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Research & Development

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Sanofi And NIH To Test 3-In-1 Antibody In HIV After Monkey Trial Success

Sanofi's focus on developing multi-specific therapies is being turned to HIV.

Clinical Trials Companies Research & Development
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Clinical Trials

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Latest From Clinical Trials

Allergan’s Two-Year NASH Data Fail To Show Fibrosis Benefit

A year after acquiring cenicriviroc in its Tobira buyout, Allergan says two-year data from a Phase IIb trial supports continued development, but analysts think the drug’s prospects have dimmed.

Clinical Trials Liver & Hepatic

VELOCITY Failure For Versartis's Lead Drug Sends Shares Into Tailspin

Versartis's long-acting growth hormone product missed Phase III non-inferiority endpoint, wiping more than 83% of the company's value.

Clinical Trials Companies

Genexine Edges Ahead In Pediatric GHD After Versartis Trial Failure

Versartis's failure in a Phase III study of somavaratan places Genexine's GX-H9 in a favorable position to become the best-in-class long-acting growth hormone for pediatric growth hormone deficiency.

Clinical Trials South Korea

APOLLO Success Clears Alnylam For Lift-Off

Phase III APOLLO results finally give the beleagured firm the first late-stage success for an RNAi thereapeutic and potentially a strong lead in the rare hereditary disease. 

Clinical Trials Drug Safety

Expanded IMPACT For GSK Respiratory Business From New Trelegy Data

Headline data from GlaxoSmithKline's IMPACT study comparing its new triple therapy Trelegy Ellipta with the company's dual therapies Breo/Relvar Ellipta and Anoro Ellipta support the product's ability to reduce exacerbations in more severe COPD. However, the benefit of IMPACT in expanding GSK's respiratory sales may be limited given pricing pressures and the make-up of GSK's current portfolio.

Clinical Trials Respiratory

Nuvelution Puts Business Model Into Action With Teva/Austedo Deal

Focused on drug development risk-sharing partnerships, Nuvelution signs its first partnership, with Teva, to conduct Phase III development of recently approved Austedo for pediatric Tourette syndrome.

Deals Research and Development Strategies
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Approvals

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Latest From Approvals

Allergan Urgently Seeks FDA Guidance To Unblock Vraylar sNDA Review

In its initial assessment of Allergan's sNDA for Vraylar, the FDA has found the application - for treating negative symptoms associated with schizophrenia – wanting, and thus says it doesn't merit a full review.

Approvals Companies

Roche Racks Up Another RoActemra Green Light To Boost Revenues

The Swiss giant's blockbuster is the first non-steroid therapy approved in Europe for giant cell arteritis and the first major advance in treatment for over 50 years.

Immune Disorders Policy & Regulation

Pipeline Watch: Phase III Progress With Lefamulin, Dupilumab, Patisiran

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.

Approvals Pipeline Watch

Merck KGaA/Pfizer Get Europe OK For Bavencio In Rare Skin Cancer

The Merkel cell carcinoma area is very niche but getting approval means that Merck and Pfizer can now prepare to compete with the likes of Opdivo and Keytruda in the European PD-1/PD-L1 space.

Approvals ImmunoOncology

EU Moves To RATIFY Novartis' Rydapt for AML

Rydapt represents the first major development in targeted acute myeloid leukaemia treatment in more than 25 years as Novartis plots its commercial launch in Europe.

Cancer Approvals

Trelegy Approval Boosts GSK's US Respiratory Business But Pressure Remains

With the FDA approval of Trelegy Ellipta, GlaxoSmithKline will enjoy first-to-market status with a LABA/LAMA/ICS triple combination therapy to treat COPD in the US. However, it faces the challenge of convincing payers.

Approvals Respiratory
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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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