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.

With a Phase II study stopped for efficacy in bleeding reduction, Anthos hopes to bring abelacimab, a dual Factor XI/XIa inhibitor to market to prevent strokes in a-fib patients and to treat cancer patients with thrombosis.

The US company has returned rights to the hypertension product to Idorsia, which was already in the grip of a cash crunch and will now face greater difficulties getting the drug to market. 

As a first-line treatment for anemia in patients with myelodysplastic syndromes, Reblozyl is approved for indications that will account for 75%-80% of the $4bn-plus in sales Bristol has forecast by 2029.

The US biotech revealed the US Food and Drug Administration would be holding an advisory committee meeting for exa-cel during its second quarter earnings, but analysts are unfazed by the news amid robust revenues and raised guidance.

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.

Following a positive opinion from the CHMP, the Spanish company is hoping to launch its challenger to Dupixent in the EU before the end of the year.

In this week's podcast edition of Five Must-Know Things: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.

A catastrophic late-stage clinical failure wipes 60% off the group’s value – and boosts a rival. 

Chiesi-owned Amryt and Krystal Biotech have approved treatments for epidermolysis bullosa but they only treat one subtype - dystrophic - and a single wound. Paradigm CEO Robert Ryan tells Scrip that SD-101, a topical cream he helped develop over 20 years ago, has the potential to be offer a far more extensive and efficacious solution for many more sufferers.   

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.

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. 

Further competition to Sanofi/Regeneron’s Dupixent in nasal polyps is on the horizon but the newcomers will have some catching up to do.

The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.

In this week's podcast edition of Five Must-Know Things: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.

First Wave is licensing Sanofi’s 5-HT4 receptor partial agonist capeserod and is having to pay a mere $500,000 in upfront fees for the privilege.

Data showing superiority on endoscopic remission and non-inferiority on clinical remission could position AbbVie’s IL-23 inhibitor to move ahead of Stelara in treatment paradigm.

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.

Industry executives, trade groups and medical organizations said the ruling undermines the US FDA, flies in the face of science and would harm innovation by drug makers if allowed to stand.

Neuroscience and oncology fuel high hopes for therapeutic R&D progress among 90-plus surveyed biopharma industry leaders.

The Boston-based biotech is weighing up its options as the fall-out from its failed IPF candidate casts a shadow over Galecto’s future.

Cytokinetics has a lot riding on the upcoming Phase III readout for aficamten, and crunch time is coming for plenty of other groups, too. 

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.

Otsuka steps into the ocular gene therapy field through a technology licensing deal worth up to $1.5bn with ShapeTX, which in turn further expands the US firm's global reach following a $3bn collaboration with Roche. 

Outlook Therapeutics received a complete response letter citing manufacturing issues and seeking more data for Lytenava (ONS-5010), its bevacizumab injection for wet age-related macular degeneration.

Oculis has enjoyed a strong first six months of 2023 after demonstrating the potential of OCS-01 to treat a variety of eye conditions and establishing a presence in the US.

Real-world cases of retinal vasculitis linked with Syfovre for geographic atrophy in age-related macular degeneration may have resulted from a material used in a specific filter needle, the US firm revealed, as analysts remained optimistic on the product.

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 expects Jardiance’s new chronic kidney disease indication to keep its sales growing by double-digit percentages over the coming years, aided by the drug’s ability to reduce hospitalizations.

The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.

These are interesting times for Mironid, a Glasgow-based biotech developing small molecule therapeutics for the treatment of autosomal dominant polycystic kidney disease, a life-threatening hereditary condition.

The Swedish biotech’s immunoglobulin A nephropathy therapy Tarpeyo is still selling well but “market access friction” is slowing growth. As US regulators grant a priority review to its data package for full approval, Calliditas’s prospects look promising.

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.