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.

Animal studies have shown that AAV viral vectors can integrate into animal cell DNA – but whether that causes cancer, or could happen in humans, remains uncertain.

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 five new hematology products that could make their market debuts (or return) next year.

The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.

The EU approval is good news for FibroGen and marketing partner Astellas, but was expected, and still leaves it pondering its future after FDA knock-back.

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.

Amryt has set out its future plans to the investment community with much depending on the successful relaunch of its just-acquired acromegaly drug Mycapssa and a potential FDA approval for its epidermolysis bullosa gel Filsuvez.

In this week's podcast edition of Five Must-Know Things: new US warnings for JAK inhibitors; strong new heart failure results for Jardiance; good head-to-head results for Pfizer in atopic dermatitis; US payers and drug exclusion lists; and a look ahead at key expected hematology launches.

Forte Biosciences’ attempts to use a new approach to treating inflammatory skin disease using a topical live biotherapeutic, FB-401, have come to a crashing halt at Phase II. Where the company goes next remains to be seen.

Topline results suggest lebrikizumab could outshine Sanofi’s Dupixent on safety and itch reduction in atopic eczema, but a direct comparison study is likely required to drive the message home.

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. 

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.

After making a move into hearing loss with an investment into Acousia Therapeutics, BI is backing a UK biotech which hopes to reverse neuropathic sensorineural hearing loss.

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.

Top-line results from a Phase IIb study of Theravance’s potential gut-selective JAK inhibitor izencitinib have not matched expectations, and results from a similar early-stage study in Crohn’s disease with the Janssen-partnered candidate are now awaited at the end of the year or in early 2022.

The company plans an intensive review to determine the path forward for SER-287. A similar deep dive led to the successful revival of its C. difficile drug, SER-109, which it plans to submit for approval.

Sosei Heptares hopes to create transformative therapeutics for immune diseases by combining its GPCR structure-based drug design and early development capabilities with InveniAI's already validated AI-based platform, its head of new target identification tells Scrip.

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.

In this audio interview, Organon’s head for the Asia Pacific region talks to Scrip on the company’s ambitions in the women’s health segment and the outlook for its biosimilars and established brands portfolios.

CEO Kevin Ali talked to Scrip about his plans for Organon, ahead of the spinout from Merck & Co. Women's health will be the top priority. 

Animal studies have shown that AAV viral vectors can integrate into animal cell DNA – but whether that causes cancer, or could happen in humans, remains uncertain.

Biotech is determining which of its mid-stage FXR candidates – MET409 and MET642 – will offer the best overall profile to take into Phase IIb. It is also studying ‘409 in combination with Jardiance and will test the FXR class in inflammatory bowel disease.

Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.

The first clinical results from its mitochondrial derived peptide pipeline is good news for CohBar, but it needs investors or big pharma partners to help it progress.

Regeneron's Eylea and Roche's Lucentis currently dominate the treatment market for wet-AMD and diabetic eye disease, but biosimilar ranibizumab and new brand launches are on the horizon.

AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

The partnership worth up to $1.75bn removes the significant risk of going it alone in a competitive market as Regenxbio awaits late-stage data for its gene therapy.

Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.

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.

The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.

Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.

Sanofi’s $1.9bn cash purchase of Kadmon surprised many analysts, coming as a bolt-on for the French pharma’s general medicines transplant portfolio rather than its specialty care pipeline, but the overall view was that it made sense.

Long touted as one of the drugs to watch in the Swiss giant's pipeline, iscalimab's chances of replacing tacrolimus as the standard of care preventing organ rejection in transplant patients have been dealt a hefty blow after a Phase II trial failure.

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.