Novartis cancels Beigene partnership as cancer drug gains EU approval

The terminated deal leaves Novartis without a PD-1 inhibitor nine years after Merck’s Keytruda won its first approval.

Startup Airna emerges from stealth to bring RNA editing to a rare disease

Airna is one of several biotechs that have set their sights on alpha-1 antitrypsin deficiency in recent years, with competitors such as AlveoGene, Wave Life Sciences and Arrowhead Pharmaceuticals.

PBMs, PhRMA trade blame over drug costs in House hearing

Pharmacy benefit manager lobby PCMA and drugmaker lobby PhRMA pointed fingers over problems in the prescription supply chain during the House committee's second hearing on the PBM industry.

Histogen plans to wind down operations after failing to find a partner

All but two employees will be gone by Sept. 30 as the company seeks shareholder approval for a dissolution plan.

Kinnate lays off 70% of staff, reorganizes pipeline

The company is restructuring its workforce and discontinuing programs, including its monotherapy combination of its drug exarafenib with Pfizer’s Mektovi. 

FDA panel backs Alnylam drug despite doubts over benefit

“There is a light wind for benefit, and no wind for risk,” said one adviser who voted with eight others to recommend the biotech’s drug Onpattro for cardiomyopathy of ATTR amyloidosis.

Updated Sept. 14, 2023

UK biotech AlveoGene launches with plans for inhaled gene therapy

The company is working on a treatment of alpha-1 antitrypsin deficiency, which it claims it can deliver direct to lung cells via a nebulizer.

CDC endorses new COVID boosters as focus turns to rollout

This fall will now feature vaccination campaigns for COVID-19, influenza and respiratory syncytial virus.

Akili cuts 40% of workforce, plans shift to non-prescription model

The digital therapeutics company expects to extend its cash runway into 2025 with the changes.

2Seventy CEO Leschly to step down as company cuts staff, spending

Citing “near-term headwinds,” the cancer cell therapy developer will lay off 176 employees and pare back spending.

After IPO success, Acelyrin hits trial setback with inflammation drug

Acelyrin’s share value collapsed Tuesday after its lead drug fell short in the company’s first big trial test since it raised $540 million in a May IPO.

Actio, a precision medicine startup, launches with $55M and a mouse lab partnership

The two-year-old San Diego biotech is allied with The Jackson Laboratory to engineer better mouse models of the rare diseases it plans to target.

With latest fundraise, Rome Therapeutics works to drug the ‘dark genome’

Johnson & Johnson and Bristol Myers Squibb have joined a group of new investors backing Rosana Kapeller’s startup, which launched in 2020 after incubating with GV.

Bausch + Lomb seeks funding for eye drug acquisition from Novartis

Fitch Ratings called the deal to buy the Xiidra treatment “strategically sound” even as the company’s plan for funding the deal would increase its leverage.

Ex-Sanofi executive Sibold joins Madrigal as new CEO

Bill Sibold will replace Paul Friedman as head of the NASH drug developer as it attempts to win approval of what could be the first medicine for the liver disease. 

New startup Arialys takes aim at the immune system, hoping to create neuropsychiatry drugs

Arialys Therapeutics launched Tuesday with $58 million in funding from a group of life sciences investors that includes Johnson & Johnson’s venture arm.

Daiichi Sankyo, with new data, to seek FDA approval of lung cancer drug

The HER3-targeting treatment could become the next antibody-drug conjugate to emerge from Daiichi Sankyo’s laboratories, after the AstraZeneca-partnered Enhertu.

FDA approves updated COVID boosters from Pfizer, Moderna

Pfizer and Moderna, which have seen slowing demand for their coronavirus vaccines, expect their reformulated shots will soon be available in the U.S.

Novartis stops work on gene therapy acquired in Gyroscope deal

The decision follows a review by a trial monitoring committee, which concluded data for the geographic atrophy treatment didn't support further development.

AstraZeneca, seeking new drug targets, taps a genomics biotech and its AI technology

The deal will give the pharma’s Alexion unit access to Verge Genomics’ platform, which uses human tissue data to find drug targets for diseases that degrade the nerve system.

In advocates’ push for superbug funding, ‘$6 billion is nothing’

The PASTEUR Act could be heading for another setback, but advocates say they see a future for funding research into antimicrobial resistance.

Otsuka partners with Shape in deal to design eye gene therapies

Shape uses machine learning and high throughput screening to identify new AAV capsids in ways the company’s CEO compares to the generative AI tools Midjourney and DALLE-2.

Manufacturing delays under-the-skin Tecentriq shot in US

Roche says it won’t be able to launch the subcutaneous version of the drug until 2024 as it works with the FDA on manufacturing updates.

Seagen partners with Nurix to create new kind of cancer drug

The alliance, which aims to combine Seagen’s antibody expertise with Nurix’s targeted protein degradation research, comes as the larger biotech awaits its acquisition by Pfizer to close. 

Alnylam says hypertension drug succeeded in mid-stage study

The trial found two higher doses of Alynlam’s RNAi therapy lowered blood pressure better than placebo. But analysts say results from a different study will be more important for the drug’s future.