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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

Sigilon Hemophilia Cell Therapy On Clinical Hold, But May Not Be Drug-Related

A patient developed Factor VIII inhibitors, but he had also recently received a COVID-19 vaccine and was genetically predisposed.

Clinical Trials FDA

Pharming And Orchard Seek Stem Cell Solution To Hereditary Angioedema

Orchard Therapeutics of the US and Dutch biotech Pharming have agreed to jointly research, develop, manufacture and commercialize the former’s newly disclosed investigational ex vivo autologous hematopoietic stem cell gene therapy as a treatment for hereditary angioedema.

Deals Clinical Trials

UniQure Needs Longer-Term Data For Hemophilia B Gene Therapy EtranaDez

The FDA may want longer follow-up data for companies developing treatments for hemophilia A as well as hemophilia B.

Gene Therapy Blood & Coagulation Disorders

Pivotal Data Boost Omeros’ Stem Cell Transplant Product After FDA Delay

Promising pivotal data boost chances for Omeros’ narsoplimab to become a highly needed, first-to-market drug for the treatment of a deadly complication of stem cell transplants.

Clinical Trials 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

Sanofi Maps Out R&D Expectations For 2H 2021

Sanofi has transformed the productivity of its R&D pipeline over the past several years, and late-stage clinical data readouts are expected in the second half of this year for new anticancer drugs, a candidate pemphigus therapy and a COVID-19 vaccine.

Clinical Trials Cancer

Almirall Focus Firmly On Lebrikizumab After Securing Klisyri Approval

Now that the actinic keratosis treatment Klisyri has got the green light in Europe, the Spanish firm's attention will be on atopic dermatitis and forthcoming Phase III data on lebrikizumab, a potential rival to Dupixent.

Approvals Dermatology

Swedish Biotech Developing Stem Cell Therapies From Amniotic Fluid

Swedish biotech Amniotics is developing a broad pipeline of unique stem cell therapeutics based on technology that is broadly applicable to major disease markets which should eventually draw the attention of big pharma players, its CEO tells Scrip.

Clinical Trials StartUps and SMEs

10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Approvals Companies
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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

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 Research and Development Strategies

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

Pharming And Orchard Seek Stem Cell Solution To Hereditary Angioedema

Orchard Therapeutics of the US and Dutch biotech Pharming have agreed to jointly research, develop, manufacture and commercialize the former’s newly disclosed investigational ex vivo autologous hematopoietic stem cell gene therapy as a treatment for hereditary angioedema.

Deals Clinical Trials

Rinvoq Shows Strong UC Efficacy, But Will JAK Ghosts Haunt It?

Safety appears balanced between the drug and placebo arms in upadacitinib’s third Phase III trial in ulcerative colitis, but there were low numbers of MACE and there are lingering safety concerns about the JAK class overall.

FDA Inflammation
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Gynecology Urology

Set Alert for Gynecology Urology

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

Myovant/Pfizer Launch Myfembree With An Emphasis On Building Uterine Fibroid Awareness

Myovant CEO David Marek talked to Scrip about why the companies believe patients and physicians will choose Myfembree over AbbVie's Oriahnn.

Gynecology & Urology Approvals

Liver Hepatic

Set Alert for Liver Hepatic

Albireo Dashes Into PFIC Market As FDA, EMA Approve Bylvay

The company anticipates an addressable global market for progressive familial intrahepatic cholestasis of 2,500 patients, with initial plans to focus on around 100 physicians at 60 centers.

Rare Diseases Approvals

Stock Watch: Poxel Passes Go…But To Where?

Poxel’s shift to new therapeutic areas may be necessary despite Japan’s approval for its diabetes drug. Twymeeg looks set to be hamstrung by placebo-controlled studies without outcomes data.

Approvals Commercial

Regeneron Lifts Stake In Biotech Partner ISA Pharma

Armed with €26m in fresh funds from investors that include partner Regeneron, ISA Pharma can now advance promising preclinical assets generated from its proprietary platform, containing a mix of synthetic antigenic peptides, its CEO tells Scrip.   

Clinical Trials Commercial

Lilly Aims For Earlier Treatment With Novel Diabetes Drugs

Lilly outlined its tirzepatide-led pipeline of incretin agonists and highlighted its once-weekly basal insulin during a post-ADA event. The company hopes to grow the GLP-1 market overall rather than shift patients from Trulicity.

Strategy Research and Development Strategies

Ophthalmic

Set Alert for Ophthalmic

AGTC Moves Past Biogen With Ophthalmic Gene Therapy

AGTC hopes to gain the first approval in X-linked retinitis pigmentosa for its gene therapy AGTC-501, now in a Phase II/III study. It also is advancing development in achromatopsia, another unmet medical need.

Gene Therapy Rare Diseases

Adverum Faces Rocky Road As It Switches Gears From DME To Wet AMD

Adverum said it would cease developing ADVM-022 for DME and focus on wet AMD, but the adverse events that prompted the shift could invite further scrutiny in an already competitive market.

Clinical Trials Gene Therapy

Novartis Q2 Preview: Where Is The Next Blockbuster Coming From?

Entresto and Cosentyx continue to grow but investors will be looking to see if there are candidates in the current portfolio or pipeline that could join them in the mega-blockbuster club.

Sales & Earnings Companies

REFLECT Study Confirms Efficacy Of GenSight's Gene Therapy Lumevoq

French biotech GenSight Biologics reports top-line results from the Phase III REFLECT study, backing the efficacy of its lead gene therapy in a devastating eye disease, and prepares plans to commercialize the product.

Gene Therapy Ophthalmic
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Orthopedics

Set Alert for Orthopedics

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

Audentes Set To Resume XLMTM Trial As US Hold Lifts

Trial of high-need gene therapy set to restart following the deaths of several participants and the lifting of a clinical hold imposed by the US FDA last year.

Gene Therapy Clinical Trials

Mereo Licenses Setrusumab To Ultragenyx For Osteogenesis Imperfecta

Ultragenyx hopes to expand its bone disease franchise in a deal that frees up Mereo to focus on its anti-TIGIT immuno-oncology pipeline asset.

Companies Deals
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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

Quick Listen: Scrip’s Five Must-Know Things

In this week's podcast edition of Five Must-Know Things: J&J’s outlook for coronavirus vaccines; Cosentyx comes in strong for Novartis; Biogen’s views on Aduhelm pricing; competition in the “dustat” sector; and dealing with endemic COVID-19.

Commercial Coronavirus COVID-19

Swedish Biotech Developing Stem Cell Therapies From Amniotic Fluid

Swedish biotech Amniotics is developing a broad pipeline of unique stem cell therapeutics based on technology that is broadly applicable to major disease markets which should eventually draw the attention of big pharma players, its CEO tells Scrip.

Clinical Trials StartUps and SMEs

Bayer Focusing On Early CKD Testing In Kerendia US Launch

The company, which set a list price of $19 per day, sees awareness of diagnosing chronic kidney disease in type 2 diabetes patients as the top challenge for newly approved finerenone in the US.

Launches Renal

10 US Approval Decisions To Look Out For In Q3

This quarter has already seen a complete response letter for Iterum Therapeutics’ antibiotic sulopenem but a raft of other products are expecting approval decisions from the US Food and Drug Administration in the next three months. With the help of analysts at Biomedtracker, Scrip takes a look at 10 of the more interesting ones.

Approvals 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
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