Bayer opens its new cell therapy manufacturing facility as it prepares a Parkinson’s disease cell therapy for Phase 2 testing. The new 100,000 square foot facility also has space for manufacturing other cell therapies in the pharma giant’s pipeline.

Avalon BioVentures unveiled new portfolio company Arialys Therapeutics. The startup’s lead program, an antibody from Astellas Pharma, is a potential treatment for anti-NMDA receptor encephalitis (ANRE), a rare autoimmune inflammatory disorder.

Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.

Santa Clara Valley Healthcare in California has begun notifying 43,000 patients about their eligibility for billing corrections and refunds. The system’s patient outreach effort is a result of a recently settled lawsuit filed against Santa Clara County. In the complaint, former patients alleged the county did not inform them about its hospitals’ charity care and discount payment policies, leading them to have to pay large bills.

Novartis and Ionis Pharmaceuticals, already partners in cardiovascular disease R&D, are expanding their alliance to see if they can develop a next-generation therapy offering efficacy and dosing advantages. But competitors are already in the mix with programs addressing the same cardiovascular disease target.

Octave Bioscience, based in Menlo Park, California, just closed a $30 million extension to its Series B funding round.

Turnstone Biologics isn’t the only cell therapy biotech focused on tumor-infiltrating lymphocytes. With $80 million in IPO cash, it can continue clinical trials that could show whether its approach to TILs has advantages.

The FDA approved Roctavian for treating hemophilia A. The regulatory decision makes the BioMarin Pharmaceutical product the first gene therapy for this inherited bleeding disorder.

Healthcare dealmakers must prepare for a new law and a recently-introduced bill in the California Senate, both of which aim to increase oversight in the healthcare M&A space. This is a legislative trend other states are beginning to participate in too — such as New York, Massachusetts and Connecticut.

California lawmakers recently passed a bill that would provide interest-free cash loans to nonprofit and public hospitals undergoing significant financial distress. The loan program would provide up to $150 million in funds over the next couple years.

SR One’s new investment fund is its second one since spinning out of GSK in 2020. The firm says it now has more than $1.5 billion in assets under management.

BioMarin Pharmaceutical’s submission of additional data for patients treated with its hemophilia A gene therapy, Roctavian, mean that the FDA will push out a regulatory decision to early summer. But it could be worth the wait as analysts anticipate FDA approval and project Roctavian becoming one of BioMarin’s biggest products.

Cargo Therapeutics is developing CAR T-cell therapies that overcome ways cancers evade currently available treatments. True to its name, the startup’s approach involves putting more cargo and more complex cargo onto engineered T cells.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.  

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. 

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.

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.

Psychologists, therapists, social workers and chemical dependency counselors at Kaiser who are part of the National Union of Healthcare Workers voted 1,561 to 36 to approve the agreement reached between the company and the union. 

As of publication, nearly 2,000 Kaiser Permanente mental health workers still had to ratify the vote, and would participate in a two-day process to do so.