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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Esperion’s Nexletol Reaches The Cholesterol Market Priced To Sell

Esperion obtained an on-time approval of Nexletol (bempedoic acid) for a pair of LDL cholesterol-lowering indications on 21 February. 
Approvals Cardiovascular

New Mechanisms: Cardior’s Non-Coding RNA Therapeutic For Heart Failure

Germany’s Cardior is conducting clinical studies with an antisense oligonucleotide which inhibits a cellular microRNA believed to be involved in the pathology of heart failure, and is attracting attention from other pharma companies interested in the potential of this new mechanism of action.

 

Cardiovascular Clinical Trials

Novartis’s Inclisiran Unscathed As Arrowhead Falls Short

Arrowhead’s drug has failed to match inclisiran’s performance, but its RNAi platform has other promising candidates.

Companies Research & Development

Novartis CEO: Inclisiran Could Be Largest Medicine In NHS History

The Swiss major has been enthusing about its population-based agreement in the UK for the investigational gene silencing cholesterol lower and plans for similar schemes in other countries.

United Kingdom Market Access

Amgen’s R&D Group Focuses On Efficiency As Drug Cost Concerns Continue

Scrip spoke with R&D head David Reese about improving R&D timelines and success rates, including through the use of genomics and proteomics, as data readouts near for key drugs in big indications.

Research and Development Strategies Companies

Zolgensma Stands Out In Strong Q4 For Novartis

CEO Vas Narasimhan is confident the Swiss major's gene therapy for spinal muscular atrophy will outperform present and future rivals – Biogen's Spinraza and Roche's risdiplam, respectively – as "we have a better profile simply because we are a one-time therapy."

Sales & Earnings Launches
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CNS

Set Alert for CNS

Latest From Neurology

Teva’s Austedo Fails In Tourette’s Syndrome

Two late-stage trials of Austedo have missed their endpoints in the neurological disorder, meaning Teva will miss out on an additional revenue stream from the VMAT2 inhibitor.

Clinical Trials Companies

Troriluzole Fails First Phase III Test As Biohaven Looks Beyond Migraine

Biohaven is still studying its glutamate modulator in three other indications, but its biggest near-term milestone will be approval of the oral CGRP inhibitor rimegepant for acute migraine.

Clinical Trials Neurology

Another Alzheimer's Setback As Roche And Lilly Drugs Fail

As Biogen moves to file its controversial amyloid drug aducanumab for approval in the US, two similar investigational Alzheimer's drugs – Eli Lilly's solanezumab and Roche's gantenerumab – did not slow memory loss or cognitive decline in a rare, inherited form of the disease.

Neurology Clinical Trials

Zogenix’s Fintepla Reduces Drop Seizure Rates, But Is It Enough?

Despite positive Phase III results in Lennox-Gastaut syndrome, the effect of the company’s low-dose fenfluramine on serious seizures may not be as good as seen with GW Pharma’s Epidiolex. 

Clinical Trials Comparative Effectiveness

Lundbeck Set For 'Transformative' Eptinezumab Launch

The Danish drugmaker's four 'strategic brands' – Brintellix, Abilify Maintena, Northera and Rexulti – are selling well. Now the focus is firmly on breaking into the anti-CGRP market with eptinezumab.

Sales & Earnings Neurology

Sanofi Highlights MS Asset After Solid Q4

The French drugmaker ended 2019 with a solid Q4 performance and news that its BTK inhibitor SAR442168 will start Phase III testing in progressive and elapsing multiple sclerosis. 

Sales & Earnings Neurology
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Merck KGaA Tightens Focus With Allergopharma Sale

Germany’s family-controlled big pharma, Merck KGaA, is divesting its allergens business, Allergopharma to the fast-growing Munich healthcare company, Dermapharm Holding.

 

M & A Immune Disorders

US Approval For Peanut Allergy Therapy Palforzia

Aimmune has secured approval for the first ever peanut allergy treatment, but safety, cost and administration issues could limit the drug's uptake.

United States Approvals

Zolgensma Stands Out In Strong Q4 For Novartis

CEO Vas Narasimhan is confident the Swiss major's gene therapy for spinal muscular atrophy will outperform present and future rivals – Biogen's Spinraza and Roche's risdiplam, respectively – as "we have a better profile simply because we are a one-time therapy."

Sales & Earnings Launches

J&J's Stelara Gets Europe OK For Pediatric Psoriasis

The European Commission has backed J&J's blockbuster to treat children with psoriasis but the drug has fallen foul of NICE for ulcerative colitis.

Immune Disorders EU

J&J’s Gorsky Hails Strong Performance By Immunology Therapies Tremfya, Stelara

A strong fourth quarter and full-year 2019 performance by J&J was driven by significant sales growth for Tremfya and Stelara. CFO Wolk said a $4bn opioids settlement remains on track.

Sales & Earnings Business Strategies

Fewer US Market Access Restrictions For Branded I&I Drugs Will Drive Growth

Access to branded drugs has remained steady, but there has been less management across brands by commercial payers, according to an analysis of the I&I market access environment by Bernstein.

Market Access Inflammation
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Job Cuts As Polyphor Focuses On First-In-Class Anticancer

Switzerland’s Polyphor has redefined its business strategy and is aiming to become a leaner organization, with a potential first-in-class immuno-oncologic, balixafortide, in late-stage clinical development for breast cancer.

 

ImmunoOncology Clinical Trials

China Uses Old To Fight New As Repurposed Drugs Take Coronavirus Role

Several newly repurposed drugs, including a Bayer antimalarial, have shown potential benefits against the new coronavirus, promoting China to add several to its latest revised treatment guidelines.

Infectious Diseases China

Bharat Biotech Plans Coronavirus Vaccine

After two Indian vaccine makers, Serum Institute of India and Cadila Healthcare joined the fight against COVID-19, Bharat Biotech may follow suit. Others like Hilleman have decided against it for the moment while Panacea Biotech is weighing the pros and cons of developing a SARS-CoV-2 vaccine after a sour experience with H1N1.

Commercial Vaccines

BrightGene Bets On Remdesivir Amid Patent Questions

Despite many uncertainties, Suzhou-based BrightGene sees a bet on generic remdesivir worthy of a $700,000 investment.
Infectious Diseases China

Global Catastrophe Or Passing Nuisance? Pharma’s Coronavirus Views

While the global health threat from the now officially named SARS-CoV-2 coronavirus has grown since the start of the quarterly earnings season in early February, even many of the companies reporting more recently do not appear overly concerned about potential business impact at this stage.

Companies Infectious Diseases

AlloVir Gains PRIME Status For Anti-Virus T-Cell Therapy

Joining the ElevateBio stable last May, the company has now gained priority status in the US and Europe for its novel therapy for viral infections in stem cell transplant patients.
Infectious Diseases Europe
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Genfit Delays NASH Data While It Confers With US FDA On Methodology

Genfit will delay unblinding of data from its nearly complete Phase III study of elafibranor to get insight from the FDA on statistical methods in order to optimize its NDA.

Clinical Trials Drug Review

Axcella Addresses Metabolic Disease Quickly With GRAS Candidates

Emerging Company Profile: Axcella uses Generally Recognized As Safe (GRAS) amino acids to create drug candidates for hepatic encephalopathy, NASH and other diseases.

StartUps and SMEs Business Strategies

A Runaway Hit In US, Pfizer Gains EU Nod for Vyndaqel In Cardiomyopathy

Vydaqel saw its uptake take off in the US last year. UK’s NICE to pass judgement on cost effectiveness by June.

Europe Commercial

FDA Requests Belviq Be Pulled From The US Market Due To Cancer Risk

The agency requested the weight loss pill be voluntarily recalled by Eisai, the death knell for a trio of obesity drugs that launched early in the last decade. 
Metabolic Disorders Drug Safety

New Phase II Data Bolster vTv Therapeutics’ Glucokinase Activator Aspirations

The future for glucokinase activation is looking brighter after fresh data on vTv’s oral adjunct to insulin therapy in type 1 diabetes.

Clinical Trials Companies

Diurnal Looking To Secure US Partner Soon For Alkindi

With its adrenal insufficiency therapy Alkindi getting established in Europe, the UK biotech is in partnering discussions in the US where approval is expected before the end of the year.

Commercial Companies
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Oncology

Set Alert for Oncology

Latest From Cancer

Japan's BioComo Pursues Novel Ligand Approach To Immuno-Oncology

Japan bioventure BioComo was set up around 10 years ago and has since been honing its technology platform. It is now preparing to move into the clinic with a novel vector for immuno-oncology and to raise new funds to support pipeline development.

Japan ImmunoOncology

GSK Partnership With Immatics Seeks TCR Therapeutics For Solid Tumors

Deal Snapshot: GSK obtains rights to two of Immatics’ TCR targets, following on the German firm’s similar deals in recent years with Celgene, Genmab and Amgen.

Deals Business Strategies

Nanobiotix CEO’s Expansion Plans Target ‘Millions’ Of Patients

Nanobiotix’s CEO outlines to Scrip how the biotech plans to develop and expand its lead asset into multiple cancer indications, and create a blockbuster.

Cancer Companies

Basilea Stresses Derazantinib's FGFR Kinase Differentiation

Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.

 

ImmunoOncology Clinical Trials

FDA Rejects Keytruda Dosing, Fast Tracks Tecentriq Lung Cancer Review

Keytruda is set to remain dominant despite knockback, though Tecentriq could claim prized NSCLC adjuvant approval first

Commercial Companies

With BMS Set To Join, What Next For CAR-T Market?

CAR-T therapies are groundbreaking in clinical terms, but have hit barriers in uptake. Can BMS’s challenger go one better than Yescarta and Kymriah?

Commercial Companies
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

GSK Has High Hopes For COPD Vaccine

By combining its expertise in respiratory and vaccines, the UK drugs giant could have a potential blockbuster for chronic obstructive pulmonary disease, which is expected to become the third leading cause of death worldwide by the end of the decade.

Respiratory Vaccines

Insmed Goes Full Steam Ahead With Bronchiectasis Candidate

Insmed shares got a 40% boost as the company announced plans to move into Phase III this year with its potential first-in-class candidate for the lung disease.

Clinical Trials Companies

Stunning Start For Vertex Cystic Fibrosis Triple Combo

Only nine weeks after US approval, Trikafta, which in theory can treat 90% of all patients with cystic fibrosis, is already Vertex's top-selling medicine.

Sales & Earnings Launches

Novartis Culls Fevipiprant After LackLUSTER Data

Any lingering hopes Novartis had that fevipiprant could become a blockbuster have disappeared and the Swiss major has ended development of the asthma drug after two more trials failed, this time for severe disease.

Respiratory Clinical Trials

Chiesi Tackles Carbon Footprint Of Inhalers

The Italian firm has laid out its ambitious plan to introduce the first carbon minimal pressurized metered dose inhaler for asthma and COPD by 2025 and secured supply of a new environmentally friendly propellant.

Innovation Respiratory

Verona Foresees FDA End-Of-Phase II COPD Meeting

Verona CEO tells Scrip Phase III COPD studies for its lead asset will start next year, take up to two years to complete, leading to commercial launch “probably in 2024.”

Companies Strategy
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