Are you prepared for CPhI Worldwide?

CPhI Worldwide

In less than 75 days, one of the most important trade shows in the pharmaceutical industry will happen in Paris. CPhI Worldwide brings together stakeholders from all aspects of the pharmaceutical supply chain, from base chemical manufacturing representatives through major drug marketers. Attendees and exhibitors will meet with customers and suppliers, discuss market trends with their global counterparts, and identify new business opportunities and partners. (more…)

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Shire’s Tax and Drug Assets Make it an Attractive Takeover Target for AbbVie

abbvie and shire deal

In a $55 billion deal, AbbVie and Shire agreed this month to combine the two companies, continuing the wave of big takeovers in the pharmaceutical industry. With Shire’s specialty drugs portfolio and pipeline, the buying of Shire by AbbVie is partly motivated by AbbVie’s strategy of reducing its reliance on its main revenue driver and anti-inflammatory blockbuster, Humira (adalimumab), which is set to lose patent protection in 2016. Shire’s British tax domicile is also a draw, as AbbVie could bring down its effective US current tax rate of about 22% to 13% by 2016 in a tactic known as tax inversion. However, the US government is urgently trying to close this tax loop hole. (more…)

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Sovaldi – Innovative, Cost Effective, Unaffordable

Sovaldi

The world changed for many HCV sufferers in December 2013, with the launch of Sovaldi (sofosbuvir) – an effective cure for chronic disease in almost 90% of subjects with type 1 infection (when used in combination with ribavirin +/- peginteferon alpha).

Or did it? The price of Sovaldi was immediately set at US $84,000 per 12-week course as Gilead sought a fast return on its investment, a cost far out of reach of the majority of HCV patients. The controversial pricing policy has reignited the debate over what is just reward for innovation, short-term costs versus long-term savings in health spending, the rights of private companies to sell products for the highest price the market can bear, and the ethics of limiting access to affordable, effective medicine. (more…)

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Product Targeting for Paragraph IV Patent Challenges

Paragraph IV

Over the years, the competitive landscape of the U.S. generic drug industry has evolved. Paragraph IV patent challenges, which at one time were undertaken primarily by the larger players in the generic field and largely focused on the best-selling products, are now standard operating procedure for ANDA filers of all sizes and for all products. Industry giant Teva has been the most prolific Paragraph IV filer over time, but Teva’s rate of filing has slowed significantly in recent years as the company has broadened its focus beyond generics. Meanwhile, other companies have joined the patent challenge fray, hoping to bring generic drugs to market in advance of the competition. (more…)

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With Great Opportunity Comes Great Challenges in the 3-D Printing Space

3-D printing in med-tech

Spider-Man fans know that with great power comes great responsibility. The same could be said of using 3-D printing, also known as additive manufacturing, in the medical field.

For as many opportunities as 3-D printing offers, the industry has to tackle a host of regulatory, financial, and legal challenges before the technology can be fully adopted for medical use. (more…)

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Partnering Returned Assets can Rescue, Maximize Value

REUTERS/Brian Snyder

Deal terminations can throw even the most confident companies for a loop, dealing a blow to the perceived value of even still-promising assets. Finding a new partner saves the day, but it takes careful strategic planning, according to panelists at the recent Allicense 2014 meeting in San Francisco.

With more than 1,300 therapeutics deals announced in the last three years, according to Thomson Reuters Cortellis and Recap, some are bound to fall apart. The reasons behind break-ups can vary. Clinical partnerships are typically terminated by the partnering company as a result of non-compelling clinical data, lower than expected commercial opportunity, development delays or a reassessment of strategic fit, according to Locust Walk Partners LLC managing director and co-founder, Jay Mohr. (more…)

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The ‘Danger Theory’ of Immune Recognition: 60 Years on from ‘Self Non-Self’

The ‘Danger Theory’ of Immune Recognition

Inducing tissue damage and inflammation to eliminate disease is a long established clinical concept. Historically, Hippocrates is claimed to have said, “Give me the power to induce fever, and I cure all diseases.” At the turn of the last century, William B Coley, a surgeon at Memorial Sloan Kettering Hospital, New York (from 1892 to 1936) used a mixed bacterial vaccine (Coley’s toxin) in a systemic way to treat patients with metastatic cancer. (more…)

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Application of Personalized Medicine in CLL

REUTERS/Andres Stapff

CLL is the most common leukemia in the Western world, accounting for a third of all leukemia cases and an incidence of 4.2 cases per 100,000 individuals. Although observed in all age groups, the incidence of CLL increases from less than 1 per 100,000 in individuals aged 40 to 44 years to 30 per 100,000 aged 80 years and older, with the majority of people diagnosed with CLL being over 60 years of age and an average age of diagnosis of 72 years. Other risk factors for the disease include a family history of blood and bone marrow cancers and exposure to certain herbicides and insecticides. Patients with CLL may experience a wide range of symptoms, including pain and swelling of the lymph nodes, tiredness, fever and infection, and weight loss. Often symptoms are not experienced for several years and CLL is frequently detected following a blood test performed for other reasons. Between 25 and 50 percent of patients are asymptomatic when diagnosed. (more…)

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Deal Making Still Continues its Torrid Pace, Report Finds

REUTERS/Tarek Mostafa

Deal making is continuing its breakneck pace in the life sciences sector with a combined total of almost $50 billion generated from 587 transactions in the first quarter of the year, according to data released in April by Thomson Reuters Recap at the Allicense 2014 meeting.

Similar to 2013, overall deals, which in addition to those involving biopharmas also includes medical devices, diagnostics and tools firms, continue to target early stage assets, leading creative deal making in which contingent-value agreements and option deals carry the day, said Laura Vitez, principal business analyst for Thomson Reuters Recap. (more…)

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3-D Printing Breaks Through Confines of Traditional Med-tech Manufacturing

3-D Printing in Med-tech

Imagine a world in which people in need of an organ transplant could jump the wait list and have a new lung or kidney 3-D printed in a matter of days. It might sound like a science fiction plot, but 3-D printing has already saved lives and the world has only seen the tip of this technological iceberg. For the next two weeks, I will explore the potential of this seemingly futuristic technology, the challenges it presents, and where 3-D printing is likely to have the greatest impact in healthcare. (more…)

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