While Orphazyme's attempts to get approval for arimoclomol failed miserably, new owner KemPharm is confident it can get the oral heat shock protein amplifier across the regulatory finishing line for Neimann-Pick disease type C.

In light of the Russia-Ukraine conflict, Scrip looks at data to gauge if manufacturing partners for COVID-19 vaccine Sputnik V or Light, in India, China and Korea could be left holding unsold inventory earmarked for exports

Public Company Edition: Applied Molecular Transport, Scholar Rock, Agios and others join many of their peers in revising their strategies and downsizing their teams. Also, Zentalis grossed $200m from a follow-on offering and OKYO Pharma went public in the year’s smallest biopharma IPO in the US. 

Roche debuts ‘responsibly priced’ Phesgo in India. Will the dramatic reduction in treatment time for women with HER2 positive breast cancer and other benefits, including insurance coverage, trigger sharp shifts towards the subcutaneous fixed-dose combination of Perjeta and Herceptin?

Taiho will pay Cullinan Oncology up to $405m for their joint venture and lead candidate for a form of lung cancer. Plus deals involving Zhaoke/Visus, AnGes/Eiger, Juniper/Helsinn, Peak Bio and more.

The big pharma company and its new partner both expect demand to continue for pre-exposure prophylaxis antibody therapies, for COVID-19 and beyond.

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

Lecanemab is now filed for accelerated approval with the US FDA, but the wait for a Phase III readout could impact the hunt for Biogen’s next CEO.

Aduhelm commercialization was a bust, so Biogen’s next big hope for a potential blockbuster Alzheimer’s therapy is partner Eisai’s amyloid protofibril-targeting antibody lecanemab. 

Junshi’s oral antiviral shows signs of effectiveness in treating patients with mild COVID-19 symptoms but more data are needed, caution researchers.

The company announced positive topline results for the drug in night vision disturbance and may conduct another pivotal trial as it focuses on myadriasis and presbyopia.

The US biotech’s RSV treatment candidate has failed a Phase II study in low-risk patients leaving some experts skeptical of its hopes for potential improved performance in a high-risk setting.