Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.

While clarification on mixed DECLARE-TIMI 58 CV top-line data in diabetes patients is awaited at November's AHA meeting AstraZeneca says it is confidently pursuing independent studies of its SGLT-2 inhibitor Farxiga in heart failure and kidney disease patients.

Portola touts exec's commercial management experience with Genentech success stories Avastin and Tarceva.

Mads Krogsgaard Thomsen tells Scrip that recent successes in stem cell research and the on-going advances in artificial intelligence helped prompt the Danish group to revamp its R&D activities.

In a Phase II study, Viking’s VK2809, with the same mechanism as Madrigal’s MGL-3196, shows significant liver fat reduction in NAFLD patients, along with reduction in LDL cholesterol.

European approval is in the bag for Onpattro for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis but in a week where ICER has criticized the price of the RNAi drug in the US, Alnylam now has to navigate reimbursement talks on this side of the Atlantic.

France's long-acting injectables technology company, MedinCell, which is collaborating with Teva on a Phase III long-acting risperidone formulation, has completed an IPO on Euronext Paris, giving a lift to its development plans.

With EU approvals in the bag for Ozalin, a novel oral midazolam solution for use in children, Switzerland-based Primex outlines plans for launch in Europe, and US development.

German Merck tells Scrip its quest to find a partner for its Bruton’s tyrosine kinase inhibitor evobrutinib should be helped by positive 24-week Phase IIb data in relapsing multiple sclerosis.

Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.

The UK company has been stunned by a complete response letter for its nausea and vomiting therapy which relates to problems at its contract manufacturer but is not linked to the data package. Despite the setback, Acacia is sticking to a first-half 2019 launch plan.

The company presented encouraging data on functional assessments of four boys treated with a micro-dystrophin gene therapy at the World Muscle Society, furthering momentum around the program.

Analysts shrugged off mixed topline data from a Phase II study showing Xencor’s lead compound XmAb5871 missed its primary endpoint in systemic lupus erythematosus (SLE), blaming the miss on the number of patients dropping out of the placebo arm of the trial.  

GlaxoSmithKline, SV Health Investors and Sofinnova are among the backers of a new Oxford-based biotech which has raised $30m in series A financing and boasts a strong line-up of academic founders. CEO Neil Weir outlines Sitryx's raison d'etre.

Kidney transplantation might be possible in difficult-to-graft highly sensitized patients using Hansa Medical's IgG-cleaving product, imlifidase. The high unmet need for such a product might usher in a Phase II data-based approval.

Alexion’s third deal this year brings privately held Syntimmune and its Phase Ib/IIa candidate for three IgG-mediated rare disorders, including warm autoimmune hemolytic anemia, for a $400m upfront price tag.

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Promising drugs from Tetraphase, ContraFect, Spero and Entasis get a platform at the Infectious Diseases Society of America’s IDWeek.

The pharma is paying $250m up front for worldwide rights to Arrowhead’s Phase I/II RNAi candidate. Arrowhead says letting J&J take the lead on HBV enables it to focus on other pipeline programs it can bring to market itself.

Ahead of an FDA decision scheduled for December 24, the Swiss major's baloxivir has improved influenza symptoms versus placebo, and to a lesser extent Roche's own Tamiflu, in people at high risk of serious complications from the virus.

Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.

Because it will be initially targeting specialists and a very sick population, the biotech thinks Arikayce will get early usage in its narrowly defined lung infection indication.

The US firm is getting its hands on eight programs from two of the world's leading drug makers, seeing an opportunity in areas such as antibiotics where solutions may be more likely to come from biotech rather than big pharma.

The company will not commercialize an insulin glargine copy already tentatively approved by FDA as Lusduna, but says it remains committed to biosimilars in oncology and immunology.

Diurnal has suffered a set-back on its road to approval and commercialization of Chronocort, but analysts still see hope for the product.

Heading into Phase III in 2019 is Lilly's dual agonist of GLP-1 and GIP, which has shown notable therapeutic effects on blood sugar and body weight in type 2 diabetics in a mid-stage clinical study. Meanwhile Lilly/Boehringer Ingelheim's SGLT2 inhibitor, empagliflozin, is being discussed with regulators with regard to its use in type 1 diabetics, an additional indication, following the release of full results from the EASE Phase III program.

With only slight potential advantages in some types of patients, ultra-rapid insulins will likely still need to compete on price to be more widely successful, analysts say.

While clarification on mixed DECLARE-TIMI 58 CV top-line data in diabetes patients is awaited at November's AHA meeting AstraZeneca says it is confidently pursuing independent studies of its SGLT-2 inhibitor Farxiga in heart failure and kidney disease patients.

Mads Krogsgaard Thomsen tells Scrip that recent successes in stem cell research and the on-going advances in artificial intelligence helped prompt the Danish group to revamp its R&D activities.

KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of metastastic breast cancer.

As F-star starts its transition into a clinical stage company underpinned by two proprietary bispecific compounds due to enter clinic late 2019, Eliot Forster joins the company as CEO with plans to expand the company’s regulatory and clinical operations capabilities and raise new funds.

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

While cancer drug makers generally applaud the rare reimbursement decision in China, some have pointed to mounting and significant pressure to lower prices, while insiders say the real battle has only just began and that translating the coverage into commercial success will take much more effort.

In a busy week, Carrick Therapeutics has added to its oncology pipeline, as well as bringing in Celgene deal maker George Golumbeski.

Emerging Company Profile: Newly formed Singapore venture DotBio aims to develop novel immuno-oncology therapies based on optimized, multi-specific humanized domain antibodies, with a focus on targeting checkpoint blockades, positive immune signals and tumor-specific processes in oncology.

Because it will be initially targeting specialists and a very sick population, the biotech thinks Arikayce will get early usage in its narrowly defined lung infection indication.

AstraZeneca's head of respiratory tells Scrip BORA Phase III data should reinforce and extend physician confidence in Fasenra as a long-term asthma biologic. The drug is also driving wider growth of biologics in asthma.

Vertex is set to reap huge benefits from its triple combination program for cystic fibrosis over the next 10 years, potentially becoming the biggest selling drug in this disease, according to a new report from Datamonitor Healthcare.

Respivant will be Roivant's 13th "vant," focused on developing what was Patara Pharma's mast cell stimulator for chronic cough in patients with idiopathic pulmonary fibrosis. Former Patara CEO Bill Gerhart will lead the firm.

Glenmark-Celon’s generic version of GlaxoSmithKline’s Seretide Accuhaler dry powder inhaler (DPI) has received the go ahead in Germany, upping the competition quotient in a significant market that has generally been seen as tough to penetrate.

Biologic's breakthrough designation is based on Phase IIb PATHWAY data that showed tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma.