J Pull Two Accelerated Approvals for Imbruvica
April 10, 2023 / AbbVie / Johnson & Johnson / Imbruvica / Drug Approvals – AbbVie and Johnson & Johnson will withdraw the accelerated approvals for Imbruvica (ibrutinib) in mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL), the companies announced Thursday. Read on BioSpace >>

// Research & Development

Sleep problems linked to fivefold rise in stroke risk, study says
April 5, 2023 / Sleep Problems / Stroke / Healthcare – Snoring, snorting, tossing and turning, napping for a long time during the day, waking up during the night, and sleeping too little or even too much all contribute to poor-quality sleep and may raise your risk for stroke, according to a new study. Read Full Article on CNN Health >>
Moderna’s Flu Shot Falls Short of Early Success Threshold
April 12, 2023 / Moderna / Flu Shot – An interim analysis of Moderna’s Phase III P302 study showed its investigational flu shot, mRNA-1010, fell short of the statistical threshold for early success due to what the company stated was a low number of infected participants. Read Full Article on Biospace >>
Trailing AstraZeneca and Merck, Junshi reports phase 3 ovarian cancer success for Lynparza rival

April 12, 2023 / Junshi Biosciences / PARP Inhibitor / Ovarian Cancer / Clinical Trial Daa – Junshi Biosciences has established its credentials as the next challenger for the increasingly congested Chinese PARP inhibitor market. A phase 3 trial of the candidate hit its primary endpoint, setting Junshi up to compete with products including AstraZeneca and Merck & Co.’s Lynparza for the ovarian cancer space. Read Full Article on Fierce Biotech >>
Chinook Therapeutics Pauses Kidney Disease Drug Trial Following Adverse Event Report
April 11, 2023 / Chinook Therapeutics / Kidney Disease / Drug Trial – The serious adverse event reported in the early-stage study resolved quickly, but Chinook Therapeutics said it is suspected to be related to its experimental primary hyperoxaluria therapy. Meanwhile, Human Immunology Biosciences is looking ahead to Phase 3 after its rare kidney disease drug posted positive mid-stage data. Read Full Article on Medcity News >>
Moderna cancer vaccine takes positive step
April 11, 2023 / Moderna / Cancer / Vaccines – Moderna has announced that mRNA-4157/V940 – its investigational cancer vaccine – in combination with Keytruda, Merck’s anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA). Read Full Article on Pharma Times >>

// Politics

White House moves to protect some abortion patients’ records
April 12, 2023 / White House / Abortion – The White House on Wednesday proposed a new federal rule to limit how law enforcement and state officials collect medical records if they investigate women who flee their home states to seek abortions elsewhere. Read Full Article on STAT News >>
Sanders plans to haul in insulin executives to testify in Senate
April 12, 2023 / Bernie Sanders / Insulin / U.S. Senate – Sen. Bernie Sanders plans to call the chief executives of the country’s largest insulin manufacturers to testify before his health committee, according to insulin maker Eli Lilly and two sources familiar with the plans. The move will keep the pressure on the companies over their prices despite the fact that they have said they plan to lower the list price of their older insulin products. Read Full Article on STAT News >>
Appeals court rules abortion drug can stay on market — but limits access
April 13, 2023 / Abortion Drug / New Drug / FDA / Drug Approval – An appellate court has blocked a ruling that would have suspended the approval of a decades-old abortion pill, but decided the medicine should only stay on the market with strict limitations. Read Full Article on Biopharma Dive >>
Next abortion battles may be among states with clashing laws
April 10, 2023 / Abortions / New Laws / Idaho – Abortion is banned in Idaho at all stages of pregnancy, but the governor on Wednesday signed another law making it illegal to provide help within the state’s boundaries to minors seeking an abortion without parental consent. Read Full Article on STAT News >>
Biotech fears ‘dangerous’ precedent as judge challenges FDA authorityApril 10, 2023 / FDA / Abortion Drug – Industry leaders warned that “any medicine is at risk” if a federal judge’s decision to overturn the approval of abortion drug mifepristone is upheld. Read Full Article on Biopharma Dive >>