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Pfizer Sets The Stage For A Biosimilar Showdown Over Exclusive Contracts

Pfizer filed a lawsuit against J&J over its efforts to block sales of Pfizer's biosimilar Inflectra through exclusive contracting for Remicade. The suit claims J&J coerced payers by vowing to withhold all Remicade rebates if any Inflectra is reimbursed. J&J says Pfizer has failed to show the value of Inflectra.

Biosimilars Legal Issues Market Access

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 Platform Technologies

Refocused Novo Nordisk Says On 'Road To Recovery' After Traumatic 2016

Novo Nordisk's head of international operations says the company has learned from the past, taken corrective steps, and is now on the road to recovery.

Business Strategies Leadership Metabolic Disorders
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Report: Women Eschew Life Science Companies That Lack Female Leadership

MassBio and Liftstream partnered on a report about women's, men's and companies' views on gender diversity in the life science industry and identified several opportunities for employers to improve, including the need to employ more women in leadership roles to attract female job-seekers.

Human Capital Leadership Business Strategies


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Commercial Explore this Topic

More Is Better? UK Crowdfunding Platform Selects First Firms

Capital Cell's effort might be the beginning of a viable alternative to VC funding for budding biotech companies.

Financing United Kingdom StartUps and SMEs

AbClon Shines On Korean Debut Amid Robust Investor Interest

AbClon has made a strong debut on the Kosdaq market with investors backing the innovative antibody drug firm in a year where IPOs by South Korean novel drug developers have been generally scarce.

Commercial Financing South Korea

Cipla Secures Ex-FDA Official As Compliance Head

Indian firms have been making extensive efforts to improve their compliance record, including getting on board top-notch global talent. Cipla, which recently appointed a new head of respiratory manufacturing, has tapped an ex-FDA investigator as its audit and compliance director.

Appointments Companies

Finance Watch: Former GSK CEO Witty, R&D Head Slaoui Join VC Firms

Medicxi's new $300m venture fund will benefit from the expertise of former GSK R&D leader Moncef Slaoui, while ex-CEO Witty will inform portfolio strategy at Hatteras. Also, Kaleido hires past Cubist CEO and brings VC funding to $65m, while Gilead sells $3bn in debt to fund Kite deal.

Leadership Financing

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

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

Deal-Making Firm On Fosun’s Agenda As Overseas Revenues Spurt

With overseas revenues rising sharply in the first half of 2017, Fosun Pharma expects to build on its global investment strategy at a fast pace, striking more deals to acquire products and companies from developed markets.

BioPharmaceutical China

The Next Roivant Or Fortress? BridgeBio Raises $135m To Spin Out New Companies

BridgeBio's hub-and-spoke model is similar to the Roivant and Fortress strategies, but with a focus on drug candidates for genetic diseases in need of a bridge to future funding.

Financing Business Strategies

Policy & Regulation Explore this Topic

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 Policy & Regulation

Nabriva's Antibiotic Lefamulin Does Well In First Of Two Pivotal Trials

Results from the first Phase III study – LEAP 1 – of the antibiotic lefamulin are positive, and Nabriva still has one trial to go. But the firm believes that regardless of that result, the totality of data could be used to support regulatory filings.

Infectious Diseases Drug Approval Standards

Fosun Tweaks Gland Deal Amid Limbo In India

China’s Fosun group isn’t backing off from its $1bn-plus buyout of Gland Pharma and will now pursue a tweaked version of the original deal that technically qualifies for automatic approval under Indian rules. Whether that means smooth sailing hereon remains unclear.

Commercial Deals

Ocrevus Delay As CHMP Continues Assessment?

The CHMP's assessment of Roche's novel multiple sclerosis therapy Ocrevus continues, making a year-end approval unlikely.

Companies Approvals

Research & Development Explore this Topic

Pipeline Watch: Phase III Readouts For ADV7103, Pembrolizumab, Upadacitinib

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 Research & Development

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

Sanofi Ready To Pull The Plug On Regeneron 'Life Support'

Global R&D President Elias Zerhouni said Sanofi has the knowledge and skills it needs to discover antibody drugs internally and it's time to end the perception that Regeneron is keeping Sanofi's R&D humming.

Deals Research & Development

JAK Inhibitors Have Dupixent In Their Sights For Atopic Dermatitis

Analysts predict that Sanofi and Regeneron's Dupixent is going to dominate the severe eczema market but the oral options of Lilly/Incyte's baricitinib and AbbVie's upadacitinib are progressing through the pipeline to make a challenge.

Immune Disorders Dermatology
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