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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Takeda Charges Into Diversification With ITP Win
The company announced positive topline results from a Phase II study of mezagitamab and expects to have five programs in Phase III development this fiscal year.
Things Get Worse For Gilead’s Magrolimab
Gilead said the FDA requested a partial clinical hold on the studies as well, just over a week after the drug maker said it would not develop the magrolimab further for blood cancers.
Grifols Aims For Largely Untapped Market With Successful Fibrinogen Deficiency Study
The Phase III trial of BT524 produced positive topline results in patients with acquired fibrinogen deficiency, potentially making it the first fibrinogen concentrate to win US FDA approval for that indication.
Crovalimab Gets First Nod In China For PNH, Fiercer Global Competition Awaits
The anti-C5 inhibitor sets an example of swift global trial and approval in China while fiercer competition awaits in the US, Europe and Japan.
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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Moonlake Aims To Defy The Single-Product Risk
The group is pushing sonelokimab into pivotal trials in two indications and starting from scratch in three more. What comes after that?
Quick Listen: Scrip's Five Must-Know Things
In this week's podcast edition of Five Must-Know Things: Galderma prepares to take on Dupixent; Pfizer’s plans for Adcetris in DLBCL; Lilly’s donanemab approval delayed again; the psychedelic R&D pipeline; and an interview with BMS’s CDTO Greg Meyers.
Almirall Casts Its Net To Cover Butterfly Skin Disease
Deal Snapshot: The Spanish company is linking up with US biotech Eloxx to get hold of an asset that will be its first in the rare dermatological disease space.
Acelyrin PsA Data Are Positive, But Is Its IL-17 Blocker Competitive?
Troubled since a miss in hidradenitis suppurativa last fall, Acelyrin’s izokibep succeeded in a psoriatic arthritis trial, but will the drug compete well against other IL-17 inhibitors?
Ear
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Fennec Finds Ex-US Commercial Partner For Pedmark In UK’s Norgine
Norgine will market Pedmark, indicated to reduce risk of chemotherapy-related hearing loss in pediatric cancer, in the EU and UK. It will seek additional approvals in Australia and New Zealand.
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.
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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Ironwood Hits Phase III Endpoint In SBS-IF, But Shareholders Show Wariness
Looking to compete with Takeda’s Gattex in short bowel syndrome with intestinal failure, Ironwood succeeds in a Phase III trial, but investors may be concerned with misses on secondary endpoints.
Arcus’s CD73 Inhibitor Could Turn ‘Cold’ Pancreatic Cancer ‘Hot’
There are promising early signals from the novel mechanism, but Arcus’ fortunes remain tied to results from the TIGIT field.
First Wave To Merge With ImmunogenX With Focus On Celiac Disease
Troubled by recent clinical disappointments, First Wave will combine with ImmunogenX to focus on that company’s Phase III-ready enzyme replacement therapy for celiac disease. A deep-pocketed partner waits in the wings.
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.
Gynecology Urology
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Scrip Asks…What Does 2024 Hold For Biopharma? Part 6: Therapeutic Area Advances
More than 100 biopharma executives and experts told Scrip their predictions for therapeutic area advances in the coming year. The recent commercial success of GLP-1s in diabetes and obesity and their potential in further disease areas fuelled excitement around the metabolic space. Expectations were also positive in neurology following the launch of Leqembi for Alzheimer’s disease in 2023, while the multiple opportunities to improve cancer treatment kept oncology top of the pile overall.
Freya Biosciences Has $38m And A Plan To Change Women’s Lives
Emerging Company Profile: Armed with a new tranche of funding, the Danish group is aiming to improve the lot of infertile couples by altering the microbiome of patients with dysbiosis.
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?
Liver Hepatic
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Madrigal Has A Slow, Steady Launch Planned For Rezdiffra
Madrigal faces the challenge of opening the metabolic-associated steatohepatitis (MASH, also known as NASH) market, but the firm has been laying groundwork for over a year.
Bangers In MASH: How Rezdiffra's Rivals Stack Up
A look at the depth of clinical responses seen with various MASH therapies suggests that Madrigal could eventually face serious competition.
Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration
As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).
Ionis Could Be A Factor In MASH With Positive Phase II Data
Ionis’s DGAT2 inhibitor showed potential to improve disease activity score and resolve metabolic-associated steatohepatitis in a Phase II study, but analysts point to fibrosis-reduction data as competitively intriguing.
Ophthalmic
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Bausch + Lomb Dry Eye Franchise Ahead Of Growth Targets
Having acquired Xiidra from Novartis and getting US approval of Miebo in 2023, B+L’s two-product dry eye franchise delivered 66% year-over-year growth during Q4 2023.
Sylentis Piles On Another Failure In Dry Eye
The PharmaMar subsidiary is the latest group to crash in a notoriously hard-to-treat disease, leaving Bausch + Lomb more firmly in command of the field.
Adverum Climbs Out Of Abyss With Promising Early Gene Therapy Data In Wet AMD
The Phase II LUNA study of ixo-vec showed a reduction in anti-VEGF use and stabilization of visual acuity and anatomic parameters that Adverum – and some analysts – called best in class.
4D Molecular Therapeutics Brings A New Dimension To Wet AMD
The eye disease gene therapy 4D-150 posted highly impressive Phase II data, prompting a near-doubling of the company’s market value.
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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Novartis’s Fabhalta Hits In Glomerulopathy But How Hard?
So far, Novartis has only reported that its Phase III trial has succeeded and investors face a wait to find out just how good the drug is.
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.
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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