// Biotech and Pharma Therapeutics
A new drug for glioma means a windfall for Agios
August 7, 2024 / Novo Nordisk / Obesity / New Drug / GLP-1
An underwhelming earnings report and ongoing questions about increasing competition in the booming obesity medicine field sent Novo Nordisk’s shares down today, as the company sought to project its ability to reach more patients by increasing supplies of its GLP-1 drugs.
After sharp declines, Merck KGaA and analysts share optimism about potential CDMO rebound
August 7, 2024 / Merck KGaA / Manufacturing
Last week, Merck KGaA reported what it deemed a “very strong” second quarter, growing sales 2% to reach 5.4 billion euros ($5.8 billion). As has been the case for the past few earnings periods, Merck KGaA credited its overall growth to the steady performance of both its healthcare and electronics arms.
Baxter Issues Voluntary Nationwide Recall of One Lot of Heparin Sodium in 0.9% Sodium Chloride Injection Due to Potential for Elevated Endotoxin Levels
August 5, 2024 / Baxter / Sodium Chloride / Injections / Recall
Use of heparin with higher than acceptable endotoxin levels may lead to significant adverse health consequences ranging from febrile reactions to toxic shock, multi-organ failure and death. To date, Baxter has not received any reports of adverse events related to this issue.
Cyber roundup: OneBlood recovers from ransomware, Change starts sending breach notices
August 7, 2024 / OneBlood / Supreme Court / Health Systems
The Orlando-based blood supplier said its network has been partially restored after a ransomware attack and encouraged blood donations with Tropical Storm Debby threatening the region, according to a report from CBS News Miami on Monday.
Exelixis drops tissue factor-targeting ADC after deciding it’s no match for Tivdak
August 7, 2024 / Exelixis / Tivdak / Cabometyx
Exelixis is giving up on its tissue factor (TF)-targeting antibody-drug conjugate after concluding the candidate was unlikely to best Pfizer and Genmab’s Tivdak.
// 4th Industrial Revolution
AI drug discovery groups benefiting from venture interest as Xaira shows the way
August 7, 2024 / Drug Discovery / Xaira / CytoReason / AI
CytoReason’s $80 million venture round may not have been the biggest in July, but it is one of a growing number of investor bets on AI-powered drug discovery this year.
FemTech: Fertilitywise Partners with Fairfax EggBank to Empower Patients
August 6, 2024 / Women’s Health / Fertilitywise / Partnership Fairfax
Through this partnership, Fairfax EggBank patients will receive a complimentary two-month membership to Fertilitywise, providing access to a wealth of evidence-based information and a supportive community. Fertilitywise offers a range of resources, including articles written by leading fertility experts, and a moderated online community where patients can connect with others facing similar challenges.
New way to protect patient data for training AI models
August 6, 2024 / Patient Data / AI / New Study
In a study, whose findings have been published in JMIR Medical Informatics, EMR data of over 300,000 patients from three hospitals – Asan Medical Center, Seoul National University Hospital, and Ewha Women’s University Seoul Hospital – were gathered to train an AI model to predict mortality rates within 30 days after surgery. These were encrypted using HE.
Pandemic Lesson: How to Move Healthcare From the Emergency Room to the Living Room
August 7, 2024 / Dementia / Emergency Room
Emergency rooms are full of stories about the grandmother who checked in with a routine broken wrist that turned into a cascading series of medical woes such as fever, infection, incontinence, and ultimately a loss of independence.
Seqera Acquires Tinybio to Democratize Access to AI-Powered Bioinformatics
August 6, 2024 / AI / Bioinformatics / Tinybio
By integrating Tinybio’s technology, Seqera plans to significantly enhance its existing offerings, including scientific pipelines, containerized software, and web resources. This will make bioinformatics tools more user-friendly and effective for researchers worldwide.
// Business & Markets
Abbott and Medtronic Partner to Integrate CGM System & Insulin Delivery Devices
August 7, 2024 / Abbott / Medtronic / Partnership / Insulin
Abbott and Medtronic announced a groundbreaking partnership to develop an integrated continuous glucose monitoring (CGM) system designed to seamlessly work with Medtronic’s automated insulin delivery (AID) and smart insulin pen systems.
Amgen’s marketing efforts help boost Tepezza sales
August 7, 2024 / Amgen / Tepezza / Horizon Therapeutics
In the second quarter, Tepezza generated $479 million in sales for an increase of 8% year over year and 13% sequentially. It was Tepezza’s highest quarterly sales figure since the fourth quarter of 2022.
Blue Shield of California Offers Blue Zones App to Encourage Healthier Living
August 6, 2024 / Blue Shield / California
Blue Shield of California is encouraging its members to live like those in “blue zones” by offering access to the Blue Zones Challenge App, the insurer announced last week. Blue zones are regions in the world where people live longer and healthier lives.
Cigna Distributes Grants to 22 Nonprofits Focused on Youth Mental Health
August 7, 2024 / Cigna / Mental Health
Cigna is distributing about $3 million to the 22 grantees. Over the next three years, the company is allocating $9 million total to nonprofits focused on youth mental health through the grant program.
Guidehealth Secures $14M for AI-Powered Value-Based Care
August 7, 2024 / Guidehealth / AI / VBC
Guidehealth has experienced rapid growth since its founding, expanding its customer base to include top health systems and CINs serving over 500,000 lives. The company’s acquisition of Arcadia’s value-based care managed services division has further strengthened its position in the market.
// Legal & Regulatory
Amgen talks obesity drug ‘differentiation’; Servier brain cancer drug approved by FDA
August 7, 2024 / FDA / Cancer / Drug Approval / Obesity
Executives at Amgen had few updates on their drug MariTide, but defended its profile to analysts. Servier’s approval, meanwhile, triggered a windfall for Agios.
Biotech firm drops defamation suit against short-sellers after researcher charged
August 5, 2024 / Cassava Sciences / Lawsuit / Alzheimer’s
Cassava Sciences (SAVA.O), opens new tab ended its defamation lawsuit against four short sellers who expressed doubts about its experimental Alzheimer’s drug after a medical professor whose research underpinned the treatment was charged with fraud.
FDA grants IND clearance for Indapta’s multiple sclerosis treatment trial
August 7, 2024 / FDA / Indapta Therapeutics
Indapta Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application, enabling a future Phase I clinical trial of IDP-023 to treat progressive multiple sclerosis (MS).
Novo Nordisk pulls its FDA heart failure submission for Wegovy, will reapply early next year
August 7, 2024 / Novo Nordisk / Wegovy / Heart Failure / Semaglutide
In its quarterly earnings presentation, the Danish company said that after discussions with the FDA, it has pulled its filing and expects to resubmit in early 2025. The resubmission will include data from the company’s FLOW trial, which evaluates kidney outcomes with a once-weekly, 1-mg injection of semaglutide, Novo said.
Pharmacosmos picks up G1 Therapeutics, FDA-approved drug Cosela in merger worth $405M
August 7, 2024 / G1 Therapeutics / Cosela / Acquisition
Cosela won FDA approval in 2021 as the first therapy cleared to reduce bone marrow damage associated with certain chemotherapy regimens used to treat extensive-stage small-cell lung cancer. Last year, the med raked in $46.3 million in sales for G1.
// Research & Development
3 years in, Genentech’s Site Alliance enrolls underrepresented patients 2 times faster than other sites
August 5, 2024 / Genentech / Clinical Trials / Patient Recruitment
Three years since founding Site Alliance in 2021, Genentech is now sharing data showing sites in the alliance enroll more Black and Hispanic/Latinx patients than other sites in the same studies and enroll these underrepresented groups about two times faster.
Earnings call: Oncolytics Biotech outlines progress in cancer trials
August 2, 2024 / Oncolytics Biotech / Cancer Trials
Oncolytics Biotech Inc., a biopharmaceutical company, recently discussed its operational highlights and financial results for Q2 2024. The company is advancing its cancer therapeutic, pelareorep, with positive developments in clinical trials for breast and pancreatic cancer. In a productive meeting with the FDA, discussions centered on the path forward for pelareorep’s use in breast cancer. The company dosed the first patient in a modified cohort of the GOBLET study for pancreatic cancer and is set to report pivotal overall survival results from the BRACELET-1 trial later in the year. With a cash position of $24.9 million as of June 30, 2024, and a cash runway extending into 2025, Oncolytics Biotech is strategically collaborating and preparing for potential registrational studies.
LLMs Outperforms Clinicians in Predicting Mental Health Crises, Study Reveals
August 6, 2024 / LLMs / Mental Health
The research analyzed data from over 460 patients, including those who had reported suicidal ideation with a plan. Both clinicians and GPT-4 were tasked with predicting the likelihood of a mental health crisis based solely on the patient’s initial complaint.
Moleculin Announces Plans for MIRACLE Phase 3 Pivotal Trial
August 1, 2024 / Moleculin / Clinical Trials
Moleculin Biotech, Inc., a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting hard-to-treat tumors and viruses, today announced the positive discussion in and outcome of its End of Phase 1B/2 (EOP1B/2) meeting with the US Food and Drug Administration (FDA) supporting the advancement of Annamycin in combination with Cytarabine (also known as “Ara-C” and for which the combination of Annamycin and Ara-C is referred to as “AnnAraC”) to a Phase 3 pivotal trial for the treatment of AML patients who are refractory to or relapsed after induction therapy (R/R AML). This Phase 3 “MIRACLE” trial (derived from Moleculin R/R AML AnnAraC Clinical Evaluation) will be a global trial, including sites in the US.
Stoke’s Dravet syndrome med released from partial clinical hold as company eyes phase 3 plans
August 7, 2024 / Stoke Therapeutics / Dravet Syndrome / FDA
Stoke Therapeutics’ Dravet syndrome drug has been freed from a partial hold, clearing the way for the construction of a phase 3 program.
// Politics
Chips, EVs and Now Biotech Shape EU-China Ties
August 1, 2024 / Evs / China / Legislation / Congress
Under its provisions, US federal-funded medical providers would be restricted from contracting with “foreign adversaries,” with life sciences companies instructed to decouple from several named Chinese firms.
Inside the unproductive and contentious end of the Mass. State House’s legislative session
August 5, 2024 / Massachusetts / New Legislation / Lawmakers
Lawmakers went into their final day with a dozen high-profile bills in compromise talks; only three made it out. The Democrats who command super-majorities in both chambers said they could not agree on legislation that would have turbo-charged clean energy projects, pumped hundreds of millions of dollars into life sciences and biotech, and created stricter oversight of for-profit hospitals.
McKinsey’s $78 million opioid settlement to reimburse insurers gets final approval
August 2, 2024 / Settlement / McKinsey / Opioids
Global consulting firm McKinsey, accused fueling the opioid crisis through its work with drug companies, will pay $78 million to settle insurers’ claims after a federal judge gave final approval to the deal on Friday.
Pharma industry urges govt for stable drug pricing policy
August 6, 2024 / OPPI / Drug Pricing
The Organisation of Pharmaceutical Producers of India (OPPI), which represents prominent multinational pharma companies, has asked the government for a “predictable” pricing policy for drugs and not to resort to Para 19 of the Drug Pricing Control Order (DPCO) that authorises the regulator to reduce prices significantly in public interest for a period as it deems fit.
Three Drug Pricing Litigation Issues to Watch in the Second Half of 2024
August 6, 2024 / Drug Pricing / New Litigation
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of 2024. The FTC and private litigants are testing the limits of Orange Book listings, and challenges to the IRA’s drug-pricing provisions continue to percolate in court. Further, the FTC seeks to lower prescription drug prices by curbing certain PBM practices, while vowing to revive the Robinson-Patman Act to do so. Below we analyze these recent developments and their implications for the industry and beyond.