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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Democrats snub 21st Century Cures bill

Nine months after U.S. House Energy & Commerce Committee chairman Rep. Fred Upton (R-Mich.) launched the 21st Century Cures initiative as a bipartisan effort, the committee released a discussion draft Tuesday without support from Democrats. Republicans can pass legislation in the House, but would need bipartisan support to pass a bill through the Senate. more >>

   COMPANY NEWS

Sandoz moves to dismiss Amgen patent suit

The Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) filed a motion in the U.S. District Court for the Northern District of California seeking an order to dismiss patent infringement and related claims from Amgen Inc. (NASDAQ:AMGN) related to Sandoz's application to market Zarxio (EP2006), a biosimilar of Amgen's neutropenia drug Neupogen filgrastim recombinant methionyl human granulocyte colony-stimulating factor (G-CSF). more >>

Express Scripts' Miller says HCV deals will save billions

Steve Miller, SVP and CMO of Express Scripts Holding Co. (NASDAQ:ESRX), wrote in a blog post that the PBM's deal last month with AbbVie Inc. (NYSE:ABBV) covering HCV treatment Viekira Pak will save its clients "more than $1 billion this year" on HCV treatments. more >>

Biogen, Google to begin MS study

Biogen Idec Inc. (NASDAQ:BIIB) and the Google X Life Sciences innovative research unit of Google Inc. (NASDAQ:GOOG) have established a collaboration to study the symptoms and progression of multiple sclerosis (MS). The two are planning a study that will use Google's sensor platforms and bio-analytical tools to monitor patients and look for clues that can predict patient outcomes. The companies did not disclose terms of the collaboration or details of the study. more >>

   FINANCIAL NEWS

Zosano raises $49.5 million in IPO

Zosano Pharma Corp. (NASDAQ:ZSAN) gained a penny to $11.01 in its first day of trading after it raised $49.5 million in an IPO on NASDAQ through the sale of 4.5 million shares at $11. The price valued Zosano at $130 million, including shares purchased by Eli Lilly and Co. (NYSE:LLY) in a concurrent $15 million private placement at the IPO price. Ladenburg Thalmann and Roth Capital Partners are underwriters. Zosano initially proposed to raise up to $65 million in its offering last June. more >>

   POLITICS & POLICY

21st Century Cures draft proposes wide reforms

The U.S. House Energy & Commerce Committee released a discussion draft Tuesday of 21st Century Cures legislation that proposes sweeping changes to FDA regulation of drugs, medical devices, clinical research and reimbursement. more >>

NICE recommends Soliris, but tries to stem costs

The U.K.'s NICE is relying on requirements around dose adjustments and stopping rules for clinical reasons to rein in costs to NHS of use of the rare disease drug Soliris eculizumab from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN). In its final guidance, NICE recommended use of the humanized mAb against complement 5 (C5) to treat atypical hemolytic uremic syndrome (aHUS). more >>

TransCelerate adds two members, appoints chair

Not-for-profit biopharma consortium TransCelerate BioPharma Inc. (Philadelphia, Pa.) added Merck & Co. Inc. (NYSE:MRK) and Novo Nordisk A/S (CSE:NVO; NYSE:NVO) as member companies. Merck acquired TransCelerate member Cubist Pharmaceuticals Inc. last week. more >>

Obama to request $1.2B for antibiotics

The White House announced Tuesday that its FY16 budget proposal will include a request to nearly double spending on combating and preventing antibiotic resistance. more >>

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BIOCENTURY

BIOCENTURY
COVER STORY

Takeda's patients

Takeda is not waiting for FDA to clarify the next steps in patient-centered drug development, and is already using patient input to design clinical trial protocols in leukemia.

PRODUCT DISCOVERY & DEVELOPMENT

Adapting for speed

AM-Pharma is using an adaptive trial design to fast track development of recAP through Phase II testing for acute kidney injury.

EMERGING COMPANY PROFILE

Digital droplet diagnostics

Velox is developing a digital droplet platform to create rapid and sensitive diagnostic tests for infections, neurological diseases and cancers.

Cloaking conjugates

Blend's Pentarin platform may produce better efficacy than ADCs by delivering more drug to the tumor with better tissue penetration.

POLITICS AND POLICY

Zarxio lessons

Why Sandoz's Mark McCamish says the U.S. biosimilars pathway is viable in the wake of FDA's first adcomm for a biosimilar.

FINANCE

Adding up the follow-on bonanza

January 2015 biggest month ever for biotech follow-on financings

Innovent's $100M for mAbs

What China mAb play Innovent plans to do with $100M in new cash

The price of HCV competition

HCV battle erodes combined $13B in market cap from AbbVie, Gilead

Proof from partnerships

RegenxBio plans to move 2 gene therapies with $30 million series C

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