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Novartis Claims New Drugs, Pipeline Will Fuel Growth, Not M&A

Novartis sees itself engaging in only modest M&A activity to avoid over-paying for targets - and will rely on newly launched drugs and promising external targets to grow sales.

Business Strategies Clinical Trials Commercial

Biogen Staying "Laser-Focused" On Neuroscience

The company is under pressure from investors to add new pipeline assets, but stronger than expected initial sales of Spinraza helped to assuage near-term growth concerns.

Sales & Earnings Business Strategies Neurology

1Q Pharma Results Preview: Biogen, Novartis, Lilly, Amgen, GSK, AstraZeneca, BMS, AbbVie, Roche, Bayer, Sanofi

Scrip offers some key points to watch for as the biopharmaceutical sales and earnings start to roll in. While the pricing debate in the US may have lost some steam, the negative impact of pricing pressure on J&J's pharma sales have analysts concerned.

Sales & Earnings Companies Business Strategies

Lilly Shows Diabetes Dominance, But Will It Last?

Lilly's first quarter benefited from rising sales for most of its diabetes products, which has become one of the most difficult therapeutic areas to do business in due to competitive and reimbursement pressures.

Sales & Earnings Market Access Companies

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Commercial Explore this Topic

Fresenius Covers All Bases With Akorn Acquisition And Merck Biosimilar Buy

Fresenius is shoring up its near-term US growth prospects by acquiring generics firm Akorn, as well boosting its future outlook by entering the biosimilars space via a deal with Merck KgaA.

Commercial Companies M & A

Discounts Will Be Key Factor In US Uptake Of Samsung's Renflexis

Samsung Bioepis, which has received its first US biosimilar approval, is now set to compete with compatriot rival firm Celltrion in the US infliximab biosimilar sector, where discounting is being seen as a key factor in the uptake of these products.

Biosimilars United States Approvals

Latest From Commercial

Asia Executives To Watch: Takeda Turns To Local Talent In Changing China

As China moves to implement a raft of planned policy and regulatory changes, including opening up more to new drugs from multinationals, companies including Takeda appear to be ringing in personnel changes and increasingly hiring local executives to senior positions.

Appointments Leadership

Can Barlow Flip E-Therapeutics From A Miss To A Hit?

Dr Raymond Barlow, the newly appointed CEO of e-Therapeutics, is hoping he can turn the lackluster business around and reposition it as a show stealing co-star for efficient drug discovery partnering, utilizing its bioinformatics platform technology.

Business Strategies StartUps and SMEs

Deal Watch: Novartis Signs Deals In Migraine & Diabetes

Novartis will invest in the Calgary-based Parvus and collaborate on a Navacim candidate for type 1 diabetes. Japan's Sawai moves into the US market by acquiring Upsher-Smith's generics business, while Denovo acquires a suspended depression candidate from AMRI for its personalized development approach.

Deals M & A

Lilly Preps Abemaciclib To Take On Ibrance; Differentiation Still A Question

The CDK4/6 inhibitor showed progression-free survival in patients with breast cancer in an interim analysis, and Lilly plans to begin global regulatory submissions for the drug in the second quarter.

Cancer Clinical Trials

BioMarin Could Launch Brineura Concurrently In US And Europe

The EU’s top advisory panel, the CHMP, has given a green light to BioMarin’s late-infantile Batten disease therapy, Brineura, one of the first therapies for the ultra-rare and fatal disease, a decision that comes just days before a US FDA decision is expected on the replacement enzyme therapy.

Advisory Committees Approvals

Almirall To Position Oral DMF For Psoriasis Ahead Of EU Biologics Use

Almirall aims to start selling its unpatented fumaric acid derivative throughout Europe in the third quarter for treating plaque psoriasis, but will not seek approval for the medicine in the US.

Approvals Business Strategies

Policy & Regulation Explore this Topic

Biogen’s Spinraza Needs Long-Term Confirmatory Data, Says EMA

The EMA may have quickly assessed the US biotech’s antisense spinal muscular atrophy therapy for Europe, but the product’s rapid clinical development means long-term data, and data on its effects in milder disease, or even cures, still need to be collected.

Approvals Rare Diseases Neurology

Pfizer Gets First Regulatory Nod For Besponsa

Pfizer's acute lymphocytic leukemia therapy Besponsa has received a positive recommendation in Europe, which should lead to the drug's first approval worldwide and will add to the high expectations for its regulatory outcome in the US later this year.

Approvals Policy & Regulation

Can Cholesterol Drug Sponsors Make The Case For Statin Intolerance?

Amgen's FOURIER outcomes study of Repatha supports LDL-lowering in high risk patients, but price may have to come down dramatically to spur wide use of the PCSK9 inhibitors with the subjective condition of statin intolerance.

Cardiovascular Reimbursement

India Pricing Authority Chief Says List Is No Attempt To Vilify Industry

The chair of India’s National Pharmaceutical Pricing Authority has tried to clear the air around the regulator’s recent public notice that lists over 600 products suspected of having flouted price caps, telling Scrip the chances of error around the data used to verify compliance is low, though at least half a dozen companies on the list indicate they have complied with the regulator’s norms.

India Pricing Debate

Research & Development Explore this Topic

Stealthy NGM And Bristol Emerge As Serious NASH Competitors

No longer quiet NGM Bio unveils Phase II data at EASL showing rapid and significant reductions of hepatic fat, while Bristol announces a partnership to produce a non-invasive diagnostic for NASH and presents promising Phase II data for its FGF21 analogue.

Clinical Trials Market Intelligence Research & Development

Latest From Research & Development

Genfit's Enrollment Delay In NASH May Aid Intercept's First-To-Market Goal

Firm cites heavy competition for NASH patients, as well as desire for balanced enrollment in elafibranor pivotal study. Competitor Intercept pushed back its Phase III enrollment timeline this past January.

Clinical Trials Market Intelligence

Lilly Preps Abemaciclib To Take On Ibrance; Differentiation Still A Question

The CDK4/6 inhibitor showed progression-free survival in patients with breast cancer in an interim analysis, and Lilly plans to begin global regulatory submissions for the drug in the second quarter.

Cancer Clinical Trials

Sarilumab Set To Clear EU Hurdle In RA But Actemra Specter Remains

While Sanofi/Regeneron's sarilumab is set to be the first of the newer IL-6 products to be cleared for rheumatoid arthritis treatment in Europe and the US, its commercial success is under doubt with physicians trying anti-TNF treatments first, followed by Roche's established IL-6 drug Actemra (tocilizumab).

Inflammation Drug Review