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Commercial

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All Change At Alexion, But Will It Boost Investor Confidence?

The US rare diseases company Alexion appoints a new COO and is now looking for a new CFO, head of R&D, and head of human resources, as leadership changes leaves its CEO searching for a new executive team.

Appointments Business Strategies Rare Diseases

Pfizer On Lung Cancer: "We Need To Have Single-Agent Avelumab"

President-Pfizer Oncology Liz Barrett said the company remains committed to demonstrating the value of Bavencio in first-line lung cancer despite a recent setback that will push data out to 2019.

Clinical Trials Business Strategies ImmunoOncology
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Companies

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Latest From Companies

Bayer's Weinand On Broadening Value-Based Pricing Views

Bayer's pharma head Dieter Weinand talks about his biggest issues with current value-based pricing assessments for new drugs and how companion diagnostics will pave the way to easier pricing of oncology therapies.

Pricing Strategies Reimbursement

Korean Pharma Spawns US Cancer Biotech Startup

Dr. Benjamin R Cowen, COO of ImmunoMet Therapeutics, reveals how the Houston-based startup is developing OXPHOS inhibitors to treat drug resistant and relapse cancers.

Companies StartUps and SMEs

Celltrion Gets Go-Ahead For Remsima Trials In China, Mulls JV

Celltrion has received approval to begin clinical trials of its biosimilar infliximab in China and also filed IND applications for other biosimilar products with the CFDA, accelerating plans to enter the world’s second biggest pharma market as it propels efforts for global leadership in the biosimilar space.

Commercial Companies

Bone Therapeutics Looks To ALLOB Data Progress

Following its IPO in 2015, Belgium's Bone Therapeutics has been making progress on its allogeneic osteoblastic cell product, ALLOB, which recently appointed CEO Thomas Lienard pegs as the company's most valuable platform. With the product currently in Phase II trials, Lienard shares his plans for the company.

Companies Research and Development Strategies

Clozel's CHF1bn Actelion Spin-Out Idorsia Awaits Janssen Buy-In

Upon completion of Johnson & Johnson's $30bn acquisition of Actelion, Jean-Paul Clozel, the latter's outgoing CEO, aims to build a new European biopharma big-hitter – Idorsia – with the earlier-stage assets Actelion leaves behind. He's hoping that J&J's Janssen will soon opt in to rights to its lead candidate. Idorsia is preparing to launch onto the Swiss Stock Exchange with CHF1bn in cash at inception.

Financing StartUps and SMEs

ARCH CV Signal Scuppers Blockbuster Hopes For Amgen/UCB's Evenity

New Phase III data for the novel osteoporosis therapy romosozumab are set to delay its approval, reduce its commercial potential and open the market to rivals.

Companies Clinical Trials
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Deals

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Latest From Deals

Aerie's M&A Potential Rises As Roclatan Passes Second Phase III Glaucoma Test

Positive Phase III data for Aerie's second glaucoma drug candidate Roclatan – which will support a US FDA submission in the first half of 2018 – have boosted the California company's M&A allure.

Research & Development Clinical Trials

Up Front Or Back End? Considering The Best Structure For Milestone Fees

PwC partner Dmitri Drone explained that a deal for an asset with high commercial expectations is best structured with more emphasis on pre-approval than post-approval payments. A post-approval focus on shared risk is more appropriate when an asset is licensed at an earlier stage of development.

Business Strategies Deals

Deal Watch: Takeda Signs Broad Cancer Collaboration With Nektar

Takeda will pair five cancer candidates with different mechanisms of action with Nektar's NKTR-214 and Merck follows up its Phase III disappointment verubecestat by licensing a preclinical Alzheimer's drug from Teijin.

Deals M & A

Bioverativ Fills Gap In Pipeline With $400m True North Buy

Bioverativ revealed its first transaction since spinning out from Biogen with the acquisition of True North for $400m plus up to $425m in milestone payments. The deal gives Bioverativ a clinical asset, helping to fill the gap between preclinical programs and commercial products in its R&D pipeline.

Deals Business Strategies

Finance Watch: Two More US Biopharma IPOs And Two New European VC Funds

Two biopharma IPOs in the US continue streak of (mostly) positive returns; two new European VC funds launch as Irish antibiotic developer raises $65m; and Halozyme, Ziopharm price offerings.

Business Strategies Commercial

Chiesi Wins EU Nod For COPD Triple Combo, But Partner Is Predicted For Launch

Chiesi's triple combination therapy for COPD, Trimbow, has secured its first approval globally after winning a positive recommendation from the CHMP for its use in Europe – but analysts expect a respiratory partner will be required to launch the product.

Approvals Respiratory
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Strategy

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Latest From Strategy

Cipla Cuts Down In-House Biosimilars Plans

Cipla is recalibrating investments in the “resource-intensive” biosimilars business, reinforcing its thrust on the respiratory and specialty products segment. Large biosimilar manufacturing plans in South Africa have been put on hold, with curtains seemingly coming down at an Indian unit.

Commercial Strategy

US Price Pressure Clouds Lupin Outlook – Can Its Pipeline Deliver?

Lupin reported a sharp decline in its fourth quarter profits, dented by heightened price pressure and competition in the US for its key products. The management sees a ‘challenging’ 2018, but underscored the strength of the firm’s ANDA pipeline and enhanced investments in the biosimilars, inhalation and injectables space.

Commercial Strategy

Clozel's CHF1bn Actelion Spin-Out Idorsia Awaits Janssen Buy-In

Upon completion of Johnson & Johnson's $30bn acquisition of Actelion, Jean-Paul Clozel, the latter's outgoing CEO, aims to build a new European biopharma big-hitter – Idorsia – with the earlier-stage assets Actelion leaves behind. He's hoping that J&J's Janssen will soon opt in to rights to its lead candidate. Idorsia is preparing to launch onto the Swiss Stock Exchange with CHF1bn in cash at inception.

Financing StartUps and SMEs

Come Flood Or High Water – How BioNet Is Shaping Its Vaccine Ambitions

Emerging Company Profile: Thailand-based BioNet stuck it out despite widespread flooding at its site and now expects to take its pertussis vaccine to key Western markets.

StartUps and SMEs Vaccines

J&J Forges Ahead In Immunology Despite Competitive Dynamics

The diversified pharma has two NMEs and three sNDAs pending at FDA in immunology, as well as six more anticipated sNDA filings. Immunology Therapeutic Head Susan Dillon told investors why there is still plenty of opportunity for growth in key autoimmune diseases.

Business Strategies Launches

Novo Nordisk CEO Puts Pricing On The Line

Lars Fruergaard Jørgensen, Novo Nordisk's CEO, says the group's pledge on price transparency, goals for improved outcomes and experimental use of digital health are commercially linked.

Commercial Companies
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Market Access

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Latest From Market Access

Scrip Asks… Is The Biosimilar Cost-Saving Theory Sustainable?

Scrip asks industry whether the promise of biosimilars producing substantial cost-savings is a sustainable model to help healthcare systems afford the next wave of expensive biologics. Drug developers and trade associations comment on the caveats still in play when it comes to biosimilars, cost-cutting and market access.

Biosimilars Market Access

Shire Discontinues Development Of Once-Weekly SHP656 For Hemophilia A

Shire's cash-strapped partner Xenetic, whose technology enabled the long-acting Factor VIII, said on May 22 that SHP656 could not achieve once-weekly dosing in a Phase I/II clinical trial. The market for such a product may be limited anyway given current competition and payer preferences.

Research & Development Commercial

Lilly-Lupin Bolster India Alliance But Cialis Faces Crowded Market

Eli Lilly and Lupin are building on their alliance in India, with Lupin introducing Lilly’s Cialis (tadalafil) – a teeming market awaits the product, however.

Commercial Generic Drugs
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Market Intelligence

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Latest From Market Intelligence

Mehta Analysis: Biopharma's 10% Myth

Viren Mehta, founder of Mehta Partners, LLC, considers the oft-repeated statement that the cost of drugs represents only 10% of US healthcare expenditure. Does it matter that the figure excludes a large and growing segment of medicine spending?

United States Pricing Debate

Scrip Asks… Is The Biosimilar Cost-Saving Theory Sustainable?

Scrip asks industry whether the promise of biosimilars producing substantial cost-savings is a sustainable model to help healthcare systems afford the next wave of expensive biologics. Drug developers and trade associations comment on the caveats still in play when it comes to biosimilars, cost-cutting and market access.

Biosimilars Market Access

The Pharma Pipeline Report Card 2017, An Infographic

The Pharmaceutical and Biotech industries’ R&D performance can be measured in a number of ways. Here is a look at its worldwide output of novel drug launches for 2016 and total pipeline size in 2017.

Research & Development Market Intelligence
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