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Research & Development

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Evotec Sets Empire Building Sights On Infectious Disease Space

As others shun anti-infectives, Evotec is consolidating its position. Through an alliance with Sanofi it is evaluating new anti-infectives in three areas, and expects soon to advance its first candidate therapeutic into the clinic.

 

Infectious Diseases Clinical Trials Research & Development
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Clinical Trials

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Latest From Clinical Trials

Sensyne Health CEO Drayson Says IPO Will See AI Group To Profitability

Flush with IPO funding, AI-focused healthcare technology group Sensyne Health will now ready additional products and find three more NHS trust partnerships. CEO Lord Drayson spoke to Scrip.

Artificial Intelligence Business Strategies

Gemphire Reels From Two R&D Blows

A series of setbacks for gemcabene has left the Livonia, MI-based company reeling, but management remains committed to its lead product.

Clinical Trials Research & Development

Evotec Sets Empire Building Sights On Infectious Disease Space

As others shun anti-infectives, Evotec is consolidating its position. Through an alliance with Sanofi it is evaluating new anti-infectives in three areas, and expects soon to advance its first candidate therapeutic into the clinic.

 

Infectious Diseases Clinical Trials

RedHill's Antibiotic Approach For Crohn's Shows Promise, Caveats Remain

Top-line data for a Phase III trial of RedHill's antibiotic combination for use in Crohn's disease show the study has hit its primary endpoint, but there is still some way to go before filings can be made for the novel approach.

Clinical Trials Research & Development

Lundbeck Breaks Into MAb Development, Adds To Suite Of Parkinson's Candidates

Denmark's mid-sized biopharma, Lundbeck, has taken another potential Parkinson's disease therapeutic into early clinical studies, the third this year, and this time it's a monoclonal antibody, not a small molecule.

 

Neurology Research & Development

Ironwood Pulls Plug On Struggling Gout Drug Zurampic

Due to poor sales, the drug, which AstraZeneca picked up through its $1.26bn acquisition of Ardea, is now being terminated in the US. Ironwood, already in the process of splitting up, is going to focus on its core gastrointestinal franchise.

Sales & Earnings Clinical Trials
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Approvals

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Latest From Approvals

Amicus' Oral Fabry Drug Priced To Compete Against Traditional ERT

FDA approved Galafold under accelerated approval, paving the way for the launch of the first oral therapy to treat a subset of patients with the rare condition Fabry disease. Amicus priced Galafold at $315,000 per year.

Rare Diseases Launches

Pipeline Watch: Phase III Progress With BL-8040, Recorlev And Estelle

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

Alnylam Offers Flexible Value-Based Deals For Breakthrough RNAi Drug Onpattro

The commercial team is on board and ready to market the first FDA-approved RNAi therapeutic patisiran for hereditary transthyretin-mediated amyloidosis.

Rare Diseases Pharmacy Benefit Management

Pipeline Watch: Phase III Starts With Bavencio, MultiStem And VT-1161

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

Pipeline Watch: Top-line Phase III Results For KX2-391, Dasotraline And Brigatinib

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

EMA ‘Yes’ For Pegfilgrastim Biosimilars Spells End For Neulasta’s EU Stronghold

Approval of the first pegfilgrastim biosimilars in the EU would mark the start of a period of accelerated sales declines for Amgen's Neulasta but the outlook for the blockbuster bio-originator is not necessarily bleak.

Biosimilars Commercial
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Post Marketing Regulation & Studies

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Latest From Post Market Regulation & Studies

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

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
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