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Research & Development

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Pressure Builds On Lundbeck After Rexulti Fails In Bipolar I Manic Episodes

Rexulti failed in two Phase III trials to statistically separate from placebo in bipolar I manic episodes.

Business Strategies Commercial Research and Development Strategies
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Clinical Trials

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Latest From Clinical Trials

Modus CEO On Its Plans For An At-Home Injectable For Sickle Cell Crises

Modus Therapeutics has begun a Phase I study with subcutaneously administered sevuparin. Its CEO says this new formulation of its lead asset has the potential to be self-administered by sickle cell disease patients at home for the treatment of vaso-occlusive crises.

Clinical Trials Companies

Korea IND Filing Moves Alteogen's Eylea Biosimilar Forward

South Korean biotech Alteogen is progressing the development of its Eylea biosimilar both at home and abroad, with the hope of becoming a global first mover with its version in wet AMD, backed by formulation and manufacturing patents.

South Korea Biosimilars

ReNeuron's Cell Therapy Garners Excitement In RP-Related Vision Loss

A surprisingly strong improvement in vision has accompanied the use of proprietary stem cells in the first three retinitis pigmentosa patients in a US Phase II study, intriguing the UK biotech, ReNeuron, and maybe attracting development partners too.

 

Clinical Trials Ophthalmic

Reata Expands Options For Bardoxolone With New CKD Data

Once suspended due to safety issues, bardoxolone now has completed a Phase II study that showed kidney function benefit in four rare types of CKD. A pivotal study is underway, with another planned and more possible.

Clinical Trials Research & Development

Tanezumab Dances Through Back Pain Studies With “Acceptable” Safety Answers

In its latest TANGO trial for chronic lower back pain, Eli Lilly and Pfizer’s tanezumab has shown efficacy at 10 mg, but its 5 mg dose missed the statistically significant mark. Vitally, analysts are encouraged by safety data.

Clinical Trials Research & Development

Merck's Keytruda Loss In Liver Cancer Could Be Gain For Rivals

The drug demonstrates improvements in overall survival and progression-free survival, but not enough for success in KEYNOTE-240.

Clinical Trials Research & Development
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Approvals

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Latest From Approvals

Pipeline Watch: Phase III Readouts For Tanezumab, Obeticholic Acid

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Pipeline Watch Approvals

Cell Therapies Forge Ahead In Japan with Reimbursement, Approval Decisions

A controversial cell therapy for spinal injuries receives coverage under Japan’s national health scheme, amid signs that the pricing of regenerative therapies may come under more scrutiny, while the first CAR-T treatment in the country takes a step closer to market.

Japan Approvals

Novo Nordisk CSO: Hemophilia Treatment ‘Segmenting’ Much Like In Diabetes

Novo Nodisk's CSO says FDA approval of extended half-life Factor VIII Esperoct treatment for people with hemophilia A will give more choice to those patients and "effectively completes" the Danish group's hitherto R&D efforts based on clotting factor deficiencies. 

Approvals Blood & Coagulation Disorders

Pipeline Watch: Phase III Starts In Prostate Cancer, C Diff Diarrhea

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

 

Pipeline Watch Approvals

Old Dog, New Tricks: Label Expansions Invigorate Diabetic Nephropathy Market

With four new entrants readying to be prescribed in the next four years, the market for diabetic nephropathy is looking more buoyant than ever. However, competition from GLP-1 agonists and eventually from generics could put a dampener on proceedings.

 

Metabolic Disorders Renal

New Option For Uncontrolled Epilepsy On Horizon As US Accepts Cenobamate NDA

New potentially effective therapy for drug-resistant epilepsy, seen as the most pressing unmet need in this market, is on the horizon as FDA begins approval review of SK’s cenobamate, also marking a first for the Korean pharma industry.

United States Approvals
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Post Marketing Regulation & Studies

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Latest From Post Market Regulation & Studies

Roche To Set Right Avastin Post-Marketing Surveillance Delay In India

Roche is working towards implementing PMS studies for Avastin (bevacizumab) and ensuring that a suspension of marketing authorization for the product in first line ovarian cancer is lifted in India.

Policy & Regulation Regulation

Real World Data Helping To Drive Rise Of Novartis' Entresto

Patients with heart failure on Entresto say they have fewer symptoms and greater quality of life, according to a registry study and Novartis is hoping that this and other real world data will propel the drug towards its peak sales target of $5bn.

Cardiovascular Life Cycle Management

Repatha Inroads Build Gradually As EU Extension Nears

Europe is expected to follow where the US led in expanding the label for Amgen's PCSK9 inhibitor Repatha to include a prevention indication for heart attacks and strokes. But growth will be hard-won.

Approvals Cardiovascular

Biogen, AbbVie Withdraw Struggling MS Drug Zinbryta Due To Safety Issues

Antibody was approved in the US with a liver safety warning while EU regulators recently limited the drug's use. Now, EMA has begun an urgent review of reports of inflammatory brain disorders related to Zinbryta.
Drug Safety Post Market Regulation & Studies

Siliq Probably Isn't The Light At The End Of Valeant's Tunnel

Valeant is touting Siliq to lead new product growth, but the drug's significant safety concerns in a competitive psoriasis market likely will offset efficacy advantages it could offer.

Drug Safety Risk Management

Nearing Finish Line, HCV Race Focuses On Salvage Therapy

With few remaining unmet needs in hepatitis C, Gilead, Merck and AbbVie are focusing on tough-to-treat niches with their next-gen combination regimens, especially treatment-experienced patients who failed on prior direct-acting antiviral therapy. Merck also is studying injectable drug users in an effort to eradicate HCV entirely.

Infectious Diseases Liver & Hepatic
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