Fierce Biotech

A new, late-phase analysis of the cholesterol-lowering inclisiran—a PCSK9 drug picked up by Novartis through its $9.7 billion acquisition of The Medicines Company—showed that it was able to cut LDL levels by 51% after nearly a year-and-a-half of treatment.

Abbott is launching a rapid coronavirus test able to deliver positive results in as little as five minutes, from a table-top box the size of a small toaster oven.

After teasing positive top-line results last November, a deeper dive into Merck & Co. and Bayer’s heart failure drug vericiguat helped kick off this year’s scientific meeting of the American College of Cardiology, presented virtually as a late-breaking trial.

Demand for critical medical supplies continues to rise, as does the number of COVID-19 cases, and 3D printers have been seen as a way to help bolster manufacturing capabilities, wherever it is needed. Now, the FDA will be working with government and public-private partners to distribute and evaluate 3D designs and models, in a bid to provide desperately needed hardware and parts.

Scientists at the University of Wisconsin - Madison are proposing a new approach to preventing Type 1 diabetes: by deleting a gene in insulin-producing beta cells that controls the response to stress. When they removed the gene, called IRE1-alpha, in mice engineered to be susceptible to the disease, the beta cells produced insulin normally and evaded attack from the immune system.

Vertex is keeping mum on exact details but, as with the rest of its biopharma peers, is seeing trial disruption due to the COVID-19 pandemic.

A who’s who of leading biopharma companies have joined forces to strengthen the drug industry’s response against the COVID-19 pandemic. Companies including Novartis and Pfizer are contributing to the joint response through actions including the sharing of proprietary compound libraries.

The FDA has expressed an openness to using virtual advisory committee meetings to mitigate the restrictions on face-to-face interactions imposed by COVID-19. However, that openness is yet to translate into action, with the FDA delaying meetings to discuss submissions by GlaxoSmithKline and Intercept Pharmaceuticals rather than having people participate remotely. 

In March, the FDA urged biopharmas and CROs to take a virtual approach to clinical trials in reaction to COVID-19 and the attempt to slow its spread.

The U.K.’s major biomedical body, the NIHR Clinical Research Network, is shutting down in the midst of the growing COVID-19 epidemic in the country.

Here comes another mRNA vaccine against the novel coronavirus. In its second partnership in the COVID-19 space, Sanofi is expanding its infectious disease pact with Translate Bio to include work on a new vaccine for COVID-19. The duo will to discover and develop “a number of” vaccine candidates against the new coronavirus.

The FDA issued a wide-ranging emergency policy allowing alternative devices to be used as potentially lifesaving ventilators as shortages begin to impact hospitals’ responses to the coronavirus pandemic.

In this week's EuroBiotech Report, U.K. government backs COVID-19 vaccine trial, Ipsen scraps pivotal trial and AstraZeneca inks siRNA deal.

Expanding the reach of its digital therapeutic programs from substance abuse disorders to insomnia, Pear Therapeutics has received a new FDA clearance for its neurobehavioral app aimed at chronic sleeplessness.

In our EuroBiotech roundup this week, Evox lands Takeda deal, Synairgen raises cash for COVID-19 trial and AstraZeneca expands Schrödinger pact.  

Pfizer has paused enrollment in many new and ongoing clinical trials in response to the COVID-19 pandemic, Reuters reports. The action sees Pfizer join Bristol Myers Squibb and Eli Lilly on the list of Big Pharma companies to revise their R&D plans in light of the novel SARS-CoV-2 coronavirus.

Despite the strong anti-cancer effects of PD-1/L1 inhibitors, many patients still don’t respond to these drugs, which work by lifting the brakes tumors use to evade immune attacks. Scientists at Scholar Rock found that selectively targeting TGF-beta1 growth factor with its investigational drug SRK-181 could overcome resistance to checkpoint inhibitors.

Urovant snags Astellas exec Robinson as CEO; Viracta poaches Nordic Nanovector CMO Rojkjaer; Epizyme brings on Kutok as CSO.

Ipsen has terminated a pivotal trial of its troubled rare disease drug palovarotene in response to the ongoing clinical hold. The action likely deprives Ipsen of a shot at generating data to bring a drug it bought in a $1.3 billion (€1.2 billion) deal to market in a blockbuster indication.

Lisa Rojkjaer, M.D., has been named Viracta’s new chief medical officer as Nordic Nanovector adds interim replacement.