AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

The battle for PCSK9 inhibitor market share continues with Amgen’s Repatha outselling Praluent, but a now-ended patent dispute no longer threatens Regeneron’s ability to sell its product in the US.

Evkeeza is the first ANGPTL3 approved by the FDA; Regeneron scientists discovered the angiopoetin gene family.

Around 100 executives highlight the hot areas to watch on the R&D front in 2021. From cancer to CNS and from regenerative medicine to real world data, expectations are high on many fronts.

With an approval nod from the EMA’s scientific committee for its fish oil product Vazkepa, launch plans for the EU for this “multi-billion dollar” opportunity are on track, says Amarin CEO.

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

While the drug may be well-positioned for registrational development, some important caveats remain after mixed data in Phase II study cohorts.

Seeing significant unmet medical needs and insufficiently met needs in narcolepsy and rare types of epilepsy, Takeda has shifted its neuroscience focus.

Korea's AriBio is poised to file for US Phase III trial approval this year for its novel Alzheimer's candidate and lead asset AR1001, which showed an improvement in cognitive function from baseline at Phase II. But will the benefits over existing therapies be enough to carve a position in the challenging field?

Acadia strikes out on potential near-term sNDA approval in a broad dementia-related psychosis indication. The firm said the agency’s view has shifted from what was previously agreed upon.

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

Drugs for inflammatory conditions and cancer drove the increase in spending among the pharmacy benefit manager’s commercial plans, according to a drug trend report from Cigna's Evernorth.

Lilly Bio-Medicines president Ilya Yuffa oversees newer products in competitive therapeutic areas and drug classes, but additional indications and new therapies within the group’s immunology, pain and neuroscience focus areas will capitalize on the group’s existing commercial expertise. 

Albert Roy, executive director of the clinical research arm of the Lupus Research Alliance, talked to Scrip about the outlook for lupus drug development.

GSK's Benlysta and Aurinia's Lupkynis for lupus nephritis are priced in line with the drug pricing watch dog's health benefit price benchmark ranges.

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

The EMA and MHRA issue parallel safety updates on the vaccine, with the UK offering an alternative of the Pfizer/BioNTech or Moderna vaccines to the under 30s.

The company doubled its series A total of $51m to not only test its coronavirus and RSV candidates, but to also advance a vaccine targeting both RSV and hMPV for pneumonia prevention in elderly adults.

Cidara partners its antiviral conjugate platform for seasonal and pandemic influenza with Janssen, which also gets option rights to an AVC candidate for respiratory syncytial virus.

The companies still plan to develop a variant-specific version, while J&J said it anticipates meeting vaccine supply goals despite a manufacturing mix-up.

An EUA would carve out a market advantage, although Moderna should be releasing similar data soon for its COVID-19 vaccine.

Top-line Phase II data show that a combo of bamlanivimab and VIR-7831, neutralizing antibodies to the SARS-CoV-2 spike protein, yielded a relative 70% reduction in viral load.

The US regulator is worried about deficiencies in the submission for Provention Bio’s high-profile therapy teplizumab for the prevention of type 1 diabetes that could significantly delay its review.

The long-running Mediator saga reached a conclusion of sorts on 29 March when fines and sentences were handed out to those involved in delaying the withdrawal of a fenfluramine derivative that is thought to have caused many thousands of serious cardiac side-effects.

Boehringer Ingelheim’s incoming India managing director outlines intent to scale up in areas including diabetes and stroke, as the private German multinational seeks to move up the rankings in the competitive Indian market. Enabling the global pipeline in field including immunology, CNS and oncology also part of the effort.

Poxel’s potential first-in-class diabetes therapy, imeglimin, could be approved in Japan this year, and a new partner is being sought for the EU and US – events that would transform the outlook for the decade-old Merck Serono spin-out.

Calcilytix chief medical officer Jonathan Fox talked to Scrip about the development plans for encaleret for the rare form of hypoparathyroidism.

Despite being third to market behind Lilly’s Baqsimi and Xeris’s Gvoke to treat emergency episodes of hypoglycemia, Zealand is confident of a successful US launch for Zegalogue (dasiglucagon).

Pfizer is looking to address breast cancer resistant to Ibrance and other CDK4/6 inhibitors, but sees potential paths to earlier lines of treatment and additional tumors.

Interview: CEO Jean-Paul Kress talked to Scrip about the US launch of Monjuvi, commercial expansion and the aspiration to build a European biotech that can compete in the big leagues.

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

ISCR conference hears how artificial intelligence and machine learning can address challenges in clinical medicine, especially for cancer, and also optimize clinical trials.

Major Japanese firm sets targets under a new mid-term plan that envisages the US oncology sector leading growth and revenues, and also casts an eye to novel assets beyond three pillar antibody-drug conjugates and new digital technologies.

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

Company develops selective JAK inhibitors for IBD and pulmonary disease that are intended to clear the body before systemic side effects can occur. It also has a drug candidate for NOH that analysts think is underappreciated.

Smoking, pollution, pandemics and now sandstorms - China faces a rising respiratory disease burden as companies aim to tackle it with new products.

Early results from its novel antiviral are encouraging, but demonstrating life-saving qualities in a short window of time will be tricky.

Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics. 

The UK-headquartered company is in transition, investing heavily in biopharma R&D and preparing to spin out its consumer division.