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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

Pfizer’s Marstacimab Wins In Phase III, But Caution On Market Position, Clotting Remain

The drug showed efficacy in hemophilia A and B with no sign of clots, an issue that historically has dogged anticoagulation agents, but it remains unclear whether that advantage will hold.

Clinical Trials Blood & Coagulation Disorders

Sobi Set To Grow Hematology Franchise With $1.7bn CTI Biopharma Buy

Sobi plans to capitalize on the complimentary expertise at CTI Biopharma to together boost sales of the latter firm’s myelofibrosis drug Vonjo and enhance the Swedish pharma firm’s overall growth.

Deals M & A

Idogen Running Out Of Survival Options

With very little cash left in the bank, Idogen is weighing up its options including a reverse merger or liquidation.

Financing Business Strategies

BioMarin’s $1m Gene Therapy Roctavian Hits Payer Problems In Germany

BioMarin has yet to treat a patient with Roctavian, the first ever hemophilia A gene therapy, eight months after its first approval in Europe, as pricing delays cloud its commercial prospects.

Commercial Companies

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

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Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: J&J’s Duarto on the importance of diversity; Teva’s views on its new risperidone launch; Almirall’s hopes for lebrikizumab; Biogen’s Viehbacher questions the need for spending on weight loss drugs; and Citeline’s annual R&D review looks at the current state of the global biopharma pipeline.

Leadership Diversity & Inclusion

Almirall On Alert As Lebrikizumab Approval Date Approaches

The Barcelona-based group is confident that Lilly-partnered lebrikizumab has the potential to become a best-in-class treatment for atopic dermatitis and take market share from Sanofi’s blockbuster Dupixent.

Sales & Earnings Dermatology

Incyte Streamlines Pipeline After Difficult Q1

The mid-sized pharma company has a blockbuster in Jakafi, but analysts are doubtful about its plans to build on that base across its now slimmed-down pipeline. 

Cancer Dermatology

10 Approvals To Look Out For In Q2

The second quarter has already seen the approval of Gamida Cell’s cell therapy Omisirge, and with the help of Biomedtracker, Scrip highlights 10 of the more interesting new drug approvals due in the next three months.

Approvals Companies
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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

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Ironwood Paying $1bn For VectivBio To Extend Its GI Franchise Beyond Linzess

Ironwood said it believes VectivBio’s once-weekly GLP-2 analog apraglutide is differentiated from Takeda’s once-daily Gattex in short bowel syndrome and could generate $1bn in peak sales.

Deals M & A

Rinvoq Approved For Crohn’s Disease In Pivotal Year For AbbVie’s Immunology Business

US FDA approval in Crohn’s disease further boosts the revenue potential for Rinvoq as AbbVie navigates a period of declining sales overall due to the introduction of US biosimilars for Humira. 

Approvals Growth

Record Revenues For Takeda But Headwinds Coming

While Japan's largest pharma company reached a number of milestones last fiscal year, it is facing a number of challenges to revenues in 2023, for which it is looking to its core commercial portfolio and pipeline to help drive growth.

Business Strategies Commercial

First Phase III IBD Trial Reads Out Positive For Janssen’s Tremfya

The IL-23 inhibitor, entering an increasingly competitive space, posted significant results at Digestive Disease Week from the Phase IIb/III QUASAR induction study in ulcerative colitis.

Clinical Trials Gastrointestinal
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Gynecology Urology

Set Alert for Gynecology Urology

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

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.

Legal Issues FDA

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

Liver Hepatic

Set Alert for Liver Hepatic

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: novel BMS drug shows promise in IPF; Novo’s oral semaglutide compares well with injectable in weight loss; Teva looks to innovative brands to return to growth; US setback for Intercept’s NASH drug; and India’s improving environment for clinical trials.

Clinical Trials Commercial

ICER’s Final NASH Report Urges Step Therapy, Specialist Prescribing, Equitable Access

When the first non-alcoholic steatohepatitis drugs reach market, the health cost watchdog says payers will be justified in setting step-therapy including weight-management efforts, while early prescribing should be by specialists.

Cost Effectiveness Drug Review

What Does The Negative FDA Review For Intercept’s OCA Hold For Other NASH Drugs?

An FDA advisory committee’s “no” votes for Intercept’s obeticholic acid in non-alcoholic steatohepatitis could augur tough reviews for other NASH candidates. But some could enjoy smoother regulatory tides than OCA.

Advisory Committees Drug Approval Standards

Will Intercept Drop OCA For NASH Following Negative FDA Panel Review?

Company tells advisory committee it is unsure of continuing on to collect Phase III outcomes data in NASH without accelerated approval, which the panel voted against.

Advisory Committees Drug Approval Standards

Ophthalmic

Set Alert for Ophthalmic

Annexon’s ANX007 Misses GA Endpoint, But May Have Visual Acuity Path Forward

The ARCHER study did not show improvement in lesion growth, but still showed an improvement in best corrected visual acuity, potentially opening a pathway toward a pivotal trial.

Ophthalmic Clinical Trials

Oculis Eyes Double DIAMOND After Initial Phase III Success In DME

The Swiss firm’s lead candidate has hit the mark in the first stage of a pivotal diabetic macular edema program, edging closer to becoming the first eye drop treatment for a condition where unmet need remains despite the advent of anti-VEGFs.

Clinical Trials Ophthalmic

B+L/Novaliq Hope Miebo Can Stand Out In Crowded Dry Eye Field

The companies got US FDA approval for the drug, which they said is the only approved medicine that targets tear evaporation rather than tear production, though its mechanism is not fully understood.

Approvals Ophthalmic

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: strong growth in blockbuster ranks in 2022; Lilly’s donanemab slow cognitive decline; FDA approves first RSV vaccine; Pfizer anticipates revenue bolus from vaccines; and Astellas buys into ophthalmology.

Approvals Biologics
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Orthopedics

Set Alert for Orthopedics

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

Avidity’s Phase I/II Success In Myotonic Dystrophy Obscured By Caveats

The US firm’s lead antibody oligonucleotide conjugate candidate has improved muscle strength and mobility in an early muscular dystrophy trial but some experts are disappointed by dose-specific data and a serious adverse event.

Clinical Trials Neurology

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
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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

$435m Impairment Loss Hits Astellas As Evrenzo Falters, Asset, Deal Dropped

Japanese major’s profit figures for fiscal year just ended will be hit by multiple accounting decisions related to sales, pipeline and partnerships.

Commercial Regenerative Medicine

HI Bio Reaches For The Lead With Phase II Primary Membranous Nephropathy Data

While Roche is in Phase III with Gazyva, HI-Bio thinks its autoantibody-depleting mechanism may be the best approach in PMN.

Clinical Trials Business Strategies

Boehringer To Profit From Jardiance Well Into Second Half Of Decade

The German firm is anticipating a major label expansion in kidney disease for its SGL2 inhibitor later this year, prompting Boehringer to gear up commercial activities as AstraZeneca’s rival Farxiga faces the threat of generic competition.

Sales & Earnings 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
See All

Wound Healing Tissue Repair 

Set Alert for 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

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
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