Similar to its post-approval strategy in aesthetics less than a year ago, Revance will initially target a small number of doctors as it Daxxify to market in the US for cervical dystonia with a broader launch in 2024.

Emerging Company Profile: The US biotech is developing a series of recombinant fusion proteins to tackle alopecia and other diseases without supressing the immune system.

Public Company Edition: The former Allergan CEO is taking a special purpose acquisition corporation public to generate $460m for deals in familiar biopharma niches. Also, IPOs are expected to keep up a robust pace in the fall and Albireo raises $160m on the success of its drug for pediatric liver diseases.

USITC’s initial decision in the Medytox and Daewoong botulinum dispute is favorable to Medytox and poised to take a toll on the Korean firm and partner Evolus as they face a 10-year ban on imports of their product to the US.

Novartis envisions the drug, the first oral monotherapy for PNH, as a “pipeline in a pill” that could see $3bn in peak sales, with a Phase III readout in IgAN in October and one in C3G expected this month.

A sea of troubles continues for the German conglomerate as a Phase III failure for one of its future blockbuster hopes sends shares diving. Flickers of hope remain for the product in stroke.

Great Britain is first to approve the groundbreaking CRISPR-based therapy for sickle cell and beta thalassemia. Vertex is yet to reveal its price, however, and wants to play down early expectations of its commercial potential.

Humira currently holds the record as the bestselling drug ever. But Keytruda is coming for its crown – and beyond that, Zepbound.

Emerging Company Profile: Patients with oral lichen planus suffer from painful lesions in the mouth that are hard to treat with topical steroids, leaving room for development of a new delivery method for the established clobetasol.

The Spanish firm is all set to launch its atopic dermatitis drug in Germany later this month and is hopeful of a smooth reimbursement path across Europe.

Deal Snapshot: In Almirall’s first de novo artificial intelligence drug discovery and development collaboration, the company will pay up to $650m to work with Absci on two dermatology candidates.

Ventyx’s TYK2 inhibitor met primary and secondary endpoints in a Phase II psoriasis trial, but the biotech determined the data are not competitive in a class led by Bristol’s Sotyktu.

Two years after its first FDA review, UCB’s next blockbuster Bimzelx finally crossed the finish line. Supplemental filings for more indications will soon follow as the company forecasts €4bn in peak sales.

The German biotech plans to prevent chemotherapy-induced hearing loss and treat chronic hearing loss by targeting a potassium channel in the ear’s sensory hair cells as it tackles a widespread but side-lined area.

With the planned $487m acquisition of sensorineural-focused Akouos, Lilly makes its second gene therapy M&A play in two years, on top of partnering/financing activity in the space.

Otividex did not significantly reduce vertigo three months after treatment, so Otonomy appears to be moving on from Meniere’s disease and focusing on earlier-stage tinnitus and hearing loss candidates.

Cisplatin is very effective but two thirds of children treated with the drug for cancer are left with some hearing loss. If approved this year, Fennec's Pedmark could go some way to preventing that distressing side effect.

A very early success with a gene therapy for a rare form of deafness puts Regeneron ahead of Lilly and Sensorion.

After successive CRLs in 2020 and 2021, the drug gained a broad label for hearing loss in children treated with cisplatin for localized, non-metastatic solid tumors.

With positive Phase III data for its Xhance (fluticasone propionate) nasal spray in chronic sinusitis, Optinose believes it is poised to expand the target market for the drug 10-fold.

Setback for company's near-term launch goals and US patients with rare esophageal inflammatory condition as regulator asks for additional clinical data. 

The first-in-class, oral GPR35 agonist has shown preclinical promise as a potential treatment for gastrointestinal indications such as ulcerative colitis.

The Swedish biotech's hopes of advancing cobitolimod lie in tatters after a Phase III study of the TLR9 agonist proved futile.

The Belgium-based biotech is transferring the rights to its only marketed product to Italy’s Alfasigma in a move aimed at cutting costs and tightening its focus on its early-stage immunology and oncology pipeline.

The French group has just listed on the NASDAQ and while its stock has already taken a couple of hits, CEO Marc de Garidel has faith that the firm’s IBD drug obefazimod will be a major player in the space.

The Danish firm’s CEO Claus Olesen tells Scrip that pudafensine could help the 35% of men who do not respond to the currently available treatments for ED.

Zoliflodacin could become the first new antibiotic for treating gonorrhea in decades, but can it change guidelines?

Organon has not strayed from its women’s health path, but is entering into earlier deals and considering technologies beyond therapeutics, while advocating increased investment in the field.

The UK major’s first-in-class asset has matched standard-of-care in two Phase III urinary tract infection trials, setting it up to become the first novel antibiotic for the condition in 20 years with a clear niche in the second-line setting.

Akero hopes to begin Phase III study of efruxifermin this year, with 89bio working to enter Phase III with pegozafermin in 2024. But just behind them, Boston Pharmaceuticals thinks it has a convenience and immunogenicity edge.

CymaBay and Genfit have been positioning their failed NASH candidates, both PPAR agonists, for approval in second-line primary biliary cholangitis. Analysts call both approvable, but say CymaBay’s drug has a better overall profile.

Inventiva’s pan-PPAR agonist and Terns’ combination strategy are targeting the NASH treatment paradigm after expected approval of Madrigal’s resmetirom. Viking is hoping to prove a better THRβ drug profile than Madrigal.

With its GLP-1 analog already a stalwart in type 2 diabetes and weight loss, Novo Nordisk is investigating semaglutide as monotherapy and in combination regimens to treat non-alcoholic steatohepatitis.

Positive Phase II data in wet AMD showing potential for dosing out to six months could spur partnering interest ahead of Phase III development.

Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.

Disappointing data from a trial of the last remaining drug in its pipeline means that the Belgium group formerly known as ThromboGenics is closing its doors after more than 30 years.

Sans Sandoz, Novartis posts a beat-and-raise but its oncology franchise remains undistinguished.

Just a month after an EU rejection, the French drugmaker’s oral retinoic acid receptor gamma agonist Sohonos has won a US thumbs up for the treatment of fibrodysplasia ossificans progressiva, an ultra-rare disorder that turns soft tissue into bone.

The UK major’s older C5 inhibitor product could soon receive EU approval for children and adolescents with the rare disease, but emerging competition from biosimilar developers and rival firms are starting to stack up.

The US approval of a more convenient formulation of its myasthenia gravis therapy, Vyvgart, should cement its market position as well as change the definition of what being "well-controlled means for patients", Argenx hopes.

Emerging Company Profile: Fresh from a $73m follow-on offering last year, the US biotech is readying its lead asset for a pivotal trial in ultra-rare but debilitating mineralization disorders that affect infants and children.

The sale of BTG Specialty Pharmaceuticals to two affiliates of European specialty firm SERB leaves Boston Scientific with BTG’s interventional oncology and vascular products.

Two major initiatives have been announced which hope to revolutionize the treatment of snakebites, which claims the lives of up to 138,000 people a year.

Addex Therapeutics says its licensing deal with Indivior to develop and commercialize its investigative addiction therapy ADX71441 'buys time' to find resources for progressing its own pipeline.

Much of the attention at the 2015 World Health Assembly (WHA) in Geneva, Switzerland later this month is expected to be focused on reforming the World Health Organization (WHO) and the failures by the international public health agency in responding to the ongoing Ebola epidemic in West Africa.

Boehringer Ingelheim and AstraZeneca are once again going up against each other in chronic kidney disease, with Phase II results for their rival new agents showing promise. Unfortunately, they both also lie in the path of Novo Nordisk’s cardiometabolic juggernaut, Ozempic.

A Phase III hit moves atrasentan a step closer to the market but the drug will have to sell very well to justify the billions Novartis paid for its originator.

Development of narsoplimab in the kidney disease has been called off, making a forthcoming regulatory decision in a different use all the more important.

Novo Nordisk’s metabolic juggernaut semaglutide is known to work in chronic kidney disease – but the group appears to want a back-up plan. 

While perhaps best known for historical achievements in immuno-oncology and CNS disorders, the Swiss biotech sector is slowly cultivating a new area of expertise in dermatology. Scrip spoke with two firms applying cell therapy technologies to the challenging area of chronic and acute wounds.

Vertex has invested heavily in advancing its stem-cell based candidates for type 1 diabetes, but Sernova has inched ahead in the race to bring a functional cure for the condition to patients.

The company estimates there are about 9,000 reimbursable patients with dystrophic epidermolysis bullosa worldwide and anticipates a third-quarter launch following FDA approval.

The Swedish firm’s lead program has unexpectedly disappointed in a Phase II scar prevention trial, prompting it to turn its efforts to its only other clinical asset for the treatment of chronic wounds.