Novo Nordisk is rumored to be considering laying off up to 3,000 staff and dropping its long-term financial targets due to challenging US market conditions which the group flagged in its first-quarter update in May.

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Esperion reported positive results from the third of five Phase III studies expected to read out this year, but data for a bempedoic acid/ezetimibe fixed-dose combo expected in August may be the key to the drug's commercial future.

After delays caused by two complete response letters, AstraZeneca’s Lokelma has been approved in the US with label benefits over its major competitor, Vifor Pharma’s Veltessa.

It has taken a while and there were concerns that another trial may be needed before approval but AndexXa has got the green light in the US as a reversal agent for Eliquis and Xarelto. It comes with a warning and post-marketing commitments but Portola has very high hopes.

On top of concerns about safety, which could present regulatory hurdles, bempedoic acid is likely to face a tougher competitive environment after the decline in PCSK9 inhibitor pricing.

Positive results for the Swiss major's oral therapy suggests that Biogen and Ionis' monopoly of the lucrative spinal muscular atrophy market with Spinraza could soon be under considerable threat.

Unlike the migraine space, there is only one competitor for Teva's CGRP inhibitor in cluster headaches, but that opportunity narrowed with fremanezumab's failure in chronic cluster headaches, though a trial in episodic cluster headaches is ongoing.

Amid multiple industry drug failures in the sector, Eisai is opening a new US research facility to discover innovative therapies for dementia based on a long-standing immunology hypothesis.

Japan’s Shionogi has gained selected Asian rights to Sage’s promising fast-acting depression drug, in a deal worth up to $575m to the US company.

The failure of BACE inhibitor lanabecestat was the latest setback in Lilly's Alzheimer's pipeline, but the company has been working in this area with almost no success for decades, yet still feels a commitment to keep trying, Lilly Research Labs President Daniel Skovronsky tells Scrip.

The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.

Hans Bijlsma, president of the European League Against Rheumatism, tells Scrip about the progress being made in rheumatic and muskuloskeletal diseases, the areas where more innovation is needed and the importance of early treatment, both clinically and financially.

South Korean biosimilars companies Samsung Bioepis and Celltrion presented new study results, designed to increase overall switching rates away from the branded originator therapies and address prescriber concerns as well as improve administration convenience, at the European League Against Rheumatology (EULAR 2018) held June 13-16 in Amsterdam, Netherlands.

Novartis immunology chief Eric Hughes tells Scrip a wealth of data is showing that early treatment with Cosentyx can prevent the structural changes that lead to lack of mobility in ankylosing spondylitis and psoriatic arthritis patients.

Calliditas is aiming to raise new funding in an IPO and listing on Nasdaq Sweden to support late-stage clinical development and commercialization of its Berger's disease candidate, and studies in additional indications.

A couple of weeks after the setback of getting a worse-than-expected label from the FDA for Olumiant in rheumatoid arthritis (RA), Lilly has some strong Phase II data banked for its JAK inhibitor in lupus.

ViiV CEO predicts strong pipeline and two-drug strategy will reinforces group's HIV market position and put it ahead of Gilead by the mid-2020s.

Emerging Company Profile: ENYO Pharma has been around for barely four years, but it is already advancing its lead programs into Phase II trials in hepatitis B and NASH, and anticipates many more uses for its virology-based platform that will go way beyond treating virus infections.

Presenting Phase IIb data on FLU-v, specialized CRO hVIVO now hopes to secure a big pharma partner for Phase III studies and commercialization of the universal flu vaccine candidate. The product has been developed in a joint venture with SEEK.

ViiV Healthcare has positive early pivotal data for its second two-drug regimen for HIV, but more reassurance is needed on the relative rates of virologic suppression in patients with low and high viral loads, as well as on the long-term risk of virologic failure. The combination should help form ViiV's defense against rival Gilead and its new triple combination Biktarvy.

Company will focus on getting oral anti-fungal candidate VL-2397 over the finish line, after another pipeline blow-up.

PacBio and Wellcome Sanger Institute tell Scrip why they've teamed up to decode genomes of more than 3,000 bacteria, including some of the world's most dangerous, and how it will help fight AMR and bioterrorism.

Boehringer Ingelheim’s US business development head Ioannis Sapountzis outlines BI’s efforts to catch up with competitors in NASH and immuno-oncology via early-stage partnerships and licensing deals.

Among other debates at the American Diabetes Association annual meeting, clinicians will discuss the future of cardiovascular outcomes studies for diabetes drugs – whether they should maintain course or are due for an overhaul.

The Israel-based biopharma company said a Phase IIb trial of its oral treatment of non-alcoholic steatohepatitis hit the necessary endpoints to support a Phase III trial and FDA marketing application.

Novo Nordisk is rumored to be considering laying off up to 3,000 staff and dropping its long-term financial targets due to challenging US market conditions which the group flagged in its first-quarter update in May.

Faster relief of debilitating menopausal symptoms in early-stage clinical trial results suggest a potential new class of products being evaluated by UK biotech KaNDy Therapeutics may be useful against the condition.

Madrigal reports data showing that MGL-3196 resolved non-alcoholic steatohepatitis and improved key secondary measures, data that suggest a better effect than other NASH candidates.

Boehringer Ingelheim’s US business development head Ioannis Sapountzis outlines BI’s efforts to catch up with competitors in NASH and immuno-oncology via early-stage partnerships and licensing deals.

An oversubscribed financing round led by new US investor MPM Capital has brought in $75m for the Belgian company. Much of it will be used to advance its potential best-in-class adenosine A2A receptor now that its IDO1 drug has been shelved.

By picking up the rest of Foundation Medicine, which is now valued at $5.3bn, the Swiss giant is expanding its leadership in cancer diagnostics, genomics and molecular information for personal medicine.

China approves first immuno-oncology drug in the form of BMS’s Opdivo for lung cancer, opening up a new potentially huge market for the class, but much will depend on pricing and reimbursement policies.

Emerging Company Profile: IGEM Therapeutics has been spun out of King's College London to evaluate the use of IgE-based monoclonal antibodies for the treatment of cancer, including difficult-to-reach solid tumors.

The tumor mutational burden biomarker had a much higher profile at this year's ASCO meeting, promising to help target treatment to individuals, though practical barriers remain and testing still is not ready for prime time yet.

Presenting Phase IIb data on FLU-v, specialized CRO hVIVO now hopes to secure a big pharma partner for Phase III studies and commercialization of the universal flu vaccine candidate. The product has been developed in a joint venture with SEEK.

FDA alerted Mylan to expect a complete response letter related to its ANDA for generic Advair. The company said it still could receive an approval prior to the standard 90-day time period after responding to the letter, because the application has a priority designation.

With financing in place, Verona will next start a Phase II study of nebulized RPL554 added onto LABA/LAMA or triple therapy as a maintenance treatment for COPD patients - and then move to the crucial Phase III program.

It is curtains for AstraZeneca's asthma therapy Fasenra as a COPD treatment after the failure of the TERRANOVA trial, which could be good news for GSK's fellow interleukin-5 drug Nucala, despite the latter's own mixed Phase III data.

Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.

Several biologic drugs are now available for the 10% of asthma patients with severe uncontrolled disease, and Dupixent could join them later this year, setting the therapy area up for a competitive showdown.