Acesion Pharma is focusing on SK channel inhibition to develop safer and more effective drugs to treat and prevent atrial fibrillation. During BIO-Europe Spring 2018, Acesion CEO Frans Wuite described to Scrip his partnering and financing ambitions for the lead program which is entering Phase I testing.

Phase II data on use with PCSK9 injectable support bempedoic acid's safety and efficacy profile as an add-on therapy in high cholesterol.

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Rival Vifor Pharma has predicted blockbuster status for Veltassa and AstraZeneca expects the same for its just-approved oral potassium-removing agent, hoping that Lokelma's faster onset of action will help it win the fight for market share in hyperkalemia.

ODYSSEY outcomes study homes in on value of PCSK9 inhibition for the subgroup of patients with LDL of at least 100 mg/dL, a potentially large market, but how much will payers ease restrictions in exchange for a lower price?

In Bristol/Pfizer's ARISTOPHANES real-world study, the rate of major bleeding with Eliquis was 46% lower than J&J/Bayer's Xarelto and 33% lower than Boehringer's Pradaxa.

Reversing an earlier decision, FDA accepted Alkermes' new drug application (NDA) for ALKS 5461 for review, with a target action date of Jan. 31. But the company could still face a tough FDA review.

Emerging Company Profile: Syndesi Therapeutics, a new biotech built upon research from UCB, aims to develop novel drugs for neurodegenerative conditions like Alzheimer's disease; the company has a stream of big name investors such as J&J Innovation and Novo Holdings.

Swedish target's sole product WTX101 is in Phase III trials for treating Wilson Disease. Alexion says expect more deals. 

Brachial plexus indication for long-acting bupivacaine liposome will launch in US with combined 2,000-rep sales force under copromotion with J&J; although Pacira did not get the broad claim requested, company sees significant commercial opportunity for an indication that is expected to encompass 60% of all nerve block procedures within the next two years.

Rigel has its first US FDA approval for Tavalisse (fostamatinib) and plans to launch the drug for adults with immune thrombocytopenia (ITP) in late May, after working on the drug's development for more than a decade across multiple indications.

Global oncology sales grew 45% to $2.31bn in the first quarter, powered by strong growth of Darzalex, Imbruvica and Zytiga, narrowing the gap with J&J's top-selling immunology franchise.

Shares in the UK biotech have fallen through the floor following a failed Phase III trial of Lupuzor but ImmuPharma remains surprisingly upbeat about the lupus drug's prospects.

Orchard Therapeutics will acquire GSK’s portfolio of approved and investigational rare disease gene therapies, including EU-approved Strimvelis and additional late-stage gene therapies.

Celgene has hit multiple roadblocks in building its inflammation and immunology (I&I) portfolio, but it has a lot of potential shots on goal to eventually help the company diversify its revenue beyond the cancer blockbuster Revlimid, starting with flagship product Otezla.

Ablynx's IL-6 inhibitor has reached the end of the road in lupus; failure of the Phase II STEADY trial is unlikely to affect the biotech's acquisition deal with Sanofi but its development partner AbbVie is expected to dump the drug.  

Denoive acquires from TVM Capital both Biovertis and Morphochem, plus a Phase II ready antibiotic asset, for an initial 4% stake worth €900,000. Since their formation, Biovertis and Morphochem have had more than $96m invested in them.

Gilead's Biktarvy (B/F/TAF) single tablet is poised to become a huge success, surpassing competitors in the HIV market by far, but the GlaxoSmithKline-backed ViiV Healthcare looks better positioned in the long run.

ViiV and Merck are looking to novel mechanisms of action as an opportunity to make up ground on HIV leader Gilead, which has de-emphasized early virology research. 

Human antibiotic consumption globally jumped dramatically between 2000 and 2015, with India posting the biggest rise, reports a new US study, which calls for a radical policy rethink to prevent antimicrobial drug resistance soaring.

Sanofi's major investments in vaccine manufacturing are continuing with the expansion of its Toronto, Canada facility, to be completed in 2021.

The Swiss developer of a Phase III potential first-in-class antibiotic for Pseudomonas infections plans to list on the Swiss Stock Exchange, SIX, underlining the unmet need for better drugs for nosocomial pneumonia, and also the upturn in the bourse's popularity for European IPOs.

Swedish target's sole product WTX101 is in Phase III trials for treating Wilson Disease. Alexion says expect more deals. 

The Italian group has got the green light in Europe for Lamzede, the first disease-modifying therapy for alpha mannosidosis and believes the drug, along with Procysbi and an investigational Fabry disease being developed with Protalix, constitute a strong portfolio in the rare metabolic disease area.

Lilly has linked up with US biotech Sigilon Therapeutics to develop encapsulated cell therapies for diabetes, a second "living therapeutics" approach to the condition to attract funding in the past six months.

Early results confirm dasiglucagon's safety profile with no treatment-induced or treatment-boosted anti-drug antibodies.

Diurnal's CEO Martin Whitaker says 2018 promises to be transformational for the late-stage endocrinology company.

Orexigen hoped its go-it-alone strategy would boost obesity drug Contrave's sales enough to keep the company afloat, but now it has initiated bankruptcy proceedings, following through on a warning in October that it might not meet debt holders' requirements.

Cancer cases are rising in China, with larger increases for certain types including thyroid and pancreatic. To combat the rising tide, the government will implement zero tariffs on imported anticancer drugs  from May.

IOnctura’s CEO Catherine Pickering outlines the company’s business model and its approach to cancer R&D targeting the tumor microenvironment.

Bristol's stock price dipped after the AACR meeting, where pivotal lung cancer data for Opdivo/Yervoy disappointed relative to Merck's Keytruda/chemo combo, but Bristol still has many immuno-oncology irons in the fire in other indications and expressed confidence in its strategy.

Global oncology sales grew 45% to $2.31bn in the first quarter, powered by strong growth of Darzalex, Imbruvica and Zytiga, narrowing the gap with J&J's top-selling immunology franchise.

Roche’s Tecentriq IMpower150 trial showed Tecentriq plus Avastin plus paclitaxel and carboplatin significantly improved progression free survival compared to Avastin and chemo alone; overall survival data will be coming later this year.

With the $2.4bn acquisition of Shire's oncology assets, including Oncaspar and Onivyde, the French drug maker has laid down a marker to become a key player in cancer and sees the US in particular as the land of opportunity.

While GSK and collaborators publish findings from the IMPACT trial comparing once-daily single-inhaler triple versus dual therapy in patients with COPD in NEJM, two clinicians in an accompanying editorial argue that the trial falls short of providing robust evidence for switching strategy.

UK biopharma Enterprise Therapeutics raises £29M in a series B round co-led by Versant Ventures and Novartis Venture Fund to advance pipeline of novel respiratory disease treatments into clinical development.

Respiratory delivery specialist Vectura is to concentrate on developing enhanced inhaled products, as well as substitutable inhaled generics for the US market, and is pulling back from NME work. CEO James Ward-Lilley explains why.

Dupixent has been initially rejected by NICE to treat eczema on cost grounds, but Sanofi remains hopeful of UK entry - and the biologic's overall promise.

Roche is "first to market" with Phase III Tecentriq data in first-line squamous NSCLC setting, but analysts note Merck and Bristol are not far behind.

 Sigurdur Olafsson is impressed with the balance sheet he has inherited at Hikma and said he is looking forward to both organic and inorganic growth.