Tag: Pharmaceuticals

December 1, 2023

The agency is due to deliver a verdict on the combination by 9th May next year and, if approved, it could be an alternative to first-line chemotherapy for all patients with this form of cancer. Nectin-4-targeting antibody-drug conjugate Padcev (enfortumab […]

November 30, 2023

Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf, who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency. “As principal deputy commissioner, […]

November 28, 2023

Results from the trial show potential for developing an advanced cell therapy treatment for the condition. Affecting around two million people globally, MS is a neurodegenerative condition that affects the brain and spinal cord. Around two-thirds of people with MS […]

November 21, 2023

Evinova will aim to better meet the needs of healthcare professionals, regulators and patients. The new healthtech business aims to bring to market established and scaled digital technology solutions which are already used globally by AZ, to pharmaceutical, biotechnology and […]

November 21, 2023

Caraway raised a small Series A round of $23 million in 2018, backed by several pharmaceutical venture arms, including Merck’s. At the time, the company went by the name of Rheostat Therapeutics. It rebranded to Caraway one year later, but […]

November 20, 2023

In biopharma manufacturing, there is a fine line between being data rich and information poor. Sites are filled with disparate systems, increasing the potential for siloed data. But since data is so key, biopharma companies must find better ways to […]

November 20, 2023

Last month, Bristol Myers delivered unwanted news, telling investors that sales of new drugs it’s counting on this decade will grow more slowly than expected. One of the chief culprits for that guidance shift was Abecma, sales of which dropped […]

November 17, 2023

Plasmid DNA is a critical raw material that is required for the manufacturing of virus-based gene therapy and gene-modified cell therapies. The current challenges with the supply of plasmid DNA varies depending on its end use, but usually production capacity, […]

November 16, 2023

The arrival of immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo transformed the treatment of lung cancer. But for patients with uncommon mutations like ROS1, ALK, KRAS and EGFR, targeted drugs are a first choice for physicians. The […]

November 15, 2023

The two companies say their partnership could unlock access to millions of customers across a network of more than 550 Chemist Warehouse retail locations in Australia and other countries including New Zealand, Ireland and China, as well as its online […]

November 15, 2023

Aliqopa (copanlisib) was given accelerated approval by the FDA in 2017 as a third-line treatment for adults with relapsed FL, a form of non-Hodgkin lymphoma (NHL), based on response rate data from the phase 2 CHRONOS-1 study. The CHRONOS-4 trial […]

November 14, 2023

The VVPs are a result of collaboration between several pathogen and vaccine experts. Led by the Product Development and Research (PDR) team in WHO’s immunisation, vaccines and biologicals department, the aim of the VVPs is to advance the development of […]

November 14, 2023

Netherlands-based biotechnology company VectorY Therapeutics has raised 129 million euros, or $138 million, to fund development of brain disease drugs. The Series A financing, announced Monday, was co-led by venture capital firm Forbion and European investor EQT Life Sciences, alongside […]

November 13, 2023

Pandemic-era changes may have permanently altered the clinical trial landscape as decentralized clinical trials gain broader acceptance. During COVID-19, more than three-quarters (76%) of pharmaceutical companies, device manufacturers and contract research organizations conducted off-site clinical trials. These types of trials […]

November 10, 2023

In a sign that suggests many American parents have become dubious about the safety of childhood vaccines, new government data shows that immunization exemptions for kindergartners have reached their highest levels ever. The latest statistics continue a decline in routine […]

November 10, 2023

The first vaccine to prevent infection with the chikungunya virus was approved by the U.S. Food and Drug Administration on Thursday. The single-dose shot, known as Ixchiq, is approved for adults who are at increased risk of exposure to the […]

November 8, 2023

The drugs targeted by FTC are largely older products that have retained some market power because competitors can’t easily duplicate their effectiveness when combined with a specialized delivery device. “Wrongfully listed patents can significantly drive up the prices Americans must […]

November 8, 2023

The Food and Drug Administration on Wednesday approved a powerful new medicine for weight loss, clearing Eli Lilly’s Zepbound for adults with obesity or who are overweight and have at least one related health condition. The drug, which was already […]

November 7, 2023

AVB-101 will now benefit from the FDA’s fast track process, which is designed to improve the efficiency of product development and accelerate the review of treatments for serious conditions. FTD, a form of early-onset dementia, is the leading cause of […]

November 3, 2023

On Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL17A), […]