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.

The company is aiming for an outcomes-based payment model in the US, while it is confident the gene therapy will fare better than some others have in Europe.

The FDA placed a partial hold on its clinical program for lovo-cel due to an adolescent patient experiencing anemia 18 months after treatment, raising uncertainty over filing plans.

The company built on its case for FDA approval with new beta-thalassemia data at ASH, but investor jitters linger after the pullout of Zynteglo from Europe amid reimbursement woes for the gene therapy.

New data show fitusiran’s promise across hemophilia A and B, but a switch to a lower dose prompted by safety concerns will delay its filing until 2024.

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 arrival on the US eczema market of a couple of oral JAK inhibitors with stellar data on itching could provide a challenge to Sanofi and Regeneron's blockbuster Dupixent. However, Pfizer and AbbVie will have to overcome dermatologists' fears about the class-effect safety warnings their drugs come with.

Scrip's Kevin Grogan joins Datamonitor's Pamela Spicer and Davinderpreet Mangat to discuss the skin disease landscape and whether atopic dermatitis is now where psoriasis was a decade ago as another wave of innovative products start to reach the market.

2021 may have been dominated by the continuing coronavirus pandemic, but that did not stop industry’s more bread and butter R&D activities. Here, Scrip takes a look at five of the more notable clinical trial hits of the year that got readers clicking.

Having just launched Opzelura in the US for atopic dermatitis, the US biotech is hoping for another approval in the next few months for its topical JAK inhibitor, this time for vitiligo.

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.

Loss of exclusivity for key Bristol Myers Squibb products, starting with top seller Revlimid, is looming over the company’s R&D pipeline. BMS believes its late-stage and newly approved products will generate more than $25bn in sales by 2029.

The companies announced positive Phase III data for the drug in patients with eosinophilic esophagitis and plan to take the results to regulators in 2022.

In this week's podcast edition of Five Must-Know Things: US tax policies challenge pharma; J&J’s long-time R&D head to retire; Legend Biotech’s CEO talks about plans; BMS disappointment in ulcerative colitis; and another gene therapy partnership for Takeda.

Emerging Company Profile: Scotland-based EnteroBiotix will use proceeds from a successful series A financing to advance its nascent pipeline of novel high-diversity microbial therapeutics, enhancing the gut microbiome and eventually targeting multiple indications.

In this week's podcast edition of Five Must-Know Things: Pfizer’s "game-changing" COVID-19 oral antiviral results; Novartis sells Roche stake; Novartis trumps productive pipeline; Bayer sees blockbuster status for hot flashes drug; and continued hesitance over Aduhelm in the US.

In a series of articles, Scrip takes a look at some of the key novel products expected to reach the market in 2022 in a cross-section of therapy areas. Here, with input from Biomedtracker, are nine new products for endocrine and metabolic disorders that could make their debuts next year.

Anandram Narasimhan, managing director of Merck Specialities Pvt. Ltd. in India, share insights on the uptick in the fertility business and the promise of new launches, including of the checkpoint inhibitor Bavencio, in the country. Overall, the “signs are good”, the executive tells Scrip in an interview.

Ogranon will pay $25m upfront for worldwide commercialization rights to ebopiprant for acute preterm labor, which currently has no approved treatments in the US.

With up to $100m from Abingworth and a recent $75m FOPO, CymaBay has runway to await pivotal data in primary biliary cholangitis in 2023 for seladelpar, after the candidate failed in NASH. It sees a significant market opportunity in the second-line setting cornered by Intercept.

The announcement that the Swiss giant is collaborating again with Alnylam could spark fresh speculation that the firms are moving closer to a merger – or not.

The coronavirus pandemic may have dominated the news in 2021, but industry’s more bread and butter R&D activities continued. Here, Scrip takes a look at five of the more notable clinical trial misses of the year that got readers clicking.

The French biotech was firmly on the ropes last year after elafibranor joined the long list of failures for NASH but the promise it has shown in primary biliary cholangitis has persuaded Ipsen to part with a hefty upfront fee.

Five notable studies are expected to report top-line data in the first quarter. With the help of Biomedtracker's Early 2022 Outlook Report, we take a look at the major catalysts likely to kick off the year, including in heart failure and wet AMD.

The firm’s lead asset, reproxalap, one-upped Novartis’s Xiidra in a mid-stage ophthalmology study, signalling its first-line promise in a market ridden with compliance issues.

Firm revises second Phase III trial for co-primary endpoints, possibly improving its chances of success for demonstrating efficacy on a sign of dry eye disease. Initial Phase III study missed ocular redness measure.

The Swiss giant is paying up to $1.5bn upfront to get hold of Gyroscope's AAV2-based one-time investigational gene therapy for geographic atrophy, an advanced form of dry AMD that leads to irreversible vision loss.

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. 

South Korean stem cell therapy company Medipost is speeding up the entry of flagship product Cartistem into global markets, with an initial focus on ASEAN countries and Japan and helped by regulators' allowance of early local trials to be waived on the back of strong Korean data.

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.

Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.

AstraZeneca and BenevolentAI claim their partnership is augmenting and accelerating validation of new drug targets.

Confirming rumors of an acquisition, CSL will venture into some new territories as well as boost its renal franchise when it takes over Switzerland’s Vifor Pharma in a deal worth $11.7bn.

Although ANG-3777, partnered with Vifor, missed its primary endpoint in cardiovascular surgery patients at risk for acute kidney injury, the companies will consider a path forward based on a renal events measure.

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.