Other Therapy Areas
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Aesthetics
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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.

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.

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.

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.
Blood and Coagulation Disorders
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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.

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.

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.

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.
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.
Dermatology
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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.

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.

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.

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.
Ear
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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.

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.

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.

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 Nose Throat
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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.

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.

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.

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.
Gastrointestinal
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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.

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.

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.

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.
Gynecology Urology
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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.

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?

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.

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.
Liver Hepatic
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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.

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.

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.

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.
Ophthalmic
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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.

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.

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.

Novartis Positive Post-Sandoz But Some Cancer Drugs Look Lackluster
Sans Sandoz, Novartis posts a beat-and-raise but its oncology franchise remains undistinguished.
Orthopedics
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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.

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.

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.

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.
Poisoning
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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.

£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.

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.
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.
Renal
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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.

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.

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.

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.
Wound Healing Tissue Repair
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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.

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.

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.

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.
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