Healthcare Industry News Weekly Wrap-Up: January 12, 2024

// Biotech and Pharma Therapeutics

CRISPR pioneer Doudna allies with Danaher for gene editing center targeting rare disease and beyond

January 9, 2024 / Jennifer Doudna / CRISPR / Danaher / Gene Editing

CRISPR pioneer Jennifer Doudna, Ph.D., looks set to continue to push the boundaries of gene editing, as she announces plans to team up with life sciences giant Danaher to create a center focused on generating new therapies for rare and other diseases.

Biogen CEO sees progress in launch of Alzheimer’s drug Leqembi

January 8, 2024 / Biogen / Alzhemier’s

Biogen has two Alzheimer’s disease medicines approved in the U.S. The first, Aduhelm, had a disastrous launch following its approval in the summer of 2021. Commercial insurers as well as the Centers for Medicare and Medicare Services weren’t convinced the drug was effective enough to warrant an annual price tag set initially set at $56,000.

Mayo Clinic taps AI start-up to unlock data

January 10, 2024 / Mayo Clinic / AI / Cerebras Systems

Cerebras Systems, a provider of artificial intelligence computing chips for deep learning applications, will provide both hardware and software development services to Mayo under the deal announced during a presentation at this week’s J.P. Morgan Healthcare Conference in San Francisco.

Oryzon med fails to improve borderline personality disorder, but executives see a path with new endpoints

January 7, 2024 / Oryzon genomics / Psychiatric Drugs / Schizophrenia / Alzheimer’s Disease

Vafidemstat was being tested in the phase 2b PORTICO clinical trial among patients with borderline personality disorder. The treatment did not spur an improvement at weeks eight to 12 as measured by the Borderline Personality Disorder Checklist, which measures diagnostic criteria such as instability, recurrent suicidal behavior, gestures, threats or self-mutilating behavior, according to a Friday press release.

J&J to acquire ADC drug developer Ambrx for $2B

January 8, 2024 / J&J / ADC Drug / J.P. Morgan Healthcare Conference

Johnson & Johnson will pay $2 billion to acquire Ambrx Biopharma and the San Diego biotechnology company’s pipeline of targeted drugs for cancer.

// 4th Industrial Revolution

Lilly, Novartis Sign AI Partnership with Alphabet’s Isomorphic

January 8, 2024 / Eli Elly / Novartis / AI

Alphabet’s digital biotech company Isomorphic Labs on Sunday bagged two big-ticket partners in Eli Lilly and Novartis, which will leverage its artificial intelligence platform to develop small molecule drugs for still-undisclosed targets.

UpDoc to develop conversational, assistant-directed AI providers

January 8, 2024 / UpDoc / AI / Med Tech

UpDoc’s remote patient intervention technology leverages conversational AI powered by multiple large language models, including GPT-4, through Microsoft’s Azure Open AI Service, Google Cloud’s MedLM and Vertex AI models.

Nabla’s AI Assistant Gets $24M Boost to Combat Clinician Burnout and Streamline Care

January 5, 2024 / AI / Nabla / Healthcare

Nabla, a Boston, MA-based ambient AI assistant for healthcare professionals, announced today the initial close of a $24M Series B funding round led by Cathay Innovation, with participation from ZEBOX Ventures. The latest round of funding brings Nabla’s total funding to over $43M and fuels its mission to revolutionize healthcare delivery by empowering clinicians and improving patient care.

AlcoChange app to help alcohol-related liver disease patients stay sober

Jaunary 8, 2024 / AlcoChange / Alcohol-related Liver Disease

Developed by Cyberliver, a UCL spin-out company, the AlcoChange app comprises several behavioural change strategies, such as a mobile phone-based breathalyser and personalised messages that allow liver disease patients to abstain from alcohol while keeping track of their progress.

Penn Medicine develops AI tool for precision oncology

January 4, 2024 / Penn Medicine / AI / Oncology

The application, known as iStar, was created by Perelman School of Medicine researchers to give clinicians more insights into gene activities in medical images and, potentially, help them diagnose cancers that might have otherwise been undetected.

// Business & Markets

Goldman Sachs Bets Big on Life Sciences with $650M Fund

January 5, 2024 / Goldman Sachs / Life Sciences

Goldman Sachs Asset Management has announced the closing of its first-ever life sciences fund, West Street Life Sciences I, surpassing its target with $650 million in commitments. This marks a significant investment in the burgeoning life sciences sector, showcasing Goldman Sachs’ confidence in the field’s potential to revolutionize healthcare.

GSK, moving fast to buy Aiolos, pays $1B to challenge Amgen, AstraZeneca for asthma market

January 9, 2024 / GSK / Asthma / Tezspire / Mergers & Acquisitions

Well, that was fast. Seventy seven days after Aiolos Bio launched to the public, GSK has disclosed a deal to buy the biotech and its phase 2 asthma treatment for $1 billion upfront and up to $400 million in regulatory milestones.

Gene editing startup Metagenomi files for an IPO

January 6, 2024 / Gene Editing / Startup / IPO / Novo Nordisk

Backed by healthcare investors and pharmaceutical firms including Novo Nordisk’s parent company and Bayer’s venture arm, Metagenomi most recently raised a $275 million Series B round. The startup is also partnered with Moderna and Ionis Pharmaceuticals.

Aclaris claims win for ‘soft’ JAK inhibitor but mixed data spooks investors

January 10, 2024 / Aclaris Therapeutics / Atopic Dermatitis / JAK inhibitor / Clinical Data

Aclaris Therapeutics has touted the latest phase 2 results for its “soft” JAK 1/3 inhibitor as a win for the beleaguered biotech, but investors appeared less enthusiastic about the wider set of mixed data.

GSK to buy asthma drug startup Aiolos for $1B

January 9, 2024 / GSK / Asthma Drug / Startup / Aiolos

Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a $1 billion buyout by GSK.

// Legal & Regulatory

FDA authorizes Florida to import drugs from Canada

January 5, 2024 / FDA / Florida / Canada

The decision is a major policy shift for the agency, which has long resisted drug importation efforts on grounds that it couldn’t ensure the safety and supply of medicines shipped from abroad. Supporters have argued that importing drugs from Canada, where medicines cost far less than in the U.S., could help rein in pharmaceutical costs.

Novo Nordisk, Eli Lilly’s weight-loss drugs under FDA scrutiny for suicidal thoughts, hair loss

January 4, 2024 / Novo Nordisk / Eli Lilly / FDA / Alopecia

Use of Novo Nordisk and Eli Lilly’s popular diabetes and weight loss drugs come with warnings about a rare intestinal blockage condition called ileus, which can be life threatening.

FDA grants real-time liver ablation AI clearance

January 9, 2024 / FDA / Liver Ablation / AI

Ablation treatment methods, like radiofrequency ablation, microwave ablation and cryoablation, are alternative first-line treatments for patients with inoperable primary and secondary liver tumors. While safely used, complications can arise as ablation zones may expand over 24 hours, until they are stabilized, and compromise blood vessels, bile ducts and other structures.

Sale of generic versions of cancer drug stops as Delhi HC prohibits patent infringement

January 10, 2024 / Cancer Drugs / Patients

Sale of generic versions of cancer medication Ibrutinib, used to treat leukaemia, has been blocked across the country, denying patients access to affordable therapy.

Qvin’s Q-Pad Makes History with First FDA Approval for Menstrual Blood Health Testing

January 9, 2024 / Qvin / Women’s Health / Menstrual Blood Testing / FDA

Biotech research company Qvin has announced the FDA clearance of its innovative Q-Pad and A1c Test, marking a significant advancement in women’s health technology. This approval introduces a new method of health monitoring for millions of American women, particularly those living with diabetes, through menstrual blood testing.

// Research & Development

Bayer heats up hot flash rivalry, hitting phase 3 goals to stay on Astellas’ heels

January 8, 2024 / Bayer / Astellas / Women’s Health / Menopause

Bayer has kept up the pressure on Astellas’ hot flash drug Veozah, reporting a clean sweep of coprimary endpoints in a pair of phase 3 trials of its rival molecule elinzanetant.

Immune cell helps predict skin cancer patients’ responses to immunotherapies

January 5, 2024 / Immune Cell / Skin Cancer / Immunotherapies

Researchers from King’s College London (KCL), Guy’s and St Thomas’ Hospital Trust and the Francis Crick Institute have revealed that a type of immune cell can help predict how melanoma patients will respond to immunotherapy treatment.

Curevo’s shingles vaccine equals GSK’s Shingrix in phase 2 head-to-head

January 8, 2024 / GSK / Shingles / Shingix / Shingles Vaccine

The Seattle-based company’s non-mRNA, adjuvanted subunit vaccine has held its own against the Big Pharma’s blockbuster Shingles vaccine in a phase 2 trial. The study of 876 patients aged 50 and over demonstrated that amezosvatein, also known as CRV-101, produced a robust humoral immune response at day 84 that was non-inferior to GSK’s market leader.

Alcon’s Investigational Drops Show Promising Phase III Data in Dry Eye Disease

January 10, 2024 / Alcon / Eye Disease / Clinical Trials

Alcon on Tuesday posted promising top-line results from two pivotal Phase III clinical trials—COMET-2 and COMET-3—demonstrating that its investigational eye drops AR-15512 improved tear production in patients with dry eye disease.

New clinical study to advance development of treatments for liver cirrhosis

January 10, 2024 / Clinical Study / Liver Cirrhosis / Boehringer Ingelheim

A new study involving Boehringer Ingelheim, Newcastle University and the University of Edinburgh has been announced to advance the development of new treatments for liver cirrhosis.

// Politics

19 Senators Urge HHS to Drop Appeal That Would Jeopardize Americans’ Access to Life-Saving Drugs

January 5, 2024 / Appeal / Bipartisan / HHS

Copay accumulators are programs health plans use to prevent copay assistance from counting toward patients’ deductibles or out-of-pocket maximums. Typically, when patients receive copay assistance from pharmaceutical companies, the amount paid by the manufacturer helps reduce the patient’s out-of-pocket costs. But with copay accumulators, the assistance from the drugmaker is not counted toward the patient’s maximum limit on out-of-pocket expenses.

Biopharma Policy in the Spotlight at JPM as Sector Gears Up for Volatile 2024

January 8, 2024 / JPM / Biden / Inflation Reduction Act

The Biden administration’s policies affecting the biopharma industry, including implementation of the Inflation Reduction Act, intellectual property challenges and mergers and acquisitions, took center stage on Sunday in San Francisco ahead of the J.P. Morgan Healthcare Conference’s official Monday kickoff.

2024 Is the Year of Medicare Drug Price Negotiations

January 10, 2024 / Medicare / Price Negotiations

The revised prices for 10 costly drugs are slated to be made public by September. The pharma industry, which calls the process price-setting, is attempting to derail it with court challenges. President Joe Biden is making the policy a core part of his argument for reelection.

Biden’s Action on Drug Pricing Set for Legal Battles in 2024

January 8, 2024 / Biden / Drug Pricing / Lawsuits

The pharmaceutical industry’s resistance to the Biden administration’s program for lowering what Medicare pays for costly drugs is expected to broaden this year, though resolution is unlikely as different lawsuits wind their way through several courts.

Courts will decide the future of Medicare’s power to negotiate drug prices within months

January 11, 2024 / Medicare / Drug Pricing / Biden

Pharmaceutical companies’ efforts to scuttle President Biden’s signature health care achievement, empowering Medicare to negotiate prescription drug prices, will soon face their first big tests.