Atara Biotherapeutics Inc. received a complete response letter from the U.S. FDA for its lead product Ebvallo (tabelecleucel), a breakthrough therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease that is already approved in the EU, the U.K. and Switzerland. The CRL – which Atara said is “solely related to inspection findings at [a] third-party manufacturer” – took investors by surprise, with the company’s shares (NASDAQ:ATRA) plunging by 42%, or $5.51, to $7.64 in early trading Jan. 16. The unexpected development places 12-year-old Atara in a tight spot as the $60 million milestone payment tied to an approval from partner Pierre Fabre Laboratories is now delayed at best. The $42 million in cash, equivalents and short-term investments that the company has, as of the end of 2024, is dwindling; therefore, the company is seeking strategic alternatives by engaging a financial advisor. If a solution is not quickly found, Atara plans to suspend all CAR T activities outside of getting Ebvallo across the finish line.

46 NCEs, 28 biosimilars among 114 drugs cleared by EMA in 2024 

The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said Steffen Thirstrup, the EMA’s chief medical officer. “This figure definitely stands out,” Thirstrup said. “It is at least a signal that some of the negative impact of COVID-19, that may have created a downturn in the number of clinical trials and activity in the pharmaceutical industry, [has dissipated],” he told attendees of a conference call held to discuss 2024 drug approvals.

China deepens drug, device reforms, aims to be global powerhouse

China is deepening its regulatory reforms of drugs and devices to foster a globally competitive innovation ecosystem to transform China from a major pharmaceutical manufacturer into a global pharmaceutical powerhouse. Issued by China’s State Council, the reforms aim to create a unified national market by 2027. Goals include a stronger legal and regulatory framework for oversight of drugs and devices and more efficient review and approval processes.

Terns aiming for CML share with allosteric bid

The chronic myeloid leukemia (CML) space is percolating, as would-be challengers line up for Novartis AG, which first gained the FDA green light in October 2021 for allosteric tyrosine kinase inhibitor (TKI) Scemblix (ascinimab). Regulators granted an accelerated approval for adults with PH-positive CML in the chronic phase who already had been treated with two or more TKIs, based on major molecular response rate at 24 weeks. Secondly, the go-ahead was granted for adults with the same disease that also bears the T315I mutation. Among the firms presenting at the J.P. Morgan Healthcare Conference in San Francisco was Terns Pharmaceuticals Inc. with early stage allosteric prospect TERN-701.

New drugs with the same old resistance tricks?

According to the World Health Organization, multidrug-resistant pathogens caused over 1.27 million deaths worldwide in 2020. And figures are rising, with projections pointing to antimicrobial resistance surpassing cancer as the leading cause of death by 2050. Now, researchers at the HUN-REN Biological Research Centre have unveiled the role of pre-existing genetic variabilities and specific cross-resistance patterns among several antibiotics designed to combat gram-positive bacteria.

The BioWorld Insider podcast: a year of interviews and insights

The BioWorld Insider podcast is a monthly dive into the business and science of drug development. Conversations with CEOs and BioWorld analysts in the past 12 months have included a wide range of chats with experts who are shaping the future. Subjects included quarterly reviews for M&As and financings, the slow but steady growth of funding and partnering for therapies to treat women, the impact of artificial intelligence and quantum computing on drug development, rare disease drug development, the costs of delays in clinical trials, and an overview of the one of the year’s biggest conferences, the annual American Society of Clinical Oncology gathering in Chicago.

2024 BioWorld Year in Review

BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025.

2024 BioWorld MedTech Year in Review

BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as med tech forges ahead in 2025.

2024 BioWorld Science Year in Review

Taking a look back at the achievements in research this year, including brain maps, pandemic breakthroughs and advances in pregnancy health.

Also in the news

Actimed, Anavex, Azitra, Be Bio, Biogen, Eisai, Hinge, Inflammasome, Iongen, Johnson & Johnson, Kazia, Keros, Mission, Next Generation Gene, Novo Nordisk, Gensight, Glaukos, Orna, OS Therapies, Parabilis, Sen-Jam, Simnova, TNF, Urogen, Vanda, Zai Lab