// Biotech and Pharma Therapeutics

Pfizer’s Litfulo enters the scene in alopecia with adolescent nod to rival Lilly’s Olumiant
June 26, 2023 / Pfizer / Alopecia / FDA Approval / U.S. FDA – On the heels of Eli Lilly’s landmark approval last summer, Pfizer is stepping up to the plate in alopecia areata—and it’s coming equipped with an adolescent nod to put the pressure on Olumiant. Read Full Article on Fierce Pharma >>
Vertex and Lonza to Build Dedicated Manufacturing Facility for Type 1 Diabetes (T1D) Cell Therapies
June 26, 2023 / Vertex / Lonza / Type 1 Diabetes / Cell Therapies – Vertex Pharmaceuticals Incorporated today announced a strategic collaboration to support the manufacture of Vertex’s portfolio of investigational stem cell-derived, fully differentiated insulin-producing islet cell therapies for people with T1D, currently focusing on the VX-880 and VX-264 programs that are currently in clinical trials.
Read Full Article on Biospace >>
Gates Foundation, Wellcome Pledge $550M for Phase III Trial of GSK’s TB Vaccine
June 28, 2023 / Gates Foundation / GSK / Vaccines / Clinical Trials – For the first time in over a century, the world could potentially see a new tuberculosis vaccine. The Bill & Melinda Gates Foundation and Wellcome announced Wednesday that they will fund an international clinical trial of an experimental TB vaccine candidate developed by GSK involving 26,000 people in Africa and Southeast Asia. Read Full Article on BioSpace >>
On conference circuit, biotechs lobby for their identity as new IRA drug pricing reforms take hold
June 28, 2023 / Inflation Reduction Act / Drug Prices / Pricing / Legislation – The biotech industry split off into two conference camps in early June: Oncology researchers headed to Chicago for the American Society of Clinical Oncology (ASCO) meeting, while business development folks gathered in Boston for the BIO International Convention. But one theme loomed large over both events: the Inflation Reduction Act (IRA). Read Full Article on Fierce Biotech >>
FibroGen plans new round of cost cuts after latest study setback
June 26, 2023 / FibroGen / Cost Cuts / Setbacks / Lung Condition – Shares of biotechnology company FibroGen collapsed on Monday after the company reported its third clinical setback since early May, this time from a study testing one of its medicines in idiopathic pulmonary fibrosis. Read Full Article on Biopharma Dive >>

// 4th Industrial Revolution

ChatGPT Accurately Selects Breast Imaging Tests, Aids Decision-Making
June 26, 2023 / ChatGPT / Clinical Trials / Breast Cancer / Decision Making / AI – Researchers from Mass General Brigham have shown that ChatGPT and other large language models (LLMs) may be able to accurately identify appropriate imaging tests for certain clinical presentations, such as breast pain and breast cancer screening, and have the potential to support clinical decision-making. Read Full Article on Health It Analytics >>
UNC Health pilots generative AI chatbot
June 26, 2023 / UNC Health / AI / OpenAI – UNC Health, participating in Epic’s generative artificial intelligence program that utilizes Microsoft Azure, will begin rolling out its internal chatbot tool with a small group of clinicians and administrators. It plans to offer the tool more broadly later this year. Read Full Article on Healthcare IT News >>
Eko Health Launches AI-Enhanced Digital Stethoscope
June 27, 2023 / Eko Health / AI / New Tech – Engineered to enhance diagnostic accuracy and early disease detection, the CORE 500™ combines artificial intelligence (AI) software, high-fidelity audio experience, full-color display, and 3-lead electrocardiogram (ECG) to deliver an essential patient assessment tool for healthcare professionals (HCPs). Read Full Article on HIT Consultant >>
Augmedics raises $82.5 million to accelerate adoption of augmented reality spine surgery
June 27, 2023 / Augmedics / AI / Spinal Surgery / New Tech – Augmedics, a pioneer in augmented reality (AR) surgical navigation, today announced the successful close of an $82.5 million Series D financing. The round was led by Dallas-based CPMG and adds Evidity Health Capital as a syndicate partner, with participation from current investors H.I.G. Capital, Revival Healthcare Capital, Almeda Ventures and others. The news comes the same week the company marks its record 4,000th US patient treated with the xvision Spine System® which uses augmented reality to give surgeons “x-ray vision” during surgery. Read Full Article on BioSpace >>
How Automation Can Help Ease Healthcare Worker Burnout
June 28, 2023 / AI / Automation / Healthcare Workers / Mental Health – With rising staffing shortages and burnout among healthcare workers, digital transformation will be key to overcoming these challenges and protecting patient care. It’s estimated that the U.S. could see a shortage of up to 124,000 physicians by 2033 and will need to hire at least 200,000 nurses per year to meet increased demand and to replace retiring nurses. The healthcare worker burnout crisis in this country began before the COVID-19 pandemic, but the public health emergency made the situation even worse as frontline health workers risked their lives to service others. Read Full Article on Healthcare IT Today >>

// Business & Markets

Illumina plans layoffs, closure of San Diego facility in push to save $100M a year
June 28, 2023 / Illumina / San Diego Biotech / Layoffs – Layoffs began last week and additional workforce reductions are planned for this year, according to a regulatory filing. The layoffs will cost $25 million to $35 million but should save the company money in the long run. Read Full Article on Biopharma Dive >>
Activist investor NexPoint threatens to block Paratek’s $462M sale
June 28, 2023 / Paratek Pharmaceuticals / Gurnet / Novo Holdings / Activist Investor – Paratek Pharmaceuticals’ annual meeting is set for July 6, but fireworks are already exploding over the company’s attempt to sell out to investment firms Novo Holdings and Gurnet Point for $462 million. Read Full Article on Fierce Pharma >>
Thermo Fisher Cuts 88 Jobs in San Diego in Fourth Round of Layoffs This Year
June 20, 2023 / Thermo Fisher / San Diego Biotech / Layoffs – Two months after it announced plans to close three sites in San Diego, Thermo Fisher Scientific plans to cut 88 workers in the area, according to a Worker Adjustment and Retraining Notification (WARN) notice filed in California. Read Full Article on Biospace >>
MoonLake Looks to Raise $250M in Stock Offering on Heels of Mid-Stage Data
June 27, 2023 / MoonLake / Mid-Stage Data / Stock Offering – MoonLake’s Phase II results had investors excited, nearly doubling its stock price on Monday. The trial focused on its novel trivalent nanobody, sonelokimab (SLK), to treat hidradenitis suppurativa (HS), an autoinflammatory disease that affects hair follicles, causing painful lumps and abscesses, most often in areas where skin touches skin. Read Full Article on BioSpace >>
Blackstone injects $140M cash into Sutro Biopharma for Vaxcyte royalties
June 26, 2023 / Sutro Biopharma / Blackstone / Vaxcyte / Pfizer – Investor Blackstone Life Sciences is paying Sutro Biopharma $140 million cash and throwing in another potential $250 million in biobucks in exchange for royalties on possible future sales of Vaxcyte’s products. Read Full Article on Fierce Biotech >>

// Legal & Regulatory

FTC proposes updates to merger review that could slow healthcare dealmaking
June 28, 2023 / FTC / Merger / Healthcare Dealmaking / Mergers – Last year, the FTC and DOJ announced they were modernizing merger guidelines for finding and studying potentially anticompetitive deals, which the regulators argued needed review to function in a modern economy. In response, the American Hospital Association said guidelines don’t need “major revisions,” and that significant change could derail beneficial mergers that take years to put together. Read Full Article on Biopharma Dive >>
Eton Pharma hit with FDA rejection for methanol poison treatment as regulator flags manufacturing concerns
June 27, 2023 / AbbVie / BeiGene / Patent Lawsuit / BTK Inhibitors – AbbVie recently filed a patent infringement lawsuit against BeiGene over their blockbuster BTK franchises. Although the litigation was launched right after a patent’s issuance, AbbVie may actually have a case here, according to one expert. Read Full Article on Fierce Pharma >>
Pfizer’s hemophilia B gene therapy inches closer to regulatory approval
June 27, 2023 / Pfizer / Regulatory Approval / FDA – Pfizer is nearing an approval of what could be its first marketed gene therapy, now that the Food and Drug Administration has begun reviewing the company’s request to approve an experimental treatment for hemophilia B. Read on Biopharma Dive >>
Eton Pharma hit with FDA rejection for methanol poison treatment as regulator flags manufacturing concerns
June 28, 2023 / Eton Pharmaceuticals / Complete Response Letter / FDA / Manufacturing – Eton Pharmaceuticals’ dehydrated alcohol injection didn’t pass muster with the FDA, instead receiving a complete response letter (CRL) raising flags the company believes are “addressable.” Read on Fierce Pharma >>
Blackstone injects $140M cash into Sutro Biopharma for Vaxcyte royalties
June 26, 2023 / Sutro Biopharma / Blackstone / Vaxcyte / Pfizer –Investor Blackstone Life Sciences is paying Sutro Biopharma $140 million cash and throwing in another potential $250 million in biobucks in exchange for royalties on possible future sales of Vaxcyte’s products. Read on Fierce Biotech >>

// Research & Development

Lilly sets ‘high bar’ with new obesity drug data
June 27, 2023 / Eli Lilly / Obesity Drug / Injectable – Obesity drug development has quickly become one of the most competitive areas of biopharmaceutical research, with Lilly, Novo Nordisk and a group of would-be rivals racing for dominance of a market some analysts estimate to be worth more than $100 billion globally. Read Full Article on Biopharma Dive >>
Pfizer drops oral obesity drug after seeing liver safety concern, focuses on less-convenient candidate
June 26, 2023 / Pfizer / Obesity Drugs / Eli Lilly / Novo Nordisk – Pfizer is dropping one of its oral obesity drug candidates after seeing elevated liver enzymes in clinical trials. The setback leaves the Big Pharma’s near-term prospects resting on a candidate that is given twice as often as rival weight loss medicines in development at Eli Lilly and Novo Nordisk. Read Full Article on Fierce Biotech >>
Sanofi’s $1.1B eczema drug hits midphase goal, spurring talk of phase 3 and new indications
June 27, 2023 / Sanofi / Kymab / Atopic Dermatitis / Eczema – One of Sanofi’s priority assets has hit the primary endpoint in a phase 2b clinical trial. The candidate, which Sanofi snagged in its $1.1 billion Kymab buyout, improved outcomes in eczema patients, clearing the French drugmaker to push into phase 3 and boosting its prospects of targeting other diseases. Read Full Article on Fierce Biotech >>
Vertex’s diabetes cell therapy spurs insulin production in a half-dozen patients
June 26, 2023 / Vertex Pharmaceuticals / Type 1 Diabetes / Cell & Gene Therapy / ViaCyte – Vertex could be “leading the path to insulin independence,” according to analysts, after another batch of data showed that the off-the-shelf diabetes cell therapy stimulated insulin production in all evaluable patients, and that two were now insulin independent. Read Full Article on Fierce Biotech >>
Pfizer, citing safety concerns, scraps one of two obesity pill hopefuls
June 26, 2023 / Pfizer / Obesity Pill / Diabetes – Like many of its peers, Pfizer is investing heavily in drugs for obesity, having brought two similar medicines known as GLP-1 agonists into mid-stage testing. Read Full Article on Biopharma Dive >>

// Politics

After House panel’s push, govt opens doors for used diagnostic devices
June 24, 2023 / Governor Newsom / California / Settlement / Covid – Months after a parliamentary panel pointed to a shortage of medical equipment in semi-urban and rural India, the government has relaxed the rulebooks to allow import of refurbished devices to ensure access to affordable health care at the last mile. Read Full Article on Economic Times >>
Biotech leaders protest ‘actively harmful’ bans on gender-affirming care
June 27, 2023 / LGBTQ+ / Diversity / ESG / Nkarta – Not every person navigating a gender transition has a team of healthcare or biotech pros or even a family behind them. With bans on gender-affirming care spreading across the U.S.—now in 31 states—a group of biotech executives decided to bring the whole industry out in vocal support for the transgender community to resist efforts to ban care. Read Full Article on Fierce Biotech >>
Energy and Commerce Committee’s Frank Pallone calls on Republicans to help tackle US drug shortage fiasco
June 27, 2023 / Frank Pallone / Drug Shortage / Democrats / Republicans – As Congress prepares to reauthorize the Pandemic and All-Hazards Prevention Act (PAHPA) this year, the ranking member of the Democrats’ Energy and Commerce Committee, Frank Pallone Jr., D-New Jersey, is calling on House Republicans to tackle the national drug shortage crisis in the U.S. Read Full Article on Fierce Pharma >>
New York Signs Law To Protect State Providers Providing Abortion Drug Telemed Services to Out-of-State Patients
June 26, 2023 / New Laws / Abortion Drug / Telemed / New York – On Friday, New York Governor Kathy Hochul signed new legislation that will protect the state’s doctors, medical providers and facilitators who prescribe abortion care telehealth services to patients outside of New York from litigation in states where abortion services are banned or restricted. Read Full Article on Medcity News>>
Government proposes improved GMO regulations to encourage health research
June 27, 2023 / GMO Regulations / Health Research – The Government is seeking feedback on changes to regulations for genetically modified organisms (GMOs) that will foster research and improve health outcomes. Read Full Article on The National Tribune >>