Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Other Therapy Areas

Set Alert for Other Therapy Areas

Aesthetics

Set Alert for Aesthetics

Revance Wins First Daxxify Therapeutic Indication, Plans Limited Initial Rollout

Similar to its post-approval strategy in aesthetics less than a year ago, Revance will initially target a small number of doctors as it Daxxify to market in the US for cervical dystonia with a broader launch in 2024.

Approvals Launches

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
See All

Blood and Coagulation Disorders

Set Alert for Blood and Coagulation Disorders

Novartis’s Fabhalta Reaches First Stop On Regulatory Journey With PNH Nod

Novartis envisions the drug, the first oral monotherapy for PNH, as a “pipeline in a pill” that could see $3bn in peak sales, with a Phase III readout in IgAN in October and one in C3G expected this month.

Approvals Blood & Coagulation Disorders

Bayer Buffeted By OCEANIC Setback

A sea of troubles continues for the German conglomerate as a Phase III failure for one of its future blockbuster hopes sends shares diving. Flickers of hope remain for the product in stroke.

Clinical Trials Companies

Vertex Achieves Gene-Editing Milestone With First Ever CRISPR Therapy Approval

Great Britain is first to approve the groundbreaking CRISPR-based therapy for sickle cell and beta thalassemia. Vertex is yet to reveal its price, however, and wants to play down early expectations of its commercial potential.

Approvals Commercial

Lilly’s Zepbound: The Biggest-Selling Drug In The World, Ever?

Humira currently holds the record as the bestselling drug ever. But Keytruda is coming for its crown – and beyond that, Zepbound.

Commercial Companies

Dental Oral

Set Alert for Dental Oral

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
See All

Dermatology

Set Alert for Dermatology

Ambitious Almirall Lays Out Ebglyss Launch Plans

The Spanish firm is all set to launch its atopic dermatitis drug in Germany later this month and is hopeful of a smooth reimbursement path across Europe.

Dermatology Launches

Almirall Enlists Absci’s AI Expertise For Dermatology Drug Discovery

Deal Snapshot: In Almirall’s first de novo artificial intelligence drug discovery and development collaboration, the company will pay up to $650m to work with Absci on two dermatology candidates.

Deals Artificial Intelligence

Ventyx Won’t Pursue Psoriasis Further Despite Phase II Success

Ventyx’s TYK2 inhibitor met primary and secondary endpoints in a Phase II psoriasis trial, but the biotech determined the data are not competitive in a class led by Bristol’s Sotyktu.

Business Strategies Clinical Trials

UCB Wins Two Key US Approvals: Bimzelx In Psoriasis, Zilbrysq In gMG

Two years after its first FDA review, UCB’s next blockbuster Bimzelx finally crossed the finish line. Supplemental filings for more indications will soon follow as the company forecasts €4bn in peak sales.

Approvals Launches
See All

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
See All

Ear Nose Throat

Set Alert for Ear Nose Throat

Regeneron Strikes A CHORD With Deafness Gene Therapy

A very early success with a gene therapy for a rare form of deafness puts Regeneron ahead of Lilly and Sensorion.

Gene Therapy 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

Gastrointestinal

Set Alert for Gastrointestinal

Sosei Heptares Eyes $3bn Sales From IBD Drug Returned By GSK

The first-in-class, oral GPR35 agonist has shown preclinical promise as a potential treatment for gastrointestinal indications such as ulcerative colitis.

Gastrointestinal Deals

Disappointed InDex CONCLUDEs Development Of Ulcerative Colitis Drug

The Swedish biotech's hopes of advancing cobitolimod lie in tatters after a Phase III study of the TLR9 agonist proved futile.

Gastrointestinal Clinical Trials

Galapagos Says Goodbye To Jyseleca And Streamlines Operations

The Belgium-based biotech is transferring the rights to its only marketed product to Italy’s Alfasigma in a move aimed at cutting costs and tightening its focus on its early-stage immunology and oncology pipeline.

Business Strategies Deals

Abivax Confident About Securing Success Stateside

The French group has just listed on the NASDAQ and while its stock has already taken a couple of hits, CEO Marc de Garidel has faith that the firm’s IBD drug obefazimod will be a major player in the space.

Financing Business Strategies
See All

Gynecology Urology

Set Alert for Gynecology Urology

Initiator Explores Unmet Need In Erectile Dysfunction Space

The Danish firm’s CEO Claus Olesen tells Scrip that pudafensine could help the 35% of men who do not respond to the currently available treatments for ED.

Clinical Trials Business Strategies

Innoviva Aims For A First-In-Class Antibiotic

Zoliflodacin could become the first new antibiotic for treating gonorrhea in decades, but can it change guidelines?

Clinical Trials Companies

Organon Widens Business Development Lens To Maintain Women’s Health Focus

Organon has not strayed from its women’s health path, but is entering into earlier deals and considering technologies beyond therapeutics, while advocating increased investment in the field.

Deals Business Strategies

GSKs Gepotidacin Could Become First Novel Antibiotic For uUTIs In 20 Years

The UK major’s first-in-class asset has matched standard-of-care in two Phase III urinary tract infection trials, setting it up to become the first novel antibiotic for the condition in 20 years with a clear niche in the second-line setting.

Clinical Trials Infectious Diseases

Liver Hepatic

Set Alert for Liver Hepatic

Who Will Emerge As Best In Class Of The FGF21 Analogs In NASH?

Akero hopes to begin Phase III study of efruxifermin this year, with 89bio working to enter Phase III with pegozafermin in 2024. But just behind them, Boston Pharmaceuticals thinks it has a convenience and immunogenicity edge.

Business Strategies Clinical Trials

CymaBay Appears Stronger Threat To Ocaliva In PBC Than Ipsen/Genfit

CymaBay and Genfit have been positioning their failed NASH candidates, both PPAR agonists, for approval in second-line primary biliary cholangitis. Analysts call both approvable, but say CymaBay’s drug has a better overall profile.

Business Strategies Clinical Trials

AASLD Notebook: Inventiva Eyes Second-To-Market Possibility In NASH

Inventiva’s pan-PPAR agonist and Terns’ combination strategy are targeting the NASH treatment paradigm after expected approval of Madrigal’s resmetirom. Viking is hoping to prove a better THRβ drug profile than Madrigal.

Business Strategies Clinical Trials

Novo Nordisk Has Plans For Semaglutide In NASH Too

With its GLP-1 analog already a stalwart in type 2 diabetes and weight loss, Novo Nordisk is investigating semaglutide as monotherapy and in combination regimens to treat non-alcoholic steatohepatitis.

Business Strategies Clinical Trials

Ophthalmic

Set Alert for Ophthalmic

EyePoint Hits New Durability Milestone For Wet AMD Treatment

Positive Phase II data in wet AMD showing potential for dosing out to six months could spur partnering interest ahead of Phase III development.

Ophthalmic Clinical Trials

Aldeyra Plans Quick Response To FDA’s CRL For Reproxalap

Aldeyra already has a special protocol assessment under review at the FDA for a trial to provide the symptom data the agency said is needed for approval of the RASP modulator in dry eye disease.

Complete Response Letters Business Strategies

Vision Failure Means End Of The Road For Oxurion

Disappointing data from a trial of the last remaining drug in its pipeline means that the Belgium group formerly known as ThromboGenics is closing its doors after more than 30 years.

Business Strategies Ophthalmic

Novartis Positive Post-Sandoz But Some Cancer Drugs Look Lackluster

Sans Sandoz, Novartis posts a beat-and-raise but its oncology franchise remains undistinguished.

Sales & Earnings Cancer
See All

Orthopedics

Set Alert for Orthopedics

Ipsen’s Sohonos Clinches First US Approval For Ultra-Rare Bone Disorder

Just a month after an EU rejection, the French drugmaker’s oral retinoic acid receptor gamma agonist Sohonos has won a US thumbs up for the treatment of fibrodysplasia ossificans progressiva, an ultra-rare disorder that turns soft tissue into bone.

Approvals Rare Diseases

AstraZeneca’s Soliris Wins EU Recommendation In Pediatric gMG As Competition Looms

The UK major’s older C5 inhibitor product could soon receive EU approval for children and adolescents with the rare disease, but emerging competition from biosimilar developers and rival firms are starting to stack up.

Approvals Companies

Argenx Gets Under Skin Of Rivals With Vyvgart Hytrulo Approval

The US approval of a more convenient formulation of its myasthenia gravis therapy, Vyvgart, should cement its market position as well as change the definition of what being "well-controlled means for patients", Argenx hopes.

United States Companies

Inozyme Targets Underserved Mineralization Disorders Market With First-In-Class Enzyme Therapy

Emerging Company Profile: Fresh from a $73m follow-on offering last year, the US biotech is readying its lead asset for a pivotal trial in ultra-rare but debilitating mineralization disorders that affect infants and children.

Emerging Company Profile Rare Diseases
See All

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
See All

Renal

Set Alert for Renal

AZ And Boehringer Move Into Phase III With Rival Next-Gen CKD Drugs

Boehringer Ingelheim and AstraZeneca are once again going up against each other in chronic kidney disease, with Phase II results for their rival new agents showing promise. Unfortunately, they both also lie in the path of Novo Nordisk’s cardiometabolic juggernaut, Ozempic.

Clinical Trials Companies

Novartis Bookends October With Two IgAN Successes

A Phase III hit moves atrasentan a step closer to the market but the drug will have to sell very well to justify the billions Novartis paid for its originator.

Renal Clinical Trials

Omeros Crashes To All-Time Low On IgAN Failure

Development of narsoplimab in the kidney disease has been called off, making a forthcoming regulatory decision in a different use all the more important.

Clinical Trials Companies

Novo Nordisk heeds KBP Biosciences’ CLARION call

Novo Nordisk’s metabolic juggernaut semaglutide is known to work in chronic kidney disease – but the group appears to want a back-up plan. 

Commercial Companies
See All

Wound Healing Tissue Repair 

Set Alert for Wound Healing Tissue Repair

Swiss R&D Innovation: A Tale Of Two Firms Developing Cell Therapies For Wounds

While perhaps best known for historical achievements in immuno-oncology and CNS disorders, the Swiss biotech sector is slowly cultivating a new area of expertise in dermatology. Scrip spoke with two firms applying cell therapy technologies to the challenging area of chronic and acute wounds.

Wound Healing & Tissue Repair Companies

Vertex’s Type 1 Diabetes Cell Therapy Gets A Boost – And Some Competition

Vertex has invested heavily in advancing its stem-cell based candidates for type 1 diabetes, but Sernova has inched ahead in the race to bring a functional cure for the condition to patients.

Metabolic Disorders Wound Healing & Tissue Repair

Krystal Clears Path To Market For Topical Gene Therapy Vyjuvek

The company estimates there are about 9,000 reimbursable patients with dystrophic epidermolysis bullosa worldwide and anticipates a third-quarter launch following FDA approval.

Approvals Gene Therapy

Promore’s Enserpetide Has Phase II Setback In Scar Prevention, Focus Shifts To Ropocamptide

The Swedish firm’s lead program has unexpectedly disappointed in a Phase II scar prevention trial, prompting it to turn its efforts to its only other clinical asset for the treatment of chronic wounds.

Clinical Trials Wound Healing & Tissue Repair
UsernamePublicRestriction

Register