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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

BI Bets On Expanding Jardiance As Diabetes Drug Sales Soar

The German major believes its drug will remain the biggest-selling SGLT-2 inhibitor boosted by expanded heart and renal disease approvals.

Commercial Companies

Missed BEAT Removes Tough Sell For United Therapeutics

The Phase III failure of esuberaprost combined with Tyvaso in pulmonary arterial hypertension has prompted United Therapeutics to stop developing a therapy that was already facing an uphill battle for potentially meager returns.

Clinical Trials Research & Development

Amarin's Vascepa Gets ADA Recommendation For Patients With Diabetes And High Triglycerides

The company has racked up a lot of wins for its proprietary fish oil derivative based on the REDUCE-IT study, the latest being inclusion in diabetes treatment guidelines. Amarin also has now submitted a supplemental NDA seeking a label update reflecting the outcomes trial results.

Cardiovascular Metabolic Disorders

DalCor Keeps Faith In CETP Biomarker, Despite No Dice For Merck's REVEAL Genetic Analysis

Hopes for a precision approach for the vast cardiovascular disease population live on – past failed studies of HDL-raising drugs and lack of evidence for genetic typing in Merck's latest analysis of anacetrapib in REVEAL.

Clinical Trials Research & Development

Latest REDUCE-IT Results Bolster Case For Amarin's Vascepa Fish Oil Pill

Data may pave way for inclusion in heart disease treatment guidelines, ACC spokesperson says.

Clinical Trials Research & Development

New CV Outcomes Study May Mean Big Boost For Amgen's Repatha Market

The addressable patient population in the US could increase by 4.5 million if new trial is successful.

Clinical Trials Research & Development
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CNS

Set Alert for CNS

Latest From Neurology

Lilly/Pfizer’s Tanezumab Safety Takes A Hit With Latest Phase III Results

Larger of two doses of the NGF inhibitor hit two efficacy endpoints, but the rate of joint health outcomes on a composite measure was higher than control by a statistically significant margin.

Clinical Trials Drug Safety

Aptinyx Sees Path Forward In DPN With Long-Term Patients

After disappointing top-line Phase II data in diabetic peripheral neuropathy with NYX-2925, Aptinyx says the full dataset shows significance across endpoints in patients four years or more past diagnosis; a second Phase II study in this subgroup is planned.

Clinical Trials Business Strategies

M&A A Major Pillar Of Sumitomo Dainippon's New Mid-Term Plan

Mid-size Japanese player Sumitomo Dainippon sets aside billions for potential M&A deals under a new business plan designed to fill gaps in its neurology pipeline as it prepares to lose exclusivity for its top global product.

Business Strategies M & A

BIO-Europe Spring 2019: Addex CEO: There’s Space For Better Therapies In Parkinson’s

At the recent BIO-Europe Spring partnering conference, Tim Dyer, CEO of Addex Therapeutics, spoke to Lucie Ellis, executive editor of In Vivo, about the company’s small-molecule allosteric modulators for central nervous system disorders.

Companies Strategy

South Korea's ADEL Innovates With Anti-Tau Antibody For Alzheimer’s Disease

Emerging Company Profile: ADEL Inc. CEO Seung-Yong Yoon tells Scrip how its anti-tau antibody brings something different to the table in the challenging field of Alzheimer's disease and what's in store for the South Korean bioventure.

South Korea Neurology

Defusing US Opioid Crisis Offers Orexo "Strong Growth Potential" Says CEO

The CEO of Swedish addiction and pain specialist Orexo tells Scrip its top drug Zubsolv will grow strongly in coming years to address the opioid crisis in the US, and that revenues will be further boosted by novel pipeline therapies likely to be commercialized in coming years.

Business Strategies Commercial
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

J&J's Spravato's Star Power Rises While Zytiga's Sets

With Spravato's launch underway, J&J reports that 800 sites have been certified to administer the depression drug. Newer drugs drove pharma sales in the first quarter, while US sales of Zytiga declined 55% due to generic competition. 

Companies Commercial

Gyroscope Merger Creates Gene Therapy Biotech For Eye Disorders

A new UK/US biotech tie-up makes a company with the technology to deliver its gene therapies.
M & A Ophthalmic

AZ Explores Orphan Diseases To Boost Fasenra Growth

The company's severe asthma drug Fasenra has demonstrated its effectiveness in a Phase II trial for hypereosinophilic syndrome, a group of rare disorders which can cause progressive organ damage.

Clinical Trials Immune Disorders

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

Galapagos Flies As Filgotinib Soars In FINCH Studies

More evidence of its strong safety profile suggests that the Belgian biotech's oral selective JAK1 inhibitor partnered with Gilead will be able to break into the crowded RA market.

Safety Immune Disorders

Lilly Opens Its Wallet For Early Immunology Tie-Up With ImmuNext

Lilly is prepared to splash over $600m on an early development deal with ImmuNext on an immunometabolism target which ties the companies together for three years while an antibody is being developed.

Deals Companies
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

BIO-Europe Spring 2019: RedHill Preps NDA Submission For Antibiotic Talicia

Gilead Raday, chief operating officer of RedHill Biopharma, talks to Lucie Ellis, executive editor of In Vivo, about recently published late-stage data and next steps for its antibiotic asset, Talicia (RHB-105), for the treatment of Helicobacter pylori infection. 

Clinical Trials Infectious Diseases

Further Iclaprim Analyses Ahead Of Crucial Months For Motif Bio

A 3 May meeting with the FDA is likely to be crucial for the future commercialization strategy for the biotech’s precision-targeted antibacterial.

Infectious Diseases Clinical Trials

ViiV's Dovato: Treatment-Naive HIV Is Earmarked For The "Complete Regimen"

The first approval in the US of a once-daily single-tablet, two-drug regimen for treatment-naive HIV from the HIV/AIDS therapy specialist, ViiV Healthcare, suggests a shift away from three-drug regimens for HIV/AIDS could be gathering pace.

Approvals Infectious Diseases

SWORD Data Sharpen Commercial Appetite For ViiV’s Juluca, But Is It Too Little Too Late?

ViiV Healthcare has published results from the first long-term Phase III study for switching from a three-drug combination, to an oral two-drug combination. It disproves resistance and safety fears that have hampered prescriber comfort, however, it may have to dampen its sales ambitions when ViiV’s soon-to-be-approved combo Tivicay/Epivir comes to market.

Infectious Diseases Clinical Trials

Galapagos Flies As Filgotinib Soars In FINCH Studies

More evidence of its strong safety profile suggests that the Belgian biotech's oral selective JAK1 inhibitor partnered with Gilead will be able to break into the crowded RA market.

Safety Immune Disorders

Alios Buy Best Forgotten For Johnson & Johnson As RSV Failure Costs It Dear

Johnson & Johnson has written off a further $700m against the RSV asset that it obtained with its $1.75bn purchase of Alios.

Companies Commercial
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

BI Bets On Expanding Jardiance As Diabetes Drug Sales Soar

The German major believes its drug will remain the biggest-selling SGLT-2 inhibitor boosted by expanded heart and renal disease approvals.

Commercial Companies

Gelesis's Obesity Product FDA Acceptance Gives Boost To PureTech's Portfolio


PureTech's affiliate Gelesis has received FDA clearance for its Plenity capsule to treat overweight-obese adults, and plans to launch it commercially in the second half. 
Approvals Metabolic Disorders

Insulin Assistance Programs: Big Help Or Just A Band-Aid?

Drug makers and other stakeholders have been rolling out insulin savings programs as the high cost of insulins come under scrutiny on Capitol Hill. Sanofi announced an expanded cost-savings program during a House hearing, but one Congresswoman called them a band-aid. 

Pricing Debate Policy & Regulation

Positive Phase III Data Set Stage For Japan Imeglimin Filing

Partners Poxel and Sumitomo Dainippon confirm Japan filing plans for novel glimin antidiabetic following positive top-line Phase III results, and cast an eye towards market positioning.

Japan Clinical Trials

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

Amarin's Vascepa Gets ADA Recommendation For Patients With Diabetes And High Triglycerides

The company has racked up a lot of wins for its proprietary fish oil derivative based on the REDUCE-IT study, the latest being inclusion in diabetes treatment guidelines. Amarin also has now submitted a supplemental NDA seeking a label update reflecting the outcomes trial results.

Cardiovascular Metabolic Disorders
See All

Oncology

Set Alert for Oncology

Latest From Cancer

Kiadis Buying CytoSen Will Combine Natural Killer And T-Cell Immunotherapies

An all-stock transaction will see Europe’s Kiadis and US’s CytoSen bring together complementary approaches to improving stem cell transplants and cancer immunotherapy.

 

M & A ImmunoOncology

Asia Begins To See Impact From Roche 'De-Siloing'

As part of a global strategy first unveiled last year, Roche is taking concrete steps to restructure its pharma operations in Asia, including the substantial downsizing of a Singapore office.

Business Strategies Asia Pacific

Finance Watch: Turning Point Launches IPO, Stock Rises 60% On First Day

Public Company Edition: Turning Point's offering priced at $18 and its stock closed at $28.90. Also, Achaogen's bankruptcy reflects difficult antibacterial market, Ophthotech's name change follows strategy shift, and Gilead lays off 150 sales reps. Plus, cell and gene therapy FOPOs flourish.

Financing Business Strategies

J&J's Spravato's Star Power Rises While Zytiga's Sets

With Spravato's launch underway, J&J reports that 800 sites have been certified to administer the depression drug. Newer drugs drove pharma sales in the first quarter, while US sales of Zytiga declined 55% due to generic competition. 

Companies Commercial

Chi-Med Files For Hong Kong Listing That Could Raise $500m

Chi-Med has applied to list in Hong Kong and will undertake a new global share offering as it looks to raise new funds to support the progress and commercialization of its growing pipeline. 

Hong Kong Financing

Tracon Bows Out Of Oncology For Lead Product As TAPPAS Is Stopped For Futility

Disappointment for the San Diego, CA-based firm as Phase III study of its lead product is deemed futile and it ends clinical research of the product in cancer.

Clinical Trials Cancer
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

'Pharma Fireworks': Pipeline Catalysts To Watch Out For In Q2

Scrip looks at some the key clinical and regulatory pharma events that will spark attention during the next three months, according to Biomedtracker's latest quarterly outlook report.

Clinical Trials Drug Review

AZ Explores Orphan Diseases To Boost Fasenra Growth

The company's severe asthma drug Fasenra has demonstrated its effectiveness in a Phase II trial for hypereosinophilic syndrome, a group of rare disorders which can cause progressive organ damage.

Clinical Trials Immune Disorders

Proteostasis Puts Best Face On Unspectacular CF Combo Data

With data showing a lung function and sweat chloride benefit for its proprietary CFTR-modulating triplet, Proteostasis says it’s moving ahead. But analysts and investors are concerned the effects are less than seen with Vertex drugs.

Clinical Trials Respiratory

Vertex CEO Defends Salary After Company Is Slammed For Orkambi Pricing At UK Hearing

Vertex CEO Jeff Leiden has defended his company’s approach to pricing, as well as his $17m salary, at a heated UK public hearing on access to cystic fibrosis drug Orkambi.

Europe United Kingdom

Vertex Stuck Between A Good Place And A Better Place

Two three-drug regimens for cystic fibrosis hit their primary endpoints in both heterozygous and homozygous patients, with good safety and tolerability, which analysts say increases the likelihood one of them will obtain approval.

Business Strategies Clinical Trials

Novavax Looks To Secondary Endpoints As Phase III RSV Vaccine Trial Fails

Novavax’s shares plunged 67% on news that its Phase III trial for RSV had failed, but are there signs of life for the product?

Clinical Trials Research & Development
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