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.

As South Korea’s drug ministry decides to rescind approval of Medytox’s botulinum toxin product following manipulation of manufacturing and quality control documents, competition among existing rivals and newcomers is expected to further intensify.

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

The company sees leniolisib as a way to expand its US and global commercial footprint before bringing in additional rare disease assets.

Sanofi announced results from its XTEND-Kids trial, clearing the last requirement before an anticipated second half filing for Altuviiio’s approval with the EMA.

A long-anticipated pruning back of the ev vivo gene therapy pipeline for sickle cell disease has arrived with Novartis, Graphite Bio and Sangamo each dropping projects, but some challengers are looking ahead to a future of in vivo approaches to the condition.

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.

Skyrizi showed better skin-clearance results than Cosentyx or Taltz in a 52-week study of patients who had suboptimal results on the latter two drugs.

Approved for psoriasis, Vtama met the primary and secondary endpoints in first of two Phase III atopic dermatitis studies. The Roivant affiliate will position the drug as a two-in-one solution for both.

Galderma said its IL-31 receptor alpha inhibitor nemolizumab succeeded in two Phase III atopic dermatitis trials, advancing the firm’s long-term goal of moving past topical dermatology drugs.

In this week's podcast version of Five Must-Know Things: Merck remains confident in TIGIT; Otezla and Sotyktu battle for share in psoriasis; GSK chief warns about worsening UK pharma sector; China plans to ban gene editing technology exports; and an interview with Boehringer Ingelheim’s head of human pharma regions.

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.

Already approved in Crohn’s disease, Skyrizi now has positive Phase III results in ulcerative colitis with more data expected this year in UC as the field grows more crowded with anti-IL-23 options.

The recent partnerships on Claudin 18.2-targeting agents between Chinese biotechs and big pharma have brought China innovation to a new phase that Chinese firms can be proud of, an executive from Keymed Biosciences, one of the Chinese biotechs involved in such deals, tells Scrip in an interview.

South Korea’s Bridge Biotherapeutics aims to continue development of its first-in-class ulcerative colitis candidate BBT-401 despite its failure to meet the efficacy endpoint in a multinational Phase IIa study, and is also looking to progress other pipeline assets and out-licensing deals.

The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.

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

After failure to close of a potential $177m buyout by EW Pharma, TherapeuticsMD will resolve its debt by selling its three-product women’s health portfolio to Mayne.

The Swiss firm has divested yet another one of its key programs in a bid to stave off insolvency and remain a listed company, forcing it to focus solely on a pre-IVF drug candidate.

After fighting for years to bridge the gender health gap where many women receive poorer treatment than men from academia and non-profits, Kelle Moley has moved into pharma with Ferring to further her vision.

89bio’s pegozafermin met co-primary endpoints of fibrosis reduction and NASH resolution in Phase IIb; the company said its methodology yielded lower placebo responses than in Akero’s Phase IIb study.

The US firm’s GLP-1/glucagon receptor agonist improved weight loss in a Phase II interim analysis, but concerns about drug safety and discontinuation have left investors cynical, even as analysts remain cautiously upbeat.

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

With a 22 June US FDA action date for obeticholic acid in non-alcoholic steatohepatitis, Intercept is thinking ahead to launch plans. Madrigal said it plans a Q2 filing for its NASH drug and hopes to find an ex-US commercial partner.

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

Having taken the special purpose acquisition corporation route to list in the US, Switzerland's Oculis is waiting for some vital late-stage data, notably on OCS-01 for diabetic macular edema.

Rumors have resurfaced that Novartis is looking to shift some of its eye drugs but the Basle-based behemoth tells Scrip it remains committed to in-market products and R&D projects in the ophthalmology space.

The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.

Emerging Company Profile: US firm Peptilogics is advancing through the clinic with its lead orthopedic anti-infective drug candidate based on an AI platform that utilizes algorithms to improve peptide design.

Faced with a scarily short cash runway and an ongoing expensive mid-stage study of an allogeneic cell therapy for the treatment of delayed-union bone fractures, Bone Therapeutics has found a saviour in France's Medsenic.

Major Korean firm Yuhan is seeing progress across multiple novel drug candidates licensed out to global partners, with two now entering pivotal trials. An innovative therapy for degenerative disc disease licensed to Spine BioPharma has received an FDA nod for a Phase III program and may change the standard of care for chronic low back pain patients.

The company said the study of JTA-004 failed to meet its primary and key secondary endpoints, though a post-hoc analysis indicated activity in a patient subset.

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.

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

Data from part B of the Swedish firm’s pivotal trial of Tarpeyo in the rare kidney disorder showed that the treatment effects lasted two years across the entire population, enabling the move from conditional to full approvals in several markets.

The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.

The Swedish group’s Tarpeyo is reaping the benefits of an expanded US sales force and the company is confident of a big revenue rise in 2023, regardless of new competition in the IgAN field from Travere’s Filspari.

Centaur-CytoTools introduces novel topical treatment for diabetic foot ulcers in India, for which they see limited direct competition and hope to change the way the difficult-to-treat diabetes complication is managed. Phase III studies are ongoing in Europe.

Ghent, Belgium-based start-up, AgomAb Therapeutics NV secures funds and license to develop HGF-mimetic agonistic monoclonal antibodies for regeneration of damaged tissues.

Focused on autologous fibroblast cell therapies for rare diseases, the biotech appears cash-poor despite one candidate moving into Phase II and another ready to enter the clinic.

CEO Crowley points to the need to focus on a pair of Fabry candidates, including the pending NDA for migalastat, and notes that other companies have reached Phase III in EB.