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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

Amarin's Vascepa May Face Generic Competition In US Next Year After Patents Ruled Invalid

Amarin had argued that Vascepa’s sales success showed that its patents were not obvious, but the court found otherwise, even as it concluded that Hikma, Dr. Reddy's and West-Ward has infringed on the fish oil pill's patents.

Legal Issues Intellectual Property

Merck/Bayer’s Vericiguat Outcomes Data Less Impressive On Fuller Disclosure

Efficacy seen in reducing hospitalization in high-risk heart failure patients, but not in reducing the risk of cardiovascular death. Analysts say this portends a more niche opportunity for vericiguat.

Clinical Trials Comparative Effectiveness

AstraZeneca Likes Sound Of Silence's Science

The UK major is getting access to Silence's small interfering RNA (siRNA) platform while the London-based biotech is getting further validation of its technology and a considerable pile of cash.

Companies Deals

Bayer, Curadev Enter ‘STING’ Pact Exploring Inflammatory Disease

Bayer and Curadev entered a research collaboration and license agreement to develop novel STING antagonists targeting inflammatory disease.

Companies Commercial

Xarelto And Eylea Keep Bayer Buoyant

The German major's two leading products continue to perform well but there are not many potential blockbusters in the pipeline.

Companies Legal Issues

Esperion Aiming For 50% Commercial Coverage For Nexletol

The company hopes to sidestep payer restrictions and patient abandonment by launching the cholesterol-lowering medicine at a palatable price point in line with where branded statins were before patent expiry.

Cardiovascular Launches
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CNS

Set Alert for CNS

Latest From Neurology

Will Novo Nordisk Get Lift From Gut-Brain Axis?

Experts think GLP-1s in neurodegeneration may be Novo Nordisk’s next opportunity and await readouts from the Phase II ELAD trial in Alzheimer's disease for signals.  

Companies Research & Development

Evotec Extends Takeda Pact to Gene Therapy

Evotec is building a gene therapy R&D center manned by ex-Takeda scientists and has already landed a multi-year drug discovery pact for it with their former Japanese employer.

Companies Deals

Interview: Arvelle Aims To Be Major Player In CNS

The Swiss biotech's focal-onset seizure therapy, which is licensed from South Korea's SK and is already approved in the US, could have potential in indications beyond epilepsy, Arvelle's CEO tells Scrip.

Neurology Business Strategies

Biohaven’s Nurtec May Be First Migraine Drug For Acute Treatment And Prevention

Approved in February as an on-demand remedy, Nurtec will be filed for migraine prevention after success in Phase III. It could be the first oral preventive therapy and first dual purpose migraine drug.

Neurology Clinical Trials

Japan Tirabrutinib Approval Breaks New BTK Ground In Lymphoma

Japan approval for BTK inhibitor marks new indication but in a small niche market, while another clearance may help extend Latuda's commercial life.

Japan Approvals

Novartis's Gene Therapy Zolgensma Has Durable Effects At Five Years

AveXis/Novartis’s one-time AAV9 vector-based intravenous gene therapy for spinal muscular atrophy, Zolgensma, continues to have beneficial effects up to five years after its administration to babies, and an intrathecal formulation has significant promise in older infants.

Gene Therapy Clinical Trials
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Pfizer’s Abrocitinib Quick Off The Mark In Atopic Dermatitis

Pfizer’s next-generation JAK1 inhibitor, abrocitinib, continues to show beneficial effects in atopic dermatitis (eczema), in the JADE COMPARE study, comparable to the positive control dupilumab and, in the case of itch, with a faster onset at the higher dose.

Dermatology Clinical Trials

For Drugs That Increase Risk Of Infection, More Questions Than Answers In The Coronavirus Era

Autoimmune disease drugs ranging from Humira to Cosentyx to Tremfya to Xeljanz carry warnings about increased risk of infections. This raises new questions in the novel coronavirus outbreak.

Coronavirus COVID-19 Immune Disorders

Sanofi To Test Arthritis Drug Kevzara For Coronavirus

The French giant is already working on a vaccine to combat COVID-19 and is now evaluating whether its rheumatoid arthritis drug Kevzara could treat pulmonary complications related to the coronavirus.

Coronavirus COVID-19 Clinical Trials

UCB Pins Growth Hopes On Burgeoning Late-Stage Pipeline

UCB's R&D efforts include late-stage diverse but complementary immunologicals and anti-neuroinflammatories.

Immune Disorders Clinical Trials

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
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Boehringer Ingelheim Boosts COVID-19 Efforts As Jardiance Continues To Impress

Germany’s family-owned Boehringer Ingelheim has supplemented its research efforts into finding COVID-19 therapies by supporting employees who volunteer to take part in COVID-19 relief efforts and by donating health care supplies, helped by a solid 2019 financial performance.

Coronavirus COVID-19 Infectious Diseases

Inovio Confirms Frontrunner Status In COVID-19 Vaccine Race, But Can It Prove Skeptics Wrong?

Its ‘virus chasing’ habits has given Inovio a bad reputation. But with backing from CEPI and Bill Gates, it has a chance to prove the doubters wrong.

Companies Coronavirus COVID-19

Coronavirus Update: BMS Expands Medicine Program, Cancer Research UK Cuts Funding

Bristol-Myers Squibb is to give away more medicines to uninsured US patients, Cancer Research UK tells of funding hardship, Oxford Biomedica joins a consortium to rapidly develop a vaccine, while a Korean company works on a stem cell therapy.

Coronavirus COVID-19 Infectious Diseases

Industry, Agencies Are Making COVID-19 Partnerships Easy

Organizations like BARDA, CEPI and others are looking to partner with industry to rapidly test, manufacture, package and deploy vaccines and therapeutics, identifying areas they want to work together during BIO’s recent summit.

Coronavirus COVID-19 Deals

Coronavirus Update: Inovio Begins Phase I Trials of DNA Vaccine, Fast-Track Drug Dialogue Continues

Inovio forges ahead into Phase I trials with DNA-based vaccine candidate, but can it prove skeptics wrong?

Coronavirus COVID-19 Infectious Diseases

Takeda, CSL, Other Blood Plasma Firms Team On Hyperimmune COVID-19 Therapy

Deal Snapshot: Six companies seek to collect convalescent plasma from COVID-19 survivors to quickly develop hyperimmune immunoglobulin therapy for serious complications of the virus.

Coronavirus COVID-19 Deals
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Will Novo Nordisk Get Lift From Gut-Brain Axis?

Experts think GLP-1s in neurodegeneration may be Novo Nordisk’s next opportunity and await readouts from the Phase II ELAD trial in Alzheimer's disease for signals.  

Companies Research & Development

Manipulating Metabolism: Lilly Links With UK Biotech Sitryx

Duo will study up to four novel preclinical targets identified by Sitryx that may lead to potential new drugs for autoimmune diseases, which Lilly would then commercialize.

Companies Deals

NGM’s Pan-FGF Receptor Approach In NASH Shows Benefits And Drawbacks

NGM’s Phase II data for FGF19 analog aldafermin shows ability to reduce liver fat and improve fibrosis, but also raises LDL-C. Company says it gets a broader effect this way and can manage the increased cholesterol.

Clinical Trials Business Strategies

Eli Lilly’s Trulicity’s Broad CV Label Spotlights GLP-1 Rivalry

Trulicity’s broad CV label awarded by the US FDA should aid overall uptake of the GLP-1 class, cushioning the direct impact on Novo Nordisk’s rival, Ozempic, analysts said.

Companies Approvals

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
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Oncology

Set Alert for Oncology

Latest From Cancer

Takeda’s Alunbrig To Battle Entrenched EU Competitors In First-Line ALK-Positive NSCLC

EU Approvals: Takeda advances its targeted ALK-positive NSCLC tyrosine kinase inhibitor into early lines of therapy, while Bayer and Finland’s Orion gain clearance for their androgen receptor inhibitor for prostate cancer.

Approvals Europe

Dissecting The Impact: Chi-Med Details Coronavirus Experience

CEO breaks down to Scrip how the Hong Kong-based company managed its way through the coronavirus outbreak in China, saying improvisation was critical. 

China Business Strategies

Good News For Immunomedics' Triple Negative Breast Cancer Trial

A Phase III trial testing the antibody-drug conjugate sacituzumab govitecan was stopped early for efficacy, boding well for the BLA pending at the US FDA.

Cancer Clinical Trials

Evotec Extends Takeda Pact to Gene Therapy

Evotec is building a gene therapy R&D center manned by ex-Takeda scientists and has already landed a multi-year drug discovery pact for it with their former Japanese employer.

Companies Deals

Interview: iTeos Attracts Investors By Targeting TIGIT

The Belgian biotech has managed to attract considerable sums from venture capitalists over the past couple of years amid hopes that its two next-generation immunotherapies will be best-in-class agents.

Financing ImmunoOncology

Sanofi’s Sarclisa Gets EMA Backing In Myeloma, Mirroring FDA OK

The EMA has recommended Sanofi’s anti-CD38 antibody Sarclisa as a combination-based third-line treatment for multiple myeloma, after US approval earlier in March.

Companies Cancer
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

ReCode Combines With TranscripTx, Raises $80m For Novel RNA Drugs

ReCode, whose platform allows for organ-specific delivery of RNA therapies, plans to start clinical trials in 2022 for its two lead programs in primary ciliary dyskinesia and cystic fibrosis.

StartUps and SMEs Drug Delivery

Bayer, Curadev Enter ‘STING’ Pact Exploring Inflammatory Disease

Bayer and Curadev entered a research collaboration and license agreement to develop novel STING antagonists targeting inflammatory disease.

Companies Commercial

Merck & Co's Gefapixant Cuts Chronic Cough in Phase III

New data puts Merck & Co's P2X3 receptor antagonist ahead of the field but Bellus Health's rival in the class may benefit from issues over taste alteration with gefapixant.

Clinical Trials Respiratory

Sanofi And Regeneron Initiate 400-Patient Coronavirus Trial With Kevzara

The Phase II/III trial will begin enrolling patients in the US immediately, with Regeneron taking the lead in US development and Sanofi leading ex-US trials. 

Clinical Trials Coronavirus COVID-19

Sanofi's Dupixent To Keep Soaring Despite NICE Blip

NICE is not recommending Dupixent for severe asthma just yet but Sanofi remains confident of hitting its sales target of €10bn a year.

Respiratory Health Technology Assessment

Open Orphan Restarts Earlier Coronavirus Vaccine Efforts

Open Orphan’s hVIVO unit, owner of Europe's only quarantine clinic with an onsite virology lab, has begun the world’s first commercial coronavirus human challenge study.

Companies Clinical Trials
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