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Out fast at opening bell Price-to-earnings: BT vs RX At the end of 1Q13, the average P/E for biotech was 21.3, up 16% from 4Q12 and up 11% from a year ago. Shares of six of the eight companies used to calculate the …
Published on 4/1/2013
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Out fast at opening bell Results by market cap All of biotech's market cap segments were up in 1Q13. The $1-$4.9 billion group performed the best, led by 60%-plus moves by Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD)…
Published on 4/1/2013
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Out fast at opening bell 1Q approvals Selected first quarter product approvals. Company Approval Alexza Pharmaceuticals Inc. (NASDAQ:ALXA) EC approves Adasuve Staccato loxapine to treat mild to moderate …
Published on 4/1/2013
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Out fast at opening bell Index performance Index 1Q12 NYSE Arca Biotechnology 18% NASDAQ Biotechnology 17% BioCentury 100 16% BioCentury Europe 15% NYSE Arca Pharmaceutical 12% DJIA 11% S&P 500 10% …
Published on 4/1/2013
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Out fast at opening bell Restructuring watch At least 10 companies reduced their workforces in 1Q13, compared to at least nine in the same period last year. All cash and operating loss figures in $M. (A) 12-month …
Published on 4/1/2013
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While sponsors may wish for more access to FDA's benefit-risk framework, the scheme will force the agency to document its regulatory thinking and provide a tool to resolve internal conflicts about regulatory actions.
Published on 3/25/2013
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Reframing FDA Patient-Focused Drug Development At an Oct. 25, 2012, public meeting, FDA asked for patient input on what diseases should be the focus of 20 patient-focused meetings it has promised over the next five …
Published on 3/25/2013
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Reframing FDA The framework FDA's proposed benefit-risk framework lays out five decision factors intended to standardize the components of the benefit-risk assessment for drug and biologics reviews. For each factor,…
Published on 3/25/2013
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Japan's biggest biotech Kyowa's pipeline Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and its partners have at least 25 compounds in clinical development, excluding line extensions and drugs already marketed by the …
Published on 3/18/2013
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Japan's biggest biotech Kyowa's sales by segment Over the last four years, Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) has simplified its business to focus on two main revenue streams -- pharmaceuticals and biochemicals…
Published on 3/18/2013
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Japan's biggest biotech Kyowa's deal flow Since 2010, Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) has done at least 13 pipeline building deals. Nine were discovery or preclinical stage. Most recent deals at top. (A) JV …
Published on 3/18/2013
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Japan's biggest biotech Kyowa's pipeline Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) and its partners have at least 25 compounds in clinical development, excluding line extensions and drugs already marketed by the …
Published on 3/18/2013
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Japan's biggest biotech Kyowa's top five drugs The top five drugs from Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) accounted for ¥135.9 billion ($1.7 billion) in sales, or about 54% of total net sales from the …
Published on 3/18/2013
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A year into the job, KHK scientist-CEO Nobuo Hanai has set a course that would feel familiar to Western biotech CEOs, growing organically by combining the company's technology with targets from academia.
Published on 3/18/2013
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The deadline to finalize the U.K.'s value-based pricing system is fast approaching. But patient groups have yet to be invited to the negotiating table, while an EU-funded study is challenging the value of QALYs.
Published on 3/11/2013
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Affymax's Omontys will reinforce a de facto two-speed system of FDA approvals under which timelines are getting shorter for targeted agents, and longer for drugs intended for use in broad populations.
Published on 3/4/2013
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Two-speed system Salving safety concerns The trifecta of a novel adjuvant, a broad population and alternatives on the market sunk Dynavax Technologies Corp.'s first attempt to gain approval for its Heplisav HBV …
Published on 3/4/2013
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A more complete telling of FDA's review of the diabetes drug illuminates the agency's reluctance to accept uncertainty about the safety of treatments it considers incremental improvements over existing therapies.
Published on 3/4/2013
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To reap the benefits of its more than $200 billion investment in life sciences, China needs to streamline and expand SFDA, while removing restrictions that make it the last stop for global drug developers.
Published on 2/25/2013
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Europe Ltd. Europe's negative numbers Aggregate European sales by 10 innovator pharmas fell $10.1 billion (11%) in 2012 compared to 2011, while U.S. sales dropped $6.2 billion (5%). The U.S. falloff was driven by …
Published on 2/18/2013
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Pharma companies are starting to shrink their footprints in Europe in the face of pressure on prices and reimbursement. But emerging markets and the U.S. won't lessen the need for new strategies to address shrinking …
Published on 2/18/2013
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The outcome of litigation brought by Novartis against the German Federal Joint Committee could determine the agency's ability to beat down prices for drugs that are already on the market.
Published on 2/18/2013
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Departing FDA neurology division Director Russell Katz now gets high marks from drug developers and patient groups, but they say his successor will need to be more risk-tolerant if new drugs are to reach patients.
Published on 2/11/2013
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Boehringer sidestepped problems that delayed a once-daily LABA from Novartis by designing a robust development program that produced a clear dose response for olodaterol in COPD.
Published on 2/4/2013
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FDA wants a public discussion on proposals to create a pathway for drugs for limited, well-defined populations with serious or life-threatening conditions. Key is finding a way to inhibit, but not prohibit, off-label …
Published on 1/28/2013