The German major believes its drug will remain the biggest-selling SGLT-2 inhibitor boosted by expanded heart and renal disease approvals.

The Phase III failure of esuberaprost combined with Tyvaso in pulmonary arterial hypertension has prompted United Therapeutics to stop developing a therapy that was already facing an uphill battle for potentially meager returns.

The company has racked up a lot of wins for its proprietary fish oil derivative based on the REDUCE-IT study, the latest being inclusion in diabetes treatment guidelines. Amarin also has now submitted a supplemental NDA seeking a label update reflecting the outcomes trial results.

Hopes for a precision approach for the vast cardiovascular disease population live on – past failed studies of HDL-raising drugs and lack of evidence for genetic typing in Merck's latest analysis of anacetrapib in REVEAL.

Data may pave way for inclusion in heart disease treatment guidelines, ACC spokesperson says.

The addressable patient population in the US could increase by 4.5 million if new trial is successful.

Larger of two doses of the NGF inhibitor hit two efficacy endpoints, but the rate of joint health outcomes on a composite measure was higher than control by a statistically significant margin.

After disappointing top-line Phase II data in diabetic peripheral neuropathy with NYX-2925, Aptinyx says the full dataset shows significance across endpoints in patients four years or more past diagnosis; a second Phase II study in this subgroup is planned.

Mid-size Japanese player Sumitomo Dainippon sets aside billions for potential M&A deals under a new business plan designed to fill gaps in its neurology pipeline as it prepares to lose exclusivity for its top global product.

At the recent BIO-Europe Spring partnering conference, Tim Dyer, CEO of Addex Therapeutics, spoke to Lucie Ellis, executive editor of In Vivo, about the company’s small-molecule allosteric modulators for central nervous system disorders.

Emerging Company Profile: ADEL Inc. CEO Seung-Yong Yoon tells Scrip how its anti-tau antibody brings something different to the table in the challenging field of Alzheimer's disease and what's in store for the South Korean bioventure.

The CEO of Swedish addiction and pain specialist Orexo tells Scrip its top drug Zubsolv will grow strongly in coming years to address the opioid crisis in the US, and that revenues will be further boosted by novel pipeline therapies likely to be commercialized in coming years.

With Spravato's launch underway, J&J reports that 800 sites have been certified to administer the depression drug. Newer drugs drove pharma sales in the first quarter, while US sales of Zytiga declined 55% due to generic competition. 

The company's severe asthma drug Fasenra has demonstrated its effectiveness in a Phase II trial for hypereosinophilic syndrome, a group of rare disorders which can cause progressive organ damage.

Ghent, Belgium-based start-up, AgomAb Therapeutics NV secures funds and license to develop HGF-mimetic agonistic monoclonal antibodies for regeneration of damaged tissues.

More evidence of its strong safety profile suggests that the Belgian biotech's oral selective JAK1 inhibitor partnered with Gilead will be able to break into the crowded RA market.

Lilly is prepared to splash over $600m on an early development deal with ImmuNext on an immunometabolism target which ties the companies together for three years while an antibody is being developed.

Gilead Raday, chief operating officer of RedHill Biopharma, talks to Lucie Ellis, executive editor of In Vivo, about recently published late-stage data and next steps for its antibiotic asset, Talicia (RHB-105), for the treatment of Helicobacter pylori infection. 

A 3 May meeting with the FDA is likely to be crucial for the future commercialization strategy for the biotech’s precision-targeted antibacterial.

The first approval in the US of a once-daily single-tablet, two-drug regimen for treatment-naive HIV from the HIV/AIDS therapy specialist, ViiV Healthcare, suggests a shift away from three-drug regimens for HIV/AIDS could be gathering pace.

ViiV Healthcare has published results from the first long-term Phase III study for switching from a three-drug combination, to an oral two-drug combination. It disproves resistance and safety fears that have hampered prescriber comfort, however, it may have to dampen its sales ambitions when ViiV’s soon-to-be-approved combo Tivicay/Epivir comes to market.

More evidence of its strong safety profile suggests that the Belgian biotech's oral selective JAK1 inhibitor partnered with Gilead will be able to break into the crowded RA market.

Johnson & Johnson has written off a further $700m against the RSV asset that it obtained with its $1.75bn purchase of Alios.

The German major believes its drug will remain the biggest-selling SGLT-2 inhibitor boosted by expanded heart and renal disease approvals.

Drug makers and other stakeholders have been rolling out insulin savings programs as the high cost of insulins come under scrutiny on Capitol Hill. Sanofi announced an expanded cost-savings program during a House hearing, but one Congresswoman called them a band-aid. 

Partners Poxel and Sumitomo Dainippon confirm Japan filing plans for novel glimin antidiabetic following positive top-line Phase III results, and cast an eye towards market positioning.

Ghent, Belgium-based start-up, AgomAb Therapeutics NV secures funds and license to develop HGF-mimetic agonistic monoclonal antibodies for regeneration of damaged tissues.

The company has racked up a lot of wins for its proprietary fish oil derivative based on the REDUCE-IT study, the latest being inclusion in diabetes treatment guidelines. Amarin also has now submitted a supplemental NDA seeking a label update reflecting the outcomes trial results.

An all-stock transaction will see Europe’s Kiadis and US’s CytoSen bring together complementary approaches to improving stem cell transplants and cancer immunotherapy.

As part of a global strategy first unveiled last year, Roche is taking concrete steps to restructure its pharma operations in Asia, including the substantial downsizing of a Singapore office.

Public Company Edition: Turning Point's offering priced at $18 and its stock closed at $28.90. Also, Achaogen's bankruptcy reflects difficult antibacterial market, Ophthotech's name change follows strategy shift, and Gilead lays off 150 sales reps. Plus, cell and gene therapy FOPOs flourish.

With Spravato's launch underway, J&J reports that 800 sites have been certified to administer the depression drug. Newer drugs drove pharma sales in the first quarter, while US sales of Zytiga declined 55% due to generic competition. 

Chi-Med has applied to list in Hong Kong and will undertake a new global share offering as it looks to raise new funds to support the progress and commercialization of its growing pipeline. 

Disappointment for the San Diego, CA-based firm as Phase III study of its lead product is deemed futile and it ends clinical research of the product in cancer.

Scrip looks at some the key clinical and regulatory pharma events that will spark attention during the next three months, according to Biomedtracker's latest quarterly outlook report.

The company's severe asthma drug Fasenra has demonstrated its effectiveness in a Phase II trial for hypereosinophilic syndrome, a group of rare disorders which can cause progressive organ damage.

With data showing a lung function and sweat chloride benefit for its proprietary CFTR-modulating triplet, Proteostasis says it’s moving ahead. But analysts and investors are concerned the effects are less than seen with Vertex drugs.

Vertex CEO Jeff Leiden has defended his company’s approach to pricing, as well as his $17m salary, at a heated UK public hearing on access to cystic fibrosis drug Orkambi.

Two three-drug regimens for cystic fibrosis hit their primary endpoints in both heterozygous and homozygous patients, with good safety and tolerability, which analysts say increases the likelihood one of them will obtain approval.

Novavax’s shares plunged 67% on news that its Phase III trial for RSV had failed, but are there signs of life for the product?