US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Bayer is boosting its AI drive by investing in One Drop’s digital platform and hopes to advance outcomes in oncology, heart disease and women’s health with data-driven solutions.

Daiichi drug shows non-inferiority to standard antithrombotic regimen in atrial fibrillation patients, adding to evidence supporting Factor Xa inhibitor's use.

Despite Phase III miss, Novartis is hopeful that the totality of the evidence will secure it at least a limited label expansion to a sizable but harder to treat portion of the heart failure market than Entresto already serves.

AstraZeneca’s head of R&D spoke to Scrip about the outstanding results for dapagliflozin in heart failure regardless of diabetes status.

Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.

ARIBIO CEO tells Scrip how the South Korean biotech is aiming to develop a multi-modal drug for both Alzheimer’s disease and vascular dementia using its innovative platform technology, which can cut development periods and costs and better predict clinical trial success.

The Swiss major has new data on its SMA gene therapy which has been found not to be the cause of the death of a six-month-old patient earlier this year.

Sanofi's latest digital health move will see it collaborating with Happify Health on a digital therapeutic for patients with multiple sclerosis, a therapeutic area it knows well.

Acceleron ended testing of ACE-083 in facioscapulohumeral muscular dystrophy after the investigational drug missed Phase II endpoints.

Many new and pipeline products were highlighted at London meeting – but no word on Spark Therapeutics deal. New products will have high profit margins.

Novartis looks to differentiate ofatumumab from Roche's entrenched MS blockbuster Ocrevus, stressing that patients can inject the therapy at home.

Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.

Promising Phase II data mean it could be third time lucky for Roche in disease with no approved treatments. 

Emerging Company Profile: This is the first human study for lead product candidate THOR-707 and for the company's Expanded Genetic Alphabet platform, starting with a recombinant IL-2 that's being tested in solid tumors.

While the BREEZE-AD7 data show that baricitinib may effectively treat AD in combination with topical corticosteroids, a patient treated with the drug in the ex-US study had a pulmonary embolism.

VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.

Amgen sees opportunity to grow Otezla sales through new indications and additional ex-US launches. The deal depends on Bristol closing its Celgene acquisition, pending FTC clearance.

Themis Bioscience CEO says the biotech’s €40m Series D financing will fund pivotal trials for its lead vaccine candidate for chikungunya and advance its oncology franchise.

Fosmanogepix, with safety and efficacy clearances to continue Phase II, could provide an IV-to-oral option for patients with potentially lethal Candida fungal infections.

The Bill & Melinda Gates Foundation has invested $55m in an infectious disease collaboration with Germany’s BioNTech that could reach up to $100m in total funding.

Mundipharma is to provide financial support and development expertise for Cidara’s Phase III clinical studies of its once-weekly echinocandin antifungal for serious infections, in return for ex-US and ex-Japanese marketing rights.

Aridis is effectively pulling the plug on AR-105 after the mAb failed in a Phase II ventilator-associated pneumonia trial. It will now focus on its remaining pipeline, led by Phase III asset AR-301.

The Glasgow-based group has raised more cash to take its new class of anti-infective through Phase IIa trials for C diff-associated disease.

US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Emerging Company Profile: CHF16m for Swiss firm that engineers liposomes to capture toxins and protect the organs of patients with acute liver failure.

Sanofi terminated its alliance for the SGLT1/2 inhibitor Zynquista, giving Lexicon full control of development in type 1 and type 2 diabetes, but it is seeking a new partner ideally with a European footprint.

Xeris’s Gvoke gets FDA approval, joining Lilly’s Baqsimi as products to treat emergency episodes of hypoglycemia with an easier-to-use kit. Xeris will launch its prefilled syringe in Q4 and an auto-injector in 2020.

Semma's innovative technology involves growing insulin-producing beta cells from stem cells and transplanting them into the liver, but it hasn't been tested in humans yet.

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.

A positive opinion for its FLT3 inhibitor for acute myeloid leukemia gives Astellas a further advantage over its Japanese competitor's same-class offering, quizartinib.

Lack of infrastructure for identifying mutations and access routes is holding back use of targeted medicines in children with cancer

Following a major setback in another indication earlier this year, ASLAN’s lead asset is now seen as a potential new option for second-line use in biliary tract cancer following promising new data from a Chinese trial.

Former Ignyta executive Zachary Hornby wasn't wowed by immuno-oncology pitches when looking for his next cancer drug development company, but was intrigued by ecDNA research at UCSD, which also could generate a tumor agnostic approach.

GSK looks to become a cancer contender once again, while Merck and Roche go toe-to-toe in TNBC.

Erleada was approved for treatment of metastatic castration-sensitive prostate cancer (mCSPC), strengthening its position versus generic Zytiga and Pfizer/Astellas's Xtandi.

The company has discontinued a Phase II trial for BG00011, which was acquired in its 2012 Stromedix purchase, due to safety issues.

The triple-combination treatment significantly reduced COPD exacerbations compared to older dual therapies in the Phase III ETHOS study, providing a boost to AstraZeneca as it closes in on approvals in the US and Europe.

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.