// Biotech and Pharma Therapeutics
Lilly’s Innovative Approach in the Pursuit of Pain Relief
June 5, 2023 / Eli Lilly / Pain Relief / Chronic Pain
Eli Lilly is venturing into the realm of pain therapeutics, an area that many big pharmaceutical companies have abandoned in favor of more challenging conditions. With a significant percentage of Americans suffering from chronic pain, Lilly aims to reinvigorate research in this field. Despite the complexities and high safety thresholds associated with pain medication trials, Lilly has developed a master pain protocol to streamline the process. This protocol allows for the seamless transfer of patients between trials or drugs, making the overall operation more efficient. By overlapping the three major pain syndromes—osteoarthritis, back pain, and neuropathic pain—Lilly can test new drug candidates across multiple indications simultaneously. Additionally, Lilly’s expertise in genetic medicine may contribute to their pain portfolio by employing targeting mechanisms, such as small interfering RNA, to deliver genetic medicines to specific neural tissues. Although swimming against the tide, Lilly remains committed to developing innovative pain therapies.
Eisai Faces Ransomware Attack and Launches Investigation Amid Data Leak Concerns
Jun 6, 2023 / Eisai / Ransomeware Attack / Data Leak / Cybersecurity
Eisai, a Japanese pharmaceutical company, experienced a cyberattack that has prompted an investigation into potential data leaks. The company has established a task force and is collaborating with external experts and law enforcement officials to respond to the incident. Eisai has temporarily taken some of its computer systems offline, while its corporate websites and email systems remain operational. The impact on the company’s earnings is being carefully examined, and revisions to the earnings forecast will be announced if necessary. This attack adds to the growing number of cyberattacks targeting pharmaceutical companies globally, highlighting the need for heightened cybersecurity measures in the industry.
Breast Cancer Canada Commits $3 Million to Precision Prevention Progress Project at Princess Margaret Cancer Centre
June 5, 2023 / Breast Cancer / Princess Margaret Cancer Center / Canada
Breast Cancer Canada has announced a significant three-year funding of $3 million for the Precision Prevention Progress Project at Princess Margaret Cancer Centre, University Health Network. The project aims to advance molecular breast cancer prevention research, with a focus on improving early detection, screening, treatment, and future prevention strategies for breast cancer patients. Led by Dr. Rama Khokha, a renowned expert in molecular cancer prevention, the research team will work towards identifying new risk factors and developing innovative screening methods to detect breast cancer at an early stage. This funding will not only propel breast cancer prevention research but also inspire the next generation of scientists in Canada.
Upstream Bio Secures $200M Funding to Advance Asthma and Allergy Pipeline
June 8, 2023 / Upsteam Bio / Asthma / Allergy / Funding
Massachusetts-based biotech company Upstream Bio has successfully closed a Series B funding round, raising $200 million to advance its investigational antibody UPB-101 in mid-stage studies for asthma and chronic rhinosinusitis with nasal polyps. The funding will support Phase II trials, translational and manufacturing activities, and device development efforts, ultimately facilitating the progression of the drug to Phase III development. UPB-101 targets the thymic stromal lymphopoietin (TSLP), an upstream player in the body’s inflammatory signaling cascade. With promising preclinical data and a focus on targeting key upstream players, Upstream Bio has garnered attention and recognition as a top life sciences startup.
Astellas Partners with Kate Therapeutics for Novel Gene Therapy in Muscle Disorder After Previous Trial Setbacks
June 8, 2023 / Astellas / Kate Therapeutics / Gene Therapy / Clinical Trials
Astellas Pharma has announced a licensing agreement with Kate Therapeutics to develop a novel gene therapy for X-linked myotubular myopathy (XLMTM), a debilitating muscle disorder. This partnership comes after safety concerns and patient deaths during clinical trials of Astellas’ previous treatment for the same condition. The collaboration aims to utilize lower doses of viral vectors to minimize adverse events and enhance safety. Kate’s KT430 gene therapy, utilizing a unique MyoAAV capsid, seeks to address XLMTM’s severe muscle weakness, respiratory failure, and premature mortality. The deal includes upfront payment, milestone payments, and royalties for Kate, while Astellas gains an exclusive license for KT430’s development and commercialization. The partnership showcases Astellas’ commitment to improving the lives of patients affected by XLMTM and validates Kate’s potential in developing innovative therapies.
// 4th Industrial Revolution
Bayer Launches Precision Health Unit to Revolutionize Personalized Healthcare
June 2, 2023 / Bayer / Precision Health Unit / Healthcare
Bayer’s Consumer Health Division has unveiled its Precision Health business unit, dedicated to developing innovative products across various everyday health categories. With a focus on empowering individuals to take charge of their personal health, the unit aims to leverage digital solutions, personal insights, and novel delivery methods. By addressing unmet needs and offering evidence-based precision health products, Bayer aims to provide comprehensive self-care solutions while expanding its global reach. The unit will collaborate with startups and digital health providers and enhance Bayer’s existing digital capabilities to drive advancements in personalized healthcare.
Apple Unveils watchOS 10 with Enhanced Mental Health and Vision Health Features
June 3, 2023 / Apple / Mental Health / Vision Health / Innovation
At the Worldwide Developers Conference 2023, Apple introduced watchOS 10, the latest update for its wearable device. This update brings new features focusing on mental health, vision health, and fitness. Users can now log their emotions and daily moods using the Mindfulness app, while the Health app offers commonly used depression and anxiety assessments. In addition, watchOS 10 includes fitness enhancements for cycling, such as workout reminders and fall detection. The update also emphasizes vision health by allowing users to track their time spent outdoors, which can impact physical and mental well-being. Furthermore, Apple announced updates to iOS17 and iPadOS17, introducing an improved Health app that identifies lifestyle factors affecting mental state. The tech giant also unveiled the Apple Vision Pro and visionOS platform, an augmented reality headset system with advanced features.
Bayer Collaborates with Biotech Powering Pfizer’s COVID-19 Vaccine to Access Gene Editing Delivery Technology
June 7, 2023 / Bayer / Acuitas Therapeutics / Pfizer / Covid-19 / Vaccine / Gene Editing
Bayer has entered into a partnership with Acuitas Therapeutics, the biotech behind the delivery technology used in Pfizer’s COVID-19 vaccine and Alnylam’s Onpattro, to utilize their lipid nanoparticle (LNP) delivery technology for in vivo gene editing candidates targeting the liver. This collaboration expands Bayer’s gene therapy efforts, which were initiated through the acquisition of AskBio in 2020. The agreement with Acuitas provides Bayer and AskBio with access to clinically-validated LNP technology, enabling the efficient delivery of gene editing RNA components to the liver. Acuitas’ expertise in LNP technology was demonstrated during the COVID-19 pandemic, making them a valuable partner for Bayer’s advancements in cell and gene therapies.
Futurists Predict Widespread Adoption of Digital Twins in Healthcare within a Decade
June 3, 2023 / Digital twins / Healthcare / TATA Consultancy Services
According to a survey conducted by TATA Consultancy Services (TCS) among futurists and industry experts, digital twins are expected to revolutionize various sectors, including healthcare, by 2035. The survey reveals that the respondents anticipate broad adoption of digital twins in healthcare within the next six years, with 52% believing it will happen in the next three years specifically in life sciences and healthcare. However, the creation of full digital twins of human bodies is considered the most challenging aspect and may take 10 years or more to become commonplace. Digital twins have the potential to enhance precision care and provide insights for decision-making in healthcare, leading to holistic patient care.
Enhanced AI Model Improves Protein Localization Predictions for Cell Functioning
June 6, 2023 / AI / Cell Functioning / Research
Researchers from the University of Missouri have upgraded their AI model, MULocDeep, to enhance its ability to predict protein location within cells of animals, humans, and plants. Accurately identifying protein localization is crucial in understanding various biological processes and disease mechanisms. By leveraging AI, researchers can gain insights into abnormal protein activity associated with conditions like metabolic disorders, cancer, and neurological disorders. The improved model aims to support the development of targeted treatments and drugs by enabling precise protein localization and enhancing our understanding of cellular functions.
// Business & Markets
Novo Nordisk Set to Acquire French Device-Maker Biocorp for $165M to Advance Connected Devices
June 5, 2023 / Novo Nordisk / Medical Devices / Drug Delivery / Acquisition
Novo Nordisk, a leading pharmaceutical company, is in discussions to acquire Biocorp, a French device-maker, for $165 million. The acquisition aims to bolster Novo Nordisk’s efforts in developing new connected devices and drug delivery solutions for individuals with chronic diseases. Biocorp specializes in connected devices such as smart caps for inhalers and pen injectors. The acquisition will provide Novo Nordisk with full ownership of Biocorp’s smart pen technology, enabling the company to enhance treatment options for patients with diabetes and potentially expand into other disease areas. The transaction is expected to be completed in the third quarter of 2023.
Novo Holdings and Gurnet Point Collaborate to Acquire Antibiotics Maker Paratek for $462M
June 6, 2023 / Novo Holdings / Gurnet Point / Collaboration / Paratek
Novo Holdings and Gurnet Point have joined forces to acquire Paratek Pharma, an antibiotics manufacturer, in a biopharma M&A deal worth approximately $462 million. The investment firms will purchase all outstanding shares of Paratek, offering $2.15 in cash per share and a contingent value right (CVR) of $0.85 per share tied to the achievement of $320 million in U.S. sales for Paratek’s flagship drug, Nuzyra. The acquisition aims to leverage Paratek’s expertise in combating antimicrobial resistance and accelerate the commercialization of Nuzyra, which treats community-acquired bacterial pneumonia and certain skin infections. The deal is expected to close in the third quarter of this year.
RegenLab USA LLC Partners with Long Island University and Dassault Systèmes to Advance Regenerative Medicine Research
June 7, 2023 / RegenLab / Collaboration / Regenerative Medicine
RegenLab, a Swiss medical technology company, has announced a collaboration agreement with Long Island University (LIU) and the Dassault Systèmes Group to establish an industrial innovation accelerator, the FabLab, dedicated to regenerative medicine and tissue engineering. The collaboration will leverage LIU’s scientific knowledge, RegenLab’s medical expertise, and Dassault Systèmes’ artificial intelligence capabilities to accelerate the development of industrial innovations in regenerative medicine. The FabLab will focus on conducting biocompatibility assessments, developing implantable processes and biomaterials using 3D printing and electrospinning, and promoting teaching and research in regenerative medicine. Additionally, an education program, including a Master of Engineering in Regenerative Medicine, will be established to foster scientific knowledge and application in this field.
Paratek Pharmaceuticals Agrees to Take-Private Buyout Amid Cash Shortage
June 6, 2023 / Paratek Pharmaceuticals / Buyout
Paratek Pharmaceuticals, a biotechnology company struggling to effectively market its antibiotic Nuzyra, has entered into a take-private agreement with life sciences investment firms Gurnet Point Capital and Novo Holdings. The deal involves an upfront payment of $2.15 per share, totaling approximately $123 million, along with the assumption of all of Paratek’s debt. Additional payments may be made if the net U.S. sales of Nuzyra surpass $320 million by the end of 2026. The buyout aims to provide Paratek with the necessary capital and resources to accelerate the commercialization of Nuzyra, which has faced challenges in a competitive market. The acquisition underscores the ongoing struggles faced by small biotech companies in developing and marketing new antibiotics.
Forward Pharma A/S Implements Ratio Change for American Depositary Shares
June 7, 2023 / Forward Pharma / American Depositary Shares
Forward Pharma A/S has announced a modification in the ratio of its American Depositary Shares (ADSs) to ordinary shares. The Board of Directors approved a change from 14 ordinary shares per ADS to 4000 ordinary shares per ADS. This adjustment is equivalent to a 1-for-285.714 reverse stock split of the ADSs. The change in ratio will not affect the total number of ordinary shares in the ADS program, the market value of the ADSs, or the company’s market capitalization. The new ratio will take effect on June 8, 2023, and no fractional ADSs will be issued, with holders receiving a cash payment instead.
// Legal & Regulatory
Patent Lawsuits Target Moderna and Pfizer Over COVID Vaccines
June 7, 2023 / Moderna / Pfizer / Patent / Lawsuits / Vaccines
New York-based Promosome has filed separate lawsuits against Moderna and Pfizer, alleging patent infringement related to mRNA technology used in their COVID-19 vaccines. Promosome claims to have discovered a method in 2009 for increasing protein expression by modifying mRNA without altering the amino acid sequence. The company holds an exclusive license for the patented technology. Promosome contends that both Moderna and Pfizer/BioNTech utilized their method to develop their COVID-19 vaccines without obtaining the necessary licenses. As a result, Promosome is seeking compensation, including a reasonable royalty, from the revenues generated by the vaccines. These lawsuits are the latest in a series of patent disputes within the pharmaceutical industry over COVID-19 vaccines.
FDA Staff Show Support for AstraZeneca and Sanofi’s RSV Drug, nirsevimab, for Infant Protection
June 6, 2023 / AstraZeneca / Sanofi / RSV
FDA staff members are displaying favorable sentiments towards the approval of nirsevimab, an antibody drug developed by AstraZeneca and Sanofi, designed to safeguard infants against respiratory syncytial virus (RSV) infections. Briefing documents revealed that the FDA staff acknowledged the safety and efficacy data provided by the pharmaceutical companies, without raising any significant concerns regarding the clinical trial results. RSV is a prominent cause of hospitalization in young children, resulting in severe respiratory infections that can be life-threatening. The existing preventive drug, palivizumab, has limitations in terms of eligibility and administration. The FDA advisers will vote on whether to recommend the approval of nirsevimab for use in infants during their first RSV season and up to 24 months of age. The FDA is anticipated to make a decision by the third quarter.
Amgen Seeks Mid-December Closing for Horizon Therapeutics Acquisition Amid FTC Lawsuit
June 5, 2023 / Amgen / Horizon Therapeutics / FTC Lawsuit
Amgen’s acquisition of Horizon Therapeutics, which was initially expected to close in the first half of 2023, has faced delays due to a lawsuit filed by the Federal Trade Commission (FTC). The court scheduling has now set a target of mid-December for the deal’s completion, subject to the court denying the FTC’s request for a preliminary injunction. The temporary restraining order has been extended until October 31, allowing the parties to present their arguments at an upcoming evidentiary hearing starting in September. Despite the litigation, Amgen remains optimistic about the potential of the acquisition to benefit patients with rare diseases.
FDA Rejects Clovis’ Bid for Approval of Rubraca as First-Line Ovarian Cancer Treatment
June 5, 2023 / FDA / Clovis / Approval / Women’s Health / Cancer
Clovis Oncology’s hopes for gaining approval of its cancer drug Rubraca have been dashed as the FDA issued a complete response letter, rejecting the company’s application for the PARP inhibitor as a first-line maintenance treatment for ovarian cancer patients. The FDA cited the need for survival data from a phase 3 study before considering the approval. However, the survival data won’t be available until 2024, leaving Clovis in a precarious position as it filed for bankruptcy six months ago. With Rubraca as its sole commercial asset, the rejection further complicates the company’s chances of survival.
FDA Sets Advisory Meeting Date for Brainstorm’s NurOwn ALS Cell Therapy
June 6, 2023 / FDA / ALS Cell Therapy / NurOwn
The Food and Drug Administration (FDA) has scheduled an advisory committee meeting on September 27 to evaluate the approval application for NurOwn, an experimental ALS (amyotrophic lateral sclerosis) treatment developed by Brainstorm Cell Therapeutics. The meeting will provide an opportunity for representatives from Brainstorm and the FDA to present their cases to an external group of experts who advise the agency on cell, tissue, and gene therapies. NurOwn, made from stem cells derived from a patient’s bone marrow, aims to slow or halt the progression of neurodegenerative diseases by implanting engineered cells that secrete protective and growth-promoting molecules back into the patient. Brainstorm has faced challenges in securing FDA approval, but remains confident in the therapy’s potential. The FDA is expected to announce its approval verdict by December 8.
// Research & Development
Enhertu, AstraZeneca and Daiichi’s Drug, Shows Potential as a Broad-Spectrum Cancer Treatment
June 5, 2023 / AstraZeneca / Daiichi Drug Shows / Enhertu / ASCO
Clinical trial data presented at the American Society of Clinical Oncology’s annual meeting revealed promising results for Enhertu, a drug jointly marketed by AstraZeneca and Daiichi Sankyo. Originally approved for certain breast, gastric, and lung cancers, Enhertu’s Phase 2 study showcased its potential to treat a wider range of tumor types across various parts of the body. The drug targets HER2-expressing tumors, a protein found in different tumor types lacking FDA-approved therapies. In the study, Enhertu demonstrated an objective response rate of 37.1% and a median duration of response of 11.8 months. While the trial is ongoing, these findings suggest that Enhertu could become a new treatment option for HER2-positive or HER2-expressing cancers, addressing an unmet need in cancer care.
CDC Report Reveals 8.2% of American Adults Not Taking Prescribed Medications Due to Cost
June 5, 2023 / CDC / Patients / Drug Cost
A recent report from the Centers for Disease Control and Prevention (CDC) highlights that approximately 8.2% of American adults aged 18 to 64 who take prescription medications did not adhere to their prescribed regimen due to financial constraints. Skipping doses, taking reduced doses, and delaying prescription fills as cost-saving strategies can lead to worsened health conditions, more serious illnesses, and the need for costly additional treatments. The report, based on data from the 2021 National Health Interview Survey, also reveals disparities based on gender, race, income, insurance coverage, and health status. Addressing medication affordability is crucial to ensuring proper medication adherence and improving overall health outcomes.
AstraZeneca’s Imfinzi-Lynparza Combination Shows Promising Results in Phase III Ovarian Cancer Study at ASCO
June 5, 2023 / AstraZeneca / Women’s Health / Ovarian Cancer / ASCO
Interim data presented at the American Society of Clinical Oncology (ASCO) annual meeting reveals that the addition of AstraZeneca’s Imfinzi (durvalumab) and Lynparza (olaparib) to the treatment regimen for advanced ovarian cancer patients without BRCA mutations extended progression-free survival by five months. The Phase III DUO-O trial demonstrated that the combination of Imfinzi and Lynparza, when added to standard chemotherapy, reduced the risk of disease progression or death by 37% in newly diagnosed patients. The results offer hope for improved outcomes in a challenging disease characterized by late-stage diagnoses and recurrence. Further research is necessary to determine the specific role of durvalumab in frontline ovarian cancer therapy.
Hoth Therapeutics Reports Positive Preclinical Results for HT-ALZ Alzheimer’s Disease Treatment
June 6, 2023 / Hoth Therapeutics / Preclinical Results / Alzheimer’s Disease
Hoth Therapeutics has announced encouraging preclinical results for HT-ALZ, a therapeutic under development for Alzheimer’s disease. The study showed promising outcomes, particularly with a higher dosage, in a spatial memory test conducted at Washington University in St Louis. Hoth has completed behavioral assessments and will now analyze brain samples to measure plaque load and beta amyloid levels. Alzheimer’s disease is a neurodegenerative condition characterized by the accumulation of amyloid β (Aβ) plaques and Tau protein tangles in the brain. These findings suggest that HT-ALZ may reduce Aβ concentration, offering potential benefits in Alzheimer’s treatment. Hoth Therapeutics is committed to advancing innovative therapies to improve the lives of patients.
Biogen Halts Phase III Parkinson’s Study to Expedite Earlier Data Analysis
June 6, 2023 / Biogen / Phase 3 / Parkinson’s
Biogen has announced the termination of its Phase III LIGHTHOUSE study, evaluating the Denali-partnered small molecule inhibitor BIIB122 for Parkinson’s disease. The decision was made due to the study’s complexity and long timeline. Instead, Biogen will focus on the Phase IIb LUMA study, which will be adjusted to include patients carrying LRRK2 mutations. The move allows Biogen to obtain timely efficacy data for early-stage Parkinson’s while generating clinical data in patients with and without LRRK2 mutations. The decision to terminate LIGHTHOUSE does not stem from safety or efficacy findings. This change is part of Biogen’s broader pipeline reprioritization initiative, including a shift away from its multiple sclerosis business.
Merck Challenges Drug Pricing Law in Lawsuit Against Biden Administration
June 6, 2023 / Biden Administration / Lawsuit / Drug Pricing / Merck
Pharmaceutical giant Merck & Co. has filed a lawsuit against the Biden administration, challenging the constitutionality of the Inflation Reduction Act aimed at drug price negotiation. Merck argues that the program, which requires biopharma companies to negotiate drug prices below market value for Medicare coverage, violates the First and Fifth Amendments. The company claims that the law infringes on free speech and fails to provide just compensation for the use of private property. Merck seeks an injunction against the requirement and is prepared to take the case to the U.S. Supreme Court if necessary. The Inflation Reduction Act, signed into law by President Biden, aims to reduce drug costs by $25 billion annually over eight years. This lawsuit reflects concerns within the industry about potential financial losses and their impact on future drug development.
Governor Newsom Mobilizes CHP and National Guard to Address San Francisco’s Fentanyl Crisis
June 6, 2023 / California / Gavin Newsom / Fentanyl Crisis / San Francisco
Governor Gavin Newsom has directed the California Highway Patrol (CHP) and the California National Guard (CalGuard) to assist San Francisco in combating the fentanyl crisis. Fentanyl, a potent synthetic opioid, has caused a surge in overdose deaths in the city. The collaborative effort aims to dismantle fentanyl trafficking networks, hold suppliers accountable, and enhance law enforcement presence. The operation will focus on targeting drug traffickers and suppliers while providing support to individuals struggling with addiction. The involvement of the CHP and CalGuard is expected to bolster ongoing efforts to address the fentanyl crisis and improve public safety in San Francisco.
Lawmakers Rally Against Drug Makers and Pharmacy Benefit Managers (PBMs) Over Soaring Medication Costs
June 6, 2023 / Lawmakers / Drug Makers / Drug Costs
Lawmakers expressed frustration and criticism towards pharmacy benefit managers (PBMs) during a hearing focused on healthcare spending. PBMs, acting as intermediaries between health insurers, manufacturers, and pharmacies, were accused of contributing to rising medication costs. Legislators emphasized the need for transparency and affordability, highlighting the detrimental impact on patients who struggle to access vital prescriptions. Calls for regulation and licensing of PBMs, as well as reforms to ensure patient access and control costs, were made. Former Governor Jane Swift also testified, sharing personal experiences of the challenges her daughter faced in obtaining necessary medication due to PBM-related issues. Lawmakers are determined to address the issue urgently.
Massachusetts looking for new ways to compete in biotech industry
June 6, 2023 / Massachusetts / Biotech Industry / Life Sciences
Massachusetts, a prominent global hub for the biotech and life sciences sectors, faces increasing competition from other states vying for the top spot. As industry leaders and government officials gather in Boston for an international convention on biotech, Massachusetts aims to signal its openness for business and explore new avenues for growth. While the state boasts over 1,000 biotech companies and a strong collaboration between industry, government, and academia, workforce shortages and competition from states like California, Texas, and North Carolina present challenges. Massachusetts plans to continue its investment in the industry, acknowledging the need for innovation and workforce development to maintain its position as a leading biotech ecosystem.
National Cancer Group Urges Government and Industry Action to Address Widespread Chemotherapy Shortages
June 8, 2023 / Cancer / National Cancer Group / Chemotherapy Shortages
The National Comprehensive Cancer Network (NCCN) has reported significant shortages of key cancer drugs, including carboplatin and cisplatin, affecting treatment centers and patients across the United States. In a survey conducted by the NCCN, 93% of treatment centers reported a carboplatin shortage, while 70% reported a cisplatin shortage. These platinum-based chemotherapies are crucial for the standard treatment of various cancer types. The NCCN has called on the government and pharmaceutical industry to address the shortages, emphasizing the need for a steady supply of critical cancer drugs. Additionally, the organization recommends the judicious utilization and prioritization of available cancer medications based on efficacy, safety, and cost. The FDA is providing assistance, including allowing imports from international manufacturers, to help alleviate the shortage and meet patient needs.