How do you send 90,000 employees home and still bring a COVID-19 vaccine to market in record time? Pfizer showed the way and at a recent virtual event, senior vice-president Robert Brown revealed how the "secret sauce" of digitalization continues to help cut medical legal review times, crunch clinical trial duration and reduce service interruptions.

The UK firm with a presence in Boston has just emerged but Pheon’s CEO Bertrand Damour tells Scrip that big pharma is already showing interest in its next-generation antibody-drug conjugate.

The first gene-edited therapy will be submitted for sickle cell disease and transfusion-dependent beta thalassemia; it will compete with bluebird in both indications, but analysts anticipate blockbuster sales in excess of $2bn.

Deal Snapshot: CRISPR-Cas9 co-inventor Jennifer Doudna-founded gene-editing firm inks its second large collaboration, teaming with Sanofi on off-the-shelf natural killer cell therapies for cancer.

Boehringer Ingelheim’s corporate senior vice president, head of global regions, Timmo Rousku Andersen, outlines at a recent summit the company’s reshaped approach to digital innovation and the need to entrench an execution bias to scale transformation initiatives.

GSK has poached its new chief financial officer from fashion brand Burberry, but Julie Brown’s experience at AstraZeneca and Roche will give her insights into how to lead GSK into its next phase.

South Korea moves to lay out clearer accounting guidelines related to R&D costs for pharma and biotech companies, making improvements to earlier official guidance in 2018 in order to ease uncertainties and help foster the sector.

Ponda Motsepe-Ditshego, who leads Amgen’s clinical trial diversity efforts, admits they are in early stages but noted progress internally and externally at better representing diverse patient groups.

After the Aduhelm controversy, Biogen has another neurodegenerative disease drug which so far can only show efficacy against surrogate biomarkers – will the FDA be swayed again this time?

Emerging Company Profile: US firm Peptilogics is advancing through the clinic with its lead orthopedic anti-infective drug candidate based on an AI platform that utilizes algorithms to improve peptide design.

Eisai and Biogen, who have an accelerated approval decision pending in the US, said they will seek traditional approvals for lecanemab by Q1 2023 based on positive results from the Phase III Clarity AD trial.

Biotech CEOs often express surprise when the FDA rejects their drugs. But collaborative interactions between regulators and drug sponsors count for little if the latter fail to adjust their clinical and regulatory efforts accordingly.