Innovation Yields New Therapies for MDR Infections, Hepatitis C and Hemophilia in 2014

innovation

2014 was another good year for the pharmaceutical and biotech industry, as evidenced by the introduction of 55 new products worldwide (as of December 23, 2014). This was the second highest performing year in the last decade, surpassed only by 2013 which saw 56 new launches, and a continued improvement over the low numbers generated at the beginning of this decade. (more…)

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New Labeling Rule Will Help, but Can’t Compensate for Scant Information on Drug Safety in Pregnancy

pregnancy

What is perceived as “safe” during pregnancy often varies among women and healthcare providers, many of whom rely on prescription drug labels to decide whether a medication’s benefits outweigh its risks to a pregnant woman, her developing fetus, or a breastfed child. The Pregnancy and Lactation Labeling Rule (PLLR), a final rule introduced by the FDA in December 2014, is meant to strengthen and standardize the content and format of product labels, to help women and their providers make informed decisions. (more…)

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New Sunscreen Approval—Why So Complicated?

sunscreen

Topically-applied sunscreen product use is a billion-dollar industry. The use of these products over the last 40 years has changed dramatically from a “niche” market of fair-skinned individuals who used small amounts on an irregular basis to the current market of a large swath of the adult and pediatric population, fair-skinned or not, over larger areas of their bodies on a much more regular basis—in some cases, daily. (more…)

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Reflecting on Generic Market Trends

Generic Market

Some key industry events are just around the corner, and many of the themes that ran throughout last year will likely continue to resonate in the industry this year. Many drug portfolios are being adapted to fit a new marketplace, as companies implement various strategies for survival in the pharmaceutical supply chain. The growth in global pharmaceutical spending in the coming years is likely to come from emerging markets and biologic medicines. As treatments become more specialized, most analysts anticipate the largest amount of spending to be in specialist therapy areas, such as oncology. While developed markets are still recovering from stagnant economies and trying to reduce healthcare spending, emerging markets are investing in healthcare systems and infrastructure. (more…)

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Notable Deals in the Pharmaceutical Industry in the 4th Quarter of 2014

Deals

During the 4th quarter of 2014, Cortellis Competitive Intelligence had 583 new deals added as part of its ongoing coverage of pharmaceutical licensing activity compared to 651 in Q3 2014 and 700 in Q4 2013. (more…)

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Ebola Vaccines: Both a Sprint and a Marathon

Ebola vaccines

Two weeks ago, policy-makers, researchers and vaccine developers met at the World Health Organization (WHO) headquarters to review the landscape of current and upcoming Ebola vaccine clinical trials. Their goal, in the words of Director-General Margaret Chan, was to “take stock, plan the next steps and make sure that all partners are working in tandem.” (more…)

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Dealmaking 2014 Boom Fueled by Strong Market, Renewed Pharma Focus

dealmaking

Dealmaking in “really robust” 2014 easily outstripped the previous year, with 3,141 agreements nailed down that year, valued at about $382.7 billion, as compared to 2013’s total of just over 2,100, worth about $158 billion, said Vinay Singh, senior deals analyst with Thomson Reuters Recap – “a third as many total deals, [with] well over twice as much” money involved. (more…)

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The Increased Importance of Dealmaking

dealmaking

Over the past few years, dealmaking has become an increasingly important strategy for pharmaceutical companies looking to expand. This increased dealmaking is largely due to slowed growth in developed markets and drug development focus shifting to specialty medicines. Pharmaceutical companies have continued to use acquisition as a way to expand market access and portfolios, but are also looking to local manufacturing partnerships, joint ventures and early stage development alliances to reach new markets, gain local expertise and share in risk. (more…)

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Celgene ‘2020’ Vision Projecting Tripled Sales in Coming Years

Celgene

Celgene Corp. kicked off the J.P. Morgan Healthcare Conference Monday morning with a long-term financial outlook that combines the firm’s tradition of conservative guidance, while placing emphasis on growing sales of top-selling drug Revlimid (lenalidomide) and a host of promising partnered programs, all with the projection of nearly tripling sales numbers by the year 2020. (more…)

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The Impact of the Changing Regulatory Environment on the Approval of New Medicines Across Six Major Authorities from 2004-2013

new medicine

Over the last decade, there have been major improvements in the global regulatory environment, leading to a reduction in the time needed by agencies to approve new medicines. Despite this, review timing is under constant scrutiny, by patients seeking quicker availability of new medicines, regulatory agencies looking to improve processes and pharmaceutical companies seeking a more timely and high-quality review. (more…)

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