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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Roxadustat CKD Doubts Fanned By FibroGen Data Blunder

AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.

Clinical Trials Companies

Boehringer Reflects On Resilience Of Older Therapies

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

Life Cycle Management Sales & Earnings

Regeneron/Sanofi, Amgen PCSK9 Rivalry Continues, But Not In US Courts

The battle for PCSK9 inhibitor market share continues with Amgen’s Repatha outselling Praluent, but a now-ended patent dispute no longer threatens Regeneron’s ability to sell its product in the US.

Intellectual Property Business Strategies

Regeneron's Evkeeza Approved For Ultra-Rare Genetic High Cholesterol – And Priced To Match

Evkeeza is the first ANGPTL3 approved by the FDA; Regeneron scientists discovered the angiopoetin gene family.

Approvals Cardiovascular

Scrip Asks…What Does 2021 Hold For Biopharma? Part 4: Technology And Disease

Around 100 executives highlight the hot areas to watch on the R&D front in 2021. From cancer to CNS and from regenerative medicine to real world data, expectations are high on many fronts.

Scrip Asks Artificial Intelligence

Amarin Builds Sales Infrastructure For EU Vazkepa Launch

With an approval nod from the EMA’s scientific committee for its fish oil product Vazkepa, launch plans for the EU for this “multi-billion dollar” opportunity are on track, says Amarin CEO.

EU Approvals
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CNS

Set Alert for CNS

Latest From Neurology

Stockwatch: The Two Sides Of A Complete Response Letter

The FDA’s rejection of Acadia’s label expansion into a broader patient population for its only approved drug resulted in an aggrieved reaction. Better disclosure from both sides would have helped.

Complete Response Letters Companies

Ventus Raises $100m To Take First Novel Compounds Into Clinic

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

Financing Innovation

Scholar Rock Sees Phase III Path For SMA Drug

While the drug may be well-positioned for registrational development, some important caveats remain after mixed data in Phase II study cohorts.

Research & Development Research and Development Strategies

Takeda Highlights Rare Neurological Disorder Programs In Wave 1

Seeing significant unmet medical needs and insufficiently met needs in narcolepsy and rare types of epilepsy, Takeda has shifted its neuroscience focus.

Neurology Rare Diseases

AriBio Progresses Novel Alzheimer's Contender Despite Mixed Phase II

Korea's AriBio is poised to file for US Phase III trial approval this year for its novel Alzheimer's candidate and lead asset AR1001, which showed an improvement in cognitive function from baseline at Phase II. But will the benefits over existing therapies be enough to carve a position in the challenging field?

Neurology Clinical Trials

US FDA Throws Acadia A Curveball On Nuplazid For Dementia Psychosis

Acadia strikes out on potential near-term sNDA approval in a broad dementia-related psychosis indication. The firm said the agency’s view has shifted from what was previously agreed upon.

Drug Review Complete Response Letters
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Ventus Raises $100m To Take First Novel Compounds Into Clinic

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

Financing Innovation

Specialty Drugs Outweighed Traditional Drug Spending For The First Time

Drugs for inflammatory conditions and cancer drove the increase in spending among the pharmacy benefit manager’s commercial plans, according to a drug trend report from Cigna's Evernorth.

Trends Immune Disorders

Lilly’s Bio-Medicines Portfolio Grows To Offset Pressures In Key Markets

Lilly Bio-Medicines president Ilya Yuffa oversees newer products in competitive therapeutic areas and drug classes, but additional indications and new therapies within the group’s immunology, pain and neuroscience focus areas will capitalize on the group’s existing commercial expertise. 

Business Strategies Launches

Lupus Pipeline Could See Momentum Following Two New US Approvals

Albert Roy, executive director of the clinical research arm of the Lupus Research Alliance, talked to Scrip about the outlook for lupus drug development.

Immune Disorders Clinical Trials

New Lupus Nephritis Treatments Are Cost Effective, ICER Determines

GSK's Benlysta and Aurinia's Lupkynis for lupus nephritis are priced in line with the drug pricing watch dog's health benefit price benchmark ranges.

Immune Disorders Cost Effectiveness

AbbVie’s Rinvoq Delay By US FDA Could Foreshadow More Trouble For JAKs

The expansion of upadacitinib for a new indication in psoriatic arthritis has been pushed out three months to late in the second quarter.

Drug Safety Immune Disorders
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Regulators Reassure On AZ Vaccine Safety After Rare Side Effect Deemed Plausible

The EMA and MHRA issue parallel safety updates on the vaccine, with the UK offering an alternative of the Pfizer/BioNTech or Moderna vaccines to the under 30s.

Companies Coronavirus COVID-19

Icosavax Raises $100m To Take RSV, COVID-19 Vaccines Into The Clinic

The company doubled its series A total of $51m to not only test its coronavirus and RSV candidates, but to also advance a vaccine targeting both RSV and hMPV for pneumonia prevention in elderly adults.

Financing Vaccines

Cidara, Janssen To Tackle Flu With Antiviral Conjugates

Cidara partners its antiviral conjugate platform for seasonal and pandemic influenza with Janssen, which also gets option rights to an AVC candidate for respiratory syncytial virus.

Deals Business Strategies

Coronavirus Update: Pfizer/BioNTech Vaccine Shows Six-Month, Variant Protection

The companies still plan to develop a variant-specific version, while J&J said it anticipates meeting vaccine supply goals despite a manufacturing mix-up.

Coronavirus COVID-19 Research & Development

Adolescent Results Put Pfizer/BioNTech Ahead Of COVID Vaccine Pack, For Now

An EUA would carve out a market advantage, although Moderna should be releasing similar data soon for its COVID-19 vaccine.

Coronavirus COVID-19 Business Strategies

Lilly And GSK/Vir Antibody Combo Reduces COVID-19 Viral Load

Top-line Phase II data show that a combo of bamlanivimab and VIR-7831, neutralizing antibodies to the SARS-CoV-2 spike protein, yielded a relative 70% reduction in viral load.

Coronavirus COVID-19 Clinical Trials
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

FDA Perturbed By Provention's Teplizumab Type 1 Diabetes Drug

The US regulator is worried about deficiencies in the submission for Provention Bio’s high-profile therapy teplizumab for the prevention of type 1 diabetes that could significantly delay its review.

Metabolic Disorders Drug Review

Servier Guilty Of ‘Involuntary Manslaughter’ in Mediator Safety Affair

The long-running Mediator saga reached a conclusion of sorts on 29 March when fines and sentences were handed out to those involved in delaying the withdrawal of a fenfluramine derivative that is thought to have caused many thousands of serious cardiac side-effects.

Commercial Companies

Boehringer Ingelheim Primes For Top Five Multinational Slot In India

Boehringer Ingelheim’s incoming India managing director outlines intent to scale up in areas including diabetes and stroke, as the private German multinational seeks to move up the rankings in the competitive Indian market. Enabling the global pipeline in field including immunology, CNS and oncology also part of the effort.

India Commercial

Poxel/Sumitomo's Novel Diabetes Therapy Imeglimin Nears Japan Market

Poxel’s potential first-in-class diabetes therapy, imeglimin, could be approved in Japan this year, and a new partner is being sought for the EU and US – events that would transform the outlook for the decade-old Merck Serono spin-out.

Metabolic Disorders Approvals

BridgeBio's Calcilytix Sees POC For Encaleret And Options To Discuss With FDA

Calcilytix chief medical officer Jonathan Fox talked to Scrip about the development plans for encaleret for the rare form of hypoparathyroidism.

Research & Development Research and Development Strategies

Zealand Set To Take On Lilly After Zegalogue US Approval

Despite being third to market behind Lilly’s Baqsimi and Xeris’s Gvoke to treat emergency episodes of hypoglycemia, Zealand is confident of a successful US launch for Zegalogue (dasiglucagon).

Metabolic Disorders Approvals
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Oncology

Set Alert for Oncology

Latest From Cancer

Pfizer Triples Down On CDK Inhibition In Breast, Other Cancers

Pfizer is looking to address breast cancer resistant to Ibrance and other CDK4/6 inhibitors, but sees potential paths to earlier lines of treatment and additional tumors.

Research and Development Strategies Cancer

MorphoSys, After Its Commercial Debut, Looks To The Next Growth Phase

Interview: CEO Jean-Paul Kress talked to Scrip about the US launch of Monjuvi, commercial expansion and the aspiration to build a European biotech that can compete in the big leagues.

Launches Cancer

Ventus Raises $100m To Take First Novel Compounds Into Clinic

Ventus raised $60m in series A venture capital 10 months ago when it had just one technology platform. It now has two platforms, five drug development programs and $100m in series B cash.

Financing Innovation

AI And Tackling Challenges In Clinical Medicine

ISCR conference hears how artificial intelligence and machine learning can address challenges in clinical medicine, especially for cancer, and also optimize clinical trials.

Research & Development Artificial Intelligence

Oncology And US Dominate Daiichi's New Mid-Term Plan

Major Japanese firm sets targets under a new mid-term plan that envisages the US oncology sector leading growth and revenues, and also casts an eye to novel assets beyond three pillar antibody-drug conjugates and new digital technologies.

Business Strategies Research and Development Strategies

Boehringer Reflects On Resilience Of Older Therapies

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

Life Cycle Management Sales & Earnings
See All

Respiratory

Set Alert for Respiratory

Latest From Respiratory

Boehringer Reflects On Resilience Of Older Therapies

The German group is investing heavily in R&D and the continued strong performance of products like Spiriva and Pradaxa is helping to pay for future innovation.

Life Cycle Management Sales & Earnings

Theravance Uses Organ-Selective R&D To Advance GI, Pulmonary Candidates

Company develops selective JAK inhibitors for IBD and pulmonary disease that are intended to clear the body before systemic side effects can occur. It also has a drug candidate for NOH that analysts think is underappreciated.

Companies Business Strategies

Worst Sandstorm In Decade Strikes Respiratory Fear In China's Capital

Smoking, pollution, pandemics and now sandstorms - China faces a rising respiratory disease burden as companies aim to tackle it with new products.

China Commercial

Merck’s ‘COVID Pill’ Shows Promise, But Mortality Benefits Will Be Hard To Prove

Early results from its novel antiviral are encouraging, but demonstrating life-saving qualities in a short window of time will be tricky.

BioPharmaceutical Companies

Amgen/AstraZeneca’s Tezepelumab Cuts Asthma Exacerbations By 56%

Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics. 

Respiratory Clinical Trials

More COVID-19 Headwinds In 2021 For GlaxoSmithKline

The UK-headquartered company is in transition, investing heavily in biopharma R&D and preparing to spin out its consumer division.

Infectious Diseases Cancer
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