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Research & Development

Set Alert for Research & Development

Xenon Down On Novel Acne Treatment Failure

Xenon Pharmaceuticals' attempts to treat acne with a SCD-1 inhibitor have met with failure at the Phase II stage, casting doubt on the therapeutic strategy and wiping more than 50% of the company's share price.

Clinical Trials Research & Development Dermatology

Sumagen’s World First Killed Whole HIV Vaccine Set For Phase II

After a positive outcome from a US Phase I study, South Korea's Sumagen is stepping closer to the launch of the world's first killed-whole HIV vaccine with potential to both prevent and treat AIDS.

Research & Development Clinical Trials Infectious Diseases
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Clinical Trials

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Latest From Clinical Trials

Bristol Teams Up With Billionaire-Backed Parker Institute On IO Research

A key goal of Bristol's second major academic research collaboration is to get trials up-and-running more quickly.

Clinical Trials Research & Development

Erytech Could Launch Several New Studies Following Pancreatic Cancer PhII Success

Erytech's lead therapy has shown strong anti-cancer activity in pancreatic cancer, on top of the hematological indications it is already targeting in late-stage trials, spelling good news for the French firm to pursue more studies in other oncology indications such as ovarian cancer.

Clinical Trials Cancer

Broad Label Gives Tesaro's Niraparib A Head Start In Ovarian Cancer

Tesaro takes opportunity of broad approval for Zejula (niraparib) in recurrent ovarian cancer to highlight franchise expansion opportunities in other tumor types, including PD-1 inhibitor combination studies.

Approvals Clinical Trials

Newron Needs To Up Ante In Large-Scale Schizophrenia Studies

Newron has reported positive Phase IIa data for schizophrenia drug evenamide but Phase III will be critical for the add-on therapy to demonstrate a more robust treatment effect to justify its use on top current treatments.

Clinical Trials Neurology

Purdue Highlights Convenience Of New Opioid Induced Constipation Drug Symproic

With oral naldemedine joining Purdue's pain portfolio, the company will look for ways to foster communication between patients and doctors about treatment for opioid-induced constipation.

Approvals Clinical Trials

CSL Behring Nears Market With Easier-To-Administer HAE Prophylactic

CSL Behring’s long-acting subcutaneous C1 inhibitor formulation, CSL830, has confirmed its efficacy for the prevention of hereditary angioedema (HAE) attacks, and is expected to be introduced this year, giving it initial traction in what could become a crowded sector.

Clinical Trials Research & Development
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Approvals

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Latest From Approvals

Sanofi/Regeneron Choose Access Over Price With Dupixent Launch

The FDA approved the IL-4/IL-13 inhibitor March 28 in a win for Sanofi and Regeneron. The companies set the biologic's price at $37,000 per year, which is lower than many biologics on the market for psoriasis.

Launches Approvals

Broad Label Gives Tesaro's Niraparib A Head Start In Ovarian Cancer

Tesaro takes opportunity of broad approval for Zejula (niraparib) in recurrent ovarian cancer to highlight franchise expansion opportunities in other tumor types, including PD-1 inhibitor combination studies.

Approvals Clinical Trials

Purdue Highlights Convenience Of New Opioid Induced Constipation Drug Symproic

With oral naldemedine joining Purdue's pain portfolio, the company will look for ways to foster communication between patients and doctors about treatment for opioid-induced constipation.

Approvals Clinical Trials

CHMP Opinions: Opdivo Sees Keytruda's Hodgkin's And Raises It Head & Neck

Merck & Co and Bristol Myers Squibb's rival anti-PD1 products continue their game of one-upmanship with each gaining a new indication in the latest round of EU CHMP opinions.

Approvals Drug Review

Pipeline Watch: Phase III Data For Abemaciclib, JZP-110 And NKTR-181

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

Pfizer's Avelumab Makes Its Debut, In Rare Form Of Skin Cancer

Pfizer got Bavencio to market by focusing on an unmet need, but the PD-L1 inhibitor is still a few years behind, competing with other checkpoint inhibitors over more valuable indications.

Approvals ImmunoOncology
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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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