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Research & Development

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Immuno-Oncology Outlook

Spark Sets Sights On Bringing First Gene Therapy To Market In 2018

A BLA for a potential gene therapy to correct vision loss due to certain inherited retinal disease has been accepted by FDA with a Jan. 12 PDUFA date. The proposed trade name is Luxturna.

Drug Review Pricing Strategies Commercial

Ironwood Hits Endpoints In GERD, But Analysts Unimpressed With Treatment Effect

The GI specialty firm hopes it has a future blockbuster with the bile acid sequestrant after hitting multiple endpoints in Phase IIb, but the treatment effect compared to PPI therapy alone was below what was previously anticipated.

Clinical Trials Gastrointestinal Research & Development
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Clinical Trials

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Latest From Clinical Trials

Bayer And Morphosys Brush Off ADC Mesothelioma Failure

A mid-stage trial of a Bayer/Morphosys antibody-drug conjugate for mesothelioma has failed, crossing one indication off the list of its potential uses, but development in other indications continues.

Clinical Trials Companies

Are Theravance And Mylan's US COPD Chances Bigger Than First Thought?

With Theravance Biopharma's promising once-daily nebulized LAMA bronchodilator, partnered with Mylan, set for FDA filing later this year, analysts say the product might have a bigger market than initially presumed, and are now looking beyond to the firm's other pipeline activities.

Clinical Trials Respiratory

Immuno-Oncology Outlook: Getting To The Root Of Head And Neck Cancer

As PD-1 inhibitors march toward earlier-stage head and neck cancers, researchers consider ways to improve the precision of immunotherapy through better patient selection and combinations for this accessible tumor type.

ImmunoOncology Cancer

UCB's Bimekizumab Could Struggle With Saturated Psoriasis Market

UCB's has reported strong Phase IIb data for its novel psoriasis therapy bimekizumab, but the drug is unlikely to launch before 2022 and is at risk of being redundant on a crowded market.

Clinical Trials Immune Disorders

Vertex Triple-Data Combos Live Up To High Hopes In Early Studies

Phase I and II results for three of Vertex's four next-generation CFTR correctors showed positive effects on pulmonary function when added to two of the company's approved cystic fibrosis therapies. The drugs are moving rapidly forward so that one or two can move into pivotal trials in 2018.

Clinical Trials Research and Development Strategies

Immuno-Oncology Outlook: Bavencio Leads PD-1/L1 Pack In Ovarian Cancer

Merck KGaA/Pfizer's Bavencio is likely to be the first checkpoint inhibitor to gain approval in ovarian cancer but Roche's Tecentriq is hot on its heels. The ovarian cancer pipeline boasts seven other late-stage drugs, including antibody-drug conjugates and small molecules, that are ready to ramp up competition on the market.

Clinical Trials ImmunoOncology
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Approvals

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Latest From Approvals

J&J's Symtuza Will Debut In Europe On Cramped HIV Market

Johnson & Johnson's combination HIV therapy Symtuza has secured a greenlight in Europe, marking its first approval worldwide – but will the big pharma be able to catch up with successful HIV opponents from AbbVie and Gilead?

Infectious Diseases Approvals

Merck KGaA/Pfizer's Bavencio Set To Enter Europe's Crowded I-O Market

The highly-competitive PD-1 field in Europe is very likely to have a new player as Bavencio gets a CHMP recommendation for Merkel cell carcinoma, but the success of Merck KGaA and Pfizer's checkpoint inhibitor will be gauged on how it competes with the competition already on the market in wider, more valuable indications.

Cancer ImmunoOncology

Pipeline Watch: Phase III Starts For Itacitinib And AXS-05

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

Roche's Tecentriq Gets The Double At The EU CHMP

Roche's checkpoint inhibitor Tecentriq clears the EU approval hurdle in locally advanced or metastatic urothelial carcinoma and locally advanced or metastatic non-small cell lung cancer.

Approvals Policy & Regulation

'Potential Blockbuster' Dupixent Set For EU Eczema OK

While Dupixent looks set for use in Europe for treating moderate-to-severe atopic dermatitis, analysts believe the biologic has a great future in other indications and could eventually become a blockbuster.

Approvals Biologics

Merck's Lantus Copy Lusduna Poised For US Market Pending Litigation

The Merck and Samsung Bioepis formulation of Sanofi's insulin glargine was tentatively approved by FDA, a designation that permits the drug to enter the market pending the resolution of ongoing patent litigation.

Biosimilars 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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