ES: Public Company Edition: Fifty biopharma companies launched initial public offerings in the US last year and there have been 52 so far in 2020, including Metacrine, Dyne, Athira and COMPASS.

A composite endpoint conceals Actemra’s lack of mortality benefit – while life-saving dexamethasone gets EMA endorsement.

Moderna led by releasing the trial protocol for its COVID-19 vaccine study, followed by Pfizer, as industry faces demands for transparency.

Japanese ophthalmic specialist picks up young private US firm and gains a small but broad set of marketed products.

Strides is expanding its presence in synthetic injectables via a new company, SteriScience, while keeping its biologics injectables business under Stelis. A head start with existing IP assets and those from a new joint venture with Brooks Labs will enable the fledgling firm to file its first ANDA in fiscal 2021, with break-even seen in two years.

Dr Reddy’s combines forces with the Russian Direct Investment Fund for clinical trials and supply of Sputnik V in India, amid what it views as “very important” data points in early studies of the COVID-19 vaccine.

China is set to grant priority reviews to major biologics from Roche, the first CAR-T therapy from Wuxi Juno, and breakthrough therapy designation to a pediatric respiratory antiviral from ArkBio.

The Indian regulator says it is not considering emergency use authorization for COVID-19 vaccines before completion of clinical trials, a stand validated by AstraZeneca halting trials of its vaccine candidate due to an adverse event in UK. Meanwhile, India has signed up for Phase III trials of Russia’s vaccine candidate

Regulators in the US have approved Gavreto for metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, setting the stage for a head-to-head battle for market share with Eli Lilly's Retevmo.

Lorbrena is approved as a second-line treatment for ALK-positive NSCLC but Pfizer believes data from the first-line Phase III CROWN study makes the drug a serious competitor to standard of care Alecensa in the first-line setting.

A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.

Data show Opdivo/Cabometyx combo bests Sutent for overall and progression-free survival and response endpoints in first-line RCC. Exelixis CEO says comparison to Sutent is standard control and allows better comparison to other combo regimens.