// Biotech and Pharma Therapeutics
AbbVie sidelines CytomX after seeing midphase oncology ADC data, opens talks on returning lead drug
March 28, 2023 / AbbVie / CytomX Therapeutics / Antibody Drug Conjugates / Emerging Biopharma
AbbVie has ditched its pact with CytomX Therapeutics. After seeing 83% of patients in the latest data cut develop anemia, the Big Pharma has dropped the cancer program for strategic portfolio reasons—and begun negotiating to sell the lead antibody-drug conjugate (ADC) back to CytomX.
Boehringer Ingelheim and Eli Lilly’s Jardiance gets big lift from heart failure indications
March 29, 2023 / Boehringer Ingelheim / Jardiance / Eli Lilly / Heart Failure
It’s been more than a year since Boehringer Ingelheim and Eli Lilly’s Jardiance became the first drug to score approvals for the two major types of heart failure (HF), opening a huge patient population and the potential for a sales bump.
Novo’s high-dose Rybelsus win tees up regulatory filings—and new rivalries
March 27, 2023 / Novo Nordisk / FDA / Eli Lilly / Rybelsus
Even as Novo Nordisk rides the momentum of Rybelsus’ hot launch, the company is testing higher-dose versions of the diabetes drug that could broaden its reach in a competitive market. Now, as part of the effort, the company is declaring a late-stage win.
With FDA nod for a Novartis castoff, Pharming is set to market a second rare disease drug
March 27, 2023 / Pharming Group / Novartis / FDA
With an infrastructure in place to market its lone commercial product Ruconest, it made sense in 2019 for Pharming Group to scoop up another rare disease candidate in the same arena.
J&J Drops Out of RSV Race, Cuts Late-Stage Vaccine Candidate
March 30, 2023 / J&J / RSV / Vaccine
The RSV race has lost one high-profile contender as Johnson & Johnson’s Janssen Pharmaceutical announced Wednesday it is discontinuing the Phase III EVERGREEN trial studying its RSV vaccine candidate.
// 4th Industrial Revolution
When It Comes to Radiology, What Can We Teach ChatGPT ?
March 30, 2023 / Radiology / Chat GBT
The potential of ChatGPT is exciting. Radiologists have come a long way on the AI journey. What started as a fear from some that AI would replace us, has evolved to a more nuanced understanding that AI’s greatest contribution in medical imaging is to make us better radiologists.
5 AI-Driven Healthcare Trends and Solutions in 2023
March 28, 2023 / AI / Healthcare
Enterprise-level healthcare is a massive business sector with seemingly infinite moving parts. With patients’ lives at stake, liability is huge, leaving little room for error. Yet human error is common in healthcare, and minor mistakes can cost millions in legal fees and lawsuits, not to mention risks to patient health. Healthcare enterprises are quickly embracing artificial intelligence solutions to mitigate loss, streamline operations, improve efficiency, and enhance customer service.
Florence Launches Modern Healthcare Experience With $20M
March 30, 2023 / Florence / Healthcare / New Tech
Comprised of physicians and engineers from leading health systems and technology companies, the Florence team has created a technology solution that provides a modern consumer experience while reducing operational overhead. The technology drives efficiency for healthcare workers and patients, enabling patients to get care faster while load-balancing in-person and virtual capacity across health systems and clinics.
Personify Care’s digital patient pathway project to go SA-wide
March 30, 2023 / Digital Health / CALHN Health IT
Health IT company Personify Care has bagged a A$5.6 million ($3.7 million) contract from SA Health to extend its digital patient pathways project across the entire state over the next two years.
Using 5G to cut down diagnostic reading by half
March 27, 2023 / 5G / Medical Center
Given a rapidly ageing population and an overwhelmed health system, hospitals like Samsung Medical Center had to deal with rising demands for health screening and other diagnostic needs. To meet these demands, SMC combined 5G connectivity and digital pathology, enhancing the speed of clinical decision-making across its facilities.
// Business & Markets
Codiak files for bankruptcy after exosome-focused biotech unable to satisfy ‘financial needs’
March 27, 2023 / Codiak BioSciences / Bankruptcy
Another biotech bites the dust. This time it’s Codiak BioSciences, whose attempts to deliver exosome-based therapeutics have reached the end of the road.
Vertex doubles down on CRISPR Therapeutics and diabetes in new $100M deal
March 27, 2023 / Vertex Pharmaceuticals / Cell & Gene Therapy / CRISPR Therapeutics
Vertex Pharmaceuticals and CRISPR Therapeutics’ therapy for beta thalassemia and sickle cell disease is awaiting a regulatory decision in the U.S. and Europe, but the cystric fibrosis drug maker is not sitting back. Vertex is now looking to double dip on the gene editing partner’s tech to develop Type 1 diabetes therapies.
Uber Health Embeds Same-Day Prescription Delivery Into Its Care Platform
March 30, 2023 / Uber Health / Healthcare
Today’s news furthers Uber Health’s mission to optimize how patients access care. The platform allows connectivity to the key services providers require to address patient needs including prescription delivery, stress-free rides, and soon, the delivery of healthy food and over-the-counter medicine for those who need it most—including Medicare Advantage and Medicaid beneficiaries.
Novartis to ride with Bicycle in radiopharmaceuticals deal that could cruise to $1.7B
March 28, 2023 / Novartis / Bicycle Therapeutics / Radiopharmaceuticals / Oncology
Novartis has hopped on Bicycle Therapeutics’ radio-conjugates ride with a $50 million upfront payment and a further $1.7 billion possible down the road.
Boehringer puts $481M on the line to pursue emerging cancer target in Covant team-up
March 28, 2023 / Emerging Biopharma / Boehringer Ingelheim / Immuno-oncology / Drug Discovery
Boehringer Ingelheim has spied an opportunity to seize the holy grail of immuno-oncology: turning cold tumors hot. In return for $10 million upfront and up to $471 million milestones, the German drugmaker has tasked Covant Therapeutics with discovering covalent candidates against an emerging cancer target.
// Legal & Regulatory
FDA Approves First Over-the-Counter Naloxone Nasal Spray
March 29, 2023 / FDA / Nasal Spray
The timeline for availability and price of this OTC product is determined by the manufacturer. The FDA will work with all stakeholders to help facilitate the continued availability of naloxone nasal spray products during the time needed to implement the Narcan switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only.
Pfizer, BMS’ Eliquis tops list of drugs destined for Medicare price negotiations in 2026: Moody’s
March 30, 2023 / Inflation Reduction Act / CMS / Eliquis / Medicare
Drug price negotiation is the boogeyman awaiting Big Pharma in 2026. So, which medicines will be subject to the U.S. government’s newfound ability to broker prices—the most impactful measure from last year’s Inflation Reduction Act?
After drug rejection, Vanda scores courtroom win over FDA in records case
March 29, 2023 / FDA / Hetlioz / Vanda Pharmaceuticals
Vanda Pharmaceuticals has scored a legal win in its long-running dispute with the FDA surrounding the agency’s 2018 rejection of Hetlioz in jet lag disorder.
March 26, 2023 / Court Ruling / Drug Manufacturers
December 29, 2022 / MediWound / FDA / NexoBrid / Thermal Burns
In recent years, manufacturers have restricted access to 340B pricing for drugs dispensed through contract pharmacies. The federal government has advised manufacturers that such restrictions are unlawful, and manufactures have challenged government enforcement actions in federal court.
FDA Approval Makes Pharming Drug First for Rare Inherited Immune Disease
March 26, 2023 / FDA / FDA Approval / Immune Disease
Pharming Group drug Joenja was awarded FDA approval for treating a primary immunodeficiency called activated phosphoinositide 3-kinase delta syndrome, or APDS. It’s the first treatment for the rare disorder.
// Research & Development
Biogen Successfully Targets Tau in Phase Ib Alzheimer’s Study
March 30, 2023 / Biogen / Alzheimer’s
With approvals for Aduhelm (aducanumab) and Leqembi (lecanemab) under its belt, Biogen presented data Wednesday for an Alzheimer’s disease therapy with a different target at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2023) in Stockholm, Sweden.
Viking sets ships toward phase 2 after obesity med passes early test
March 28, 2023 / Viking Therapeutics / Novo Nordisk / Eli Lilly / Obesity Drugs
Viking Therapeutics was a stock market winner Tuesday after encouraging phase 1 data posted earlier in the day sent shares up nearly 70%.
OncoRix’s breast cancer integrative solution demonstrated enhanced efficacy when combined with chemotherapy in an ex-vivo model
March 30, 2023 / Breast Cancer / Oncorix / Chemotherapy
The ex-vivo model is based on a unique technology developed at the Weizmann Institute, and it can predict oncological treatment success and personalize the right treatment for each patient.
PDS Biotech Announces Plan to Initiate Phase 3 Study Evaluating PDS0101 in Combination with KEYTRUDA® in Head and Neck Cancer in 2023
March 30, 2023 / Biotech / Cancer
In preparation for the VERSATILE-003 trial, PDS Biotech plans to submit an amended Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) in the third quarter of 2023. VERSATILE-003 is expected to involve approximately 90-100 clinical sites globally.
Nanoscope’s phase 2 win for gene therapy shows potential of light-sensitive approach to eye disease
March 30, 2023 / Nanoscope Therapeutics / Cell & Gene Therapy / Emerging Biopharma
Nanoscope has scored a phase 2 win for its gene therapy using light-sensitive molecules to treat retinal disease, keeping alive the hope of a first treatment to improve vision in these patients.
Biden’s science adviser on the US push to compete with China
March 29, 2023 / Biden / China
Arati Prabhakar speaks to Nature about innovation, science’s role in political decision-making and taking the reins after scandal.
Bio-Europe Spring: Lobbyists slam US “Innovation” Reduction Act
March 27, 2023 / Bio-Europe / Innovation / Reduction Act
At Bio Europe Spring last week, David Thomas, VP of Industry Research at lobby group the Biotechnology Innovation Organization (BIO), reflected on the “very tough times” the biotech industry has experienced over the past year due to reduced public and private funding.
When Big Business Married Big Government
March 26, 2023 / Big Business / Big Government
From banking and chips to broadband and pharma, Biden has ushered in a new era of corporate dependency on D.C.
Under pressure, biotech and pharma grapple with how to take climate action
March 29, 2023 / Biotech / Pharma / Climate Change
As the health impacts of climate change become harder to ignore, biotechnology and pharmaceutical companies are facing increasing pressure from investors, employees, and government regulators to reduce their carbon emissions, and to make environmental sustainability a core part of their business.
Bipartisan caucus in US Congress looks to boost domestic drug manufacturing
March 30, 2023 / Drug Manufacturing / API / House of Representatives / Supply Chain
Four members of the U.S. House of Representatives have formed a bipartisan group dubbed the Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress. The group will focus on domestic production of finished drugs and active pharmaceutical ingredients.