Healthcare Industry News Weekly Wrap-Up: December 29, 2023

// Biotech and Pharma Therapeutics

How Merck extended its monopoly on a blockbuster diabetes drug

December 23, 2023 / Merk / Diabetes / Regulators

Merck’s monopoly on a blockbuster diabetes drug that has generated about $50 billion in global sales seemed like it might be coming to an end over the past couple years.

AstraZeneca pays $1B to take the wheel of Gracell’s CAR-T ‘fast car’

December 27, 2023 / AstraZeneca / Gracell / CAR-T / Mergers / Acquisitions

While you could forgive Big Pharma for backing away from CAR-Ts in the wake of the FDA’s decision to investigate the risk of secondary cancers, AstraZeneca has decided that a cell therapy company would make the perfect Christmas present.

Bristol-Myers buying Karuna signals a biotech boom ahead: Jefferies

December 23, 2023 / Bristol-Myers / Karuna Therapeutics

Karuna Therapeutics Inc (NASDAQ: KRTX) ended nearly 50% up on Friday after Bristol-Myers Squibb Co (NYSE: BMY) said it will buy the biopharmaceutical firm for $14 billion.

The Nordics pick climate tech over AI as the golden ticket in 2023

December 26, 2023 / Nordics / AI / New Tech

2023 hasn’t been a great year for raising money — and the Nordics have been no exception. But while it has been AI that has bucked the trend in other European nations, climate tech has kept the Nordic tech wagon on the road.

Pfizer’s Hospira recall spree bleeds into 2024 with product pulls for multiple hospital drugs in shortage

December 27, 2023 / Pfizer / Hospira / Sterile Injectables / Voluntary Recall

After a year plagued by recalls, Pfizer’s sterile injectables unit Hospira seems no closer to righting the ship over its glass-contamination woes. What’s more, the company’s latest product pulls threaten to intensify the ongoing shortages of several critical hospital drugs.

// 4th Industrial Revolution

Samsung Announces New Medications Tracking Feature for Samsung Health

December 21, 2023 / Samsung Health / Digital Health

Samsung Health, according to Hon Pak, Vice President and Head of Digital Health Team, MX Business at Samsung Electronics, aims to assist individuals in comprehending and handling their health through a comprehensive platform that connects devices, services, and people.

St Vincent’s Health reports data heist before Christmas

December 27, 2023 / St Vincent’s Health / Data Breach

Less than a week before Christmas day, St Vincent’s Health, one of Australia’s largest not-for-profit health and aged care providers, detected a breach in its IT system.

Sri Lanka’s national emergency service launches AI, mixed reality-powered connected ambulance

December 25, 2023 / Sri Lanka / AI / Emergency Response

Mediwave’s Emergency Response Suite digitises emergency service processes, including the creation of patients’ electronic health records using an AI-powered speech-to-text transcriber. It enables remote care featuring the Microsoft HoloLens for augmented reality (AR) and the Internet of Medical Things. Mediwave recently launched the same range of solutions in Malaysia.

Women-led Pakistani telehealth startup bags $3M Series A funding

December 25, 2023 / Telehealth / Startup / Sehat Kahani / AI / Pakistani

Pakistani telemedicine startup Sehat Kahani has gained $2.7 million in a Series A funding round led by the health tech fund Amaanah Circle from Singapore.

Successful RPM needs leading edge tech, thoughtful implementations

December 27, 2023 / Healthcare / RPM

This flu season will see at least 26 million cases, 290,000 hospitalizations, and 19,000 deaths, according to the U.S. Centers for Disease Control and Prevention. Pair that with a longstanding physician shortage and it could be a recipe for disaster in ERs and urgent care centers this winter.

// Business & Markets

AstraZeneca to acquire Gracell, furthering cell therapy ambition across oncology and autoimmune diseases

December 26, 2023 / Auto Immune Disease / AstraZeneca / Oncology

AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases, furthering the AstraZeneca cell therapy ambition.

BMS enters radiopharma race with $4.1B acquisition of RayzeBio just 3 months after biotech went public

December 27, 2023 / Bristol Myers Squibb / RayzeBio / Mergers & Acquisitions / Radiopharmaceutical

There’s been no festive respite for Bristol Myers Squibb’s M&A team as the Big Pharma follows up its acquisition of Karuna Therapeutics with the announcement straight after Christmas that it’s also buying radiopharmaceuticals-focused RayzeBio for cash.

BMS unwraps $14B deal for Karuna, adding a schizophrenia drug awaiting FDA OK

December 22, 2023 / Karuna Therapeutics / Bristol Myers Squibb / Mergers & Acquisitions / Biotech Deals

Christmas has come early for Karuna Therapeutics’ shareholders. Bristol Myers Squibb has unwrapped a $14 billion deal to acquire the biotech, which sits on the cusp of having the first schizophrenia treatment approved in years.

Cytokinetics’ heart failure drug improves exercise capacity, sending shares soaring in long-awaited win

December 27, 2023 / Cytokinetics / Heart Failure / Cardiomyopathy / Heart Disease

Cytokinetics’ Christmas wish has come true. Cardiomyopathy treatment aficamten has improved exercise capacity in a pivotal phase 3 trial, sending the biotech’s shares soaring by more than 50% in pre-market trading Wednesday.

Astra Boosts Push Into China Biotech Scene With $1.2 Billion Buy

December 17, 2023 / AI / Investment / Medical Devices

AstraZeneca Plc agreed to acquire Chinese cell therapy developer Gracell Biotechnologies Inc. for as much as $1.2 billion as the British drug giant steps up efforts to tap pharma innovations from China’s burgeoning biotech industry.

// Legal & Regulatory

FDA Prepares for High Court, Final Rule Moves in Election Year

December 28, 2023 / FDA / Regulate / High Court

The nation’s food and drug regulator is set to move forward in 2024 on long-awaited rules and guidances, spurred on by an election year that comes amid a legal battle at the US Supreme Court over the agency’s actions.

It’s time FDA and CISA update their medical device agreement, says GAO

December 28, 2023 / FDA / CISA / Medical Devices

GAO said in a summary released along with the December 21 report that it interviewed 25 non-federal entities representing healthcare providers, patients and medical device manufacturers to learn how they are challenged to access federal cybersecurity support for medical devices and then how agencies are addressing the challenges.

FDA Issues Alert to Mitigate Risks to a Widely Used Allergy, Nausea Drug

December 28, 2023 / FDA / Allergy Drug

The FDA communication covers promethazine hydrochloride, a medicine approved for managing allergic reactions, motion sickness, and post-operative nausea and vomiting. It’s also used as a sedative or as an adjunct to analgesics.

Samsung Bioepis receives clinical trial suspension for violation of MFDS regulatory requirements

December 22, 2023 / Samsun Bioepis / MSDS / Clinical Study

The Korean Ministry of Food and Drug Safety (MFDS) has imposed an administrative penalty on Samsung Bioepis for violating regulatory requirements in conducting a clinical study. This penalty is equal to a 1.5-month suspension of clinical trials for SB15-3001, an aflibercept biosimilar for neovascular age-related macular degeneration (nAMD).

NewYork-Presbyterian pays $300K to settle NY pixel tracking case

December 28, 2023 / New York / Health System

NewYork-Presbyterian Hospital will pay $300,000 for its use of third-party tools that disclosed the protected health information of people who visited its website, New York AG Letitia James said on Dec. 27.

// Research & Development

Oncternal Therapeutics reports patient death in CAR-T dose-escalation study

December 28, 2023 / Oncternal Therapeutics / B-cell Lymphoma / Blood Cancer / Patient Death

Oncternal Therapeutics has reported the death of a patient in a clinical trial following an elevated dose of its autologous CAR-T therapy aimed at aggressive B-cell lymphomas.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

December 26, 2023 / Jemincare / Clinical Trials / FDA

Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer, kidney and anti-infectious diseases, including 4 approvals from National Medical Products Administration (NMPA) and 2 approvals from the U.S. Food & Drug Administration (FDA).

Renamed, common liver diseases might get fairer shake at treatment, researchers hope

December 28, 2023 / Liver Disease / New Research / NAFLD / MASLD

A group of over 200 physicians, public health experts, industry representatives, regulatory officials, and patient advocates made the call in a supermajority vote: Non-alcoholic fatty liver disease, or NAFLD, would be renamed metabolic dysfunction-associated steatotic liver disease. MASLD for short (pronounced MAA-zuld).

Medicaid Spending on Prescriptions Has Risen Despite Lower Utilization

December 28, 2023 / Medicaid / Drug Costs / Prescriptions

The KFF report relied on 2016 to 2022 State Drug Utilization Data, as well as CMS-64 Financial Management Reports from fiscal year 2017 to fiscal year 2022. It comes as states unwind the continuous enrollment provision, which prevented states from disenrolling Medicaid enrollees during the Covid-19 public health emergency. Because of the continuous enrollment provision, Medicaid and CHIP enrollment reached historic highs, peaking at 94.5 million people in April. This represents an increase of 23.1 million people from 2020.

Cytokinetics Heart Drug’s Trial Data Look Competitive With BMS Med Camzyos

December 27, 2023 / Cytokinetics / Cardiovascular / Drug Trial / Bristal Myers Squibb / Phase 3

An experimental Cytokinetics drug has Phase 3 data showing it improved the ability of the heart to work during exercise. In addition to meeting this main goal of its pivotal test in a rare cardiovascular disease, the results look competitive with a Bristol Myers Squibb product already on the market.

// Politics

Cutting-edge drugs could vanish under Biden’s unprecedented move to seize patents

December 28, 2023 / White House / Biden / Innovations / Prescription Drugs

Such an aggressive use of federal power may tackle high-priced prescription drugs that frustrate Americans, but critics warn that Mr. Biden could end up preventing the creation of advanced medications.

The year in opioid settlements: 5 things you need to know

December 26, 2023 / Opioid Settlements / Opioid Crisis

This year, about $1.5 billion has landed in state and local government coffers from court settlements made with more than a dozen companies that manufactured, sold, or distributed prescription painkillers and were sued for their role in fueling the opioid crisis.

Chinese Spy Agency Rising to Challenge the C.I.A

December 27, 2023 / CIA / China / AI

The Chinese spies wanted more. In meetings during the pandemic with Chinese technology contractors, they complained that surveillance cameras tracking foreign diplomats, military officers and intelligence operatives in Beijing’s embassy district fell short of their needs.

How Virginia is spending money won in court to fight the opioid crisis

December 27, 2023 / Cytokinetics / Opioid Crisis

In 2021, lawmakers created the Opioid Abatement Authority, a state agency to oversee the distribution of more than $500 million that the state expects to recieve from companies like Walgreens, CVS, Purdue Pharma, and others involved in making or distributing opioid pills.

In 2023 fentanyl overdoses ravaged the U.S. and fueled a new culture war fight

December 28, 2023 / Overdose / Fentanyl Crisis

When the history of the fentanyl crisis is written, 2023 may be remembered as the year Americans woke up to an unprecedented threat scouring communities – and a deepening cultural divide over what to do about it.