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.

The drug showed efficacy in hemophilia A and B with no sign of clots, an issue that historically has dogged anticoagulation agents, but it remains unclear whether that advantage will hold.

Sobi plans to capitalize on the complimentary expertise at CTI Biopharma to together boost sales of the latter firm’s myelofibrosis drug Vonjo and enhance the Swedish pharma firm’s overall growth.

With very little cash left in the bank, Idogen is weighing up its options including a reverse merger or liquidation.

BioMarin has yet to treat a patient with Roctavian, the first ever hemophilia A gene therapy, eight months after its first approval in Europe, as pricing delays cloud its commercial prospects.

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.

In this week's podcast edition of Five Must-Know Things: J&J’s Duarto on the importance of diversity; Teva’s views on its new risperidone launch; Almirall’s hopes for lebrikizumab; Biogen’s Viehbacher questions the need for spending on weight loss drugs; and Citeline’s annual R&D review looks at the current state of the global biopharma pipeline.

The Barcelona-based group is confident that Lilly-partnered lebrikizumab has the potential to become a best-in-class treatment for atopic dermatitis and take market share from Sanofi’s blockbuster Dupixent.

The mid-sized pharma company has a blockbuster in Jakafi, but analysts are doubtful about its plans to build on that base across its now slimmed-down pipeline. 

The second quarter has already seen the approval of Gamida Cell’s cell therapy Omisirge, and with the help of Biomedtracker, Scrip highlights 10 of the more interesting new drug approvals due in the next three months.

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.

Ironwood said it believes VectivBio’s once-weekly GLP-2 analog apraglutide is differentiated from Takeda’s once-daily Gattex in short bowel syndrome and could generate $1bn in peak sales.

US FDA approval in Crohn’s disease further boosts the revenue potential for Rinvoq as AbbVie navigates a period of declining sales overall due to the introduction of US biosimilars for Humira. 

While Japan's largest pharma company reached a number of milestones last fiscal year, it is facing a number of challenges to revenues in 2023, for which it is looking to its core commercial portfolio and pipeline to help drive growth.

The IL-23 inhibitor, entering an increasingly competitive space, posted significant results at Digestive Disease Week from the Phase IIb/III QUASAR induction study in ulcerative colitis.

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.

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.

In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.

When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.

An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.

Company tells advisory committee it is unsure of continuing on to collect Phase III outcomes data in NASH without accelerated approval, which the panel voted against.

The ARCHER study did not show improvement in lesion growth, but still showed an improvement in best corrected visual acuity, potentially opening a pathway toward a pivotal trial.

The Swiss firm’s lead candidate has hit the mark in the first stage of a pivotal diabetic macular edema program, edging closer to becoming the first eye drop treatment for a condition where unmet need remains despite the advent of anti-VEGFs.

The companies got US FDA approval for the drug, which they said is the only approved medicine that targets tear evaporation rather than tear production, though its mechanism is not fully understood.

In this week's podcast edition of Five Must-Know Things: strong growth in blockbuster ranks in 2022; Lilly’s donanemab slow cognitive decline; FDA approves first RSV vaccine; Pfizer anticipates revenue bolus from vaccines; and Astellas buys into ophthalmology.

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 US firm’s lead antibody oligonucleotide conjugate candidate has improved muscle strength and mobility in an early muscular dystrophy trial but some experts are disappointed by dose-specific data and a serious adverse event.

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.

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.

Japanese major’s profit figures for fiscal year just ended will be hit by multiple accounting decisions related to sales, pipeline and partnerships.

While Roche is in Phase III with Gazyva, HI-Bio thinks its autoantibody-depleting mechanism may be the best approach in PMN.

The German firm is anticipating a major label expansion in kidney disease for its SGL2 inhibitor later this year, prompting Boehringer to gear up commercial activities as AstraZeneca’s rival Farxiga faces the threat of generic competition.

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

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.

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.