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Therapy Areas

Cardiovascular

Set Alert for Cardiovascular

Latest From Cardiovascular

'That's Huge, Folks': Amarin's Vascepa Cuts CV Risk By 25% On Top Of Statins

Cardiovascular outcomes data exceeded expectations for the fish oil pill, vindicating Amarin, which has fought long and hard for Vascepa's place in the CV disease prevention market. A filing based on REDUCE-IT is expected in early 2019.

Clinical Trials Comparative Effectiveness

Mixed Results In AZ's DECLARE-TIMI 58 CV Trial Cloud Implications For Farxiga

While clarification on mixed DECLARE-TIMI 58 CV top-line data in diabetes patients is awaited at November's AHA meeting AstraZeneca says it is confidently pursuing independent studies of its SGLT-2 inhibitor Farxiga in heart failure and kidney disease patients.

Clinical Trials Companies

Garland Takes Helm Of Portola At A Crucial Time

Portola touts exec's commercial management experience with Genentech success stories Avastin and Tarceva.

Commercial Sales & Earnings

Novo Nordisk CSO Says R&D Revamp Reflects New Stem Cell And AI Focus

Mads Krogsgaard Thomsen tells Scrip that recent successes in stem cell research and the on-going advances in artificial intelligence helped prompt the Danish group to revamp its R&D activities.

Business Strategies Commercial

Viking’s Liver Fat Reduction Data Portend A New Competitor In NASH

In a Phase II study, Viking’s VK2809, with the same mechanism as Madrigal’s MGL-3196, shows significant liver fat reduction in NAFLD patients, along with reduction in LDL cholesterol.

Clinical Trials Liver & Hepatic

Alnylam Switches Attention To Access After Onpattro EU Okay

European approval is in the bag for Onpattro for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis but in a week where ICER has criticized the price of the RNAi drug in the US, Alnylam now has to navigate reimbursement talks on this side of the Atlantic.

Reimbursement Approvals
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CNS

Set Alert for CNS

Latest From Neurology

MedinCell Boosts Funding For Long-Acting Injectables Portfolio

France's long-acting injectables technology company, MedinCell, which is collaborating with Teva on a Phase III long-acting risperidone formulation, has completed an IPO on Euronext Paris, giving a lift to its development plans.

 

Neurology Financing

Primex Pharmaceuticals Plots Launch Plans For Oral Pediatric Sedative

With EU approvals in the bag for Ozalin, a novel oral midazolam solution for use in children, Switzerland-based Primex outlines plans for launch in Europe, and US development.

 

Neurology Pediatrics

Merck of Germany's Hunt For MS BTKi Partner Boosted By Evobrutinib Data

German Merck tells Scrip its quest to find a partner for its Bruton’s tyrosine kinase inhibitor evobrutinib should be helped by positive 24-week Phase IIb data in relapsing multiple sclerosis.

Clinical Trials Companies

Akcea Expects Convenience Edge For Tegsedi, Despite Monitoring Requirements

Approved two months after Alnylam’s Onpattro, Tegsedi is priced almost identically in the same hATTR indication. Ionis affiliate Akcea hopes weekly subcutaneous administration will provide convenience benefit compared to I.V. Onpattro.

Approvals Commercial

Acacia Aghast As FDA Says No To Barhemsys

The UK company has been stunned by a complete response letter for its nausea and vomiting therapy which relates to problems at its contract manufacturer but is not linked to the data package. Despite the setback, Acacia is sticking to a first-half 2019 launch plan.

FDA Manufacturing

Sarepta Commits To Rapid, Thorough Pivotal Study For DMD Gene Therapy Based On Functional Improvements

The company presented encouraging data on functional assessments of four boys treated with a micro-dystrophin gene therapy at the World Muscle Society, furthering momentum around the program.

Rare Diseases Clinical Trials
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Immunology

Set Alert for Immunology

Latest From Immune Disorders

Can Lilly's Olumiant Prickle Xeljanz In India?

Lilly’s Olumiant has hit the Indian market, upping the level of competition in a rheumatoid arthritis sector that already includes the fellow JAK inhibitor Xeljanz from Pfizer and at least half a dozen biosimilar versions of Humira, among other products. But could pricing cloud Olumiant’s uptake?
India Commercial

Analysts Up-Beat On Xencor's XmAB5871 Despite Phase II 'Placebo Hiccup' in SLE

Analysts shrugged off mixed topline data from a Phase II study showing Xencor’s lead compound XmAb5871 missed its primary endpoint in systemic lupus erythematosus (SLE), blaming the miss on the number of patients dropping out of the placebo arm of the trial.  

Clinical Trials Immune Disorders

GSK-Backed Sitryx Launches With Six Immunometabolism Eggs In Its Basket

GlaxoSmithKline, SV Health Investors and Sofinnova are among the backers of a new Oxford-based biotech which has raised $30m in series A financing and boasts a strong line-up of academic founders. CEO Neil Weir outlines Sitryx's raison d'etre.

StartUps and SMEs Financing

Data Raise Hopes Of Accelerated Approval For Hansa's Kidney Transplant-Enabling Imlifidase

Kidney transplantation might be possible in difficult-to-graft highly sensitized patients using Hansa Medical's IgG-cleaving product, imlifidase. The high unmet need for such a product might usher in a Phase II data-based approval.

 

Renal Clinical Trials

Alexion Continues Pipeline Rebuilding With $400m Takeout Of Syntimmune

Alexion’s third deal this year brings privately held Syntimmune and its Phase Ib/IIa candidate for three IgG-mediated rare disorders, including warm autoimmune hemolytic anemia, for a $400m upfront price tag.

Deals Rare Diseases

AbbVie Deployed Nurses As 'Runners And Cappers' In Humira Kickback Scheme, Suit Alleges

California Insurance Commissioner claims AbbVie gave kickbacks for healthcare providers to prescribe Humira and had nurse 'ambassadors' insert themselves between patients and physicians.

Advertising, Marketing & Sales Legal Issues
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Infectious

Set Alert for Infectious Diseases

Latest From Infectious Diseases

Four Early-Stage Antibacterial Drugs To Watch: Highlights From IDWeek

Promising drugs from Tetraphase, ContraFect, Spero and Entasis get a platform at the Infectious Diseases Society of America’s IDWeek.

Infectious Diseases Clinical Trials

J&J Bets Big On Arrowhead’s Early Promise In Hepatitis B

The pharma is paying $250m up front for worldwide rights to Arrowhead’s Phase I/II RNAi candidate. Arrowhead says letting J&J take the lead on HBV enables it to focus on other pipeline programs it can bring to market itself.

Deals Commercial

Roche Registers Fresh Win For New Flu Drug

Ahead of an FDA decision scheduled for December 24, the Swiss major's baloxivir has improved influenza symptoms versus placebo, and to a lesser extent Roche's own Tamiflu, in people at high risk of serious complications from the virus.

Infectious Diseases Clinical Trials

Paratek's Antibiotic Nuzyra Survived 20 Years – Now For The US Launch

Company still mulling pricing for broad-spectrum antibiotic Nuzyra (omadacycline), which is set to launch in the US in the first quarter, following FDA approval Oct. 2.

Approvals Infectious Diseases

Arikayce’s Limited Population, Black Box Warning Won’t Limit Launch, Insmed Says

Because it will be initially targeting specialists and a very sick population, the biotech thinks Arikayce will get early usage in its narrowly defined lung infection indication.

Approvals Commercial

Boston Bags Assets From GSK and Novartis

The US firm is getting its hands on eight programs from two of the world's leading drug makers, seeing an opportunity in areas such as antibiotics where solutions may be more likely to come from biotech rather than big pharma.

Infectious Diseases Deals
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Metabolic

Set Alert for Metabolic

Latest From Metabolic Disorders

Merck Steps Out Of Insulin Glargine Market, But Says It Remains Committed To Biosimilars

The company will not commercialize an insulin glargine copy already tentatively approved by FDA as Lusduna, but says it remains committed to biosimilars in oncology and immunology.

Biosimilars Strategy

Chronocort European Phase III Study Failure “Surprises” Diurnal, All To Play For In US Studies

Diurnal has suffered a set-back on its road to approval and commercialization of Chronocort, but analysts still see hope for the product.

Clinical Trials Research & Development

"Impressive" HbA1c And Weight Reductions Spur Phase III Plans For Lilly's Dual Incretin Agonist

Heading into Phase III in 2019 is Lilly's dual agonist of GLP-1 and GIP, which has shown notable therapeutic effects on blood sugar and body weight in type 2 diabetics in a mid-stage clinical study. Meanwhile Lilly/Boehringer Ingelheim's SGLT2 inhibitor, empagliflozin, is being discussed with regulators with regard to its use in type 1 diabetics, an additional indication, following the release of full results from the EASE Phase III program.

Metabolic Disorders Clinical Trials

Lilly’s Ultra Rapid Lispro Mealtime Insulin Sails Through Phase III, But Will It Be Enough?

With only slight potential advantages in some types of patients, ultra-rapid insulins will likely still need to compete on price to be more widely successful, analysts say.

 

Metabolic Disorders Life Cycle Management

Mixed Results In AZ's DECLARE-TIMI 58 CV Trial Cloud Implications For Farxiga

While clarification on mixed DECLARE-TIMI 58 CV top-line data in diabetes patients is awaited at November's AHA meeting AstraZeneca says it is confidently pursuing independent studies of its SGLT-2 inhibitor Farxiga in heart failure and kidney disease patients.

Clinical Trials Companies

Novo Nordisk CSO Says R&D Revamp Reflects New Stem Cell And AI Focus

Mads Krogsgaard Thomsen tells Scrip that recent successes in stem cell research and the on-going advances in artificial intelligence helped prompt the Danish group to revamp its R&D activities.

Business Strategies Commercial
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Oncology

Set Alert for Oncology

Latest From Cancer

Pivotal Data Put Roche's Kadcyla In Position For Earlier Breast Cancer

KATHERINE supports filings for earlier use of Kadyla in adjuvant setting of metastastic breast cancer.

Clinical Trials ImmunoOncology

Former Immunocore Boss Forster Replaces Haurum At F-star Helm

As F-star starts its transition into a clinical stage company underpinned by two proprietary bispecific compounds due to enter clinic late 2019, Eliot Forster joins the company as CEO with plans to expand the company’s regulatory and clinical operations capabilities and raise new funds.

 

 

Appointments ImmunoOncology

Bristol’s Checkmate-331 Failure Not Likely To Endanger SCLC Labeling For Opdivo

Opdivo failed to meet an overall survival endpoint in a Phase III confirmatory study in small-cell lung cancer. But several analysts think Bristol will keep the SCLC labeling obtained in August due to lack of treatment options for these patients.

ImmunoOncology Clinical Trials

China Vs. Cancer: Coverage For 17 Drugs Unveils Price Pressures, Commercial Battleground

While cancer drug makers generally applaud the rare reimbursement decision in China, some have pointed to mounting and significant pressure to lower prices, while insiders say the real battle has only just began and that translating the coverage into commercial success will take much more effort.

China Reimbursement

Carrick Targets Ovarian Cancer With BTG Deal, Entices Celgene’s Former Top Deal Maker

In a busy week, Carrick Therapeutics has added to its oncology pipeline, as well as bringing in Celgene deal maker George Golumbeski.

Deals Cancer

Singapore's DotBio Begins Play For Antibody Domain

Emerging Company Profile: Newly formed Singapore venture DotBio aims to develop novel immuno-oncology therapies based on optimized, multi-specific humanized domain antibodies, with a focus on targeting checkpoint blockades, positive immune signals and tumor-specific processes in oncology.

Singapore Biologics
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Respiratory

Set Alert for Respiratory

Latest From Respiratory

Arikayce’s Limited Population, Black Box Warning Won’t Limit Launch, Insmed Says

Because it will be initially targeting specialists and a very sick population, the biotech thinks Arikayce will get early usage in its narrowly defined lung infection indication.

Approvals Commercial

AZ Respiratory Head: Fasenra As Add-On Maintenance Can Reduce Exacerbations

AstraZeneca's head of respiratory tells Scrip BORA Phase III data should reinforce and extend physician confidence in Fasenra as a long-term asthma biologic. The drug is also driving wider growth of biologics in asthma.

Clinical Trials Companies

Vertex Set To Dominate Cystic Fibrosis Market For The Next Decade

Vertex is set to reap huge benefits from its triple combination program for cystic fibrosis over the next 10 years, potentially becoming the biggest selling drug in this disease, according to a new report from Datamonitor Healthcare.

Respiratory Market Intelligence

Roivant's New Respiratory-Focused Vant Adds Chronic Cough Candidate To The Portfolio

Respivant will be Roivant's 13th "vant," focused on developing what was Patara Pharma's mast cell stimulator for chronic cough in patients with idiopathic pulmonary fibrosis. Former Patara CEO Bill Gerhart will lead the firm.

Deals Research and Development Strategies

Can Glenmark-Celon’s Generic Seretide DPI Break Into Germany?

Glenmark-Celon’s generic version of GlaxoSmithKline’s Seretide Accuhaler dry powder inhaler (DPI) has received the go ahead in Germany, upping the competition quotient in a significant market that has generally been seen as tough to penetrate.

 

Respiratory Generic Drugs

Tezepelumab Deemed Breakthrough But Can Phase III Reproduce Data?

Biologic's breakthrough designation is based on Phase IIb PATHWAY data that showed tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthma.

Commercial Policy & Regulation
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