AstraZeneca’s SGLT2 inhibitor has grabbed attention for its potential role in chronic heart failure patients, with or without type 2 diabetes, following initial results from the DAPA-HF study.

The trial linked ANGPTL3 antibody evinacumab to a steep decline in LDL cholesterol in patients with homozygous familial hypercholesterolemia, setting Regeneron up to file for US FDA approval next year.

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Public Company Edition: Two months before the deadline for the company's sNDA, the US FDA has not indicated it will hold an advisory committee meeting for the triglyceride-lowering drug. Also, Seattle Genetics raises $575m, Atara and Ra bring in $150m each and Cara completes $145.5m offering.

The UK-based group will help Bayer accelerate clinical development of new treatments for cardiovascular disease using Sensyne Health’s clinical AI technology platform and NHS data.

Entresto has narrowly failed to hit the primary endpoint in a Phase III trial in heart failure with preserved ejection fraction, a potentially lucrative indication with no approved treatments.

Fosmetpantotenate missed all endpoints in a Phase III trial, so Retrophin will shelve the candidate for the rare disease PKAN. Now, the biotech turns focus to Phase III sparsentan in a pair of indications.

The US FDA issued a complete response letter rejecting golodirsen based on risk of infection at intravenous infusion ports and preclinical renal toxicity.

Lundbeck highlighted R&D and the strong growth of four strategic products in the first half, as revenues were hit by generic competitors to top-selling products.

Jazz’s $312.5m acquisition will add to the company’s pipeline of products in neurological conditions, but only at the Phase-II stage.

The Dementia Discovery Fund is backing the UCL spin-off's efforts to develop therapies that modulate astrocyte function.

A post-hoc analysis linked “physical differences” in two lots of Nektar’s drug to lower efficacy when given in combination with Bristol-Myers Squibb’s Opdivo. Nektar’s share price tumbled following the update.

AbbVie now has both of its Humira successors approved in the US, following April’s Skyrizi approval for psoriasis. But Rinvoq faces stiff competition both within the JAK1 class and in rheumatoid arthritis generally.

Lilly's IL-17A inhibitor ixekizumab outperformed J&J's IL-23 inhibitor guselkumab on achieving complete skin clearance in moderate-to-severe psoriasis patients at 12 weeks in a head-to-head trial. 

The Dutch rare disease group says licensing CDZ173 from Novartis is Pharming’s first step towards building off the commercial success of its sole product, Ruconest, in HAE.

Markets are re-assessing Amgen’s long-term value after a US judge upheld two patents relating to Amgen's blockbuster rheumatoid arthritis drug Enbrel, denying a challenge by Novartis and allowing investors to focus now on the pharma’s promising pipeline.

Italy’s privately held Zambon could pay up to €500m to bulk up its respiratory products pipeline, producing a nice return for Breath Therapeutics’ syndicate of European investors.

Topline results from the Phase III ATLAS-2M study indicate that injections every two months of ViiV/Janssen’s two-drug anti-HIV regimen are non-inferior to a once-monthly injectable regimen.

Lefamulin was approved in the US to treat community-acquired bacterial pneumonia, providing a needed IV and oral drug initially in the hospital setting, but new antibiotics have been a tough sell.

Emerging Company Profile: Osivax is using its oligoDOM technology platform to developer a vaccine pipeline. The French biotech aims to establish proof-of-concept in influenza A then expand the pipeline to provide a universal flu vaccine.

PALM study stopped early after two agents being tested proved better than ZMapp, the current standard of care, in the ongoing Ebola outbreak in the Democratic Republic of Congo. One is being developed by Regeneron.

US FDA advisory committee members urge agency to hold a firm line against labeling, promotional or educational materials that suggest Descovy has better efficacy or is safer than Truvada, which will face generic competition in 2020. Panel backs HIV pre-exposure prophylaxis indication for Descovy but recommends excluding cisgender women due to lack of clinical efficacy data.

The first pivotal Phase III study required for US approval of Basilea’s ceftobiprole has reported positive topline results; a second study is expected to read out in 2021.

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

The Danish group is beefing up its operations across the Atlantic as it prepares filings for dasiglucagon and glepaglutide.

Sales of injectable semaglutide shored up Novo's second quarter, but all eyes are on the expected launch of an oral version in the third quarter.

Setmelanotide reduced feelings of hunger in patients with POMC and LEPR deficiency obesities and helped many lose weight, with some caveats across certain endpoints.

The Series A financing positions Alizé to take a rival to Shire’s Natpara through to clinical proof of concept over the next few years.

The company has two oncolytic virus platforms – a herpes simplex-based intratumoral injection and a synthetic virus-based intravenous technology for repeat systemic administration.

The Phase III NEPTUNE lung cancer trial found the combination of Imfinzi and tremelimumab was no better than chemotherapy at extending overall survival. After repeat setbacks, AstraZeneca is now running out of opportunities to show its dual checkpoint blockade is effective in NSCLC.

United HealthCare agreed to cover Mvasi and Kanjinti in a preferred position. Amgen VP-oncology sales & marketing Susan Logan talked to Scrip about the company's first US biosimilar launches.

CMO Sandra Horning will retire at the end of the year, to be succeeded by Lilly's former senior VP of oncology R&D on 1 October.

Investors in Impact Biosciences, which sold the selective JAK2 inhibitor to Celgene for $1.1bn up front, could double their money with milestone fees based on fedratinib's approval.

Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.

Following major global licensing out deals in the sector this year by South Korean bioventures Bridge Biotherapeutics and TiumBio, Scrip takes a look at why firms in the country are competitively pursuing development of drugs for IPF.

The drugs major believes it has assembled a pipeline that is looking well stocked for several years to come.

Italy’s privately held Zambon could pay up to €500m to bulk up its respiratory products pipeline, producing a nice return for Breath Therapeutics’ syndicate of European investors.

Pre-IPO Bridge Biotherapeutics inks major idiopathic pulmonary fibrosis license agreement with Boehringer Ingelheim, marking the biggest single product licensing out deal by a South Korean biotech. The move is poised to further bolster the German firm's leading position in the field and reflects global pharma's increasing interest in IPF.

The new indication represents the third one for Sanofi/Regeneron's IL-4/IL-13 inhibitor, after atopic dermatitis and moderate to severe asthma.

Glenmark will market three COPD therapies from Novartis in Brazil and expects a significant uptick in its Latin America business on the back of such alliances.