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Other Therapy Areas

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Aesthetics

Set Alert for Aesthetics

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

AbbVie Updates Exec Team, Creates A Separate Aesthetics Business Unit

The only addition to AbbVie’s leadership after it closes the $63bn acquisition of Allergan will be Carrie Strom, who will lead the Allergan Aesthetics business.

Leadership Aesthetics
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Blood and Coagulation Disorders

Set Alert for Blood and Coagulation Disorders

BioMarin Gears Up To Give Roctavian Another Go

The company is aiming for an outcomes-based payment model in the US, while it is confident the gene therapy will fare better than some others have in Europe.

Business Strategies Companies

Safety Concerns Hit Bluebird Sickle Cell Trial, Again

The FDA placed a partial hold on its clinical program for lovo-cel due to an adolescent patient experiencing anemia 18 months after treatment, raising uncertainty over filing plans.

Gene Therapy Safety

Bluebird Confident Beti-Cel Will Fare Better In US Than Europe

The company built on its case for FDA approval with new beta-thalassemia data at ASH, but investor jitters linger after the pullout of Zynteglo from Europe amid reimbursement woes for the gene therapy.

Gene Therapy Business Strategies

Fitusiran Delay Dents Sanofi’s Hemophilia Challenge

New data show fitusiran’s promise across hemophilia A and B, but a switch to a lower dose prompted by safety concerns will delay its filing until 2024.

Blood & Coagulation Disorders 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
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Dermatology

Set Alert for Dermatology

Pfizer And AbbVie JAKs Finally Join Dupixent In US Atopic Dermatitis Space

The arrival on the US eczema market of a couple of oral JAK inhibitors with stellar data on itching could provide a challenge to Sanofi and Regeneron's blockbuster Dupixent. However, Pfizer and AbbVie will have to overcome dermatologists' fears about the class-effect safety warnings their drugs come with.

Approvals Dermatology

A Deep Dive Into The Game-Changing Drugs For Skin Diseases

Scrip's Kevin Grogan joins Datamonitor's Pamela Spicer and Davinderpreet Mangat to discuss the skin disease landscape and whether atopic dermatitis is now where psoriasis was a decade ago as another wave of innovative products start to reach the market.

Approvals Dermatology

Five (Non-COVID) Clinical Trial Hits Of 2021

2021 may have been dominated by the continuing coronavirus pandemic, but that did not stop industry’s more bread and butter R&D activities. Here, Scrip takes a look at five of the more notable clinical trial hits of the year that got readers clicking.

Scrip Perspectives Clinical Trials

Dermatology To Become A Key Franchise For Incyte

Having just launched Opzelura in the US for atopic dermatitis, the US biotech is hoping for another approval in the next few months for its topical JAK inhibitor, this time for vitiligo.

Dermatology Drug Review
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Ear

Set Alert for Ear

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

Astellas Adds To Regenerative Medicine Portfolio In Hearing Loss Deal With Frequency

Astellas adds a large-market drug candidate to its regenerative medicine portfolio, while Frequency Therapeutics almost doubles its fundraising to date. It traded ex-US rights to hearing loss candidate FX-322 for $80m up front and up to $545m in milestone fees plus royalties.

Deals Regenerative Medicine

Protecting Against Hearing Loss: Acousia Pursues A New Approach

German biotech Acousia Therapeutics closes a series B round with corporate and institutional VC firms, and aims to advance its drugs into clinical trials for hearing loss associated with cancer chemotherapy. 

Financing Ear
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Ear Nose Throat

Set Alert for Ear Nose Throat

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

Merck & Co's Gefapixant Effective In Refractory Cough, But Taste Concerns Remain

Updated results from two Merck & Co Phase III studies, COUGH-1 and COUGH-2, confirm the drug’s efficacy in reducing the frequency of refractory cough and its association with taste disturbances.

Clinical Trials Respiratory

Marinomed Marches Towards Approval For Hay Fever Drug

With Budesolv hitting key endpoints in a Phase III allergy trial, the Austrian biotech is stepping up its partnership discussions for the allergic rhinitis drug.

Ear, Nose & Throat Clinical Trials

Gastrointestinal

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Bristol’s Bold Projections Grow Bolder As Confidence In R&D Programs Rises

Loss of exclusivity for key Bristol Myers Squibb products, starting with top seller Revlimid, is looming over the company’s R&D pipeline. BMS believes its late-stage and newly approved products will generate more than $25bn in sales by 2029.

Launches Strategy

Sanofi/Regeneron’s Esophagitis Data Add To Dupixent’s Winning Streak

The companies announced positive Phase III data for the drug in patients with eosinophilic esophagitis and plan to take the results to regulators in 2022.

Gastrointestinal Clinical Trials

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: US tax policies challenge pharma; J&J’s long-time R&D head to retire; Legend Biotech’s CEO talks about plans; BMS disappointment in ulcerative colitis; and another gene therapy partnership for Takeda.

Companies ImmunoOncology

Investors Back Microbial Specialist EnteroBiotix’s Series A Financing

Emerging Company Profile: Scotland-based EnteroBiotix will use proceeds from a successful series A financing to advance its nascent pipeline of novel high-diversity microbial therapeutics, enhancing the gut microbiome and eventually targeting multiple indications.

Financing Commercial
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Gynecology Urology

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Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: Pfizer’s "game-changing" COVID-19 oral antiviral results; Novartis sells Roche stake; Novartis trumps productive pipeline; Bayer sees blockbuster status for hot flashes drug; and continued hesitance over Aduhelm in the US.

Business Strategies Companies

Nine Endocrine And Metabolic Disease Drug Launches To Look Out For In 2022

In a series of articles, Scrip takes a look at some of the key novel products expected to reach the market in 2022 in a cross-section of therapy areas. Here, with input from Biomedtracker, are nine new products for endocrine and metabolic disorders that could make their debuts next year.

Approvals Companies

Merck KGaA Stepping Up In India, Eyes On Bavencio Trajectory

Anandram Narasimhan, managing director of Merck Specialities Pvt. Ltd. in India, share insights on the uptick in the fertility business and the promise of new launches, including of the checkpoint inhibitor Bavencio, in the country. Overall, the “signs are good”, the executive tells Scrip in an interview.

India Commercial

Organon's First Move Post Spinout Is A Licensing Deal With ObsEva In Preterm Labor

Ogranon will pay $25m upfront for worldwide commercialization rights to ebopiprant for acute preterm labor, which currently has no approved treatments in the US.

Gynecology & Urology Deals

Liver Hepatic

Set Alert for Liver Hepatic

Life After NASH For CymaBay: An Interview With CEO Sujal Shah

With up to $100m from Abingworth and a recent $75m FOPO, CymaBay has runway to await pivotal data in primary biliary cholangitis in 2023 for seladelpar, after the candidate failed in NASH. It sees a significant market opportunity in the second-line setting cornered by Intercept.

Companies Business Strategies

Novartis Opts For Alliance Rather Than Acquisition With Alnylam

The announcement that the Swiss giant is collaborating again with Alnylam could spark fresh speculation that the firms are moving closer to a merger – or not.

Deals Liver & Hepatic

Five (Non-COVID) Clinical Trial Misses Of 2021

The coronavirus pandemic may have dominated the news in 2021, but industry’s more bread and butter R&D activities continued. Here, Scrip takes a look at five of the more notable clinical trial misses of the year that got readers clicking.

Scrip Perspectives Clinical Trials

Ipsen Gives Genfit Liver Drug New Lease Of Life

The French biotech was firmly on the ropes last year after elafibranor joined the long list of failures for NASH but the promise it has shown in primary biliary cholangitis has persuaded Ipsen to part with a hefty upfront fee.

Liver & Hepatic Companies

Ophthalmic

Set Alert for Ophthalmic

Five Pivotal Trial Read-Outs To Look Out For In Early 2022

Five notable studies are expected to report top-line data in the first quarter. With the help of Biomedtracker's Early 2022 Outlook Report, we take a look at the major catalysts likely to kick off the year, including in heart failure and wet AMD.

Clinical Trials Companies

Aldeyra Therapeutics Eyes First Line Market As Phase II Dry Eye Candidate Impresses

The firm’s lead asset, reproxalap, one-upped Novartis’s Xiidra in a mid-stage ophthalmology study, signalling its first-line promise in a market ridden with compliance issues.

Clinical Trials Ophthalmic

Aldeyra Looking At Paths To Approval In Dry Eye After Phase III Miss

Firm revises second Phase III trial for co-primary endpoints, possibly improving its chances of success for demonstrating efficacy on a sign of dry eye disease. Initial Phase III study missed ocular redness measure.

Clinical Trials Drug Approval Standards

Novartis Sneaks Ahead Of Sanofi To Buy Gyroscope

The Swiss giant is paying up to $1.5bn upfront to get hold of Gyroscope's AAV2-based one-time investigational gene therapy for geographic atrophy, an advanced form of dry AMD that leads to irreversible vision loss.

Ophthalmic M & A
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Orthopedics

Set Alert for Orthopedics

Bone Has Tough Path Forward After Phase III Knee Osteoarthritis Fail

The company said the study of JTA-004 failed to meet its primary and key secondary endpoints, though a post-hoc analysis indicated activity in a patient subset.

Clinical Trials Research & Development

Further Analyses To Delay Ipsen’s Palovarotene Progress In Ultra-Rare Disease

Ipsen has withdrawn the US NDA for palovarotene in an ultra-rare bone condition in order to conduct additional data analyses, but intends to resubmit once they are complete.

Rare Diseases Clinical Trials

Flexion’s Pandemic Rebound: How Zilretta Dropped 80% But Is Still Coming Out Ahead

The knee osteoarthritis injection was hit hard by COVID-19 restrictions, at first. But CEO Mike Clayman reflected in an interview about how the pandemic experience is helping fuel further growth for Zilretta. 

Launches Coronavirus COVID-19

Medipost Accelerates Global Push For Lead Stem Cell Therapy

South Korean stem cell therapy company Medipost is speeding up the entry of flagship product Cartistem into global markets, with an initial focus on ASEAN countries and Japan and helped by regulators' allowance of early local trials to be waived on the back of strong Korean data.

Regenerative Medicine Biologics
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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

Argenx, Calliditas Hit The Ground Running After FDA Approvals

Two European companies - the Belgian-Dutch biotech Argenx and Calliditas of Sweden - are going it alone to commercialize their just-approved rare disease therapies in the US.

Approvals Rare Diseases

AstraZeneca And BenevolentAI Advance AI Partnership With Second Novel Target

AstraZeneca and BenevolentAI claim their partnership is augmenting and accelerating validation of new drug targets.

Respiratory Renal

CSL Makes $11.7bn Move On Vifor Pharma In Renal Disease Push

Confirming rumors of an acquisition, CSL will venture into some new territories as well as boost its renal franchise when it takes over Switzerland’s Vifor Pharma in a deal worth $11.7bn.

Companies Deals

Angion’s HGF Mimetic Fails Second Phase II Study, But Not Shuttered Yet

Although ANG-3777, partnered with Vifor, missed its primary endpoint in cardiovascular surgery patients at risk for acute kidney injury, the companies will consider a path forward based on a renal events measure.

Clinical Trials Drug Approval Standards
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Wound Healing Tissue Repair 

Set Alert for 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

Struggling Fibrocell To Consider All Strategic Directions Going Forward

Focused on autologous fibroblast cell therapies for rare diseases, the biotech appears cash-poor despite one candidate moving into Phase II and another ready to enter the clinic.

Business Strategies Commercial

Amicus Drops Epidermolysis Bullosa Candidate Following Phase III Failure

CEO Crowley points to the need to focus on a pair of Fabry candidates, including the pending NDA for migalastat, and notes that other companies have reached Phase III in EB.

Clinical Trials Rare Diseases
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