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May 17, 2017

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Today's Rundown

  1. Bayer cancer drug boards path to speedy approval at FDA

  2. G1 pitches IPO to advance lung and breast cancer candidates

  3. AstraZeneca sets out post-Brexit wish list for U.K. politicians

  4. Johnson & Johnson sets sights on introducing 11 blockbusters by 2021

  5. Concert hit with alopecia drug delay as FDA puts it on clinical hold

  6. China's FDA aims to speed drug OKs with shift to U.S.-style clinical trial application process

Featured Story

Bayer cancer drug boards path to speedy approval at FDA

The FDA has granted priority review status to Bayer’s copanlisib, setting the PI3K inhibitor up to speed through the regulatory process in six months or less. Bayer secured the privileged position on the strength of data from a mid-phase trial in patients with non-Hodgkin lymphoma.

Top Stories

G1 pitches IPO to advance lung and breast cancer candidates

G1 Therapeutics thinks it has a winner on its hands with CDK4/6 inhibitor trilaciclib and is embarking on an initial public offering to give it the resources it needs to bring it to market.

AstraZeneca sets out post-Brexit wish list for U.K. politicians

AstraZeneca EVP Mene Pangalos has laid out how he wants the next government to support the United Kingdom’s life sciences sector through Brexit. The R&D leader’s wish list to U.K. politicians includes a “welcoming” environment for global talent and a local regulatory agency aligned with the EMA.

Johnson & Johnson sets sights on introducing 11 blockbusters by 2021

Johnson & Johnson has listed the pipeline prospects it expects to drive the growth in its biopharma business for years to come. The company is hoping to get 11 potential blockbusters ready for market by 2021, starting with regulatory green lights for psoriasis candidate guselkumab and rheumatoid arthritis prospect sirukumab.

Concert hit with alopecia drug delay as FDA puts it on clinical hold

Concert Pharmaceuticals' just-started phase 2a trial of its baldness candidate CTP-543 has been halted by an FDA request to look at preclinical toxicity data.

China's FDA aims to speed drug OKs with shift to U.S.-style clinical trial application process

China's FDA is proposing another round of policy changes designed to hasten clinical trial approval and lift restrictions placed on trial sites, with the ultimate goal of allowing drugs to get into the clinic faster.

News of Note

The CEO of Novelion left the Novo Nordisk board over a NASH conflict. Reuters article

Conatus Pharmaceuticals completed a public offering to fund the expansion of its pipeline. Statement

Merck and Aduro Biotech agreed to test Keytruda in combination with CRS-207. Release

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The U.S. Department of Justice has collected upwards of $17 billion in settlements from the healthcare industry since 2009, including more than $2 billion from a single life sciences company.

Events

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