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.

A patient developed Factor VIII inhibitors, but he had also recently received a COVID-19 vaccine and was genetically predisposed.

Orchard Therapeutics of the US and Dutch biotech Pharming have agreed to jointly research, develop, manufacture and commercialize the former’s newly disclosed investigational ex vivo autologous hematopoietic stem cell gene therapy as a treatment for hereditary angioedema.

The FDA may want longer follow-up data for companies developing treatments for hemophilia A as well as hemophilia B.

Promising pivotal data boost chances for Omeros’ narsoplimab to become a highly needed, first-to-market drug for the treatment of a deadly complication of stem cell transplants.

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.

Sanofi has transformed the productivity of its R&D pipeline over the past several years, and late-stage clinical data readouts are expected in the second half of this year for new anticancer drugs, a candidate pemphigus therapy and a COVID-19 vaccine.

Now that the actinic keratosis treatment Klisyri has got the green light in Europe, the Spanish firm's attention will be on atopic dermatitis and forthcoming Phase III data on lebrikizumab, a potential rival to Dupixent.

Swedish biotech Amniotics is developing a broad pipeline of unique stem cell therapeutics based on technology that is broadly applicable to major disease markets which should eventually draw the attention of big pharma players, its CEO tells Scrip.

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

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.

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.

Orchard Therapeutics of the US and Dutch biotech Pharming have agreed to jointly research, develop, manufacture and commercialize the former’s newly disclosed investigational ex vivo autologous hematopoietic stem cell gene therapy as a treatment for hereditary angioedema.

Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.

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. 

Myovant CEO David Marek talked to Scrip about why the companies believe patients and physicians will choose Myfembree over AbbVie's Oriahnn.

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

Poxel’s shift to new therapeutic areas may be necessary despite Japan’s approval for its diabetes drug. Twymeeg looks set to be hamstrung by placebo-controlled studies without outcomes data.

Armed with €26m in fresh funds from investors that include partner Regeneron, ISA Pharma can now advance promising preclinical assets generated from its proprietary platform, containing a mix of synthetic antigenic peptides, its CEO tells Scrip.   

Lilly outlined its tirzepatide-led pipeline of incretin agonists and highlighted its once-weekly basal insulin during a post-ADA event. The company hopes to grow the GLP-1 market overall rather than shift patients from Trulicity.

AGTC hopes to gain the first approval in X-linked retinitis pigmentosa for its gene therapy AGTC-501, now in a Phase II/III study. It also is advancing development in achromatopsia, another unmet medical need.

Adverum said it would cease developing ADVM-022 for DME and focus on wet AMD, but the adverse events that prompted the shift could invite further scrutiny in an already competitive market.

Entresto and Cosentyx continue to grow but investors will be looking to see if there are candidates in the current portfolio or pipeline that could join them in the mega-blockbuster club.

French biotech GenSight Biologics reports top-line results from the Phase III REFLECT study, backing the efficacy of its lead gene therapy in a devastating eye disease, and prepares plans to commercialize the product.

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.

Trial of high-need gene therapy set to restart following the deaths of several participants and the lifting of a clinical hold imposed by the US FDA last year.

Ultragenyx hopes to expand its bone disease franchise in a deal that frees up Mereo to focus on its anti-TIGIT immuno-oncology pipeline asset.

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.

In this week's podcast edition of Five Must-Know Things: J&J’s outlook for coronavirus vaccines; Cosentyx comes in strong for Novartis; Biogen’s views on Aduhelm pricing; competition in the “dustat” sector; and dealing with endemic COVID-19.

Swedish biotech Amniotics is developing a broad pipeline of unique stem cell therapeutics based on technology that is broadly applicable to major disease markets which should eventually draw the attention of big pharma players, its CEO tells Scrip.

The company, which set a list price of $19 per day, sees awareness of diagnosing chronic kidney disease in type 2 diabetes patients as the top challenge for newly approved finerenone in the US.

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

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.