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J&J Immunology Growth Now Hinges On Stelara, Tremfya After RA Setback

The company said it will pull global regulatory filings for the interleukin-6 inhibitor sirukumab for rheumatoid arthritis after determining regulatory delays would put it too far behind the competition.

Business Strategies Immune Disorders Sales & Earnings

Smooth AdCom Passage Expected For Novo's Semaglutide Despite Retinopathy Queries

Novo Nordisk's Victoza follow-on semaglutide, forecast to become the third once-weekly GLP-1 product available on the highly competitive US diabetes market, is expected to secure a market-leading spot, by revenue, before 2025.

Metabolic Disorders Advisory Committees Policy

Life In The Old Dog Yet: Growth In Dyslipidemia Market Expected To 2025

Despite the further genericization of statins and ezetimibe, the arrival of expensive new therapies means the dyslipidemia market is still set for growth over the next eight years, say analysts from Datamonitor Healthcare.

Commercial Market Intelligence Cardiovascular

Publisher's Spotlight: Informa’s CARE Awards Open For Nominations

Enter your clinical research team, novel trial design, outstanding results and more for Informa Pharma Intelligence’s 2018 Clinical and Research Excellence (CARE) Awards.

Clinical Trials Innovation Research and Development Strategies

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Commercial Explore this Topic

Consolidation in Generics Sector As Impax Merges With Amneal

The deal will create the fifth-largest generics company in the US with one of the largest pipelines, with about 150 pending ANDAs and 165 projects in active stages of development.

M & A Generic Drugs Commercial

Scrip Asks… What's The Current Climate For Deal-Making? (Part 1)

Following Gilead's acquisition of Kite, buzz grew that the deal might catalyze a surge in deal-making. Scrip asked a broad cross-section of biopharma insiders and observers about the deal-making environment – first up are responses from small biotechs.

Business Strategies M & A Deals

UK R&D Centre for Antimicrobial Resistance Goes Into Battle

The UK's recently launched AMR Centre has launched two R&D collaborations and plans two more this year.

Business Strategies Commercial

Silence Seeks Share Of Alnylam RNAi Success In Legal Action

The UK firm believes its siRNA stabilisation chemistryis represented in several late-stage RNAi studies and that market leader Alnylam requires a license that could have a material impact on Silence's market capitalization.

Intellectual Property Commercial

Lynparza Partners AZ And Merck & Co Target US Breast Cancer Market

AstraZeneca and Merck & Co's strategic collaboration on the development of olaparib and other anticancers has the US breast cancer sector in its sights, with approval of a US sNDA in the indication expected in early 2018.

Approvals Cancer

Ukraine Nod Paves Way For Panacea Sales To 49 Other Nations

Panacea Biotec has received another piece of good news as it strives to return to profit – this time from Ukraine which has awarded a GMP certificate to the Indian drug firm to supply 22 medicinal products to the country. It also opens up 49 other nations for the firm’s products.

Commercial Strategy

HemoShear's Human Disease Model Validated By Takeda NASH Deal

Emerging Company Profile: HemoShear thinks its REVEAL-tx platform can identify novel targets and validate drug candidates better than existing bench research methods. Japan’s Takeda is betting in a new collaboration that HemoShear can deliver novel targets in NASH.

StartUps and SMEs Deals

Asia Executives To Watch: Pfizer Japan New President, Novo Nordisk China GM

Pfizer appoints new leadership in Japan amid sluggish growth. Top executive changes also made at Novo Nordisk and Stryker in China, Hutchison MediTech and Boston Scientific in the Asia Pacific.

Commercial Appointments

Policy & Regulation Explore this Topic

Ipsen To File Cabozantinib For Liver Cancer In 1H 2018

Exelixis and Ipsen's Phase III CELESTIAL trial succeeds: cabozantinib meets primary overall survival endpoint in patients with advanced liver cancer. 

Cancer Clinical Trials Research and Development Strategies

Allergan May Rue Mohawk Tribe Deal As Court Invalidates Restasis Patents

District court questions legitimacy of Allergan's patent transfer tactic, saying it 'could spell the end of the PTO's IPR program.'

Intellectual Property Legal Issues

European Approval Recommendation Delayed Again For Roche’s Ocrevus

No European approval recommendation for Roche multiple sclerosis drug Ocrevus but the Swiss major tells Scrip it is hopeful of getting approval within four months.

Neurology Drug Review

Spark's Gene Therapy Is On The Cusp Of Approval; Now It Gets Interesting

Spark's Luxturna is all but guaranteed to reach the US market as the first gene therapy following a unanimous positive FDA advisory committee review. Discussions about cost and value are sure to intensify.

Advisory Committees Market Access

Research & Development Explore this Topic

Chi-Med's Savolitinib: Overcoming Treatment Resistance in NSCLC

China-based but UK- and US-quoted Chi-Med is building up clinical data for its late-stage anticancer savolitinib, this time in patients with treatment-refractory lung cancer.

Clinical Trials Cancer Research & Development

Momentum For ViroMed's Gene Therapy After ‘Exceptional’ Trial Go-Ahead In China

China FDA has granted earlier-than-expected approval to begin a Phase III clinical trial of ViroMed's gene therapy VM202. Successful trials in China are expected to support global commercialization of the first-in-class therapy for cardiovascular and neurological diseases, which is also in late-stage clinical development in the US.

Research & Development Clinical Trials

Cara Ready To Move Into Pivotal Studies In ESRD Pruritus

With a successful end-of-Phase II meeting with FDA concluded, Cara moves closer to bringing the first drug to market for pruritus in ESRD patients on dialysis.

Clinical Trials Drug Approval Standards

Roche Goes Back To Nature With Warp Drive Antibiotic Pact

The Swiss major is paying up to $387m to get access to potential natural antibiotics that have not been analyzed previously, 'owing to historical technology limitations.'

Infectious Diseases Research & Development