// Biotech and Pharma Therapeutics

BMS publishes ‘modest’ multiple myeloma survival data on heir to Revlimid, Pomalyst
August 30, 2023 / Bristol Myers Squibb / Multiple Myeloma / Clinical Trial Data –
Bristol Myers Squibb has reported full phase 1 data on one of its successors to Revlimid and Pomalyst. An outside expert called the multiple myeloma survival data “modest,” but the potential for the therapy, mezigdomide, to find a place in combination therapies is spurring hopes heading into phase 3 readouts. Read Full Article on Fierce Biotech >>
Regional think tank planning medical liability conference in Amman
August 27, 2023 / Medical Liability / AMMAN – WAC’s president, Nasser Abu Rumman, a Jordanian lawyer, activist, and professor of law, said the rationale behind planning such an event is to set up a platform to unite global perspectives on medical liability. Read Full Article on Jordan News>>
AstraZeneca uses Farxiga’s versatility to guide pipeline work, exec says
August 28, 2023 / AstraZeneca / Farxiga / European Society of Cardiology / Heart Failure – With seven posters and nine presentations on Farxiga over the weekend at the European Society of Cardiology (ESC) scientific sessions in Amsterdam, AstraZeneca made it clear that it has lots to say about its SGLT2 inhibitor. Read Full Article on Fierce Pharma >>
Researchers behind AstraZeneca’s COVID shot reunite to prepare for future pathogens
August 30, 2023 / University of Oxford / CEPI / AstraZeneca / Covid-19 – Scientists at the University of Oxford are once again teaming up with the Coalition for Epidemic Preparedness Innovations (CEPI) as part of a new $80 million research pact focused on future pandemic prevention. Read Full Article on Fierce Biotech >>
ImmunoGen Announces Collaboration with Takeda to Develop and Commercialize ELAHERE® in Japan
August 28, 2023 / ImmunoGen / Takeda- ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced it has entered into an exclusive collaboration with Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) to develop and commercialize ELAHERE (mirvetuximab soravtansine-gynx) in Japan. Read Full Article on BioSpace >>

// 4th Industrial Revolution

Regard Launches Chatbot + Clinical Workflow LLM, Powered by OpenAI’s ChatGPT-4
August 30, 2023 / Chatbot / Clinical Workflow / ChatGPT – Investing in healthcare-focused Generative AI is crucial now, given its potential to revolutionize the entire healthcare ecosystem. While the industry is exploring impactful applications, innovative companies like Regard are leading the way in piloting new functionalities, testing cost and outcome impacts and sharing insights with the broader market, making this partnership and work cutting-edge. Read Full Article on Hit Consultant >>
Exploring AI’s Impact on Biotech Breakthroughs and International Funding
August 29, 2023 / AI / Biotech – In his opening speech, Dr. Wallace Lin, Secretary General of Taiwan Bio Industry Organization (Taiwan BIO), cited the recently released movie Oppenheimer as an example to underscore the collaborative endeavor that scientific progress truly is. He stressed the value of cross-industry participation and expressed hope that this forum would spark fresh insights and invigorate Taiwan’s biotech sector through enhanced financial support, communication, and collaboration. Read Full Article on Gene Online >>
Deep Learning Model Automates Severe Heart Valve Disease Detection
August 30, 2023 / Deep Learning / Cardiovascular / News Tech – Researchers at Yale School of Medicine have developed a deep learning (DL) approach that can accurately detect aortic stenosis by analyzing heart ultrasound scans, according to a study published last week in the European Heart Journal. Read Full Article on Health IT Analytics >>
ChatGPT scored 72% in clinical decision accuracy, MGB study shows
August 29, 2023 / ChatGPT / Clinical Decisions – Putting ChatGPT to the test to see if AI can work through an entire clinical encounter with a patient – recommending a diagnostic workup, deciding a course of action and making a final diagnosis – Mass General Brigham researchers have found the large language model to have “impressive accuracy” despite limitations, including possible hallucinations. Read Full Article on Healthcare IT News >>
Automation helps return time to patients, reduce clinician burnout
August 25, 2023 / Clinician Burnout / Healthcare – Automation and artificial intelligence have become crucial tools in transforming healthcare. Today, innovative use of AI helps ensure clinicians have more time to dedicate to their patients. Read Full Article on Healthcare IT News >>

// Business & Markets

Novo Nordisk swallows another obesity biotech, paying $16M upfront for its preclinical partner
August 30, 2023 / Novo Nordisk / Mergers & Acquisitions / Obesity / Obesity Drugs – Novo Nordisk is continuing to seek out obesity assets, paying 15 million euros ($16 million) to snap up Embark Biotech in its second weight loss takeover in quick succession. Read Full Article on Fierce Biotech >>
Epigenic joins wave of startups raising cash to edit the epigenome
August 30, 2023 / Epigenic / Epigenome / China / DNA – TNobel-prizing winning work on CRISPR gene editing has opened the doors to a raft of new companies that promise ever-greater precision. Read Full Article on Biopharma Dive >>
Novo Bolsters Obesity Pipeline with Potential $500M Embark Biotech Buy
August 30, 2023 / Novo Nordisk / Obesity / Pipeline – Novo Nordisk has again bought a weight-loss focused biotech, as the obesity market heats up. Announced Wednesday, the Danish pharma plans to buy Embark Biotech for $16.3 million up front with close to $500 million on the line in milestone payments—Novo’s second obesity-focused acquisition in three weeks. Read Full Article on Biospace >>
Johnson & Johnson’s spinoff of Kenvue provides $13.2B in potential M&A firepower
August 30, 2023 / Johnson & Johnson / M&A / Joe Wolk / Joaquin Duato – Last month, during a quarterly conference call—as Johnson & Johnson considered its future beyond the separation of its consumer health unit—Chief Financial Officer Joe Wolk described the company’s appetite for M&A as “voracious.” Read Full Article on Fierce Pharma >>
AI launches Nvidia’s earnings toward the stratosphere—and investors toward their calculators
August 35, 2023 / AI / Nvidia – Whichever AI segment you follow most closely, be it healthcare or any other, you had to pause to absorb this week’s financial report from Nvidia. Read Full Article on AI in Healthcare >>

// Legal & Regulatory

FDA grants Orphan Drug Designation to Faron’s bexmarilimab in AML
August 29, 2023 / FDA / Orphan Drug / Faron / Clinical Development – Faron Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its bexmarilimab for acute myeloid leukaemia (AML). Read on PharmaTimes >>
Opioid Settlement May Spur Cannabis as Potential New Pharmacy Revenue Stream
August 30, 2023 / Opioid / Settlement / Cannabis – The opioid crisis has profoundly impacted communities across the United States, prompting a $50 billion opioid settlement framework approved by a consortium of attorney generals and the US Justice Department.1 This landmark settlement holds pharmaceutical and health insurance companies accountable for their involvement in the opioid epidemic. Read Full Article on Pharmacy Times >>
Pfizer’s RSV vaccine receives EC approval to protect infants and older adults
August 25, 2023 / Pfizer / RSV Vaccine – Pfizer’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) to protect both infants and older adults against RSV-caused lower respiratory tract disease (LRTD). Read Full Article on Pharma Times >>
Bon Secours Mercy Health Sues Anthem Health Plans of Virginia for Unpaid Claims
August 28, 2023 / Mercy Health / Lawsuit / Anthem Health – Bon Secours Mercy Health Virginia (BSMH Virginia), a health system comprising 10 hospitals, filed a lawsuit Monday against insurer Anthem Health Plans of Virginia (Anthem) for unpaid and underpaid health claims. Anthem Health Plans of Virginia is a subsidiary of Elevance Health. Read on Med City News >>
Pfizer, BioNTech seek administrative review of 2 Moderna patents at heart of mRNA vaccine litigation
August 29, 2023 / Pfizer / BioNTech / Moderna / Comirnaty –As Moderna’s COVID vaccine patent lawsuits wind their way through courts around the globe, Pfizer and BioNTech contend their rival is trying to monopolize the entire mRNA field. Read on Fierce Pharma >>

// Research & Development

Bayer Pushes Ahead With Parkinson’s Cell Therapy on Heels of Positive Phase 1 Data
August 28, 2023 / Bayer / Parkinson’s / Cell Therapy / Phase 1 – Standard Parkinson’s disease treatment continues to be old drugs that get nerve cells to make dopamine, a brain chemical whose deficiency drives the central nervous system disorder. Bayer is taking a novel approach: a cell therapy that replaces dopamine production. Read Full Article on Med City News >>
FibroGen Continues Losing Streak with Phase III DMD Failure
August 30, 2023 / FibroGen / Phase III / DMD Failure – FibroGen announced Tuesday that its investigational antibody fell short of its primary efficacy endpoint in the Phase III LELANTOS-2 trial in Duchenne muscular dystrophy. Read Full Article on Biospace >>
New MD Anderson Research Uncovers Drug Combo That Could Eliminate Pancreatic Cancer Tumors
August 27, 2023 / MD Anderson / Cancer Tumors – Researchers at the University of Texas MD Anderson Cancer Center published two studies this week on a new approach that could improve treatment for patients with pancreatic cancer — a disease that an estimated 64,050 U.S. adults will be diagnosed with in 2023. Read Full Article on Med City News >>
Neumora, with Arch and Amgen in its corner, files for IPO to fund late-phase depression clinical trials
August 28, 2023 / Neumora Therapeutics / ARCH Venture Partners / Amgen / Emerging Biopharma – The long-frozen biotech IPO waters may be thawing slightly—provided you’re one part of a rare breed of biotech. Shortly after RayzeBio filed to go public, Neumora Therapeutics, another well-financed, late-phase business, made its pitch for funding to study treatments for brain diseases including depression. Read Full Article on Fierce Biotech >>
Allucent to expedite Covid-19 booster vaccines development
August 29, 2023 / Allucent / Covid-19 / Vaccine Development – Allucent has received a contract from the Biomedical Advanced Research and Development Authority (BARDA) to expedite clinical research and development of next-generation booster vaccines for Covid-19. Read Full Article on Pharmaceutical Business Review >>

// Politics

Biden administration announces 1st drugs subject to Medicare price negotiations: List
August 29, 2023 / Biden Administration / Medicare / Diabetes – The Biden administration unveiled Tuesday the names of the first 10 drugs subject to price negotiations in Medicare, including blood thinners and diabetes medications. Read Full Article on ABC 7 >>
The Inflation Reduction Act’s Impact on Drug Development for Rare Diseases
August 30, 2023 / Inflation Reduction Act / Drug Development / Medicare – The Inflation Reduction Act was created and passed to reduce patient and government burden in paying for expensive drugs. While the new legislation is intended to provide Medicare patients with better access to the treatments they need, certain provisions have the effect of penalizing research and driving companies away from developing specific types of drugs—in particular, potential treatments for rare diseases. Read Full Article on Med City News >>
West Virginia can restrict abortion pill sales, judge rules
August 28, 2023 / West Virginia / Abortion Pill – U.S. District Court Judge Robert C. Chambers determined Thursday that the near-total abortion ban signed by Republican Gov. Jim Justice in September 2022 takes precedence over approvals from the U.S. Food and Drug Administration. Read Full Article on Review Online >>
Mass. Sen. Warren calls on FDA to close loopholes keeping generics off the market
August 29, 2023 / FDA / Senator Warren / Loopholes – Big Pharma is exploiting loopholes that keep generic drugs off the market, a move that drives up costs for consumers, allowing the companies to maximize their profits, two Capitol Hill Democrat argued Tuesday, as they called on federal regulators to close them. Read Full Article on Mass Live >>
Delegation from U.S. Department of Health and Human Services, U.S. Food and Drug Administration, and Local Government Officials Visit Amneal Manufacturing Site in India
August 29, 2023 / FDA / India – Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that a delegation of senior members of the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) together with local government officials recently visited the Company’s manufacturing facility in Matoda, India. The visit followed the G20 Health Ministers’ meeting in Gandhinagar, India on August 18 and 19, where health ministers from around the world met to discuss global health issues. Read Full Article on Business Wire >>