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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Bayer's Finerenone Hints Positive In Diabetic Kidney Disease

The Phase III FIDELIO trial of finerenone has been a success but analysts want to see some actual data before declaring it an unqualified one.

Renal Clinical Trials

COVID-19 Cash Crisis Leaves UK Research Charities On The Cusp

Over 150 medical charities including the British Heart Foundation and Cancer Research UK are forecasting a 41% decrease in their research budgets over the next year and are demanding £310m in 2020/21 from the UK government as part of a matched funding program.

Financing Clinical Trials

Kancera Targets COVID-19 With Fractalkine Inhibitor

Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.

Clinical Trials Companies

MyoKardia Readies First-Ever Hypertrophic Cardiomyopathy Drug For US Filing

The Phase III EXPLORER-HCM trial evaluating mavacamten in obstructive hypertrophic cardiomyopathy (oHCM) succeeded on all primary and secondary endpoints.

Clinical Trials Cardiovascular

AZ To Adopt Indication-Based Pricing For Farxiga In Heart Failure

AstraZeneca's biopharmaceuticals president Ruud Dobber tells Scrip that the price for Farxiga in the heart failure indication should reflect its potential to improve survival and reduce the need for hospitalization.

Pricing Strategies Cardiovascular

AstraZeneca Will Test More Assets Against COVID-19

AstraZeneca, during a strong first-quarter update, underscored its determination to test existing portfolio assets for use in fighting the COVID-19 pandemic.

Clinical Trials Companies
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CNS

Set Alert for CNS

Latest From Neurology

Getting Its ACT Together: EXACT-Tx Raises NOK155m

EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.

Financing Commercial

Second Biogen/Eisai Antibody Moves AHEAD, In Asymptomatic Alzheimer’s

More progress for partners’ amyloid-targeting antibody portfolio as they look to demonstrate benefit of early intervention in pre-symptomatic disease in new collaborative Phase III trial.

Clinical Trials Research & Development

Doubts Over China's First Alzheimer's Drug Resurface Amid Research Miscount Allegation

Biogen/Eisai’s US filing of aducanumab for Alzheimer’s has a ripple effect in China, where a leading biomedical researcher has publicly questioned data for the country’s first approved drug for the disease, GV971.

China Policy & Regulation

Biogen/Eisai Hit ‘Send’ On High Stakes BLA For Aducanumab In Alzheimer’s Disease

Some analysts see a 50-50 chance of US FDA approval despite the controversial dataset for the anti-amyloid antibody, but at least one expects an eventual CRL requesting a third Phase III trial.

FDA Neurology

Idorsia Heralds Second Positive Study of Sleep Drug Daridorexant

The Swiss biotech will be hoping that the improved daytime functioning seen with daridorexant in trials will allow the drug to complete in the DORA class led by Merck & Co's Belsomra and Eisai's Dayvigo.

Clinical Trials Neurology

Quick Listen: Scrip’s Five Must-Know Things

Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of the global biopharmaceutical industry.

Business Strategies Coronavirus COVID-19
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Atox ‘Remains On Track’ Despite ACCUTE Setback

After talking with the FDA, Atox will file an NDA for its necrotizing soft tissue infections therapy despite missing primary endpoints in a pivotal trial, the biotech’s CEO tells Scrip.

Clinical Trials Commercial

Anergis And Virometix Collaborate On Fast-Acting Allergy Immunotherapy

An ultra-fast-acting allergy immunotherapy to induce tolerance to house dust mites is being sought in a collaboration between two Swiss biotechs, Anergis and Virometix.

Deals Immune Disorders

Sanofi Nabs Kymera IRAK4 Protein Degrader As It Continues To Build In I&I

Kymera will receive $150m upfront from Sanofi in a deal the big pharma views as an opportunity to develop a breakthrough oral drug for atopic dermatitis and other conditions.

Deals Immune Disorders

Sweden’s Gesynta ‘Phase IIa Ready’ After Private Placing

Gesynta’s SEK190m ($20m) private placement allows its lead asset to enter Phase IIa studies for treating chronic inflammatory conditions in certain systemic sclerosis patients.

Clinical Trials Commercial

AbbVie Eyes Japan Oncology Growth As Humira Biosimilar Looms

AbbVie Japan has seen strong growth for its commercial and R&D portfolios over the past few years, but with flagship product Humira facing its first local biosimilar competition, the company is looking to brand strength and an increased oncology presence to address the challenge.

Japan Commercial

No Looking Back For Sanofi In R&D Turnaround Quest

Sanofi's R&D operation has shaken the dust of diabetes off its feet with an update on its ambitious pipeline plans at an R&D day event.

Companies Clinical Trials
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Coronavirus Update: Hardest Hit US States Will Test Moderna’s Vaccine

A round-up of developments in the COVID-19 vaccine field from Moderna, Fosun, Merck & Co and Medicago and more.

Coronavirus COVID-19 Clinical Trials

Moderna’s COVID-19 Vaccine Spurs Immune Response In All Phase I Subjects At All Doses

Neutralizing antibodies were seen in all 45 people injected across three dose levels in the first-in-human study. The middle dose of 100mcg will be tested in the company’s Phase III trial starting 27 July.

Clinical Trials Coronavirus COVID-19

Coronavirus Update: Pfizer Vaccine Candidates Gain Fast-Track Status

The granting of fast-track status is a clear signal that the US FDA wants to maintain its high standards of drug and vaccine appraisal.

Coronavirus COVID-19 Companies

Getting Its ACT Together: EXACT-Tx Raises NOK155m

EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.

Financing Commercial

Coronavirus Update: Lower Immune Responses Could See ‘Shake Out’ Of Vaccine Contenders

Leader of London university's vaccine contender hopeful of breakthrough in early 2021, but thinks Oxford's forecast of September overly optimistic.

Coronavirus COVID-19 Companies

Quick Listen: Scrip’s Five Must-Know Things

Join us for a quick audio roundup of five useful things to know from Scrip's recent coverage of the global biopharmaceutical industry.

Commercial Business Strategies
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Bayer's Finerenone Hints Positive In Diabetic Kidney Disease

The Phase III FIDELIO trial of finerenone has been a success but analysts want to see some actual data before declaring it an unqualified one.

Renal Clinical Trials

EC Approves Extended Invokana Indication On Renal Outcomes In DKD

Mundipharma has announced the European Commission’s extension of the indications for Invokana to include renal outcomes data from the Phase III CREDENCE study.

Renal Approvals

No Looking Back For Sanofi In R&D Turnaround Quest

Sanofi's R&D operation has shaken the dust of diabetes off its feet with an update on its ambitious pipeline plans at an R&D day event.

Companies Clinical Trials

Novo Nordisk Fortifies Cardio-Renal Efforts With Corvidia Buy

Novo Nordisk is paying $725m to acquire the VC-backed US biotech, Corvidia Therapeutics and its promising Phase II candidate, ziltivekimab, for chronic kidney disease, but further payments could total more than $2bn.

M & A Metabolic Disorders

US Medicare Insulin Demo Could Expand To Other Drugs

Eighty-eight insurers who offer Medicare Part D plans are interested in the demonstration project, which would limit insulin copays to $35.

Medicare Pricing Debate

Hanmi In Tough Spot After Sanofi Efpeglenatide U-Turn

Sanofi’s decision to return to originator Hanmi all rights to the novel diabetes candidate efpeglenatide, which is in global Phase III trials, has placed the South Korean pharma in a difficult spot. Unless there are some surprisingly positive data, finding a major global partner for commercialization may be tough.

South Korea Deals
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Oncology

Set Alert for Oncology

Latest From Cancer

Zepzelca To Help Diversify Jazz Pharma's Portfolio, Revenue Base

Licensed from PharmaMar for the US market at the start of the year, Jazz Pharmaceuticals is hoping its new small-cell lung cancer therapy, Zepzelca (lurbinectedin), may have potential for other cancer types and in different combinations.

Cancer Research and Development Strategies

GSK’s Myeloma Drug Gets AdComm Backing, But Limitations Remain Clear

The antibody-drug conjugate now looks set for US approval, but its limitations leave plenty of scope for CAR-T and bispecific rivals.

Cancer BioPharmaceutical

Roche Backs Blueprint's Precision Therapy Pralsetinib To Challenge Lilly

The collaboration between the Swiss major and Blueprint Medicines, which could be worth up to $1.7bn, should help pralsetinib provide stiff competition to Eli Lilly's RET mutation drug Retevmo.

Personalized Medicine Deals

Getting Its ACT Together: EXACT-Tx Raises NOK155m

EXACT-Tx will use funds from a NOK155m private placing to harness ultrasound in precision therapeutic targeting across a variety of indications and product classes.

Financing Commercial

Early Promise Of NextCure’s Novel IO Candidate Continues To Fade

Lead immuno-oncology asset NC318 targeting Siglec-15 showed encouraging early activity in patients refractory to PD-1/L1 inhibitors, but now Phase II plans are scuttled in lung and ovarian cancers.

Clinical Trials ImmunoOncology

Concerns About Eye Toxicity Could Limit GSK’s Myeloma Drug Potential

Company told more measures needed to limit damage to patients' eyes caused by antibody drug conjugate.

Commercial Companies
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Novartis Triple Combo Enerzair Gets EU OK For Asthma

The Swiss company's asthma triplet is now approved in Europe and Japan but Enerzair is well behind GSK's rival LABA/LAMA/ICS in the US where Novartis's product has not even been submitted yet.

Respiratory Approvals

Exvastat Enters COVID-19 Arena With Intravenous Imatinib

The UK firm has tapped into EU funds through an Irish subsidiary to advance its treatment for acute respiratory distress syndrome based on a reformulation of Novartis's Gleevec.

Coronavirus COVID-19 Financing

Verona Details COPD Opportunity For Ensifentrine

Verona Pharma’s candidate COPD therapy ensifentrine has a first-in-class dual mechanism of action and is to be explored as an add-on to LAMA and LABA therapy in two Phase III clinical studies.

Clinical Trials Respiratory

Kancera Targets COVID-19 With Fractalkine Inhibitor

Sweden-based Kancera hopes to advance its investigative anti-inflammation drug in a Phase II trial to treat severe COVID-19 patients and then build its applications from there.

Clinical Trials Companies

Abivax To Launch ‘Triple-Action’ COVID-19 Therapy Trial

Abivax will test its anti-inflammatory ABX464 in early COVID-19 patients after the small molecule showed it could reduce SARS-CoV-2 viral replication in human lung tissue in addition to its anti-inflammatory and tissue-healing effects.    

Coronavirus COVID-19 Clinical Trials

Can Glenmark’s Triple Therapy Combo Move COPD Treatment Needle?

Glenmark rolls out three-in-one inhaler therapy for COPD in India and hopes to address challenges faced by patients suffering from the severe form of the disease. Some early physician outlook appears mixed for the new combination in a segment where leading respiratory player Cipla has an established product.

Commercial Strategy
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