Cardiologists in Europe who have so far been unwilling to embrace the SGLT2 class now have two drugs approved for heart failure with reduced ejection fraction, with Jardiance soon to join Farxiga on the market, potentially attractive options especially for their diabetic patients.

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.

TG Therapeutics is confident its late-stage candidate can take a slice of the multiple sclerosis market away from Roche’s blockbuster.

Biogen’s investigational anti-tau antibody gosuranemab has missed its primary efficacy endpoint in a Phase II study in patients with Alzheimer's disease, prompting the end of the trial and termination of the compound’s further clinical development.

The drug may have enough efficacy for approval, but data fell short of the benchmark seen as necessary for commercial adoption

In this week's podcast edition of Five Must-Know Things: a ground-breaking approval for Alzheimer’s in the US; LAG-3 inhibitors and new Keytruda data generate excitement at ASCO; and clinical progress for another COVID-19 vaccine.

Biogen has warned that uptake for its newly approved Alzheimer’s therapy will be slow in the beginning and doctors confirm it will take time to figure which patients can and should be treated.

The co-founder of the Swiss company which discovered aducanumab looks back over its 20 year wait for approval, and ahead to future growth plans.

Competition to GlaxoSmithKline’s Benlysta in the systemic lupus erythematosus space finally looks imminent with approval decisions on AstraZeneca's anifrolumab pending. The company has presented more data at EULAR to make its case for the first-in-class type I interferon inhibitor.

Top-line results from the Phase III JUNIPERA study of Novartis’s IL17A-targeting anti-inflammatory Cosentyx support its use in juvenile idiopathic arthritis, and the company intends to move quickly to enter the marketplace in pediatric patients with two subtypes of the condition.

Dermatologists have compared the current market for vitiligo to that of psoriasis 30 years ago, which grew from one with a dearth of therapies to one worth about $8bn.

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.

NIH director Francis Collins and former FDA commissioner Margaret Hamburg outline learnings from the COVID-19 pandemic and what needs to be done next amid concerns around the dangerous Delta and also Lambda variants. They also discuss the role of the WHO, which has “many masters to try and satisfy.”

ViiV Healthcare’s head of R&D tells Scrip that extending the durations of its long acting HIV treatments is possible using drug delivery technology from Halozyme Therapeutics to expand the body’s capacity to absorb injected medicines.

Sotrovimab data could help with uptake, though the market remains challenging as infections fall. Plus RedHill presents encouraging Phase II data for oral drug to treat COVID-19 infection and inflammation after completing Phase II/III study enrollment and Japan taps its world-leading supercomputer.

Aiming to mimic public-private COVID-19 vaccine success, the US NIH will fund pandemic drug research, including taking candidates up to Phase II.

CureVac is not throwing in the towel just yet, but the odds are stacked against a successful end result.

News and views from day three of the BIO Digital annual meeting include Amgen’s CEO on speedy development and NIH’s chief on bringing personalized medicine to COVID vaccines.

Arrowhead and Horizon Therapeutics have inked a deal to develop an investigational RNA interference therapy for uncontrolled gout, under which Arrowhead stands to get $40m upfront and up to $660m in milestones.

With US FDA approval of Wegovy for obesity, Novo Nordisk prices the weekly injectable at par with its other obesity brand Saxenda. Ramping up sales will require patient, clinician and payer education, the company says.

Novo Nordisk has initiated its Phase III trial assessing its oral GLP-1 semaglutide in early Alzheimer’s disease patients. The firm’s veteran GLP-1 agonist pioneer Lotte Bjerre Knudsen explains its promise to Scrip.

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.

Combining Merck & Co’s pembrolizumab with chemotherapy first-line improves survival and PFS in metastatic cervical cancer, reinforcing its position in a condition in the sights of a number of other companies, although usually in later lines of therapy.

Confounding earlier speculation, the first CAR-T cell therapy to gain approval in China is from the Fosun-Kite joint venture rather than Juno-WuXi AppTec. But pricing and market competition challenges are just beginning.

Blackstone is providing $250m to combine Intellia’s gene editing and Cellex’s cell manufacturing capabilities in a new CAR-T company using Cellex subsidiary GEMoaB’s technology and pipeline as a foundation.

TG Therapeutics is confident its late-stage candidate can take a slice of the multiple sclerosis market away from Roche’s blockbuster.

Koselugo (selumetinib) was largely forgotten after failing Phase III trials in thyroid and lung cancer, as well as uveal melanoma, but its approval in Europe for inoperable plexiform neurofibromas in patients with neurofibromatosis type 1, which follows a US approval for the rare condition last year, has breathed new life into the once-lauded MEK 1/2 inhibitor.

Shaw cites manufacturing speed and success as competitive edges. The Gilead subsidiary unveiled data at ASCO positioning Tecartus, its second CAR-T therapy, to add B-cell acute lymphoblastic leukemia to label.

Lupin’s plans for a US generic to GSK’s Advair Diskus have turned awry as its contract with Celon Pharma is close to being terminated. The company has focused on other respiratory drugs like generic ProAir and Fostair even as the revenue potential for Advair has been shrinking post Mylan’s launch.

Cash-rich private equity firms are eyeing opportunities in healthcare, especially among listed companies with sluggish share prices. The Carlyle Group could be getting a bargain if it seals a deal for the Chippenham-based inhalation specialist.

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.