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.

Given mixed Phase III results for the Alzheimer’s drug and potentially severe side effects for the once-monthly infused therapy, ICER’s recommendation came in below analyst expectations.

Vertex is advancing its sodium channel inhibitor VX-548 to mid-stage trials in the second half of the year as a potential treatment for pain after bunionectomy and abdominoplasty procedures.

Cell, gene and RNA therapies are starting to transform the healthcare landscape and a report from the American Society of Gene + Cell Therapy and Informa Pharma Intelligence maps the progress the sector made in the first quarter of 2021.

Roche’s Q1 update highlighted some key coming drug catalysts and early stage clinical efforts, including those for a potential COVID pill and for targeted cancer vaccines.

With an FDA approval decision for preventing episodic migraines expected during Q3, atogepant would add an oral CGRP antagonist to classmate Ubrelvy for acute attacks and Botox for prevention of chronic episodes.

The company has identified 600 sites of care to treat Alzheimer's patients with aducanumab in the US and is confident on its pricing strategy, management said.

Sanofi executives are upbeat about the potential advantages of its monoclonal antibody-based approach to the prevention of RSV infections in infants, the future growth of the company’s Dupixent franchise, and the progress of its novel anticancers.

The company has not even filed the TYK2 inhibitor deucravacitinib for psoriasis, but Bristol will be a new player in a category dominated by entrenched rivals.

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.

The pharmaceutical industry in Europe has attacked the US decision to come out in support of a relaxation of IP rights that is designed to boost global production of COVID-19 vaccines. But the move by the Biden administration could well cause other countries to rethink their opposition to the move.

Drug manufacturers still have a variety of ways to limit the impact of the Biden administration’s historic decision. Whether the huge political loss for industry translates into more than just headline-risk or faster global COVID vaccination remains to be seen. It is also not clear whether it is an ominous sign for other industry battles in the US, including the drug pricing debate.

Data on medRxiv showed a 90% improvement in likelihood of need for mechanical ventilation in the intent-to-treat population. The company plans a filing in Q2.

Descovy saw a sales decline, though that was due to payer discounts for PrEP, with the drug’s market share continuing to grow.

A CDC recommendation slowed non-pandemic vaccinations, but Shingrix shots will likely increase as more eligible consumers are fully vaccinated against SARS-CoV-2.

Pfizer will develop the novel antifungal fosmanogepix. The big pharma has made several other recent anti-infective deals, including when it expanded its BioNTech vaccine alliance to include COVID-19.

Novo Nordisk at its Q1 update lifted full-year guidance and voiced confidence it can double sales of innovative treatments for obesity by 2025.

AstraZeneca’s SGLT2 inhibitor produced 50% growth in Q1, and its new chronic kidney disease approval will give it an edge over Lilly and Boehringer’s Jardiance.

Following last year's licensing deal with Precision Biosciences and the acquisition of Prevail Therapeutics, Eli Lilly is expanding its gene therapy efforts by backing Jaguar, a start-up staffed by former AveXis bosses.

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.

The partnership helps close the gap between Nkarta and Fate Therapeutics in terms of the breadth of their pipelines.

After five years of failure in NSCLC trials, AstraZeneca’s immunotherapy combo shows survival benefits in POSEIDON.

Market Snapshot: GSK's Blenrep and BMS's Abecma are the first of many drugs for the late-line setting. In many cases, the CAR-T may be the first choice, but some patients are unable to handle it or risk progressing while awaiting treatment.

Sanofi executives are upbeat about the potential advantages of its monoclonal antibody-based approach to the prevention of RSV infections in infants, the future growth of the company’s Dupixent franchise, and the progress of its novel anticancers.

The company provided updates on the timing of some data from its extensive clinical program for its KRAS G12C inhibitor Lumakras, but not for certain high-profile combinations.

Emerging Company Profile: STORM Therapeutics publishes data in Nature showing its first-in-class inhibitor of METTL3 is effective as a new therapeutic strategy against AML.

Chiesi may not be a big pharma giant but it is very good at spotting early-stage innovative projects and partnering with the likes of Moderna, Protalix and Bioasis to tackle respiratory and rare diseases, CEO Ugo Di Francesco tells Scrip.

SaNOtize is in partnering talks with large firms in India to manufacture and distribute its nitric oxide nasal spray for COVID-19. The Canadian company believes the product, which already has an interim approval in Israel, could potentially reduce viral load of SARS-CoV-2 variants, as well as influenza and other respiratory viruses.

UK studies indicate the potential of inhaled budesonide in improving COVID-19 recovery time in specific groups, with some leading Indian physicians suggesting that the widely available asthma/COPD therapy should be selectively evaluated in the Indian context as well.

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.