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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

ASCO Data Show A Battle Ahead For Roche And Genmab’s Lymphoma Bispecifics

Roche looks set to gain first and second place in the race to bring CD3Xcd20s to market – but Genmab and AbbVie have a strong challenger.

Commercial Clinical Trials

GSK Can Seize Chance In Anemia After Rivals Rejected But FDA Caution Will Remain

GSK’s drug is the first in the class to show non-inferiority to standard therapy in safety, but the data still contains areas of doubt.

Commercial Companies

Still Looking For The Off-The-Shelf Breakthrough, Allogene Touts Myeloma CAR-T Candidate

While a cloud hangs over the future of its CD19-targeting allogeneic candidate, Allogene points to preclinical potential of superior efficacy for ALLO-715.

Cancer Blood & Coagulation Disorders

Sanofi Looks To Dominate $5bn Hemophilia A Factor Market After Trial Success

Phase III success for efanesoctocog alfa sets up a filing in the near future, and a chance to seize market share from existing Factor VIII products, as well as Roche’s Hemlibra.

Companies Blood & Coagulation Disorders

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

Dermavant Prepares For First Launch, Looking To Build A Blockbuster Psoriasis Brand

The Roivant-owned company's Vtama topical cream was approved by the US FDA with a broad label permitting use for mild, moderate or severe psoriasis.

Approvals Launches

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: a US setback for UCB; Lilly challenges Novo’s GLP franchise; Seagen searches for CEO after scandal; Hengrui hopes for US PD-1 success; and a look ahead at ASCO.

Commercial Executive Changes

Almirall Views Vitiligo As Next Dermatology Opportunity

As it prepares to file lebrikizumab for atopic dermatitis, the Spanish group is looking to expand into vitiligo through a collaboration with France’s Inserm Transfert to develop topical therapies for the condition where pale patches develop on the skin caused by the lack of melanin.

Dermatology Deals

UCB Rocked By US FDA Rejection Of Blockbuster-In-Waiting Bimzelx

The Belgian group’s US launch of Bimzelx could be delayed by up to a year after the FDA hit UCB with a complete response letter which states that "certain pre-approval inspection observations must be resolved” before the drug can get the green light for psoriasis.

Complete Response Letters Immune Disorders
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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

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

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

Gastrointestinal

Set Alert for Gastrointestinal

Etrasimod Results Justify Pfizer’s Leap Of Faith In Arena Buyout

Detailed data presented at Digestive Disease Week show competitive efficacy in ulcerative colitis and a potential best-in-class safety profile for the S1P receptor modulator Pfizer acquired earlier this year. 

Clinical Trials Gastrointestinal

AbbVie Ups Its IBD Game With Latest Crohn’s Data For Rinvoq

The leader in inflammatory bowel disease via Humira, AbbVie awaits a US FDA decision in June for Skyrizi in Crohn’s disease and plans to add a Crohn’s indication to Rinvoq’s ulcerative colitis approval.

Clinical Trials Gastrointestinal

Takeda Sees Mainstays Tiding It Over Upcoming Expiries

As Takeda reported what its CEO described as "a remarkable year," the company sees itself as well positioned to ride out the expiries over the next few years of exclusivity for several big-selling products, as it looks to mainstays and more organic growth to tide it over the "temporary headwinds."

Japan Commercial

Microbiome Modulators Slowly Nurture Investor Confidence

Once deemed an intimidating and risky space, microbiome modulator firms are slowly winning over investors as robust clinical data surface, with one company, Microbiotica, recently hitting an EU financing record.

Financing Companies
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Gynecology Urology

Set Alert for Gynecology Urology

How Organon Expects To Steer Its Women’s Health Engine In India

Organon commercial director and lead for the South Asia Region, Anjan Sen, lays out how the Merck spin-out expects to scale up activities in markets like India. A mix of new products, targeted repurposing efforts and access-driven pricing are part of the strategy that could potentially see the company double its presence in the region.

Commercial Strategy

Rare Setback For Merck & Co And AstraZeneca’s Keytruda-Lynparza Combo In Prostate Cancer

Metastatic prostate cancer continues to evade the checkpoint inhibitor class but Merck is not giving up on an area where overall survival remains limited.

Cancer Gynecology & Urology

Myovant's Next Act: Commercial Execution And Business Development

The company is ramping up the launches of Orgovyx for prostate cancer and Myfembree for uterine fibroids, including indication and geographic expansions, and evaluating business development opportunities.

Business Strategies Commercial

Astellas’s Long-Term Safety Data Could Boost Fezolinetant’s Approval Chances

With a pair of successful Phase III pivotal studies in hand, the Japanese pharma reports that its nonhormonal hot flash/night sweats candidate demonstrated safety and tolerability over 52 weeks.

Clinical Trials Drug Safety

Liver Hepatic

Set Alert for Liver Hepatic

Unicyte’s Unique Stem Cell Approach Could Cure Children With Rare Disorder

Emerging Company Profile: Swiss biotech Unicyte is using donor-derived liver stem cells across a range of therapeutic areas, with its lead asset showing curative potential in urea cycle disorders.

Emerging Company Profile Liver & Hepatic

Quick Listen: Scrip's Five Must-Know Things

In this week's podcast version of Five Must-Know Things: big changes at Biogen; Paxlovid still a work in progress; Farxiga goes stellar; Moderna hints at M&A; and a chat with Roche Pharma India’s CEO on rare diseases.

Commercial Companies

Intercept Offloads Ex-US Business To Advanz, May Be Doubling Down On NASH In US

Still working to refile its NASH fibrosis NDA 22 months after an FDA complete response letter, Intercept gets $405m up front for its ex-US business, including commercial rights to Ocaliva in PBC.

Deals Business Strategies

Phase III Data In Suspected NASH Boost Madrigal’s Profile, But Bigger Data To Come

Resmetirom, Madrigal’s THRβ agonist, demonstrates safety and tolerability, and succeeds on secondary efficacy endpoints in a study serving as a precursor to the firm’s pivotal Phase III trial.

Clinical Trials Drug Approval Standards

Ophthalmic

Set Alert for Ophthalmic

Vertex Spots Potential Bargain Of $60m Entry Into Complement Regulation

Vertex has acquired the full assets to a promising protease-based drug platform from Catalyst, broadening its R&D base once again.

Deals Ophthalmic

Ocuphire Chalks Up Another Phase III Success For Nyxol

The company announced positive topline results for the drug in night vision disturbance and may conduct another pivotal trial as it focuses on myadriasis and presbyopia.

Business Strategies Ophthalmic

Oxurion Pins Hopes On THR-149 After THR-687 Flops In DME

THR-687’s failure in Phase II marks the second drug to flunk in the disease after a Phase IIa study of THR-317 showed disappointing results in 2019, but THR-149 has shown some encouraging data.

Business Strategies Clinical Trials

Four Major Clinical Trial Readouts To Watch Out For In Q2

Four prominent drug candidates are expecting topline mid- or late-stage data over the next few months. With the help of Biomedtracker's Q2 Outlook Report, we take a look at the assets that could help validate some of the companies developing them, from oncology to psychiatry.

Clinical Trials Companies
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Orthopedics

Set Alert for 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

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
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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

Stada Poised To Launch As Calliditas Finally Wins EU Nod For Kinpeygo

The Swedish biotech’s patience paid off as it received a positive EU CHMP opinion on its rare nephrology drug Kinpeygo, known elsewhere as Tarpeyo, following delays related to manufacturing questions.

Approvals Renal

AstraZeneca’s Farxiga Flies Across $1bn Barrier

First-quarter sales jumped by 56% to $11.39bn at AstraZeneca and while its COVID-19 products brought in $1.6bn, it was the performance of the diabetes, heart failure and chronic kidney disease drug Farxiga that impressed most.

Coronavirus COVID-19 Sales & Earnings

Four Major Clinical Trial Readouts To Watch Out For In Q2

Four prominent drug candidates are expecting topline mid- or late-stage data over the next few months. With the help of Biomedtracker's Q2 Outlook Report, we take a look at the assets that could help validate some of the companies developing them, from oncology to psychiatry.

Clinical Trials Companies

Boehringer Pharma Chief Confident Of Continued Success For Jardiance

Carinne Brouillon, head of the German major’s human pharma business unit, tells Scrip that Jardiance’s leadership in interconnected cardio-metabolic-renal diseases has been demonstrated and the product is set to keep rising as new indications come onboard.

Business Strategies Leadership
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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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