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Other Therapy Areas

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Aesthetics

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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

Flush With CF Success, Vertex Prepares Next-Gen Pipeline For Busy 2023

Vertex’s dominance in cystic fibrosis looks secure for years to come, and 2023 and 2024 could see it bring more ground-breaking innovation to market.

Sales & Earnings Commercial

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

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

Set Alert for Dermatology

UCB Makes Another Push To Get Bimzelx Over Finishing Line In US

The Belgian group was stunned by an FDA rejection in May for its dual IL-17A and IL-17F inhibitor and although the refiling is complete, UCB may still have to wait six months to get Bimzelx into the all-important US psoriasis market.

Dermatology Complete Response Letters

Arcutis’s Phase III AD Win Bodes Well For Soon-To-Report Second Study

One analyst said efficacy data for roflumilast in INTEGUMENT-1 suggest limited competitiveness against Incyte’s topical JAK inhibitor, Opzelura, while others were more optimistic.

Clinical Trials Dermatology

Incyte Signals Increasing Focus In Dermatology With Villaris Buyout

With Opzelura approved for vitiligo in July, Incyte acquires Villaris and its preclinical IL-15-targeted antibody to potentially add to its vitiligo portfolio.

M & A Business Strategies

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
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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

Set Alert for Gastrointestinal

Prometheus Phase II Data For Novel TL1A Inhibitor Impresses On Efficacy

The company plans to move PRA023 forward into Phase III studies based on positive Phase II safety and efficacy data in UC and Crohn's disease, positioning Prometheus in a race with Roivant.

Clinical Trials Inflammation

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: a market snapshot of inflammatory bowel disease; will biotech bounce back in 2023?; Phase III miss for Roche’s Alzheimer’s candidate; how Japan’s top firms did in the quarter; and China showcase hints at policies and strategies.

Gastrointestinal Biologics

Sosei Heptares Eyes Asia Build-Out On Internal, External Assets

Japan-UK firm is looking to build on a combination of internal and external assets to pursue a more independent business development path in Japan and beyond, in parallel with ongoing discovery and development collaborations.

Asia Pacific Japan

IBD Market Snapshot: Payers May Shift Preferred Products To Accommodate New Drugs

Multi-product players may be able to use bundled rebates for preferred formulary status and biosimilars offer a new competitive dynamic, but there is hope for novel therapies.

Gastrointestinal Market Access
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Gynecology Urology

Set Alert for Gynecology Urology

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

ObsEva Stays Afloat By Selling Lead Women’s Health Asset To XOMA

The Swiss firm has divested yet another one of its key programs in a bid to stave off insolvency and remain a listed company, forcing it to focus solely on a pre-IVF drug candidate.

Deals Gynecology & Urology

New Ferring Head Laments Woeful Neglect Of Women's Health

After fighting for years to bridge the gender health gap where many women receive poorer treatment than men from academia and non-profits, Kelle Moley has moved into pharma with Ferring to further her vision.

Clinical Trials Gynecology & Urology

Myovant Accepts Higher Sumitovant Offer In Deal That Values It At $2.9bn

Sumitovant, a Sumitomo subsidiary, will pay $27 per share for the 48% of Myovant shares it does not already own, for a deal value of $1.7bn, up from a $22.75-per-share bid in early October.

M & A Strategy

Liver Hepatic

Set Alert for Liver Hepatic

Genfit Pivots To Opposite End Of The Liver Disease Spectrum

Genfit CEO Pascal Prigent talks to Scrip about the company's high-profile trial failure in NASH and the pipeline pivot to various other drug candidates for rare liver diseases.

Restructuring Business Strategies

Imminent Madrigal, Viking Trial Readouts Will Shape NASH R&D Expectations

While neither company reported new data from their ongoing trials at AASLD, the firm’s competing THRβ agonists are viewed as leading lights in the non-alcoholic steatohepatitis competition.

Business Strategies Clinical Trials

GSK Reaches ‘First Base’ In Hep B Functional Cure But Has More To Prove

GSK is the first to raise the functional cure rate with its antisense drug, Phase II data suggest, but the company is looking for ways to boost responses across hepatitis B patients in its Phase III study.

Clinical Trials Companies

Albireo Ready To Seek Second Bylvay Indication In Alagille Syndrome

With Bylvay approved last year for progressive familial intrahepatic cholestasis, Albireo looks to add an estimated 25,000 addressable patients to IBAT inhibitor’s label with strong Phase III data in ALGS.

Business Strategies Clinical Trials

Ophthalmic

Set Alert for Ophthalmic

Viatris Buys Two Eye Specialists, Setting The Stage For ‘Phase Two’ Of Its Growth Plan

The company will buy Oyster Point Pharma and Famy Life Sciences for $700m to $750m in total as management tries to move the business towards more innovation.

Deals M & A

Apellis Aims New Pegcetacoplan Data At Market, Not Regulators

The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.

FDA Ophthalmic

Unity Looks Ahead To Pivotal Study With Positive DME Data For UBX1325

The company announced 24-week results from the Phase II BEHOLD trial in diabetic macular edema patients already treated with anti-VEGF therapy, showing gains in a tough population.

Clinical Trials Ophthalmic

Nicox’s NCX 470 Hits Phase III Endpoint In Glaucoma But Misses Superiority

NCX 470 demonstrates non-inferiority in intraocular pressure reduction versus latanoprost in the first of two Phase III studies, but does not meet a secondary endpoint that would have shown superiority.

Clinical Trials 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

Calliditas Spies Chinese Market As Tarpeyo Continues Upwards Sales Curve

The Swedish biotech’s successful launch in the US of Tarpeyo for immunoglobulin A nephropathy is progressing well and a Chinese approval is on the horizon as partner Everest’s application is accepted by regulators.

Sales & Earnings Business Strategies

Flush With CF Success, Vertex Prepares Next-Gen Pipeline For Busy 2023

Vertex’s dominance in cystic fibrosis looks secure for years to come, and 2023 and 2024 could see it bring more ground-breaking innovation to market.

Sales & Earnings Commercial

Tricida's Future In Doubt After Renal Outcomes Failure In CKD With Metabolic Acidosis

The company's hopes to bring veverimer to market to slow chronic kidney disease progression in patients with metabolic acidosis appear to be dashed.

Clinical Trials Renal

Travere’s Sparsentan Faces Slower Uptake Due To Liver Monitoring Requirement

The FDA required an updated REMS for liver monitoring out of caution over potential liver toxicity, though the drug has not caused drug-induced liver injury in development to date.

Business Strategies Renal
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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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