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Research & Development

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Novartis Combo On Track To Be First Targeted BRAF NSCLC Therapy

The EU's CHMP has granted a positive opinion for Novartis' combo of MEK inhibitor Mekinist and BRAF inhibitor Tafinlar for BRAF-positive non-small cell lung cancer patients.

Approvals Commercial Companies

Patient Death Casts Cloud Over Roche Emicizumab Hemophilia Trial

The death of a patient during the HAVEN 1 study of Roche's investigational hemophilia product, emicizumab, may be nothing to panic about, but it is increasing concerns over its likely impact on the potential blockbuster drug's label.

Clinical Trials Drug Safety Research & Development
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Clinical Trials

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Latest From Clinical Trials

OncoSec Pushes IL-12 Approach Forward In PD-1 Melanoma Failures

Company plans to pursue accelerated approval based on a single-arm registrational study of PD-1 failures, after reporting positive results from a Phase II study at the ASCO-SITC meeting.

Clinical Trials ImmunoOncology

Argos And Agenus Trials Pile On Fresh Cancer Vaccine Disappointments

Argos mum on details surrounding Phase III failure of rocapuldencel-T in kidney cancer, while Agenus distances itself from failed Phase II glioblastoma study of Prophage G-200 as an investigator-sponsored trial with a challenging design.

Research & Development Clinical Trials

What Progress In The Rare Disease, Osteogenesis Imperfecta?

Two-year-old biotech Mereo BioPharma Group plc is planning to start a pivotal Phase IIb study in osteogenesis imperfecta patients in the first-half of this year with its anti-sclerostin antibody, BPS-804, and if the results are promising, EU patients could gain early access through the region’s adaptive pathways program.

Rare Diseases Clinical Trials

Melior, Bukwang Seek Diabetes Edge With Novel Insulin Sensitizer

MLR-1023, a repositioned oral compound being developed for type 2 diabetes by Melior and Bukwang, is set to move into Phase IIb in the US and South Korea, and the firms are looking to its novel mechanism of action, improved tolerability and efficacy to carve a niche in a highly competitive sector.

Research & Development Diabetic Care

After APOLLO: Trevena Weighs Commercial Viability Of Opioid Oliceridine

A mixed bag of safety results for the new opioid Olinvo (oliceridine) in the Phase III APOLLO pain trials disappoints the market, but analysts are encouraged by the totality of the data and optimistic about approval.

Clinical Trials Neurology

Novel Antibody Products Ring The Treatment Changes In HIV

Two Canadian companies – Theratechnologies and CytoDyn – exploring the use of monoclonal antibodies in the fight against HIV presented data for their novel late-stage candidates at the recent CROI meeting in Seattle. They are aimed at patients experiencing multi-drug resistance and represent a change in this mature therapy area dominated by small-molecule oral products.

Clinical Trials Companies
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Approvals

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Latest From Approvals

AZ’s ZS-9 Targets Hyperkalemia Sector As It Nears EU Market

A potential near-blockbuster drug, AstraZeneca’s Lokelma (ZS-9), has received a positive opinion from Europe’s CHMP and, if approved, will soon have to justify best-in-class plaudits and a hefty acquisition price.

Approvals Market Intelligence

New FDA Revlimid Approval Extends Celgene's Myeloma Empire

Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.

Approvals Policy & Regulation

Celltrion's Truxima First Biosimilar MAB In Oncology To Win EU Approval

Celltrion's version of Roche’s MabThera (rituximab), Truxima, has become the first biosimilar anticancer to win marketing authorization in Europe.

Approvals Biosimilars

Parsabiv Could Allow Amgen To Maintain Control Of Calcimimetics Market

Amgen's oral calcimimetic Sensipar faces generic competition in 2018, but the new intravenuous Parsabiv has advantages that could make it the more popular alternative.

Reimbursement Approvals

Pipeline Watch: Top-Line Tenapanor, Doravirine And Tofacitinib Results

Pipeline Watch has been updated to bring greater depth and detail to a potential therapeutic product’s progress through the R&D pipeline. The table brings you a snapshot of selected late-stage clinical trial events in the pharma and biotech industries.

Pipeline Watch Approvals

Siliq US Approval Expected To Make Little Dent In Valeant Debt Mountain

A Black Box warning on suicidal ideation and behavior, a REM program and a Medication Guide may hold back the sales growth of Valeant’s new psoriasis therapy in the US, Siliq, following its Feb. 15 approval, although the drug has been associated with high levels of total skin clearance, a finding that could differentiate it from competing products.

Approvals Dermatology
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Post Marketing Regulation & Studies

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Latest From Post Market Regulation & Studies

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

Korea To Limit Olmutinib Usage, Monitor All Patients

After distributing safety letters on several cases of serious adverse skin reactions that occurred during the clinical development of Hanmi’s olmutinib, South Korean authorities have decided to limit the EGFR inhibitor to consenting patients and are closely monitoring its use.

Policy & Regulation Safety
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