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 only addition to AbbVie’s leadership after it closes the $63bn acquisition of Allergan will be Carrie Strom, who will lead the Allergan Aesthetics business.

Roche looks set to gain first and second place in the race to bring CD3Xcd20s to market – but Genmab and AbbVie have a strong challenger.

GSK’s drug is the first in the class to show non-inferiority to standard therapy in safety, but the data still contains areas of doubt.

While a cloud hangs over the future of its CD19-targeting allogeneic candidate, Allogene points to preclinical potential of superior efficacy for ALLO-715.

Phase III success for efanesoctocog alfa sets up a filing in the near future, and a chance to seize market share from existing Factor VIII products, as well as Roche’s Hemlibra.

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 Roivant-owned company's Vtama topical cream was approved by the US FDA with a broad label permitting use for mild, moderate or severe psoriasis.

In this week's podcast version of Five Must-Know Things: a US setback for UCB; Lilly challenges Novo’s GLP franchise; Seagen searches for CEO after scandal; Hengrui hopes for US PD-1 success; and a look ahead at ASCO.

As it prepares to file lebrikizumab for atopic dermatitis, the Spanish group is looking to expand into vitiligo through a collaboration with France’s Inserm Transfert to develop topical therapies for the condition where pale patches develop on the skin caused by the lack of melanin.

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

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.

Astellas adds a large-market drug candidate to its regenerative medicine portfolio, while Frequency Therapeutics almost doubles its fundraising to date. It traded ex-US rights to hearing loss candidate FX-322 for $80m up front and up to $545m in milestone fees plus royalties.

German biotech Acousia Therapeutics closes a series B round with corporate and institutional VC firms, and aims to advance its drugs into clinical trials for hearing loss associated with cancer chemotherapy. 

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.

Updated results from two Merck & Co Phase III studies, COUGH-1 and COUGH-2, confirm the drug’s efficacy in reducing the frequency of refractory cough and its association with taste disturbances.

With Budesolv hitting key endpoints in a Phase III allergy trial, the Austrian biotech is stepping up its partnership discussions for the allergic rhinitis drug.

Detailed data presented at Digestive Disease Week show competitive efficacy in ulcerative colitis and a potential best-in-class safety profile for the S1P receptor modulator Pfizer acquired earlier this year. 

The leader in inflammatory bowel disease via Humira, AbbVie awaits a US FDA decision in June for Skyrizi in Crohn’s disease and plans to add a Crohn’s indication to Rinvoq’s ulcerative colitis approval.

As Takeda reported what its CEO described as "a remarkable year," the company sees itself as well positioned to ride out the expiries over the next few years of exclusivity for several big-selling products, as it looks to mainstays and more organic growth to tide it over the "temporary headwinds."

Once deemed an intimidating and risky space, microbiome modulator firms are slowly winning over investors as robust clinical data surface, with one company, Microbiotica, recently hitting an EU financing record.

Organon commercial director and lead for the South Asia Region, Anjan Sen, lays out how the Merck spin-out expects to scale up activities in markets like India. A mix of new products, targeted repurposing efforts and access-driven pricing are part of the strategy that could potentially see the company double its presence in the region.

Metastatic prostate cancer continues to evade the checkpoint inhibitor class but Merck is not giving up on an area where overall survival remains limited.

The company is ramping up the launches of Orgovyx for prostate cancer and Myfembree for uterine fibroids, including indication and geographic expansions, and evaluating business development opportunities.

With a pair of successful Phase III pivotal studies in hand, the Japanese pharma reports that its nonhormonal hot flash/night sweats candidate demonstrated safety and tolerability over 52 weeks.

Emerging Company Profile: Swiss biotech Unicyte is using donor-derived liver stem cells across a range of therapeutic areas, with its lead asset showing curative potential in urea cycle disorders.

In this week's podcast version of Five Must-Know Things: big changes at Biogen; Paxlovid still a work in progress; Farxiga goes stellar; Moderna hints at M&A; and a chat with Roche Pharma India’s CEO on rare diseases.

Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.

Resmetirom, Madrigal’s THRβ agonist, demonstrates safety and tolerability, and succeeds on secondary efficacy endpoints in a study serving as a precursor to the firm’s pivotal Phase III trial.

Vertex has acquired the full assets to a promising protease-based drug platform from Catalyst, broadening its R&D base once again.

The company announced positive topline results for the drug in night vision disturbance and may conduct another pivotal trial as it focuses on myadriasis and presbyopia.

THR-687’s failure in Phase II marks the second drug to flunk in the disease after a Phase IIa study of THR-317 showed disappointing results in 2019, but THR-149 has shown some encouraging data.

Four prominent drug candidates are expecting topline mid- or late-stage data over the next few months. With the help of Biomedtracker's Q2 Outlook Report, we take a look at the assets that could help validate some of the companies developing them, from oncology to psychiatry.

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.

Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.

The knee osteoarthritis injection was hit hard by COVID-19 restrictions, at first. But CEO Mike Clayman reflected in an interview about how the pandemic experience is helping fuel further growth for Zilretta. 

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.

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.

First-quarter sales jumped by 56% to $11.39bn at AstraZeneca and while its COVID-19 products brought in $1.6bn, it was the performance of the diabetes, heart failure and chronic kidney disease drug Farxiga that impressed most.

Four prominent drug candidates are expecting topline mid- or late-stage data over the next few months. With the help of Biomedtracker's Q2 Outlook Report, we take a look at the assets that could help validate some of the companies developing them, from oncology to psychiatry.

Carinne Brouillon, head of the German major’s human pharma business unit, tells Scrip that Jardiance’s leadership in interconnected cardio-metabolic-renal diseases has been demonstrated and the product is set to keep rising as new indications come onboard.

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.