// Biotech and Pharma Therapeutics
Pfizer to deepen cost cuts as latest sales forecasts miss expectations
December 13, 2023 / Pfizer / Wall Street / Cost Cutting
Pfizer on Wednesday upped the target for its cost-cutting program, revealing the additional spending cuts alongside a sales forecast for 2024 that disappointed Wall Street analysts and sent shares down to their lowest levels in more than a decade.
Merck and Eisai’s Keytruda-Lenvima combo comes up short yet again, this time in endometrial cancer
December 8, 2023 / Merck / Eisai / Keytruda / Lenvima
Merck and Eisai’s combo of Keytruda and Lenvima has missed the mark yet again, rounding out a year of multiple trial flops for the pairing. This time, the duo chalked up a flop in a specific group of patients with endometrial carcinoma.
Tome Biosciences debuts with $213M and a new way to edit the genome
December 12, 2023 / Tome Biosciences / Genome / DNA / Startup
The recent arrival of the blood disease treatment Casgevy was a milestone for gene editing research, a field of science that’s exploded in the last decade. It is the first approved medicine based on the gene editing system known as CRISPR, and its initial clearances came only a decade after published papers described the system’s potential as a gene editing tool.
J&J, Genmab Unveil Darzalex Faspro Data with Eye Toward Earlier Multiple Myeloma Lines
December 13, 2023 / Johnson & Johnson / Genmab / Myeloma
The data displayed favorable progression-free survival in for a combination treatment of Darzalex (daratumumab and hyaluronidase-fihj) with bortezomib, lenalidomide and dexamethasone, followed by the anti-CD38 antibody. The combo also demonstrated improvement in the complete response rate and “better and minimal” residual disease negativity over the comparator arm.
Ex-Novartis research head Bradner tapped to lead R&D at Amgen with Reese moving to chief technology officer
December 14, 2023 / Amgen / Novartis / R&D
The former president of the Novartis Institutes for BioMedical Research has been appointed executive vice president, head of R&D and chief scientific officer of the Southern California pharma, according to an announcement Thursday. His predecessor, David Reese, M.D., will take on the chief technology officer role.
// 4th Industrial Revolution
Deep Learning Accurately Predicts Antihypertensive Treatment Success
December 11, 2023 / AI / Deep Learning / Hypertension
Researchers have developed a deep neural network-based model to predict the most successful antihypertensive treatment for an individual, according to a study published recently in Mayo Clinic Proceedings: Digital Health.
Where AI will impact healthcare in 2024
December 14, 2023 / AI / Healthcare / Digital Health / Clinical Trials
Following the considerable increase in the use of AI in healthcare in 2023, stakeholders expect next year to bring even wider adoption of the technology across various sectors, from implementation in physician-facing tools that help ease provider burnout to addressing consumers’ loneliness.
3D Printing the Unprintable: An Interview with Elementum 3D CEO Jacob Nuechterlein
December 14, 2023 / 3D Printing / Elementum 3D
We recently had the opportunity to interview Jacob Nuechterlein, CEO of Elementum 3D, about the company’s development of high-performance powders for 3D printing. A former researcher and graduate of the Colorado School of Mines, Nuechterlein founded Elementum to innovate in the field of additive manufacturing (AM). The company employs its proprietary reactive AM (RAM) process, which involves adding micron-sized ceramic particles to metal alloys. This unique method enhances various material properties, including durability, corrosion resistance, fatigue strength, and overall strength.
Veradigm shakes up its leadership – and adds generative AI
December 11, 2023 / AI / Veradigm
Veradigm announced Friday that its board of directors asked Poulton and Jones to resign over issues related to “financial reporting and internal controls over financial reporting and disclosure controls,” the company announced Friday.
NIST drafts privacy protection guidance for AI-driven research
December 13, 2023 / NIST / AI / Privacy
Tasked under the Biden Administration’s Executive Order on AI Offers, the U.S. National Institute of Standards and Technology released draft guidance on evaluating data privacy protection for use with artificial intelligence on Monday.
// Business & Markets
Best Buy Health, Biobeat partner on RPM wearables
December 13, 2023 / Best Buy Health / Biobeat / wearables / New Tech
Israeli healthtech startup Biobeat and Best Buy Health are teaming up to integrate the capabilities of Biobeat’s wrist and chest monitors, tying them into Best Buy Health’s Current Health platform.
Bluebird signs major coverage deal for sickle cell gene therapy Lyfgenia, easing some price concerns
December 14, 2023 / Bluebird Bio / Cell Therapy / Gene Therapy / Lyfgenia / Sickle Cell Disease
Despite the high list price of Lyfgenia, bluebird has signed a large reimbursement deal for the sickle cell disease (SCD) gene therapy less than a week after its FDA approval.
Sanofi Abandons Deal for Rare Disease Drug Amid FTC’s Monopoly Concerns
December 12, 2023 / Sanofi / Pompe Disease / Maze Therapeutics
The French pharmaceutical giant already markets Lumizyme and Nexviazyme for the disorder, called Pompe disease. Until this year, they were the only available Pompe treatments. In an administrative complaint filed Monday, the anti-trust regulator said Sanofi’s deal for Maze’s drug candidate amounts to a large company trying to eliminate a smaller competitor.
Humira leads ICER’s latest list of ‘unsupported’ price hikes
December 11, 2023 / Humira / ICER’s / Drug Costs / AbbVie / Healthcare
Price hikes for eight drugs increased U.S. healthcare spending by nearly $1.3 billion last year despite a lack of new evidence supporting their health benefits, according to a new report published Monday by the Institute for Clinical and Economic Review.
Biotech IPO window will ‘gradually reopen’ in 2024 as M&A remains ‘healthy’: PwC
December 14, 2023 / PwC / Mergers / Acquisitions / IPO / Deals
After a year when most biotechs had given up on going public in the near term, the IPO window will “gradually reopen” next year—at least that’s what analysts at PwC are betting on.
// Legal & Regulatory
Vertex, CRISPR score landmark FDA approval for sickle cell disease gene therapy Casgevy
December 8, 2023 / Vertex / CRISPR Therapeutics / Sickle Cell Disease / Gene Therapy
None of the buzzwords sound adequate to describe Friday’s FDA approval of Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy (exa-cel) to treat sickle cell disease (SCD).
FDA Creates Adcomm for Genetic Metabolic Diseases and Potential Treatments
December 13, 2023 / FDA / Metabolic Disease
The FDA on Tuesday announced it is establishing a new advisory committee that will discuss and evaluate potential treatments for genetic metabolic diseases which disrupt the body’s metabolism.
First-ever drug application for MDMA finally reaches FDA after near 40-year journey
December 13, 2023 / MDMA / New Drug Application / FDA / Psychedelic Drug
Figuring out how long it’s taken the Multidisciplinary Association for Psychedelic Studies’ (MAPS) application to reach the FDA’s desk all depends on when you start counting.
Vertex passes neuropathic pain test, teeing up pivotal trials in pursuit of blockbuster opportunity
December 13, 2023 / Neuropathic Pain / Vertex Pharma / Clinical Trial Data
Vertex’s decision to double down on a pain program has delivered a phase 2 win. The biotech linked its NaV1.8 inhibitor VX-548 to statistically significant improvements in pain intensity in people with painful diabetic peripheral neuropathy (DPN), encouraging it to start planning a pivotal program.
Cybercriminals seek to extort Fred Hutch patients for about $2M
December 11, 2023 / Cybercriminals / Data
Nick Quinlan, a Fred Hutch patient, was asked to pay 50 bitcoin to prevent his data from being leaked, according to the NBC15 Seattle report.
“They had the chance to protect your data, but they refused to make a deal,” the attackers said, according to a screenshot of an email Quinlan received on December 6.
The email claims that names, social security numbers, addresses, phone numbers, medical history, lab results and insurance histories of 800,000 Fred Hutch patients have been compromised.
// Research & Development
Vertex builds case for non-opioid pain drug ahead of key study readouts
December 13, 2023 / Vertex / Non-Opioid / Pain-Killer
In a pain market dominated by opioids and their associated addiction risks, the promise of a medicine that works in a new way is enticing. To date, the pharmaceutical industry’s attempts to find alternatives have fallen short.
Agomab Starts Phase 1 Clinical Study for AGMB-447 in Healthy Subjects and Patients with Idiopathic Pulmonary Fibrosis
December 14, 2023 / Clinical Study / Idiopathic Pulmonary Fibrosis
Agomab Therapeutics NV (‘Agomab’) today announced that it has dosed the first subject in a first-in-human Phase 1 clinical study of AGMB-447, an inhaled lung-restricted small molecule inhibitor of ALK5 (TGFβRI or ALK5). The study is evaluating AGMB-447 in healthy subjects and in patients with idiopathic pulmonary fibrosis (IPF).
Reneo pulls plug on only asset after phase 2b fail, sending 70% of staff out the door and stock plummeting
December 14, 2023 / Layoffs / Genetic Diseases / Clinical Trials / Clinical Data
Reneo Pharmaceuticals’ rare genetic disease study has missed both primary and secondary goals, prompting the California biotech to halt the development of its only asset and lay off 70% of staff.
MindMed links LSD to reduced anxiety in phase 2b, plots pivotal trials
December 14, 2023 / Psychedelic Drug / Anxiety / Hallucinogens / Clinical Trial Data
Mind Medicine has linked its psychedelic medicine to improvements in patients with generalized anxiety disorder. After one hit of lysergide d-tartrate, a hallucinogen better known as LSD, patients in some of the phase 2b dose cohorts experienced reductions in anxiety that persisted through the four-week trial.
Study confirms safety of new flow-diverting stent to treat brain aneurysms
December 13, 2023 / New Study / Brain Aneurysms / Neuroscience
Researchers from King’s College London’s (KCL) School of Biomedical Engineering and Imaging Sciences have confirmed the safety of a new flow-diverting stent device to prevent blood flow into brain aneurysms.
// Politics
Bipartisan Price Transparency Bill Passes in House
December 12, 2023 / Transparency Act / Drug Costs / Bipartisan
It passed on a 320 to 71 vote. The bill was led by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Washington), Ranking Member Frank Pallone, Jr. (D-New Jersey), House Ways and Means Committee Chair Jason Smith (R-Missouri) and House Education and the Workforce Committee Chair Virginia Foxx (R-North Carolina). It was introduced on September 8.
After swell of biopharma outrage, Supreme Court takes up high-profile mifepristone case
December 13, 2023 / Supreme Court / Mifepristone
After last year’s explosive ruling to overturn the historic abortion ruling reached in Roe v. Wade, abortion access is back up for debate in the Supreme Court. This time, the FDA’s power is on the table, too.
Supreme Court case halts distribution of vital funds
December 10, 2023 / Supreme Court / OxyContin
Following the approval for OxyContin in 1995, the drug has continued to haunt the streets taking hundreds of lives daily with 7.49% of nationwide overdose deaths occurring in Florida alone.
OxyContin maker’s bankruptcy deal goes before the Supreme Court, with billions of dollars at stake
December 9, 2023 / OxyContin / Bankruptcy / Supreme Court
The Supreme Court on Monday is hearing arguments over a nationwide settlement with OxyContin maker Purdue Pharma that would shield members of the Sackler family who own the company from civil lawsuits over the toll of opioids.
Biden’s prescription for disaster
December 13, 2023 / Biden / Prescription Drug
When I was very young, my mother lost her right leg, above the knee, to arteriosclerosis, or circulatory problems, to put it in the most basic terms. I have a few fuzzy memories of her with two legs, or walking without crutches, but that’s all. I admired the hell out of her because she didn’t let it stand in the way of her living her life.