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  • Paving the way

    How Amgen, Sandoz IP battles may unleash a flood of Humira, Enbrel biosimilars

    Amgen and Sandoz are likely to gain approval of biosimilar versions of Humira and Enbrel, but they won't have the U.S. market to themselves for long.

    Published on 7/25/2016
  • Table: Enbrel biosimilars

    Paving the way Enbrel biosimilars At least nine programs have made it to the clinic with biosimilars of autoimmune drug Enbrel etanercept from Amgen Inc. (NASDAQ:AMGN). While the GP2015 BLA from the Sandoz unit of…

    Published on 7/25/2016
  • Table: Humira biosimilars

    Paving the way Humira biosimilars At least 16 biosimilars of Humira adalimumab from AbbVie Inc. (NYSE:ABBV) have made it into the clinic, including two that are approved in India. A BLA for ABP 501 from Amgen Inc.…

    Published on 7/25/2016
  • Eurosimilars

    Why it's hard to extrapolate European biosimilars market penetration to the U.S.

    European biosimilars market penetration and prices are all over the map, making it hard to extrapolate the EU experience to the U.S.

    Published on 7/25/2016
  • PRO-fessional label

    How a new PRO could end up on cancer drug labels

    FDA is hopeful that data from a new PRO launched by NCI could find its way onto drug labels in the next year or two.

    Published on 7/18/2016
  • Shedding red

    Biotech winners, losers in 2Q16

    Brexit soured what looked to be a rebound quarter for biotech.

    Published on 7/11/2016
  • Figure: Biotech fund flows

    Ground up Biotech fund flows Biotech funds have seen net outflows in every month of 2016, though the outflow of $933.3 million in 2Q16 was less than either of the first two months of the year. In 1H15, fund …

    Published on 7/11/2016
  • Table: Follow-on performance

    Ground up Follow-on performance Thirty-seven biotechs raised a combined $2.1 billion in follow-ons last quarter, bringing the total for 1H16 to $3.9 billion. In 1H15, 150 companies raised $19 billion. The 2Q16 …

    Published on 7/11/2016
  • Table: IPO performance

    Ground up IPO performance Sixteen biotechs raised $767.5 million in IPOs last quarter, bringing the total raised in 1H16 to $1.4 billion. In 1H15, there were 50 biotech IPOs that raised a total of $5 billion. The …

    Published on 7/11/2016
  • Table: IPO queue

    Ground up IPO queue At least eight companies have announced plans to go public since the start of 2Q16, bringing the IPO queue to at least 23. Unless noted, companies are seeking to list on NASDAQ. Filings are …

    Published on 7/11/2016
  • Ground up

    How biotech stocks may navigate post-Brexit, pre-election waters

    Biotech stocks are shaking off a Brexit hangover while facing a presidential election overhang. Both have curbed generalists' appetite for risk.

    Published on 7/11/2016
  • Rethinking risk

    Investors' top names and milestones in 3Q16

    Going into 2H16, some buysiders want companies that have turned over their data cards. Others are combing a plethora of Phase II and III events for upside.

    Published on 7/11/2016
  • Figure: London vs. Europe

    Shedding red London vs. Europe The BioCentury Europe index rose 9% in 2Q16, as 10 of 19 continental European companies in the market cap-weighted index showed gains. The big driver was Genmab A/S (CSE:GEN), which …

    Published on 7/11/2016
  • Figure: Price-to-earnings: BT vs. RX

    Shedding red Price-to-earnings: BT vs. RX Biotech's average P/E ended 2Q at 24, up 16% from 1Q16 and down 8% from a year ago. The 2Q16 average is inflated by Vertex Pharmaceuticals Inc. (NASDAQ:VRTX). Backing out …

    Published on 7/11/2016
  • Figure: Results by market cap

    Shedding red Results by market cap Companies in the $1-$4.9 billion market cap segment were the best performing band in 2Q, finishing the quarter up a median of 1.9%. The $500-$999 million segment and those valued…

    Published on 7/11/2016
  • Table: 2Q approvals

    Shedding red 2Q approvals Selected 2Q approvals. Company Approval AbbVie Inc. (NYSE:ABBV) / Genentech Inc. / Roche (SIX:ROG; OTCQX:RHHBY) FDA grants accelerated approval to Venclexta venetoclax to treat …

    Published on 7/11/2016
  • Table: 3Q milestones

    Rethinking risk 3Q milestones Selected products with clinical or regulatory milestones expected in 3Q16. (A) Jazz Pharmaceuticals plc (NASDAQ:JAZZ) is acquiring Celator Pharmaceuticals Inc. (NASDAQ:CPXX); Source: …

    Published on 7/11/2016
  • Table: Index performance

    Shedding red Index performance Index 2Q16 1H16 BioCentury Europe 9% -3% NYSE Arca Pharmaceutical 7% -2% BioCentury London 7% -1% NYSE Arca Biotechnology 2% -21% S&P 500 2% 3% BioCentury 100 2% -…

    Published on 7/11/2016
  • Table: Restructuring watch

    Shedding red Restructuring watch At least 13 companies reported workforce reductions in the second quarter compared to at least five in the same period last year. Table below is sorted by date ascending. All cash …

    Published on 7/11/2016
  • Is that clear?

    How Vermont's drug price transparency law could pave the way for price controls

    Vermont's drug price transparency law is part of a national strategy that is aiming for price controls.

    Published on 6/27/2016
  • Box: PhRMA explains

    Is that clear? PhRMA explains In March 30 testimony about Vermont's drug price transparency law, PhRMA Assistant General Counsel John Murphy discussed the industry's perspective on drug pricing. The PhRMA …

    Published on 6/27/2016
  • Figure: Transparency provisions

    Is that clear? Transparency provisions Vermont is the first state to enact a drug price transparency law, but at least a dozen were introduced in state legislatures during 2015-16. Some of them have expired …

    Published on 6/27/2016
  • Fireside with Califf

    FDA Commissioner Califf's priorities on patients, communication and FDA staffing

    FDA's Robert Califf says industry should communicate directly with patients, and more progress is needed to match patients with experimental drugs.

    Published on 6/20/2016
  • Califf gets precise

    How Califf sees FDA's role in the Precision Medicine Initiative

    Robert Califf on why he turned from skeptic to advocate for exploiting genomics in precision medicine.

    Published on 6/20/2016
  • Triple's shot

    ASCO 2016: How triple-negative breast cancer landscape is evolving

    A handful of abstracts at ASCO suggest that targeted therapies could finally be on the horizon for triple-negative breast cancer.

    Published on 6/13/2016

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