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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

Round Two: BioMarin Resubmits Hemophilia A Gene Therapy Roctavian In US

BioMarin maintains its lead in the race to win approval for a hemophilia A gene therapy in the US by resubmitting Roctavian two years after the FDA issued a CRL in response to the original BLA.

Gene Therapy Strategy

Vertex/CRISPR Prepare To Take Exa-Cel To Regulators For SCD, TDT

The first gene-edited therapy will be submitted for sickle cell disease and transfusion-dependent beta thalassemia; it will compete with bluebird in both indications, but analysts anticipate blockbuster sales in excess of $2bn.

Gene Therapy Blood & Coagulation Disorders

AstraZeneca Hopes Danicopan Interim Data Will Prove Sufficient For NDA Filing

Danicopan seen as potential add-on therapy for paroxysmal nocturnal hemoglobinuria patients getting suboptimal results from Soliris or Ultomiris therapy. AstraZeneca will investigate filing for approval on 12-week data.

Clinical Trials Drug Approval Standards

Twin Intellia Readouts Further Bolster CRISPR Platform

The company presented interim data for NTLA-2002 in hereditary angioedema, along with interim data for Regeneron-partnered NTLA-2001 in transthyretin amyloidosis with cardiomyopathy. The company plans a rapid expansion of its programs.

Business Strategies Gene Therapy

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

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a big US approval for BMS; Roche touts its diverse R&D pipeline; Lumakras’s mixed Phase III results in lung cancer; Japan controversy over a COVID-19 antiviral; and GSK's vaccine strategy in India.

Commercial Business Strategies

Novartis’s Cosentyx Secures Qualified Win In Hidradenitis Suppurativa

The Swiss major’s Cosentyx has succeeded in two trials for the debilitating skin condition but there are concerns that the data may not be sufficient to shift AbbVie’s Humira off the top spot for treatment.

Clinical Trials Strategy

BMS Aims To Unseat Otezla In Psoriasis With US FDA-Approved Sotyktu

Chief commercialization officer Chris Boerner said BMS plans to replace Otezla as the oral standard of care for moderate-to-severe psoriasis with Sotyktu (deucravacitinib); its list price is about 40% higher than Amgen’s product.

Launches Dermatology

Arcutis Eyes Atopic Dermatitis Opportunity With Ducentis Buy

Arcutis's CEO believes that with "a modest investment," the company can generate proof-of-concept data "against a de-risked target in a high-value indication,” Ducentis's preclinical atopic dermatits drug DS-234.

Commercial Deals
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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

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

Set Alert for Gastrointestinal

Ironwood’s Phase III Data Could Expand Linzess Market Share

The company also hopes that positive safety data for pediatric patients could help with discussions with the FDA to make an OTC version of the drug.

Gastrointestinal Business Strategies

Big Pharmas Trust To The Science In Zantac Lawsuits

Billions of dollars have been wiped off the value of big pharma stocks as the market finally woke up to widescale litigation concerning allegations of increased cancer risk associated with the use of ranitidine. Two companies, GSK and Sanofi, are confident that there is no link. 

Legal Issues Companies

Currency Tailwinds, Mainstays Help Takeda To Core Growth

A weak yen and strong mainstays helped Takeda in its fiscal first quarter, enabling Japan's largest pharma company to overcome the impact of a big divestment last year, while several new products got off on the right foot in the US.

Commercial Sales & Earnings

France’s Enterome Eyes Merger To Make NASDAQ Move

CEO Pierre Belichard tells Scrip that the French biotech has enough cash and assets to prosper alone but it is also weighing up a reverse merger that would give Enterome a listing on the NASDAQ.

Business Strategies Gastrointestinal
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Gynecology Urology

Set Alert for Gynecology Urology

ObsEva Slashes 70% Of Staff To Survive

Having surrendered the rights to linzagolix, its GnRH antagonist for bleeding associated with uterine fibroids that the FDA blocked, ObsEva is showing the door to most of its staff in a bid to cut costs and keep in business.

Restructuring Gynecology & Urology

Myovant Expects Gradual Growth For Myfembree With Endometriosis Approval

Myovant and partner Pfizer have expected a slow ramp for Myfembree in uterine fibroids and new indication endometriosis as they build awareness and grow the market for the GnRH antagonist class.

Approvals Business Strategies

ObsEva Ends Linzagolix Launch Plans, Casting Another Shadow Over Women's Health

The Swiss drug maker will initiate a "mass dismissal" and return rights to its lead drug candidate after the US FDA alerted the company to NDA deficiencies.

Gynecology & Urology Business Strategies

CEO Kevin Ali Marks Organon’s Progress In First Post-Spin Year

A year after Organon spun out of Merck, the company has delivered on its financial guidance, generated double-digit biosimilars sales growth and executed six deals to grow in women’s health.

Business Strategies Companies

Liver Hepatic

Set Alert for Liver Hepatic

Intercept Not Changing NDA Refiling Plans After OCA Misses NASH Cirrhosis Endpoint

Obeticholic acid failed to separate from placebo in a Phase III study of non-alcoholic steatohepatitis patients with cirrhosis, but Intercept said it still plans to refile an NDA for pre-cirrhotic NASH by year’s end.

Clinical Trials Business Strategies

Axcella Hopes Interim NASH Data Can Help Extend Its Financial Runway

Axcella’s AXA1125, a therapeutic combination of amino acids, shows liver stiffness, liver enzyme and fat reduction benefits in Phase IIb interim look, but the firm lacks the cash to complete the trial.

Clinical Trials Liver & Hepatic

Genfit To Pick Up Second Liver Failure Candidate In €40m Versantis Buyout

Focused on rare liver diseases such as acute-on-chronic liver failure following its 2020 disappointment in NASH, Genfit looks to become sector leader in ACLF and other indications such as hepatic encephalopathy.

M & A Deals

Akero’s Phase II Success Could Augur Brighter Days For NASH R&D

With Akero’s FGF21 analog showing ability to reduce fibrosis and resolve non-alcoholic steatohepatitis, some analysts think classmate BIO89-100 could yield a better overall profile. NASH data are starting to pour in.

Business Strategies Clinical Trials

Ophthalmic

Set Alert for Ophthalmic

SparingVision Eyes The Clinic With Two Assets After €75m Series B Raise

The French firm will use the funds to establish proof-of-concept for two gene therapy programs in a rare eye condition as it strives to become a world leader in ophthalmic genomic medicine, its CEO tells Scrip.

Financing Ophthalmic

High-Dose Eylea’s Improved Durability Could Protect Regeneron’s Market Share

The US firm’s high-dose reformulation of Eylea reduced dosing burden for patients with DME and wet AMD in two pivotal studies and could match Roche’s rival drug.

Ophthalmic Clinical Trials

Iveric's Zimura Shows Benefit In Geographic Atrophy, An Area Poised For New Options

The company plans to file the complement C5 inhibitor with the US FDA, but Apellis already has a drug pending for the indication.

Clinical Trials Ophthalmic

Outlook Eyes Blockbuster-Sized Sales For An Old Eye Drug In Wet-AMD

The company is seeking FDA approval for a first-time ophthalmic formulation of bevacizumab and also refiled its BLA.

Ophthalmic Business Strategies
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Orthopedics

Set Alert for Orthopedics

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

Spine Takes Yuhan’s Peptide Into US Phase III For High-Need DDD

Major Korean firm Yuhan is seeing progress across multiple novel drug candidates licensed out to global partners, with two now entering pivotal trials. An innovative therapy for degenerative disc disease licensed to Spine BioPharma has received an FDA nod for a Phase III program and may change the standard of care for chronic low back pain patients.

South Korea Clinical Trials

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
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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

Terlivaz Approved By FDA As Mallinckrodt Seeks To Advance New Business Strategy

Terlivaz is the first product approved to improve kidney function in adults with hepatorenal syndrome (HRS). The approval is a milestone in a long regulatory road for the drug.

Approvals Rare Diseases

Alnylam/Regeneron Face Crowded IgA Nephropathy Field, But Combinations Likely

Phase II data position cemdisiran well for Phase III, but several agents are already well ahead. However, Alnylam foresees a polypharmacy approach.

Renal Business Strategies

Amgen’s $3.7bn ChemoCentryx Buy May Help Offset Growing Pains

Amgen is acquiring a pipeline-in-a-pill with ChemoCentryx’s Tavneos, currently approved for ANCA-associated vasculitis, at a time when the company’s existing portfolio is struggling to maintain sales growth.

Growth M & A

Roche To Take Ionis Drug Forward Into Crowded Nephropathy Field

Roche is not disclosing Phase II results yet, but must exceed late-stage rival drug’s 50% reduction in protein build up to compete in immunoglobulin A nephropathy.

Deals 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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