// Biotech and Pharma Therapeutics

Atea rejects takeover bid from Concentra
May 30, 2023 / Atea / Concentra / Acquisitions – In March, the investment firm made a successful takeover bid for cancer drug developer Jounce Therapeutics, proposing a similarly structured deal that would give shareholders a portion of the proceeds if Concentra sells its assets. Read Full Article on Biopharma Dive >>
HeartBeam Forms Strategic Alliance with Samsung
May 30, 2023 / HeartBeam / Samsung / FDA / Alliance – HeartBeam, a pioneering cardiac technology company, has partnered with Samsung through a Strategic Alliance Agreement to explore collaboration opportunities in the assessment and monitoring of cardiac symptoms. HeartBeam brings its expertise and patented technology in 3D-vector electrocardiogram (VECG) platforms designed for at-home patient use, building upon the existing alliance between Samsung and LIVMOR. HeartBeam acquired LIVMOR’s assets, which include the FDA-cleared Halo™ Atrial Fibrillation (AF) Detection System, a prescription wearable that provides continuous cardiac rhythm monitoring. The collaboration aims to leverage medical-grade equipment and extend cardiovascular health monitoring capabilities to improve patient care and detection of AF. Read Full Article on HIT Consultant >>
Sun Pharma and Philogen enter into an Exclusive Distribution, License, and Supply Agreement for Commercializing specialty product, NIDLEGY™ in Europe, Australia and New Zealand
May 30, 2023 / Sun Pharma / Philogen / Nidlegy – Sun Pharmaceutical Industries Limited and Philogen S.p.A have entered into an exclusive licensing agreement for the commercialization of Nidlegy™, a specialty product developed by Philogen, in Europe, Australia, and New Zealand. Nidlegy™ is an anti-cancer biopharmaceutical currently in Phase III clinical trials, aiming to treat melanoma and non-melanoma skin cancers. Sun Pharma will have exclusive rights to commercialize Nidlegy™ for skin cancers in the designated territories, while Philogen will complete clinical trials, pursue regulatory approvals, and manufacture the product. The collaboration aligns with Sun Pharma’s goal of providing innovative solutions for patients and expanding its offerings in the field of onco-dermatology.
Read Full Article on BioSpace >>
Startup Eikon, led by Merck vets, buys drugs from three biotechs and banks another $106M
June 1, 2023 / Startup / Eikon / Merck – Its funding strategy is a sign of the times for startups. Venture capital firms have been selective about their investments during the sector’s downturn and, with IPOs difficult to pull off, keeping their portfolio companies private for longer. Read Full Article on Biopharma Dive >>
Theseus Pharmaceuticals to Participate in the 2023 Jefferies Healthcare Conference
May 31, 2023 / Theseus / Healthcare / Jefferies Healthcare Conference – Theseus is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients through the discovery, development, and commercialization of transformative targeted therapies. Theseus is working to outsmart cancer resistance by developing pan-variant tyrosine kinase inhibitors (TKIs) to target all classes of cancer-causing and resistance mutations that lead to clinically relevant variants in a particular protein in a given type of cancer. Theseus’ lead product candidate, THE-630, is a pan-variant KIT inhibitor for the treatment of patients with advanced gastrointestinal stromal tumors (GIST), whose cancer has developed resistance to earlier lines of kinase inhibitor therapy. Theseus is also developing THE-349, a fourth-generation, selective epidermal growth factor receptor (EGFR) inhibitor for C797X-mediated resistance to first- or later-line osimertinib treatment in patients with non-small cell lung cancer (NSCLC), and a pan-variant BCR-ABL inhibitor for the treatment of relapsed/refractory chronic myeloid leukemia (CML) and newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). Read Full Article on BioSpace >>

// 4th Industrial Revolution

ChatGPT Misses the Mark in Healthcare – What It Needs to Succeed
May 31, 2023 / ChatGBT / Healthcare / AI – The advent of OpenAI’s ChatGPT3 (GPT3) Artificial Intelligence (AI)-powered chatbot sparked an unprecedented societal appreciation for the power of AI. While AI has been broadly deployed across industries for a decade, it remained mostly hidden from the typical user. The release of GPT3 in late 2022 changed all of that. Read Full Article on Healthcare It Today >>
Primary care practices identify needed improvements for telemedicine
May 31, 2023 / Primary Care / Telemedicine / Virtual Healthcare – Qualitative data provided by 87 primary care practices in New York and Florida showed that while telehealth experiences differed on the basis of pre-pandemic clinician and practice familiarity with virtual care platforms, varying state regulations during the public health emergency, the lack of formal guidelines and physician burnout affected how quickly telemedicine offerings matured within practices. Read Full Article on Healthcare IT News >>
Retailers Are Making a Big Push Into Healthcare. Is Our Sector Ready?
May 30, 2023 / Healthcare / CVS Pharmacy / Walgreens / Amazon – The trend of brand-name retailers growing their presence in healthcare continues to build. In the past couple of years Amazon, CVS Health, and Walgreens have spent billions of dollars in acquisitions to stake their claim. From primary and specialty care to home health and retail health, these companies are betting on putting their years of experience creating innovative systems to work. Read Full Article on MedCity News >>
Tomorrow Health ends medical supply business
May 30, 2023 / Tomorrow Health / Medical Supply – Looking to grow its home-based care business platform, which manages home medical equipment orders, payment processing and delivery to patients, Tomorrow Health says it will close the books on its own home medical equipment “to remove barriers and unlock new opportunities” for its network. Read Full Article on Healthcare IT News >>
Why The Evolution of Tech Will be Based on APIs
May 31, 2023 / APIs / New Tech – Layoffs continue to ripple across the economy. Starting with big tech firms and the digital businesses that overhired during the early days of the pandemic, pink slips have now spread to the industrial, manufacturing and professional services industries.
Read Full Article on HIT Consultant >>

// Business & Markets

Carrum Health Closes $45M Series B to Scale Oncology & Acute Surgical Care
May 30, 2023 / Carrum Health / Oncology / Acute Surgical Care / OMERS Growth Equity – Utilizing a Centers of Excellence (COE) network, with an all-inclusive pricing model and a 30-day warranty on care, Carrum members receive surgical and cancer treatment guidance and coordination through the entire care journey with upfront pricing, ensuring the highest quality, most appropriate care. Carrum Health’s COE solution not only reduces unnecessary procedures by as much as 30%, leading to better patient outcomes, it can result in savings of up to 45% per care episode, according to a published study by the RAND Corporation. Read Full Article on HIT Consultant >>
Can Rain ride the storm out? Cancer biotech lays off 65% of workforce after phase 3 fail
May 30, 2023 / Layoffs / Failed Trials / Emerging Biopharma / Chief Medical Officer – Rain acquired the oral, small molecule inhibitor from Daiichi Sankyo in 2020 and built its pipeline around it, testing the therapy in an array of solid tumor indications. The biotech plans to walk away from the liposarcoma indication after last week’s fail. Read Full Article on Fierce Biotech >>
Defence Announces Additional and Final Exercises of Warrants for Gross Proceeds of Over $2.3 Million
May 30, 2023 / Defence Therapeutics / Immune-oncology / Vaccines – TAs final part of the Early Warrant Exercise Program, 1,846,900 common share purchase warrants (each a “Warrant”) issued by the Company on December 24, 2020 have been exercised at an exercise price of $1.25 per share for gross proceeds of $2,308,625, under the Early Warrant Exercise Program (the “Final Exercises”). The Final Exercises conclude the Early Warrant Exercise Program. Read Full Article on BioSpace >>
SPAC takes Anew path, pivoting from energy storage to merge with Alzheimer’s gene therapy biotech
May 30, 2023 / Cell & Gene Therapy / Neurodegenerative Diseases Alzheimer’s Disease – Anew Medical has found a way to fund development of its neurodegenerative disease gene therapies. By merging with a blank check company, the biotech plans to land a Nasdaq listing and $54 million in cash, provided investors don’t pull their money before the deal closes. Read Full Article on Fierce Biotech >>
Stealth BioTherapeutics Enters into Exclusive Licensing Agreement with Pharmanovia to Commercialize Elamipretide for the Treatment of Barth Syndrome in Europe and Key Global Territories
May 30, 2023 / Stealth BioTherapeutics / Barth Syndrome / Pharmanovia – Under the terms of the agreement, Pharmanovia receives exclusive rights to commercialize elamipretide for the treatment of Barth syndrome in the European Union and other European countries, the Middle East and Northern Africa. In exchange, Stealth BioTherapeutics will receive upfront and future development, regulatory, and commercial milestone payments, plus tiered royalties on net sales of elamipretide in the licensed territories.
Read Full Article on BioSpace >>

// Legal & Regulatory

Akebia says FDA will give its once-rejected anemia pill a second chance
May 30, 2023 / Akebia / FDA / Second Chance – Though the FDA had struck down vadadustat and another drug like it from FibroGen over safety concerns, it cleared a rival medicine from GSK for use in kidney disease patients on dialysis. Akebia appealed the FDA’s rejection of its medicine, and while that effort has now failed, the company sees an opportunity to bring vadadustat back to the FDA without running another trial. Read Full Article on Biopharma Dive >>
Biohaven sends latest drug to FDA, despite past trial setback
May 31, 2023 / Biohaven / Trial Setback / FDA – The current version of Biohaven was spun out following the company’s acquisition by Pfizer in a near-$12 billion deal last year. The pharmaceutical company was interested in Biohaven’s migraine treatments, and sent the rest of the biotech’s pipeline to the newly created spinout. Read Full Article on Biopharma Dive >>
FDA pauses PepGen’s plans to test muscle disease drug
May 31, 2023 / FDA / PapGen / Clinical Testing – PepGen said Tuesday the agency had placed a clinical hold on a planned Phase 1 trial for the treatment, which is being developed for an inherited muscle-wasting condition known as myotonic dystrophy type 1, or DM1. The FDA will detail the reasons for its decision in an official letter within 30 days, PepGen said. Read on Biopharma Dive >>
With court’s blessing, billionaire Sackler family awarded legal protections in Purdue’s $6B settlement
May 31, 2023 / Sackler Family / Legal Protections / Opioids / Oxycontin / Bankruptcy – The U.S. Court of Appeals reversed a prior lower court decision that took away protections for the family in the settlement. Now, the Sacklers can shield themselves from opioid-related lawsuits despite not filing for bankruptcy. Read on Fierce Pharma >>
Eikon Acquires Broad Development Pipeline, Raises $106M in Series C Funding
June 1, 2023 / Eikon / Broad Development Pipeline / Funding –Led by biopharma titan Roger Perlmutter, Eikon Therapeutics kicked off 2022 with a Series B financing worth $517.8 million. The Bay Area-based biotech made another splash Thursday, announcing a $106 million Series C raise and the acquisition of exclusive, global rights to several early- to mid-stage assets. Read on BioSpace >>

// Research & Development

AbbVie’s Rinvoq passes midstage test in systemic lupus erythematosus, heads into phase 3
May 31, 2023 / AbbVie / Rinvoq – AbbVie’s Rinvoq is delivering blockbuster sales and driving growth for the drugmaker after its January loss of exclusivity for top-selling Humira. Now, Rinvoq is taking a step toward another potential label expansion. Read Full Article on Fierce Pharma >>
Sanofi announces positive data for frexalimab in relapsing MS
May 31, 2023 / Sanofi / Frexalimab / Neurological Disease – Sanofi has reported positive new data from a mid-stage study of its investigational anti-CD40L antibody in patients with relapsing forms of multiple sclerosis (MS). Read Full Article on PharmaTimes >>
AstraZeneca’s Ultomiris approved in Japan for prevention of relapses in patients with NMOSD
May 30, 2023 / AstraZeneca / Ultomiris / NMOSD / Patient – AstraZeneca has announced that Ultomiris (ravulizumab) has been approved in Japan as a long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica. Read Full Article on PharmaTimes >>
Pfizer’s hemophilia drug hits in phase 3, giving it a chance to leapfrog Novo Nordisk
May 30, 2023 / Pfizer / Hemophilia / Clinical Trial Data / Novo Nordisk – Pfizer is looming large in Novo Nordisk’s rearview mirror. Weeks after seeing its rival for the hemophilia market stumble, Pfizer has reported phase 3 data that suggest its candidate is competitive and position it to file for approval in the coming months. Read Full Article on Fierce Biotech >>
Moderna Announces Phase 2 Data on mRNA-4157 (V940), an Investigational Individualized Neoantigen Therapy, to be Presented at the 2023 ASCO Annual Meeting
May 30, 2023 / Moderna / Phase 2 / Neoantigen Therapy – Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that two abstracts on mRNA-4157 (V940), an investigational mRNA individualized neoantigen therapy, have been accepted for presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held June 2-6 in Chicago, IL. mRNA-4157 (V940) is being jointly developed by Moderna and Merck, known as MSD outside of the United States and Canada. Read Full Article on BioSpace >>

// Politics

Biden Administration calls for feedback on AI safety, R&D
May 30, 2023 / Biden Administration / AI Safety / R&D – New initiatives launched by the White House include an updated strategic plan for artificial intelligence from the Office of Science and Technology Policy and a new RFI seeking input on mitigating AI risks. Read Full Article on Healthcare IT News >>
Sen. Elizabeth Warren probes abortion access amid states’ patchwork plans
May 30, 2023 / Senator Warren / Abortion / Patchwork Plans – Sen. Elizabeth Warren (D-Mass.) is launching a fresh round of questioning on states’ limits to abortion rights as a battle on medication abortion hangs in the balance at a federal court. Read Full Article on STAT News >>
Why one expert says America’s fentanyl crisis has geopolitical roots
May 29, 2023 / Fentanyl Crisis / Overdose – In 2022, nearly 110,000 Americans died from drug overdose, according to preliminary data from the CDC. That’s an average of about 300 people per day. As the opioid crisis escalates, the U.S. continues to grapple with solutions on how to combat it. One expert argues that this public health crisis also has geopolitical roots. That expert joins me now. Vanda Felbab-Brown is a senior fellow at the Brookings Institution. Read Full Article on NPR >>
It’s time to shine some light on drug prices
May 29, 2023 / Drug Prices – There has been much attention surrounding secrecy in politics, from federal nonprofit and corporate accounts that keep specific donors and expenses secret to the fact that the state legislature and executive office are not subject to the Freedom of Information Act. Read Full Article on Crain’s Detroit Business >>
Michigan lawmakers urge action on chemo drug shortage
May 28, 2023 / Michigan / Lawmakers / Chemo Drug Shortage – Michigan’s entire delegation in Congress came together this past week to urge the U.S. Food and Drug Administration to mitigate a shortage of chemotherapy drugs affecting Michigan hospitals and cancer patients, in part by permitting the temporary importation of alternate drugs. Read Full Article on The Detroit News >>