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  • More with less

    How Merck KGaA's new R&D chief is shaping the pipeline

    The first half of next year will bring evidence of whether Merck Serono's new R&D chief has put the pipeline on solid footing.

    Published on 11/23/2015
  • Figure: Merck KGaA's pipeline progress

    More with less Merck KGaA's pipeline progress In his first 16 months as head of R&D at Merck KGaA (Xetra:MRK)'s biopharma unit, Luciano Rossetti has advanced six programs within the company's core focus areas of …

    Published on 11/23/2015
  • Scaling compassion

    FDA, industry, patient groups charting compassionate use policies

    Compassionate use experiments are improving fairness and transparency but are not sufficient to ensure access or avert aggressive social media campaigns.

    Published on 11/16/2015
  • Demanding rights

    State right-to-try laws reveal patient demand for preapproval access to drugs

    The most controversial preapproval access experiment is being conducted by state legislatures. Critics say right-to-try laws help no one.

    Published on 11/16/2015
  • Pfizer's growth spurt

    How Allergan would fit with Pfizer

    Pfizer has created its own growth story over the last 18 months, making a takeout of Allergan more an amenity than a necessity.

    Published on 11/9/2015
  • Box: Establishing the business

    Pfizer's growth spurt Establishing the business Pfizer Inc.'s established pharma business includes drugs that are generic or will be by the end of 2015, as well as biosimilars and sterile injectables. Revenues …

    Published on 11/9/2015
  • Figure: Growth potential

    Pfizer's growth spurt Growth potential Since last year’s aborted attempt to acquire AstraZeneca plc (LSE:AZN; NYSE:AZN), Pfizer Inc. (NYSE:PFE) has increased top- and bottom-line growth rates through acquisition …

    Published on 11/9/2015
  • Figure: Pfizer's pipeline progress

    Pfizer's growth spurt Pfizer’s pipeline progress In the last 18 months, Pfizer Inc. (NYSE:PFE) has gotten three new products approved and advanced 10 other late-stage programs to the next phase of development or …

    Published on 11/9/2015
  • Figure: Trailing off?

    Flight to liquidity Trailing off? Private investing by some of biotech's most active crossover investors, such as Fidelity, Rock Springs and Jennison, appears to be dropping off this quarter, but with two months …

    Published on 11/2/2015
  • Table: Crossing guards

    Flight to liquidity Crossing guards The 27 IPOs shown below — which constitute three-quarters of the 36 U.S. IPOs that raised more than $100 million in 2014-15 — all received crossover funds while still private. …

    Published on 11/2/2015
  • Flight to liquidity

    How crossover fall-off is changing private financing strategies

    An uncertain IPO market is eliminating an arbitrage opportunity that helped fuel the sector's biggest and most successful public exits.

    Published on 11/2/2015
  • Freeing speech

    Amarin, Pacira cases will determine how FDA changes off-label regulations

    A relentless stream of legal losses is forcing FDA to revamp regulation of off-label communications.

    Published on 10/26/2015
  • Box: Amarin's ANCHOR

    Freeing speech Amarin's ANCHOR Amarin Corp. plc sued FDA in the U.S. District Court for the Southern District of New York in May 2015 after the agency warned it against off-label promotion of Vascepa icosapent …

    Published on 10/26/2015
  • Box: Intended use

    Freeing speech Intended use In September FDA released a proposed rule overhauling its regulations on "intended use" that would reduce the chances that drug companies will be put in legal jeopardy based solely on …

    Published on 10/26/2015
  • Box: Pacira's pain

    Freeing speech Pacira's pain A lawsuit filed by Pacira Pharmaceuticals Inc. in the U.S. District Court for the Southern District of New York breaks new ground because it seeks First Amendment protection for …

    Published on 10/26/2015
  • Box: Supplementing indications

    Freeing speech Supplementing indications Extending First Amendment protections to off-label communications would reduce or eliminate incentives for companies to conduct rigorous research on new indications, …

    Published on 10/26/2015
  • Table: Protecting commercial speech

    Freeing speech Protecting commercial speech For most of U.S. history, courts ruled that speech by and on behalf of businesses was not protected by the First Amendment to the Constitution. This began to change in …

    Published on 10/26/2015
  • Unleashing China's innovators

    How China FDA reforms may unleash development of innovative drugs

    An ambitious slate of China FDA reforms could profoundly affect development of innovative drugs in and for China.

    Published on 10/19/2015
  • Box: Unintended consequences

    Unleashing China's innovators Unintended consequences If regulatory reforms proposed in August by China's State Council succeed in boosting domestic development of innovative drugs, China FDA's GCP certification …

    Published on 10/19/2015
  • Table: China's regulatory ambitions

    Unleashing China's innovators China's regulatory ambitions China's State Council has proposed an ambitious slate of reforms to bring China FDA to international regulatory standards as part of a greater plan to …

    Published on 10/19/2015
  • Trans-Pacific politics

    Pharma and biotech companies weighing political responses to TPP deal

    PhRMA and BIO's response to the TPP deal is all about protecting biosimilars exclusivity in the U.S.

    Published on 10/12/2015
  • Box: Hillary's TPP strategy

    Trans-Pacific politics Hillary's TPP strategy Given the drug industry's antipathy for the Trans-Pacific Partnership, it may seem curious that Hillary Clinton cited its benefits to pharmaceutical companies as one …

    Published on 10/12/2015
  • Figure: Mapping exclusivity

    Trans-Pacific politics Mapping exclusivity In the short term, the biologics exclusivity provisions of the Trans-Pacific Partnership (TPP) are neutral or moderately favorable for innovative manufacturers. The …

    Published on 10/12/2015
  • Volatile, not futile

    Biotech turned red in 3Q15 but bankers, buysiders say it's the lone growth sector

    Pricing is on the radar of generalist investors, and likely will remain an issue through next year's presidential election in the U.S.

    Published on 10/5/2015
  • Drawn and quartered

    Biotech winners, losers in 3Q15

    3Q15 saw every biotech market cap band post big losses, although a few winners emerged in each group.

    Published on 10/5/2015

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