A series of setbacks for gemcabene has left the Livonia, MI-based company reeling, but management remains committed to its lead product.

Company reported only $33,000 in sales for late anticoagulant market entrant Bevyxxa and $2.2m for the antidote Andexxa, leaving a lot of challenges ahead after the retirement of CEO Bill Lis, effective Aug. 1.

The Swiss major is very happy indeed with the growth trajectory of Cosentyx and Entresto and pleased with how its migraine drug Aimovig has started. However the revelation of manufacturing problems with its CAR-T therapy Kymriah marred Novartis' second-quarter results.

As many as 14 new products are up for US approval in the third quarter, research by Informa Pharma's Biomedtracker shows. Scrip takes a look at the candidates and their chances of reaching the market.

Former UK science minister Lord Drayson explains to Scrip his plans for Sensyne Health, an Oxford, UK-based AI-focused healthcare technology company, to go public after securing a second deal with an NHS Foundation Trust while seeking big pharma research collaborations.

Novo Nordisk is rumored to be considering laying off up to 3,000 staff and dropping its long-term financial targets due to challenging US market conditions which the group flagged in its first-quarter update in May.

With strong quarterly sales of Mavenclad in Europe, and a recent re-filing of the drug with the FDA, Merck KGaA continues to play the waiting game for top-line growth to return as it banks on the new addition to its MS franchise.

With a new CEO taking the reins in September and a candidate entering the clinic for Parkinson’s disease, Lundbeck has opportunities for refreshment, both in the pipeline and the boardroom. But with generic competition battering down the company’s financial outlook, it may not be enough to bring the market along for the ride.

Denmark's mid-sized biopharma, Lundbeck, has taken another potential Parkinson's disease therapeutic into early clinical studies, the third this year, and this time it's a monoclonal antibody, not a small molecule.

Building on its national expertise in the area, Japan is starting the first clinical trial globally to assess the use of iPS-derived cells for the treatment of Parkinson’s disease.

Laquinimod fails to impress in a Phase II study in Huntington's disease, adding to a series of clinical trial setbacks over past years for the potential oral immunomodulator.

Early clinical-stage products for neurological and autoimmune diseases are progressing through the European biopharma's pipeline.

Having recently got hold of GlaxoSmithKline's gene therapy assets, Orchard has completed another whopping financing which has got observers thinking that an IPO could soon be in the offing.

Early clinical-stage products for neurological and autoimmune diseases are progressing through the European biopharma's pipeline.

Swiss group raises guidance for second time this year despite looming biosimilar competition and Cabilly patent loss.

GSK President R&D Hal Barron came to a big investor meeting with one bit of tangible news, a collaboration with consumer genetics leader 23andMe. Barron and CEO Emma Walmsley talked about the deal and Barron's California headquarters in a media briefing. 

Sangamo is to pay €72m to acquire France's TxCell, a specialist in chimeric antigen receptor-modified regulatory T-cells. It hopes ultimately to apply its zinc finger nuclease gene editing technology to develop next-generation allogeneic CAR-Treg therapies for immunological conditions.

Swedish rare diseases specialist Sobi has reported strong financials and the acquisition of a rare disease candidate on the verge of US approval. Could partner Sanofi pop the question soon?

FDA panel's recommendation that liposome inhalation suspension be labeled only for refractory nontuberculous mycobacterial lung disease and not first-line use aligns with analyst expectations; panel cites lack of clinical studies in treatment-naive patients and adverse event profile as reasons for limiting drug to patients with limited or no treatment options.

As others shun anti-infectives, Evotec is consolidating its position. Through an alliance with Sanofi it is evaluating new anti-infectives in three areas, and expects soon to advance its first candidate therapeutic into the clinic.

Top-line data for a Phase III trial of RedHill's antibiotic combination for use in Crohn's disease show the study has hit its primary endpoint, but there is still some way to go before filings can be made for the novel approach.

Led by eight-week, pan-genotypic combo Mavyret, AbbVie’s HCV franchise grows despite a declining US market that has taken a toll on competitors Gilead and Merck. Still, AbbVie expects a falloff in the third quarter.

GSK President R&D Hal Barron came to a big investor meeting with one bit of tangible news, a collaboration with consumer genetics leader 23andMe. Barron and CEO Emma Walmsley talked about the deal and Barron's California headquarters in a media briefing. 

Long-term top-line market forecasts for Novo Nordisk are heavily reliant on its GLP-1 portfolio's potential - so pricing uncertainties, especially in the US,  can unnerve sentiment, as seen when it reported Q2 results.

Sales of PCSK9 inhibitors have been improving, though are still low, and inclusion of lower LDL-C targets in practice guidelines coming this November would be a boost.

BioGeneration Ventures has given birth to a new European biotech, Azafaros, supplying seed funding for the development of a new generation of compounds to tackle rare metabolic disorders.

The Swiss major is very happy indeed with the growth trajectory of Cosentyx and Entresto and pleased with how its migraine drug Aimovig has started. However the revelation of manufacturing problems with its CAR-T therapy Kymriah marred Novartis' second-quarter results.

Takeda and Norgine’s decision to finally end their alliance for cetilistat in Japan, years after the obesity drug was approved in its first potential market, serves as another sign of the sector’s challenges in the country.

The Japanese pharma says it will discuss the data with US FDA, with hopes of potential to incorporate secondary endpoint data in labeling.

With strong quarterly sales of Mavenclad in Europe, and a recent re-filing of the drug with the FDA, Merck KGaA continues to play the waiting game for top-line growth to return as it banks on the new addition to its MS franchise.

Regeneron will make a $100m equity investment in bluebird to collaborate on the discovery of antibodies and T cell receptors, with the hope of building out in immuno-oncology and overcoming some of the early cell therapy challenges. Regeneron's business development chief talks to Scrip about its strategy.

As drug fails in DLBCL, firm focuses on lifting partial clinical hold on other trials. A first filing in a rare sarcoma has also been pushed back.

When Merck realized that demand in China is so large for its HPV vaccine Gardasil, the US company wanted to understand more about the market, but a coordinated pre-launch awareness campaign appears to have helped. 

Otsuka's guadecitabine has missed co-primary endpoints in older treatment-naïve AML patients but it continues to be evaluated in relapsed and refractory patients, in a therapeutic area undergoing considerable innovation.

Respiratory viral infections are a frequent cause of COPD exacerbations and the German major is joining forces with the Austrian biotech and Evotec to find new antivirals to tackle the disease.

FDA panel's recommendation that liposome inhalation suspension be labeled only for refractory nontuberculous mycobacterial lung disease and not first-line use aligns with analyst expectations; panel cites lack of clinical studies in treatment-naive patients and adverse event profile as reasons for limiting drug to patients with limited or no treatment options.

The London-headquartered firm believes that its efficient control of costs and strong data in support of its investigational treatments for rare respiratory, bone and endocrine diseases will attract investors across the Atlantic once it decides to refile for a listing on the Nasdaq.

Novel asthma/COPD drugs, including GlaxoSmithKline’s biologic therapy Nucala, are on the horizon in India, set to expand treatment options in the competitive segment. But pricing is expected to be key in pushing uptake, and health care delivery in asthma/COPD in India remains rather sub-optimal, notwithstanding the interest around new launches.

The German major is making its first foray into gene therapy and is looking to license a new viral vector-based product that could create a new therapeutic pathway for CF patients, regardless of their mutations.

Biotech's CEO says its lead respiratory candidate RV521 has 'caught up with rivals' in efficacy and safety.