Healthcare Industry News Weekly Wrap-Up: January 4, 2024

// Biotech and Pharma Therapeutics

AI is ‘not a panacea’ for all drug discovery challenges, but partnerships can be for Generate

January 4, 2024 / Generate Biomedicines / AI / Drug Discovery / Machine Learning

The geniuses of biotech—the Mozarts and Beethovens, as Generate Biomedicines CEO Mike Nally calls them—can only find so many new drugs. Without the limits of human discovery, AI can churn out as many programs as you have servers to run it. But then you hit another limit: how many programs can your biotech actually handle?

CVS to Remove AbbVie’s Humira from Reimbursement Lists, Cover Biosimilars

January 4, 2024 / CVS Health / AbbVie / Humira / Arthritis

CVS Caremark, the pharmacy benefit management subsidiary of CVS Health, on Wednesday announced that it would remove AbbVie’s arthritis therapy Humira (adalimumab) from its major national commercial template formularies, and that it would instead cover the medication’s biosimilars.

Novo Nordisk, Eli Lilly’s obesity drugs will lead in new drug sales in 2024: Evaluate

January 3, 2024 / Novo Nordisk / Eli Lilly / Roche / Pfizer

Booming demand for blood sugar-modulating diabetes and obesity drugs became the top trend in the biopharma industry in 2023, with two companies—Novo Nordisk and Eli Lilly—overwhelming the market with their dominance.

A new startup from Feng Zhang and an ex-Illumina executive zeroes in on the epigenome

January 4, 2024 / Startup / CRISPR

The former Illumina and Grail executive has spent decades examining the human genome, starting with his postdoctoral studies at Stanford University in the early aughts. There, he befriended a graduate student by the name of Feng Zhang.

Roche joins startup Remix in bet on another way to drug RNA

January 3, 2024 / Roche / Startup / RNA

Ongoing research of RNA, the messenger molecule that cells use to turn genetic blueprints into proteins, has catalyzed new attempts to develop chemical-based medicines that can target it.

// 4th Industrial Revolution

AI Cybersecurity in Healthcare: Key Risks and Security Measures

December 29, 2024 / AI / Cybersecurity / Healthcare

Leaps in healthcare technology continue to benefit humankind: from the advent of the X-ray in the 19^th century to dialysis, CT, MRI, and other machines in the 20^th century, to a new breadth of digital tools in this era. Perhaps the most auspicious of these is artificial intelligence (AI), with its wide-ranging applications for predictive analytics, drug development, personalized medicine, and robot-assisted surgery.

Novo Nordisk to open new AI hub in UK for drug discovery

January 3, 2024 / Novo Nordisk / AI / Drug Discovery

Novo Nordisk has announced its plans to open a new, artificial intelligence (AI)-based research facility to advance drug discovery operations in London.

Are Rare Brain Diseases the Next Commercial Frontier for Gene Therapy?

January 2, 2024 / Gene Therapy / Neurological Disease / FDA

Approximately 80 percent of rare diseases are caused by mutations in a single gene, and these monogenic disorders can be excellent candidates for gene therapies. These mutations can produce devastating symptoms that limit individuals’ ability to achieve independence, pursue an education, start a family, and participate in the economy and the normal activities of everyday living.

Mayo Clinic lines up AI collabs in colon, breast cancer with Aiforia, SimBioSys

Jaunary 2, 2024 / Mayo Clinic / AI / Breast Cancer / Colorectal Cancer

In separate announcements Tuesday, AI software developers Aiforia and SimBioSys each unveiled new tie-ups with the healthcare giant, both with an aim of applying AI-based tools to improve care for cancer patients.

How opioid overdoses in public restrooms led an electrician to invent ‘safe bathrooms’

January 3, 2024 / Opioid / Overdose

First, a light starts to flash. Then a high-pitched siren starts to blare. Then come the sounds of nearby doors being flung open, and the frantic footsteps of doctors and nurses rushing toward a restroom at the end of a hallway. They’re in a hurry for good reason. These distress signals have a specific meaning: Somebody in the bathroom is overdosing.

// Business & Markets

Boehringer double dips at 3T, inking second T-cell anticancer deal to swell potential payday to $538.5M

January 4, 2024 / Boehringer Ingelheim / Solid Tumor / T-cell Therapy / Deals

Boehringer Ingelheim’s business development team has scorched out of the traps in 2024. On Thursday, Jan. 4, the German drugmaker unveiled its second deal of the year, revealing another T-cell anticancer therapy partnership with 3T Biosciences to swell the potential payday to $538.5 million.

Novo Nordisk offers 2 Flagship biotechs up to $1B total for obesity, MASH deals

January 4, 2024 / Novo Nordisk / Flagship Pioneering / Omega Therapeutics / Cellarity

As part of a pact with Flagship Pioneering, Novo Nordisk has inked separate cardiometabolic disease research deals with two Flagship-founded biotechs that are worth up to $532 million each.

Goldman Sachs gets into biotech investing with new venture fund

January 3, 2024 / Goldman Sachs / Investing

Goldman’s foray into the biotech world shows continuing investor appetite in the venture capital arena, even while the public biotech market remains tepid. The last year featured a number of new VC fund launches, including from Dimension, Cure Ventures, Yosemite, Foundery and Bioluminescence Ventures.

Boehringer bets $2B in biobucks to unlock siRNA targets for MASH treatments

January 3, 2024 / Boehringer Ingelheim / NASH / Suzhou Ribo Life Science / siRNA

Boehringer Ingelheim is having another crack at using RNA to treat metabolic-associated steatohepatitis (MASH). Six years after inking deals for a pair of prospects, the German drugmaker has committed more than $2 billion in biobucks to enter into a multi-target pact with a Chinese biotech and its Swedish subsidiary.

CardioMech Snags $13M For Its Mitral Valve Repair Tech

January 3, 2024 / CardioMech / Startup / New Tech

Medical device startup CardioMech announced this week that it has raised $13 million in new capital, bringing its total funding to $42 million. With the fresh funds, the company hopes to advance the development and validation of its flagship device, which is designed to treat mitral valve disease.

// Legal & Regulatory

5 FDA decisions to watch in the first quarter

January 4, 2024 / FDA / Cancer / Cell Therapy

By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while the agency’s biologics division cleared 15 more. The clearances offer some counterbalance to a prolonged market downturn, during which the sector has struggled with a range of financial and regulatory headwinds.

McKinsey to pay $78M US opioid settlement with health insurers, company benefit plans

December 30, 2023 / McKinsey / Health Insurers

Consulting giant McKinsey & Company agreed to a $78 million settlement in a case over its role in advising opioid manufacturers to design misleading marketing campaigns.

AstraZeneca, Sanofi win nod in China for RSV antibody Beyfortus

January 2, 2024 / Sanofi / AstraZeneca / Beyfortus / RSV

AstraZeneca and Sanofi have scored first in China with an approval for their respiratory syncytial virus (RSV) immunization Beyfortus for infants, with the companies expecting the shot to be available there for the 2024-25 season.

Pfizer’s Hemophilia B Gene Therapy Wins Approval in Canada, FDA Decision Looms

January 4, 2024 / Pfizer / Gene Therapy / FDA / Approval

Health Canada on Wednesday approved Pfizer’s gene therapy fidanacogene elaparvovec, now to carry the brand name Beqvez, for the treatment of adults with hemophilia B.

FDA ends busy year with three drug rejections

January 2, 2024 / FDA / Amgen / Zealand / Merck / Approval

The Food and Drug Administration closed out 2023 with rejections of three drugmaker applications for first approval or expanded use, handing Amgen, Zealand Pharma and Merck & Co. complete response letters for medicines to treat cancer, low blood sugar and chronic cough.

// Research & Development

10 clinical trials to watch in the first half of 2024

January 2, 2024 / Clinical Trials / Vertex / Alnylam / Roche

In December, the Federal Reserve signaled plans to cut interest rates next year, accelerating a market run that has helped biotechs’s two main stock indexes finish 2023 in the green.

ConcertAI to Acquire CancerLinQ to Build the Leading Healthcare Learning and Research Network in Oncology

January 2, 2024 / AI / Healthcare / Oncology

ConcertAI today announced the acquisition of CancerLinQ, previously a subsidiary of the American Society of Clinical Oncology (ASCO). In conjunction with the acquisition, ASCO will maintain a multi-year cooperation agreement with CancerLinQ. Building on CancerLinQ’s mission when launched by ASCO in 2013, this new venture will enhance and expand CancerLinQ’s use of real-world data, analytics, next-generation AI, and other technologies to improve cancer care and speed clinical research.

Bayer’s AskBio checks off another early win for gene therapy platform with Parkinson’s safety data

January 4, 2024 / Bayer / Asklepios BioPharmaceutical / Parkinson’s Disease / Cell & Gene Therapy

Bayer’s AskBio gene therapy unit has achieved a key safety milestone in an early-stage trial for an investigational Parkinson’s disease treatment that must be delivered surgically into the brain.

Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

January 2, 2024 / Medicaid / Drug Costs / Prescriptions

Longboard Pharmaceuticals is chasing much bigger companies already in the market with therapies for rare forms of epilepsy. The biotech has gone from saying its drug could be differentiated to claiming it has best-in-class potential. Longboard now has some early clinical data to help build that case.

Pfizer wins Canadian OK for hemophilia treatment, its first gene therapy

January 3, 2024 / Pfizer / Gene Therapy / Hemophilia / Sickle Cell Disease

Hemophilia and other blood disorders like sickle cell disease and beta thalassemia have drawn intense investment from genetic medicine developers. in December, the FDA approved two such treatments for sickle cell, clearing Vertex Pharmaceuticals’ gene editing drug Casgevy and Bluebird bio’s viral vector therapy Lyfgenia.

// Politics

Insulin $35 cap price now in effect, lowering costs for many Americans with diabetes

January 3, 2024 / Insulin / Diabetes / Sanofi

A price cap on insulin from one of the three major manufacturers took effect on New Year’s Day, giving more Americans with diabetes more affordable treatments.

U.S. senators continue to look for answers to slow country’s prescription drug shortage

January 2, 2024 / Senators / Drug Shortage

Another cause for the shortage is some pharmaceutical companies try to keep the cheaper versions of their products unavailable for purchase as long as possible.

Congress looking to cut pharmacy benefit manager profits

January 3, 2024 / Congress / Drugmakers

Some members of Congress are trying to make prescription drugs cheaper, but they’re getting pushback from an industry most Americans have likely never heard of before.

California Legislature starts 2024 session in big budget hole

January 3, 2024 / California / Legislature

After three-and-a-half months at home, California legislators return to Sacramento today for a seven-month session where a budget deficit and the election will be top of mind.

Amid Biden admin’s drug-pricing push, Big Pharma kicks off 2024 with hundreds of price hikes: report

January 2, 2024 / Pfizer / Hospira / Takeda / Baxalta

While public and political scrutiny around drug pricing has reached a fever pitch in the wake of 2022’s Inflation Reduction Act (IRA), that hasn’t stopped pharma majors from ringing in 2024 with their favorite New Year tradition: a hefty round of medication price hikes.