Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Other Therapy Areas

Set Alert for Other Therapy Areas

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
See All

Blood and Coagulation Disorders

Set Alert for Blood and Coagulation Disorders

CRISPR Therapeutics Moves Into Off-The-Shelf CAR-T Lead, But Durability Test Awaits

Some remain unconvinced on durability, but CRISPR Therapeutics is looking at a second ‘consolidation’ dose and other measures to boost CTX110’s efficacy in a pivotal trial.

Blood & Coagulation Disorders Cancer

BioMarin Trial Halt Raises Another Safety Flag On AAV Gene Therapy

Animal studies have shown that AAV viral vectors can integrate into animal cell DNA – but whether that causes cancer, or could happen in humans, remains uncertain.

Liver & Hepatic Blood & Coagulation Disorders

Five Hematology 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 five new hematology products that could make their market debuts (or return) next year.

Approvals Companies

FibroGen May Have A New Opening For Roxadustat In The US

The company announced positive Phase II data for roxadustat in chemotherapy-induced anemia.

Blood & Coagulation Disorders Research & Development

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
See All

Dermatology

Set Alert for Dermatology

Sanofi Scores Clinical Win In Sixth Disease For Dupixent

The French major and partner Regeneron expect to file Dupixent for the rare skin disease next year after a Phase III trial of the blockbuster hit its primary and secondary endpoints.

Inflammation Clinical Trials

UCB Frustrated By FDA Failure To Inspect Facility For Psoriasis Drug

The Belgian group is the latest to be hit by the FDA's difficulties in address the growing backlog of facility inspections, leaving bimekizumab in limbo in the US, despite having just been approved as Bimzelx in Europe.

Drug Review Immune Disorders

Brickell’s Phase III Data Sets Up NDA Filing In Axillary Hyperhidrosis

Meeting all primary and secondary endpoints in a pair of pivotal trials, Brickell says sofpironium bromide gel will be ready for FDA filing in mid-2022. The topical is already approved in Japan as Ecclock.

Clinical Trials Business Strategies

Sanofi And Amgen Make The Case For OX40 Drugs In Atopic Dermatitis

As the European Academy of Dermatology and Venerology congress closed its doors, two OX40 atopic dermatitis drugs from Sanofi and Amgen/Kyowa Kirin caught the eye.

Immune Disorders Clinical Trials
See All

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
See All

Ear Nose Throat

Set Alert for Ear Nose Throat

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

Boehringer Doubles Down On Deafness With Rinri Backing

After making a move into hearing loss with an investment into Acousia Therapeutics, BI is backing a UK biotech which hopes to reverse neuropathic sensorineural hearing loss.

Ear, Nose & Throat StartUps and SMEs

Gastrointestinal

Set Alert for Gastrointestinal

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

Theravance's Gut-Selective JAK Inhibitor Disappoints In Ulcerative Colitis Study

Top-line results from a Phase IIb study of Theravance’s potential gut-selective JAK inhibitor izencitinib have not matched expectations, and results from a similar early-stage study in Crohn’s disease with the Janssen-partnered candidate are now awaited at the end of the year or in early 2022.

Gastrointestinal Clinical Trials
See All

Gynecology Urology

Set Alert for Gynecology Urology

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

Organon APAC Head On Why World Needs A Company Dedicated To Women’s Health

In this audio interview, Organon’s head for the Asia Pacific region talks to Scrip on the company’s ambitions in the women’s health segment and the outlook for its biosimilars and established brands portfolios.

Commercial Asia Pacific

Liver Hepatic

Set Alert for Liver Hepatic

Metacrine’s Shift Means Further Attrition In FXR Agonist Class For NASH

Metacrine halts development of its FXR agonist compounds in NASH and turn its focus to inflammatory bowel disease. Firm plans Phase II ulcerative colitis study in 2022 with MET642.

Business Strategies Drug Approval Standards

AstraZeneca's Imfinzi/Tremelimumab Combo Conquers HIMALAYA

After the combination's success in the non-small cell lung cancer POSEIDON study, AstraZeneca's Imfinzi and tremelimumab could now be on the way to approval as a first-line treatment for hepatocellular carcinoma.

Liver & Hepatic Clinical Trials

Mirum Targets $500m Sales For Just-Approved Rare Liver Disorder Drug

Regulators have approved Mirum's IBAT inhibitor as the first medication for a genetic disorder which affects up to 2,500 children in the US.

Approvals Liver & Hepatic

BioMarin Trial Halt Raises Another Safety Flag On AAV Gene Therapy

Animal studies have shown that AAV viral vectors can integrate into animal cell DNA – but whether that causes cancer, or could happen in humans, remains uncertain.

Liver & Hepatic Blood & Coagulation Disorders

Ophthalmic

Set Alert for Ophthalmic

Roche’s Port Delivery System Approved, Paving The Way For Ophthalmology Expansion

Susvimo, a PDS version of the blockbuster Lucentis, is a refillable eye implant that will extend Roche's commercial opportunity in wet-AMD but presents training challenges. Pricing is slightly below Lucentis.

Approvals Launches

Ocular’s Dry Eye Drug Fails In Phase II, But It Isn’t Giving Up Yet

Company hopes a different formulation of its intracanicular insert of cyclosporin might provide longer duration of drug in the eye and better tear production with it.

Clinical Trials Drug Approval Standards

Oyster Point Prepares Major Push For New Dry Eye Drug

Execs told Scrip they hope to get Tyrvaya (varenicline) onto formularies and aim for pricing that would make its nasal spray competitive with Restasis and Xiidra.

Approvals Ophthalmic

SparingVision Eyes CRISPR Promise With Intellia Ocular Pact

The French biotech has managed to bag a blue-chip partner to advance its ambitions to be the leading company in the ocular genomic medicine space, getting access to Intellia's CRISPR/Cas9 technology.

Ophthalmic Gene Therapy
See All

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
See All

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
See All

Renal

Set Alert for Renal

ChemoCentryx Gains Runway To Grow With Avacopan Approval

ChemoCentryx gets US approval of Tavneos for ANCA vasculitis, which it says may gradually ramp up to a blockbuster revenue opportunity. Current steroid-heavy standard of care has many drawbacks.

Approvals Commercial

Vifor Clinches Deal For Travere's Rare Kidney Disorder Drug

The Swiss group has delivered on its promise to secure more deals in the nephrology space by bagging the rights in Europe, Australia and New Zealand to sparsentan, which is deep into a Phase III program for focal segmental glomerulosclerosis and IgA nephropathy.

Renal Deals

Delay For Calliditas Kidney Drug Not Major Cause For Concern

Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.

Drug Review Renal

Sanofi’s Kadmon Bolt-On Bolsters Its General Medicine Division

Sanofi’s $1.9bn cash purchase of Kadmon surprised many analysts, coming as a bolt-on for the French pharma’s general medicines transplant portfolio rather than its specialty care pipeline, but the overall view was that it made sense.

M & A Companies
See All

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
UsernamePublicRestriction

Register