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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Novo Anticipates Q4 Soft Launch For Closely Watched Oral GLP-1 Agent Rybelsus In The US

US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Approvals Metabolic Disorders

Bayer Aims To Take AI-Driven One Drop Beyond Diabetes

Bayer is boosting its AI drive by investing in One Drop’s digital platform and hopes to advance outcomes in oncology, heart disease and women’s health with data-driven solutions.

 

Digital Health Companies

ENTRUST Bolsters Edoxaban As VKA Alternative In AF Patients

Daiichi drug shows non-inferiority to standard antithrombotic regimen in atrial fibrillation patients, adding to evidence supporting Factor Xa inhibitor's use.

Clinical Trials Comparative Effectiveness

PARAGON-HF: Novartis Hangs Onto Hope For Entresto In HFpEF

Despite Phase III miss, Novartis is hopeful that the totality of the evidence will secure it at least a limited label expansion to a sizable but harder to treat portion of the heart failure market than Entresto already serves.

Cardiovascular Clinical Trials

Interview: AstraZeneca’s Pangalos on Landmark DAPA-HF Results

AstraZeneca’s head of R&D spoke to Scrip about the outstanding results for dapagliflozin in heart failure regardless of diabetes status.

Cardiovascular Clinical Trials

Vascepa Included In European Dyslipidemia Guidelines Ahead Of Approval

Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.

Cardiovascular Regulation
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CNS

Set Alert for CNS

Latest From Neurology

ARIBIO Counts On Multi-Modal Drug For Alzheimer's And Vascular Dementia

ARIBIO CEO tells Scrip how the South Korean biotech is aiming to develop a multi-modal drug for both Alzheimer’s disease and vascular dementia using its innovative platform technology, which can cut development periods and costs and better predict clinical trial success.

South Korea Research and Development Strategies

Novartis Says SMA Baby Death Not Due To Zolgensma

The Swiss major has new data on its SMA gene therapy which has been found not to be the cause of the death of a six-month-old patient earlier this year.

Gene Therapy Neurology

Sanofi To Co-Develop Digital Therapeutic For MS Patients

Sanofi's latest digital health move will see it collaborating with Happify Health on a digital therapeutic for patients with multiple sclerosis, a therapeutic area it knows well.

 

Digital Health Deals

Acceleron Ends ACE-083 FSHD Testing After Phase II Failure

Acceleron ended testing of ACE-083 in facioscapulohumeral muscular dystrophy after the investigational drug missed Phase II endpoints.

Neurology Clinical Trials

Bucking Biosimilar Threat, Roche Sees Further Growth

Many new and pipeline products were highlighted at London meeting – but no word on Spark Therapeutics deal. New products will have high profit margins.

Cancer Neurology

Novartis Upbeat As Ofatumumab Data Delivers In MS

Novartis looks to differentiate ofatumumab from Roche's entrenched MS blockbuster Ocrevus, stressing that patients can inject the therapy at home.

Neurology Clinical Trials
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

US FDA AdComm Win For Aimmune’s Palforzia Bodes Well For DBV’s Peanut Allergy Patch

Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.

Advisory Committees Drug Review

Breakthrough Designation Confirms Gazyva Promise In Lupus Nephritis

Promising Phase II data mean it could be third time lucky for Roche in disease with no approved treatments. 

 

Commercial North America

Synthorx Throws THOR-707 Into Competitive IL-2 Space With HAMMER, Its First-Ever Clinical Trial

Emerging Company Profile: This is the first human study for lead product candidate THOR-707 and for the company's Expanded Genetic Alphabet platform, starting with a recombinant IL-2 that's being tested in solid tumors.

Business Strategies ImmunoOncology

Lilly's Latest Olumiant Data Raise Question Of JAK Inhibitor Role In Atopic Dermatitis

While the BREEZE-AD7 data show that baricitinib may effectively treat AD in combination with topical corticosteroids, a patient treated with the drug in the ex-US study had a pulmonary embolism.

Clinical Trials Drug Safety

Lilly's Taltz Approved For AS As New Guidelines Keep TNF Inhibitors In Front Line

VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.

Approvals Inflammation

Amgen's $13.4bn Otezla Buy Helps Bristol/Celgene Merger Close By Year-End

Amgen sees opportunity to grow Otezla sales through new indications and additional ex-US launches. The deal depends on Bristol closing its Celgene acquisition, pending FTC clearance.

Deals Business Strategies
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Themis CEO: Chikungunya Vaccine Could Be Approved In Two Years

Themis Bioscience CEO says the biotech’s €40m Series D financing will fund pivotal trials for its lead vaccine candidate for chikungunya and advance its oncology franchise.

Commercial Companies

Amplyx Cleared To Complete Phase II Study Of New Antifungal Class

Fosmanogepix, with safety and efficacy clearances to continue Phase II, could provide an IV-to-oral option for patients with potentially lethal Candida fungal infections.

Clinical Trials Infectious Diseases

BioNTech Gets Gates Foundation Funding For HIV, TB Drug Discovery

The Bill & Melinda Gates Foundation has invested $55m in an infectious disease collaboration with Germany’s BioNTech that could reach up to $100m in total funding.

Commercial Companies

Cidara's Once-Weekly Antifungal Gets Phase III Boost From Mundipharma

Mundipharma is to provide financial support and development expertise for Cidara’s Phase III clinical studies of its once-weekly echinocandin antifungal for serious infections, in return for ex-US and ex-Japanese marketing rights.

 

Infectious Diseases Deals

After AR-105 VAP Failure, Aridis Looks To AR-301 For Value Justification

Aridis is effectively pulling the plug on AR-105 after the mAb failed in a Phase II ventilator-associated pneumonia trial. It will now focus on its remaining pipeline, led by Phase III asset AR-301.

Clinical Trials Companies

Scotland's MGB Bags More Funds To Tackle Antibiotic Resistance

The Glasgow-based group has raised more cash to take its new class of anti-infective through Phase IIa trials for C diff-associated disease.

Financing Infectious Diseases
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Novo Anticipates Q4 Soft Launch For Closely Watched Oral GLP-1 Agent Rybelsus In The US

US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Approvals Metabolic Disorders

Versantis Gets Cash For Toxin 'Undelivery' Product

Emerging Company Profile: CHF16m for Swiss firm that engineers liposomes to capture toxins and protect the organs of patients with acute liver failure.

 

StartUps and SMEs Companies

With $260m Settlement From Sanofi, Lexicon Looks For New Zynquista Partner

Sanofi terminated its alliance for the SGLT1/2 inhibitor Zynquista, giving Lexicon full control of development in type 1 and type 2 diabetes, but it is seeking a new partner ideally with a European footprint.

Deals Business Strategies

Xeris Joins Lilly On Market With Approval Of Easier-To-Use Glucagon

Xeris’s Gvoke gets FDA approval, joining Lilly’s Baqsimi as products to treat emergency episodes of hypoglycemia with an easier-to-use kit. Xeris will launch its prefilled syringe in Q4 and an auto-injector in 2020.

Approvals Business Strategies

Vertex Buys Semma, Gaining Cell Therapy-Based Type 1 Diabetes Treatments

Semma's innovative technology involves growing insulin-producing beta cells from stem cells and transplanting them into the liver, but it hasn't been tested in humans yet.

Deals Metabolic Disorders

Novo Nordisk's Ultra-Fast Acting Insulin Cleared For Pediatric Use In EU

A market opportunity has just opened up for Novo Nordisk’s ultra-fast acting mealtime insulin, Fiasp: its indications have just been extended to include younger EU patients who are aged more than one year.

 

Metabolic Disorders Approvals
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Oncology

Set Alert for Oncology

Latest From Cancer

Astellas Stays Ahead of Daiichi Sankyo In AML With CHMP Nod For Xospata

A positive opinion for its FLT3 inhibitor for acute myeloid leukemia gives Astellas a further advantage over its Japanese competitor's same-class offering, quizartinib.

Drug Review Cancer

Gene Profiling Identifies Drugs For Childhood Cancers But Access A Problem

Lack of infrastructure for identifying mutations and access routes is holding back use of targeted medicines in children with cancer

Cancer Personalized Medicine

Brighter News For Varlitinib As Results In Tough Cancer Type Encourage ASLAN

Following a major setback in another indication earlier this year, ASLAN’s lead asset is now seen as a potential new option for second-line use in biliary tract cancer following promising new data from a Chinese trial.

Clinical Trials Cancer

Boundless Bio Launches With $46m And Novel Oncology Focus On Extrachromosomal DNA

Former Ignyta executive Zachary Hornby wasn't wowed by immuno-oncology pitches when looking for his next cancer drug development company, but was intrigued by ecDNA research at UCSD, which also could generate a tumor agnostic approach.

StartUps and SMEs Financing

ESMO Preview: Five Key Oncology Battlegrounds To Watch

GSK looks to become a cancer contender once again, while Merck and Roche go toe-to-toe in TNBC.

Cancer Research & Development

J&J's Erleada Approved By FDA In New Prostate Cancer Indication

Erleada was approved for treatment of metastatic castration-sensitive prostate cancer (mCSPC), strengthening its position versus generic Zytiga and Pfizer/Astellas's Xtandi.

Cancer Approvals
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

IPF Failure Sets Back Biogen’s Diversification Efforts

The company has discontinued a Phase II trial for BG00011, which was acquired in its 2012 Stromedix purchase, due to safety issues.

Clinical Trials Business Strategies

AstraZeneca’s COPD Triple Combo Drug Succeeds in ETHOS Phase III, Setting Up GSK Showdown

The triple-combination treatment significantly reduced COPD exacerbations compared to older dual therapies in the Phase III ETHOS study, providing a boost to AstraZeneca as it closes in on approvals in the US and Europe.

Clinical Trials Companies

Korea Races For IPF Drug Development Amid Keen Global Interest

Following major global licensing out deals in the sector this year by South Korean bioventures Bridge Biotherapeutics and TiumBio, Scrip takes a look at why firms in the country are competitively pursuing development of drugs for IPF.

South Korea Respiratory

AZ Heads Talk Pipeline And Partnerships

The drugs major believes it has assembled a pipeline that is looking well stocked for several years to come.

Strategy Clinical Trials

Breath Therapeutics Snapped Up Post Series A By Specialty Company Zambon

Italy’s privately held Zambon could pay up to 500m to bulk up its respiratory products pipeline, producing a nice return for Breath Therapeutics’ syndicate of European investors.

 

M & A Respiratory

Boehringer Further Buoys IPF Portfolio With Bridge's Autotaxin Inhibitor

Pre-IPO Bridge Biotherapeutics inks major idiopathic pulmonary fibrosis license agreement with Boehringer Ingelheim, marking the biggest single product licensing out deal by a South Korean biotech. The move is poised to further bolster the German firm's leading position in the field and reflects global pharma's increasing interest in IPF.

South Korea Deals
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