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Research & Development

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Merck Develops 'New And Improved' CRISPR

Merck of Germany has developed a new genome editing tool that it believes improves on the popular, but IP battle-worn, CRISPR technology. How this will affect the existing IP landscape is as yet unknown.

Research & Development Intellectual Property BioPharmaceutical

Cardior Exploring MicroRNAs As Heart Failure Target

Emerging Company Profile: The German company Cardior has been set up to evaluate inhibitors of a microRNA in the treatment of heart failure, a condition that is poorly treated by current therapies.

Financing Research and Development Strategies Research & Development
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Clinical Trials

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Latest From Clinical Trials

Aerie's M&A Potential Rises As Roclatan Passes Second Phase III Glaucoma Test

Positive Phase III data for Aerie's second glaucoma drug candidate Roclatan – which will support a US FDA submission in the first half of 2018 – have boosted the California company's M&A allure.

Research & Development Clinical Trials

GW's Epidolex Epilepsy Data Paves Way For Cannabinoids

Safety and efficacy in study published in New England Journal of Medicine bode well for cannabinoid therapy Epidiolex, which is headed to FDA mid-year.

Neurology Clinical Trials

Patient Group Collaboration In Rare Diseases Offers Model For Cell/Gene Therapy Firms

Companies doing groundbreaking work in cell and gene therapies should look to how rare disease drug developers partnered with patient advocacy groups and disease foundations to advance their shared goals, suggested speakers at the Cell & Gene Exchange conference.

Research and Development Strategies Regenerative Medicine

Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void

FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.

Approvals Research and Development Strategies

Neurocrine Blames Sub-Par Dosing For Ingrezza Study Failure

Neurocrine's stock fell 9% on May 24 after the company said a closely-watched Phase II study for Ingrezza in pediatric Tourette's syndrome failed, but blamed a sub-therapeutic dose for the disappointing results. Most analysts gave the prospects for a higher dose study the benefit of the doubt.

Clinical Trials Neurology

NeuroVive To Take Traumatic Brain Injury Drug Into Mid-Stage Studies

Protecting the function of mitochondria may be key to developing medicines to reduce the nerve damage caused by traumatic brain injuries. NeuroVive Pharmaceutical is moving its cyclosporine candidate into Phase IIb studies.

Clinical Trials Research & Development
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Approvals

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Latest From Approvals

Pipeline Watch: Top-Line Ozanimod, Romosozumab, Cariprazine Phase III Results

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

Sickle Cell Innovators Required: Emmaus' Pending Approval Highlights Rare Disease Void

FDA approval is likely for Emmaus' sickle cell drug L-glutamine this summer, representing the first new product for the disease since 1998 – a decision FDA advisory committee panelists hope will spur more innovation.

Approvals Research and Development Strategies

Keytruda Approval Opens New Routes For Immuno-Oncology

Merck's PD-1 inhibitor holds the first cancer indication based on biomarkers rather than tumor location. The most significant market will be colorectal cancer, but Bristol-Myers Squibb's Opdivo is pending for the same subgroup and Roche's Tecentriq could eventually gain a broader approval.

Approvals Drug Approval Standards

Pipeline Watch: Top-Line Lanadelumab, Inotersen, Durvalumab Results

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

Chiesi Wins EU Nod For COPD Triple Combo, But Partner Is Predicted For Launch

Chiesi's triple combination therapy for COPD, Trimbow, has secured its first approval globally after winning a positive recommendation from the CHMP for its use in Europe – but analysts expect a respiratory partner will be required to launch the product.

Approvals Respiratory

LEO Pharma Gets EU Go-Ahead For Psoriasis Latecomer Brodalumab

The Danish speciality dermatology company LEO Pharma has achieved a key plank in its plans to provide products for the range of psoriasis patients with an EU go-ahead for brodalumab.

Drug Review Approvals
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Post Marketing Regulation & Studies

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Latest From 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

Intercept Seeks Long-Term Data To Build Ocaliva Market In PBC

The FXR agonist is the first new drug approved for primary biliary cholangitis in 19 years, but the lack of long-term outcomes data leaves a perceived opportunity for a host of mid-stage candidates also pursuing the indication. Intercept is conducting a Phase IV study to obtain such data with Ocaliva.

Commercial Business Strategies

Off-Label Communication: Pfizer Highlights Burdens Of FDA Policy

Seeking relaxation of US agency restrictions, Pfizer cites three examples where company delayed or decided against distributing medically relevant information beyond the product labeling; PhRMA survey shows almost half of all requests for information by prescribers and payers relate to off-label use.

Regulation Advertising, Marketing & Sales

Orexigen Begins Slow Climb Up Slippery Slope Of Obesity Drug Sales

Orexigen has a tough climb ahead as it sets out without a US partner to boost sales for its obesity drug Contrave with the goal of profitability by 2019, but it appears that doctors, patients and payers are becoming more open to pharmaceutical treatment.

Advertising, Marketing & Sales Strategy

Investors Relieved As Mylan Settlement Avoids Investigation

Mylan shares rallied on Oct. 7 following the company’s late-day Oct. 10 announcement that it agreed to settlement terms with the Department of Justice related to Epipen rebates for Medicaid prescriptions, but separate investigations and competition are looming.

Commercial Companies
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