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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 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

European Approval For Roxadustat Is Silver Lining For FibroGen

The EU approval is good news for FibroGen and marketing partner Astellas, but was expected, and still leaves it pondering its future after FDA knock-back.

Blood & Coagulation Disorders Commercial

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

Analysts Impressed By Amryt As EB Drug Action Date Approaches

Amryt has set out its future plans to the investment community with much depending on the successful relaunch of its just-acquired acromegaly drug Mycapssa and a potential FDA approval for its epidermolysis bullosa gel Filsuvez.

Business Strategies Rare Diseases

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: new US warnings for JAK inhibitors; strong new heart failure results for Jardiance; good head-to-head results for Pfizer in atopic dermatitis; US payers and drug exclusion lists; and a look ahead at key expected hematology launches.

Biologics Research & Development

Forte Biosciences' Future In Doubt After Only Product Fails

Forte Biosciences’ attempts to use a new approach to treating inflammatory skin disease using a topical live biotherapeutic, FB-401, have come to a crashing halt at Phase II. Where the company goes next remains to be seen.

Clinical Trials Companies

Lilly’s Eczema Contender Promising, But Needs Head-To-Head Data To Dent Dupixent Dominance

Topline results suggest lebrikizumab could outshine Sanofi’s Dupixent on safety and itch reduction in atopic eczema, but a direct comparison study is likely required to drive the message home.

Biologics Clinical Trials
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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

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

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

Seres Plans Deep Dive After Microbiome Drug Fails In Ulcerative Colitis Trial

The company plans an intensive review to determine the path forward for SER-287. A similar deep dive led to the successful revival of its C. difficile drug, SER-109, which it plans to submit for approval.

Clinical Trials Gastrointestinal

Sosei Heptares Turns To AI In GPCR-Focused Drug Discovery Pact

Sosei Heptares hopes to create transformative therapeutics for immune diseases by combining its GPCR structure-based drug design and early development capabilities with InveniAI's already validated AI-based platform, its head of new target identification tells Scrip.

Companies Deals
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Gynecology Urology

Set Alert for Gynecology Urology

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

Organon Is Serious About Building A Women's Health Company, Deal By Deal

CEO Kevin Ali talked to Scrip about his plans for Organon, ahead of the spinout from Merck & Co. Women's health will be the top priority. 

Business Strategies Leadership

Liver Hepatic

Set Alert for 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

Metacrine Choosing Between Two NASH FXR Agonists It Calls Best-In-Class

Biotech is determining which of its mid-stage FXR candidates – MET409 and MET642 – will offer the best overall profile to take into Phase IIb. It is also studying ‘409 in combination with Jardiance and will test the FXR class in inflammatory bowel disease.

Clinical Trials Research & Development

AZ's Rare Disease Unit Reports Positive Phase III Results For Copper-Binding ALXN1840

Alexion/AstraZeneca has announced positive top-line results from the Phase III study of ALXN1840 in patients with the rare genetic disorder, Wilson disease, including in patients already on standard-of-care therapies. The compound is ahead of two candidate gene therapies from other companies at early-stage clinical development.

Rare Diseases Clinical Trials

CohBar’s First Mitochondria Based Therapy Shows Promise In NASH

The first clinical results from its mitochondrial derived peptide pipeline is good news for CohBar, but it needs investors or big pharma partners to help it progress.

Liver & Hepatic Metabolic Disorders

Ophthalmic

Set Alert for Ophthalmic

Wet AMD Market Snapshot: A High-Growth Market Poised For Change

Regeneron's Eylea and Roche's Lucentis currently dominate the treatment market for wet-AMD and diabetic eye disease, but biosimilar ranibizumab and new brand launches are on the horizon.

Ophthalmic Market Intelligence

Aerie Misses Quick Path To Dry Eye Approval, But Is Still Moving Forward

AR-15512 missed the primary endpoints in a Phase IIb dry eye disease study that could have served as a pivotal trial, but Aerie’s drug hit enough signs and symptoms of the disease to justify a Phase III.

Clinical Trials Drug Approval Standards

AbbVie Extends Reach Of Regenxbio’s Wet AMD Program

The partnership worth up to $1.75bn removes the significant risk of going it alone in a competitive market as Regenxbio awaits late-stage data for its gene therapy.

Deals Gene Therapy

Apellis Says Mixed Phase III Results Position Geographic Atrophy Candidate For Filing

Apellis plans to file pegcetacoplan for approval as the first drug to treat the advanced AMD condition geographic atrophy, despite the C3 inhibitor hitting its endpoint in only one of two pivotal trials.

Clinical Trials Drug Approval Standards
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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

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

Novartis's Big Hopes For Transplant Drug Blown Apart

Long touted as one of the drugs to watch in the Swiss giant's pipeline, iscalimab's chances of replacing tacrolimus as the standard of care preventing organ rejection in transplant patients have been dealt a hefty blow after a Phase II trial failure.

Renal Clinical Trials
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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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