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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

Pfizer’s Buying Spree Continues With GBT, Gaining A Sickle Cell Disease Franchise

Pfizer has reached a deal to buy Global Blood Therapeutics for $5.4bn, gaining the sickle cell therapy Oxbryta and building on efforts to reach underserved patient groups.

Blood & Coagulation Disorders Deals

Japan-Specific Approval For Hemlibra In Acquired Hemophilia A

Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting. 

Japan Approvals

Freeline Evaluating Options After No Home Run For Hem B Gene Therapy

Freeline’s FLT180a could still prove to be the best-in-class gene therapy for hemophilia B but its cash and time are running out as rivals grow closer to market.

Blood & Coagulation Disorders Companies

Novo Nordisk’s Concizumab Could Be First In New Class For Hemophilia

Phase III data for the drug showed strong efficacy among hemophilia A and B patients with inhibitors. The drug’s approval would help drive continued segmentation of the hemophilia market.

Clinical Trials Business Strategies

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

Concert’s Patient-Reported Outcome Could Help Differentiate Its Alopecia Therapy

Concert’s CTP-543 would be second or third to market in alopecia areata, behind Lilly and likely Pfizer, but the biotech thinks its drug will have the best profile based on efficacy and patient satisfaction.

Clinical Trials Business Strategies

Arcutis Launches Zoryve For Psoriasis As A New Topical In A Growing Category

Zoryve joins Dermavant's Vtama as a new topical drug with a broad label for plaque psoriasis and offers some points of differentiation, including price.

Launches Approvals

Incyte Bolsters Dermatology Ambitions With Vitiligo Approval For Topical Ruxolitinib

Opzelura, already approved for atopic dermatitis, gives Incyte a second indication for its topical JAK inhibitor. It is the first treatment approved for vitiligo.

Approvals Business Strategies

Galderma Hopes To Break Into Prurigo Nodularis Market, But May Face Rivals

The dermatology specialist announced positive results from the OLYMPIA 2 trial of nemolizumab, but Sanofi and Regeneron are already pursuing a similar indication for Dupixent. 

Clinical Trials Business Strategies
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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

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

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

Gastrointestinal

Set Alert for Gastrointestinal

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

4D Pharma Is Latest Biotech Casualty After Creditor Calls Time

The UK biotech looks to have reached the end of the road, despite some encouraging signs from its microbiome-based pipeline.

Companies Commercial
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Gynecology Urology

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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

EW Healthcare Partners Adds Women’s Health Heft With TherapeuticsMD Buyout

Deal Snapshot: The UK-based private equity firm will acquire troubled specialty pharma TherapeuticsMD for roughly $177m, after the company’s three-product portfolio yielded revenues of $85.8m in 2021.

Deals Business Strategies

Liver Hepatic

Set Alert for Liver Hepatic

Vertex Expands In Vivo Gene-Editing Plans With Verve Liver Disease Pact

Vertex is expanding its investments across advanced therapies again, R&D chief David Altshuler adding a second in vivo gene-editing deal to its pipeline.

Commercial Companies

CAMP4 Charts A Different Course In RNA-Based Therapeutics

Financing Snapshot: The company announced a $100m series B round that it plans to use to develop its regulatory RNA platform technology, with an eye toward entering the clinic in mid-2023.

Financing Neurology

Will Intercept’s New NASH Analysis Pass FDA’s Muster?

The new analysis of REGENERATE, based on an FDA-requested methodology, shows continued efficacy for OCA, but analysts were circumspect about whether the benefit/risk profile would sway the agency.

Business Strategies Clinical Trials

Stock Watch: The Stubborn Hurdle Of Chronic Hepatitis B

Most of the money raised by biotech companies to address chronic hepatitis B has resulted in failed programs. But wait, a glimmer of light from yonder pharma breaks.

Stock Watch Vaccines

Ophthalmic

Set Alert for Ophthalmic

Bayer Backs Eylea's Prospects Despite Lucentis Biosimilars

Competition, both branded and generic, is on the rise but the German group believes that Eylea will continue to outperform given its safety and efficacy profile and the potential of a longer-lasting version of the eye therapy.

Sales & Earnings Ophthalmic

Roche Inks Another AAV Capsid Platform Technology Deal, With Avista Therapeutics

Deal Snapshot: Roche and University of Pittsburgh spinout Avista Therapeutics signed the pact to enable the Swiss drug maker to develop gene therapies for retinal diseases using Avista’s platform tech.

Deals Gene Therapy

Aldeyra Claims Success In Final Phase III For First-In-Class Dry Eye Drug

The company plans to submit an NDA for reproxalap for dry eye disease based on the results and hailed the crossover trial design as unique in the therapeutic area.

Clinical Trials Ophthalmic

Adverum Makes Job Cuts To Advance Wet AMD Gene Therapy

The California-based biotech is reducing its workforce to help finance a Phase II study of Ixo-vec, its eye gene therapy which has been blighted by safety concerns.

Gene Therapy Ophthalmic
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Orthopedics

Set Alert for 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

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
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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

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

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
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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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