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Other Therapy Areas

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Aesthetics

Set Alert for Aesthetics

BiologicsMD Uses Unique Fusion Proteins To Treat Alopecia Safely

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.

Emerging Company Profile Companies

Finance Watch: Brent Saunders Plots Return To Deal-Making With A SPAC IPO

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.

Financing Business Strategies

ITC Takes Medytox’s Hand In US Botulinum Case, Bans Daewoong’s Imports

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.

Aesthetics Legal Issues

Korea Botox Rivalry To Intensify After Meditoxin Measures

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.

South Korea Biologics
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Blood and Coagulation Disorders

Set Alert for Blood and Coagulation Disorders

Scrip Asks…What Does 2023 Hold For Biopharma? Part 8: Therapeutic Area Advances

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

Scrip Asks Research & Development

Pharming Leniolisib Launch Will Require Identifying Patients With Ultra Rare APDS

The company sees leniolisib as a way to expand its US and global commercial footprint before bringing in additional rare disease assets.

Business Strategies Blood & Coagulation Disorders

Altuviiio May See Rapid Uptake Upon European Approval In Hemophilia A

Sanofi announced results from its XTEND-Kids trial, clearing the last requirement before an anticipated second half filing for Altuviiio’s approval with the EMA.

Clinical Trials Blood & Coagulation Disorders

Intellia Says Sickle Cell Therapy Still ‘Wide Open’ As Novartis And Others Exit

A long-anticipated pruning back of the ev vivo gene therapy pipeline for sickle cell disease has arrived with Novartis, Graphite Bio and Sangamo each dropping projects, but some challengers are looking ahead to a future of in vivo approaches to the condition.

Clinical Trials Gene Therapy

Dental Oral

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Start-up AFYX Applies Ultra-Sticky Patch Technology To Underserved Oral Mucosal Disease

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.

StartUps and SMEs Dental Oral
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Dermatology

Set Alert for Dermatology

AbbVie Data Show Skyrizi Tops IL-17 Competitors In Skin Clearance

Skyrizi showed better skin-clearance results than Cosentyx or Taltz in a 52-week study of patients who had suboptimal results on the latter two drugs.

Clinical Trials Business Strategies

Dermavant’s Vtama Appears Well Positioned To Compete With Other Topicals In AD

Approved for psoriasis, Vtama met the primary and secondary endpoints in first of two Phase III atopic dermatitis studies. The Roivant affiliate will position the drug as a two-in-one solution for both.

Business Strategies Clinical Trials

Galderma Readies Its First Therapeutic Biologic For Two US Launches In 2024

Galderma said its IL-31 receptor alpha inhibitor nemolizumab succeeded in two Phase III atopic dermatitis trials, advancing the firm’s long-term goal of moving past topical dermatology drugs.

Strategy Dermatology

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: Merck remains confident in TIGIT; Otezla and Sotyktu battle for share in psoriasis; GSK chief warns about worsening UK pharma sector; China plans to ban gene editing technology exports; and an interview with Boehringer Ingelheim’s head of human pharma regions.

Commercial Clinical Trials
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Ear

Set Alert for Ear

Acousia To Refresh Stagnant Hearing Loss Space With New Potassium Channel Approach

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.

Emerging Company Profile Companies

Lilly Builds On Gene Therapy Focus With Akouos Takeout

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.

M & A Gene Therapy

Otonomy’s Otividex Fails Again In Phase III Meniere’s Study

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.

Clinical Trials Business Strategies

Fennec Nears Market For Chemo-Induced Hearing Loss in Children

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.

Ear Drug Review
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Ear Nose Throat

Set Alert for Ear Nose Throat

Fennec Prepared For Market As Pedmark Finally Gets FDA Nod

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.

Approvals Cancer

Optinose Looking For A Partner To Optimize Big Opportunity In Chronic Sinusitis

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.

Ear, Nose & Throat Clinical Trials

Budesonide CRL Another Setback For Takeda’s ‘Wave 1’ Pipeline

Setback for company's near-term launch goals and US patients with rare esophageal inflammatory condition as regulator asks for additional clinical data. 

United States Complete Response Letters

AZ’s Fasenra Joins GSK’s Nucala In Nasal Polyp Pursuit Of Sanofi’s Dupixent

Further competition to Sanofi/Regeneron’s Dupixent in nasal polyps is on the horizon but the newcomers will have some catching up to do.

Companies Clinical Trials

Gastrointestinal

Set Alert for Gastrointestinal

AbbVie’s Skyrizi Checks One Last Box With Phase III Success In Ulcerative Colitis

Already approved in Crohn’s disease, Skyrizi now has positive Phase III results in ulcerative colitis with more data expected this year in UC as the field grows more crowded with anti-IL-23 options.

Clinical Trials Gastrointestinal

Chinese Biotechs Ascend Deal-Making By Partnering Up Claudin 18.2 Agents

The recent partnerships on Claudin 18.2-targeting agents between Chinese biotechs and big pharma have brought China innovation to a new phase that Chinese firms can be proud of, an executive from Keymed Biosciences, one of the Chinese biotechs involved in such deals, tells Scrip in an interview.

China Deals

Bridge Bio Committed To Novel UC Candidate Despite Phase II Efficacy Miss

South Korea’s Bridge Biotherapeutics aims to continue development of its first-in-class ulcerative colitis candidate BBT-401 despite its failure to meet the efficacy endpoint in a multinational Phase IIa study, and is also looking to progress other pipeline assets and out-licensing deals.

South Korea Clinical Trials

Prometheus Phase II Data For Novel TL1A Inhibitor Impresses On Efficacy

The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.

Clinical Trials Inflammation
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Gynecology Urology

Set Alert for Gynecology Urology

Scrip Asks…What Does 2023 Hold For Biopharma? Part 8: Therapeutic Area Advances

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

Scrip Asks Research & Development

TherapeuticsMD Finds New Exit With Mayne Pharma Licensing Pact

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.

Deals Business Strategies

ObsEva Stays Afloat By Selling Lead Women’s Health Asset To XOMA

The Swiss firm has divested yet another one of its key programs in a bid to stave off insolvency and remain a listed company, forcing it to focus solely on a pre-IVF drug candidate.

Deals Gynecology & Urology

New Ferring Head Laments Woeful Neglect Of Women's Health

After fighting for years to bridge the gender health gap where many women receive poorer treatment than men from academia and non-profits, Kelle Moley has moved into pharma with Ferring to further her vision.

Clinical Trials Gynecology & Urology

Liver Hepatic

Set Alert for Liver Hepatic

89bio’s Phase IIb Data Heighten Competition Within NASH FGF21 Analog Class

89bio’s pegozafermin met co-primary endpoints of fibrosis reduction and NASH resolution in Phase IIb; the company said its methodology yielded lower placebo responses than in Akero’s Phase IIb study.

Clinical Trials Business Strategies

Altimmune’s Pemvidutide Garners Mixed Reviews Following Phase II Obesity Data

The US firm’s GLP-1/glucagon receptor agonist improved weight loss in a Phase II interim analysis, but concerns about drug safety and discontinuation have left investors cynical, even as analysts remain cautiously upbeat.

Clinical Trials Metabolic Disorders

Scrip Asks…What Does 2023 Hold For Biopharma? Part 8: Therapeutic Area Advances

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

Scrip Asks Research & Development

Intercept, Madrigal Get Ready For NASH Commercialization

With a 22 June US FDA action date for obeticholic acid in non-alcoholic steatohepatitis, Intercept is thinking ahead to launch plans. Madrigal said it plans a Q2 filing for its NASH drug and hopes to find an ex-US commercial partner.

Business Strategies Clinical Trials

Ophthalmic

Set Alert for Ophthalmic

Scrip Asks…What Does 2023 Hold For Biopharma? Part 8: Therapeutic Area Advances

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

Scrip Asks Research & Development

NASDAQ Listing Done, Oculis Eyes Phase III Readouts

Having taken the special purpose acquisition corporation route to list in the US, Switzerland's Oculis is waiting for some vital late-stage data, notably on OCS-01 for diabetic macular edema.

Ophthalmic M & A

The Eyes Still Have It For Novartis Despite Sell-Off Rumors

Rumors have resurfaced that Novartis is looking to shift some of its eye drugs but the Basle-based behemoth tells Scrip it remains committed to in-market products and R&D projects in the ophthalmology space.

Ophthalmic Restructuring

Aldeyra All Set For Double Date With The FDA

The US agency is reviewing two of the US biotech’s drug with decisions expected on its methotrexate product for ocular lymphoma by June and on the dry eye drug reproxalap in November, as Aldeyra mulls its marketing strategy for both.

Ophthalmic Drug Review
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Orthopedics

Set Alert for Orthopedics

Peptilogics’ AI Peptide Platform Could Help Address Orthopedic Unmet Need

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.

Emerging Company Profile Orthopedics

Bone Gets Lucky Break At Last With Medsenic Merger

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.

M & A Orthopedics

Spine Takes Yuhan’s Peptide Into US Phase III For High-Need DDD

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.

South Korea Clinical Trials

Bone Has Tough Path Forward After Phase III Knee Osteoarthritis Fail

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.

Clinical Trials Research & Development
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Poisoning

Set Alert for Poisoning

SERB Pays $800m For Boston Scientific Specialty Pharma Business

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.

Deals M & A

£80m To Tackle Snakebite Is A Wellcome Boost

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.

Poisoning Research & Development

Indivior Pact Buys Addex Time For Progressing Dipraglurant And Pipeline

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.

Commercial Companies

US Capitol Capsule: Move over Ebola! Fake drugs fight needs global attention, too

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.

Infectious Diseases Cancer
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Renal

Set Alert for Renal

Scrip Asks…What Does 2023 Hold For Biopharma? Part 8: Therapeutic Area Advances

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

Scrip Asks Research & Development

Calliditas Eyes Full Approval For Tarpeyo In IgAN After Positive Pivotal Update

Data from part B of the Swedish firm’s pivotal trial of Tarpeyo in the rare kidney disorder showed that the treatment effects lasted two years across the entire population, enabling the move from conditional to full approvals in several markets.

Clinical Trials Renal

After US Woes, Akebia Celebrates EU Nod For Vafseo

The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.

Approvals Renal

Calliditas Confident Of Keeping Ahead Of Travere In IgAN

The Swedish group’s Tarpeyo is reaping the benefits of an expanded US sales force and the company is confident of a big revenue rise in 2023, regardless of new competition in the IgAN field from Travere’s Filspari.

Sales & Earnings Business Strategies
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Wound Healing Tissue Repair 

Set Alert for Wound Healing Tissue Repair

Indo-German Collaboration Delivers Novel Diabetic Foot Ulcer Treatment

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.

Commercial India

AgomAb Raises €21m Series A To Regenerate Damaged Tissues

Ghent, Belgium-based start-up, AgomAb Therapeutics NV secures funds and license to develop HGF-mimetic agonistic monoclonal antibodies for regeneration of damaged tissues.

Commercial Financing

Struggling Fibrocell To Consider All Strategic Directions Going Forward

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.

Business Strategies Commercial

Amicus Drops Epidermolysis Bullosa Candidate Following Phase III Failure

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.

Clinical Trials Rare Diseases
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