California

California Lawmaker Introduces Bill to Keep Rural Hospitals From Closing as They Work to Meet Seismic Compliance

A California lawmaker recently introduced legislation designed to keep the state’s small and rural hospitals from closing as they work to meet seismic safety compliance requirements. The bill would require California’s Department of Health Care Access and Administration to provide grant funding to small and rural hospitals so they can achieve compliance amid times of severe financial distress.

By Katie Adams

BioPharma, Devices & Diagnostics

FDA Authorizes First Covid-19 and Flu Test, But Its Maker Files for Bankruptcy

Lucira Health now has the first FDA authorized diagnostic that detects the novel coronavirus and influenza in a single test. But the regulatory decision comes too late for the diagnostics developer, which has filed for bankruptcy protection.

By Frank Vinluan

With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?

Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.

BioPharma, Pharma

AbbVie Pays Capsida $70M to Expand Gene Therapy Alliance to Eye Diseases

AbbVie and Capsida Therapeutics are expanding their gene therapy R&D alliance to the eyes. Capsida is in line to receive $70 million now and up to $595 million later, depending on the progress of the eye programs.

By Frank Vinluan

Legal

California lawsuit targets insulin costs as Biden also takes aim in SOTU

High prices have drawn other critics, as well, including President Joe Biden. He renewed his call for a broad price cap during his annual State of the Union address. Pharma companies insist they have been part of the solution.

By Joel Berg

BioPharma, Pharma

Gilead Sciences Drug Wins FDA Approval in Most Common Type of Breast Cancer

Gilead Sciences drug Trodelvy is now approved for treating patients whose breast cancer is classified as HR positive and HER2 negative, expanding use of the drug to a much wider group of patients. In other regulatory approval news, use of a Takeda Pharmaceutical rare disease drug has expanded to younger children.

By Frank Vinluan

BioPharma, Artificial Intelligence

Nvidia’s AI Tech Designs Proteins Never Seen in Nature, Pointing Way to New Therapies

A collaboration between Nvidia and startup Evozyne was able to produce novel versions of a human protein never before seen in nature but with enhanced function and the same safety as native protein. The research lays the groundwork for potential new therapies for a rare inherited disorder.

By Frank Vinluan

BioPharma, Pharma

Scripps Spinout Belharra Unveils $130M to Catch Next Big Wave of Drug Discovery

Versant Ventures-backed Belharra Therapeutics has launched with $130 million in funding and a partnership with Roche subsidiary Genentech. The startup’s technology analyzes proteins in the context of the entire cell, enabling it to discover molecules that bind to targets previously deemed undruggable.

By Frank Vinluan

BioPharma, Pharma, Legal

Claiming Insulin Price Conspiracy, CA Sues Lilly, Novo Nordisk, Sanofi & PBMs

California's Office of the Attorney General contends that drugmakers and pharmacy benefit managers work together to “aggressively raise the list price of insulin in lockstep with each other to artificial levels.” Insulin manufacturers deny the allegations, pointing to availability of lower-cost versions of their products.

By Frank Vinluan

BioPharma, Pharma

Eli Lilly Turns to Startup Capsida to Bring Gene Therapy Into the Brain

Eli Lilly is paying $55 million up front to begin an alliance with Capsida Biotherapeutics pursuing gene therapies for central nervous system disorders. Capsida’s technology enables the delivery of a gene therapy to a single organ or multiple organs, a capability that could bring such treatments to a wider range of diseases.

By Frank Vinluan

BioPharma, Pharma

Gilead Sciences Kicks Off 2023 With New Autoimmune Disease Alliance

Gilead Sciences is building up its autoimmune disease drug pipeline by turning to EVOQ Therapeutics, a startup with technology that takes a novel approach to restoring immune tolerance. For EVOQ, the Gilead deal is its second with a big pharma company.

By Frank Vinluan

Health Services

Maximize Revenue and Patient Care with Strategic Weight Loss Management

We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.

By Build My Health and MedCity News

BioPharma, Pharma

Atara Approval Marks Cell Therapy First; Entrada on Hold, Bluebird Freed & More

The first regulatory approval of an allogeneic cell therapy goes to Atara Biotherapeutics. Other regulatory news highlights from the past week include proposed reforms of the FDA’s accelerated approval process, approval of the first gene therapy for bladder cancer, and a clinical hold for a biotech developing a new class of medicines.

By Frank Vinluan

BioPharma, Pharma

Amgen to Buy Horizon Therapeutics for $28B, Edging Out Sanofi in Bidding War

Sanofi submitted the first unsolicited offer to acquire Horizon Therapeutics, but Amgen ultimately won what became a competitive bidding process. Amgen says Horizon's drug lineup complements its own portfolio of autoimmune and inflammatory disorder products.

By Frank Vinluan

BioPharma, Pharma

Gilead Sciences Gets a Shot at Next-Gen Cell Therapy With $325M Arcellx Alliance

In partnering with clinical-stage Arcellx, Gilead Sciences gains the opportunity to develop a cell therapy for multiple myeloma that could offer advantages over currently available therapies for the blood cancer. The deal announced Friday came as Arcellx reported additional data during the annual meeting of the American Society of Hematology that showed continued durability of the cell therapy.

By Frank Vinluan

BioPharma, Pharma

Amgen Weighs In to Chase Rival Obesity Drugs From Novo Nordisk and Eli Lilly

An Amgen drug led to weight loss that was sustained, clinical data that support advancing the molecule to a Phase 2 test expected to start in early 2023. While AMG 133 trails rival products from Novo Nordisk and Eli Lilly, Amgen hopes to offer patients a dosing edge.

By Frank Vinluan

BioPharma, Startups

With Secreted Proteins Map, Juvena Finds Path to $41M for New Regenerative Meds

Juvena Therapeutics is developing secreted protein drugs built on new knowledge gleaned from proprietary technology that maps these proteins and the tissues in the body where they offer a regenerative effect. The startup’s lead program is in development for the muscle disorder myotonic dystrophy type 1.

By Frank Vinluan