Business Strategy

Data from SHORELINE’s 50mg cohort sparked mixed opinions from analysts, with some suggesting they still showed a risk-benefit profile that could challenge the drug commercially.

VBI Vaccines obtained FDA approval of its three-antigen hepatitis B vaccine PreHevbrio and will take on GSK’s Engerix-B and Dynavax’s Heplisav-B as CDC recommends universal HBV immunization.

As well as buying Origimm, the French giant will also apply its mRNA vaccine platform, acquired through the recent $3.2bn acquisition of Translate Bio, to discover and develop other acne vaccines, aided by the Vienna-headquartered firm's know-how in the field.

The response rate, with five complete responses, exceeds known responses to standard-of-care chemotherapy in heavily pre-treated folate receptor alpha-high patients. A US FDA filing is on track for early 2022.

PI3K-delta inhibitors have often suffered from safety and tolerability issues, but Phase II data show higher efficacy and lower discontinuation rates for zandelisib than others in the class.

After investing more than €23m in Sanifit, the Spanish firm being acquired by Vifor Pharma, Caixa Capital's director of life sciences investments spoke to Scrip about the venture capital firm's long-term approach.

Executives from J&J, Pfizer and Johns Hopkins share ideas on driving Indian biopharma innovation via innovation centers and incubators set up in association with academic institutions. On the other side of the table, Indian academia highlights the need for industry participation in skill building and the perils of ‘targeted thinking’

A regulatory filing for Vyjuvek in the US is targeted for the first half of 2022 following the positive results of a Phase III trial, positioning Krystal for its first commercial launch.

Lengo’s preclinical LNG-451, along with Blueprint’s BLU-945 and BLU-701, could create a portfolio of therapies covering 97% of non-small cell lung cancer cases involving EGFR exon mutations.

The VMIC has neither confirmed or denied to Scrip a report from the Financial Times that the project, which has received many millions of taxpayer money, is about to be sold off privately, with Oxford BioMedica mentioned as a potential bidder. 

The London-based biotech is hoping to turn the dream of liver organ transplant without the need for lifelong immunosuppression into reality.

In this week's podcast edition of Five Must-Know Things: the prospects and plans for J&J’s pharma and oncology business; China looks more inward under new policies; an important US approval for Takeda; and Moderna’s co-founder shares tips on innovation.