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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Anthos Changing Course With Factor XIa Inhibitor, Targeting Atrial Fibrillation Patients First
With a Phase II study stopped for efficacy in bleeding reduction, Anthos hopes to bring abelacimab, a dual Factor XI/XIa inhibitor to market to prevent strokes in a-fib patients and to treat cancer patients with thrombosis.

Johnson & Johnson Gets Its Aprocitentan Money Back
The US company has returned rights to the hypertension product to Idorsia, which was already in the grip of a cash crunch and will now face greater difficulties getting the drug to market.

BMS Broadens Market, De-Risks Long-Term Revenue Potential For Reblozyl
As a first-line treatment for anemia in patients with myelodysplastic syndromes, Reblozyl is approved for indications that will account for 75%-80% of the $4bn-plus in sales Bristol has forecast by 2029.

US FDA AdComm For Vertex’s Sickle Cell Gene Therapy ‘Not A Concern’
The US biotech revealed the US Food and Drug Administration would be holding an advisory committee meeting for exa-cel during its second quarter earnings, but analysts are unfazed by the news amid robust revenues and raised guidance.
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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All Systems Go At Almirall To Enter Tough Atopic Dermatitis Market With Ebglyss
Following a positive opinion from the CHMP, the Spanish company is hoping to launch its challenger to Dupixent in the EU before the end of the year.

Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.

Acelyrin Goes From Float To Sink
A catastrophic late-stage clinical failure wipes 60% off the group’s value – and boosts a rival.

Paradigm Plots Revival Of Butterfly Skin Drug After Amicus Deal
Chiesi-owned Amryt and Krystal Biotech have approved treatments for epidermolysis bullosa but they only treat one subtype - dystrophic - and a single wound. Paradigm CEO Robert Ryan tells Scrip that SD-101, a topical cream he helped develop over 20 years ago, has the potential to be offer a far more extensive and efficacious solution for many more sufferers.
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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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.

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.
Gastrointestinal
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A Year And A Half After Giving Up On TAK-721, Takeda Seeks Approval In EoE
The US FDA rejected TAK-721 for eosinophilic esophagitis (EoE) in 2021, requiring another study, and Takeda ended development in 2022, but in a newly accepted NDA it is seeking a short-term treatment indication.

Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Biomarin’s next chapter; Amgen’s obesity plans; Daiichi’s new ADC data; Acelyrin hit by clinical failure; and Skyrizi beats Stelara in Crohn’s.

First Wave Rises With Sanofi GI Deal
First Wave is licensing Sanofi’s 5-HT4 receptor partial agonist capeserod and is having to pay a mere $500,000 in upfront fees for the privilege.

AbbVie’s Skyrizi Bests Stelara Head-To-Head In Crohn’s
Data showing superiority on endoscopic remission and non-inferiority on clinical remission could position AbbVie’s IL-23 inhibitor to move ahead of Stelara in treatment paradigm.
Gynecology Urology
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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.

Drug Makers Denounce Court Ruling Overturning Abortion Drug Approval
Industry executives, trade groups and medical organizations said the ruling undermines the US FDA, flies in the face of science and would harm innovation by drug makers if allowed to stand.

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.
Liver Hepatic
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The Game Looks Up For Galecto
The Boston-based biotech is weighing up its options as the fall-out from its failed IPF candidate casts a shadow over Galecto’s future.

Biopharma’s Must-Know Q4 Catalysts
Cytokinetics has a lot riding on the upcoming Phase III readout for aficamten, and crunch time is coming for plenty of other groups, too.

Infographic: A Snapshot Of Non-Alcoholic Steatohepatitis R&D
After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

A Look Into The Future Of NASH
The liver disease is one of the hottest areas of drug development. Here are some upcoming catalysts to look out for.
Ophthalmic
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Otsuka Expands Ocular Gene Therapy Interests Through ShapeTX Deal
Otsuka steps into the ocular gene therapy field through a technology licensing deal worth up to $1.5bn with ShapeTX, which in turn further expands the US firm's global reach following a $3bn collaboration with Roche.

Outlook Aims To Reverse US FDA’s Rejection Of Bevacizumab For AMD
Outlook Therapeutics received a complete response letter citing manufacturing issues and seeking more data for Lytenava (ONS-5010), its bevacizumab injection for wet age-related macular degeneration.

Oculis Eyes Success In Wide Range Of Ophthalmic Conditions
Oculis has enjoyed a strong first six months of 2023 after demonstrating the potential of OCS-01 to treat a variety of eye conditions and establishing a presence in the US.

Apellis Bounces Back After Needle Discontinuation Amid Syfovre Safety Concerns
Real-world cases of retinal vasculitis linked with Syfovre for geographic atrophy in age-related macular degeneration may have resulted from a material used in a specific filter needle, the US firm revealed, as analysts remained optimistic on the product.
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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Jardiance Improves Double-Digit Growth Potential With US Approval In CKD
Boehringer expects Jardiance’s new chronic kidney disease indication to keep its sales growing by double-digit percentages over the coming years, aided by the drug’s ability to reduce hospitalizations.

Travere Hopes For FDA Full Approval Despite Filspari Trial Endpoint Miss
The company said the “totality of data” from the confirmatory PROTECT trial in IgA nephropathy showed the drug slowed decline in kidney function.

Mironid Gets Roche Backing To Tackle Hereditary Kidney Disease
These are interesting times for Mironid, a Glasgow-based biotech developing small molecule therapeutics for the treatment of autosomal dominant polycystic kidney disease, a life-threatening hereditary condition.

Calliditas Confident Despite Cutting Tarpeyo Sales Guidance
The Swedish biotech’s immunoglobulin A nephropathy therapy Tarpeyo is still selling well but “market access friction” is slowing growth. As US regulators grant a priority review to its data package for full approval, Calliditas’s prospects look promising.
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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