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BIOCENTURY EXTRA LATEST HEADLINES


   TOP STORY

Tokai raises $92.7M in upsized IPO

Tokai Pharmaceuticals Inc. (NASDAQ:TKAI) was up $8.76 (58%) to $23.76 on its first day of trading Wednesday after raising $97.2 million through the sale of 6.5 million shares at $15 in an IPO. The IPO price valued the company at $327.6 million. BMO Capital Markets Corp; Stifel; William Blair; and Janney Montgomery Scott are underwriters. more >>

   CLINICAL NEWS

Gilead's simtuzumab misses in pancreatic cancer

Gilead Sciences Inc. (NASDAQ:GILD) said simtuzumab (GS-6624) missed the primary endpoint of progression-free survival (PFS) in a Phase II trial to treat patients with advanced pancreatic cancer. more >>

Flexion falls on FX006 trial hold

Flexion Therapeutics Inc. (NASDAQ:FLXN) fell $4.38 (23%) to $15.00 in early after-hours trading on Wednesday on post-market news that FDA placed a clinical hold on an ongoing Phase IIb trial of FX006 to treat osteoarthritis (OA) knee pain. more >>

   COMPANY NEWS

CVS reports on Sovaldi discontinuation rates

Discontinuation rates for HCV drug Sovaldi sofosbuvir from Gilead Sciences Inc. (NASDAQ:GILD) were nearly four times higher in a real-world setting than in clinical trials, according to an analysis of 1,965 patients from pharmacy benefits manager CVS Caremark Corp. (NYSE:CVS). more >>

Sutro, Merck KGaA in ADC deal

Sutro Biopharma Inc. (South San Francisco, Calif.) and the EMD Serono division of Merck KGaA (Xetra:MRK) partnered to use Sutro's Xpress CF and Xpress CF+ cell-free protein synthesis technologies to discover and develop antibody-drug conjugates (ADCs) against undisclosed cancer targets. more >>

Sun licenses Merck's tildrakizumab

Merck & Co. Inc. (NYSE:MRK) granted Sun Pharmaceutical Industries Ltd. (BSE:524715; NSE:SUNPHARMA) exclusive, worldwide rights to tildrakizumab (MK-3222). The anti-IL-23 antibody is in two Phase III trials to treat chronic plaque psoriasis, with data expected in June 2015. more >>

Sanofi, MyoKardia in cardiomyopathy deal

Sanofi (Euronext:SAN; NYSE:SNY) and MyoKardia Inc. (San Francisco, Calif.) partnered to develop targeted therapeutics for hypertrophic cardiomyopathy (HCM) and dilated cardiomyopathy (DCM). more >>

Auxilium jumps on Endo bid

Auxilium jumped $9.66 (45%) to $31.18 on Wednesday after Endo International plc (NASDAQ:ENDP; TSX:ENL) made an unsolicited bid to acquire the specialty pharma postmarket on Tuesday (see BioCentury Extra, Sept. 16). more >>

NICE draft recommends Olysio for some HCV patients

The U.K.'s NICE issued draft guidance recommending Olysio simeprevir from Medivir AB (SSE:MVIR B) and Johnson & Johnson (NYSE:JNJ) in combination with peginterferon alfa and ribavirin to treat HCV genotype 1 infection. more >>

NICE backs Tafinlar

The U.K.'s NICE issued a final appraisal determination (FAD) recommending Tafinlar dabrafenib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to treat adults with unresectable or metastatic melanoma with a BRAF V600 mutation, its approved indication. more >>

   POLITICS & POLICY

NICE still mulling changes

The U.K.'s NICE said it is undecided on how to amend its medicine and technology appraisal methods. Moreover, NICE said any changes to its appraisal methods will not sufficiently address concerns about how the NHS accesses new treatments. more >>

FDA awards C-Path $2.1M

FDA awarded the first $2.1 million of a potential $10.5 million five-year grant to the not-for-profit Critical Path Institute (Tucson, Ariz.). C-Path creates public-private partnerships to speed up drug development and approval. more >>

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BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS

BIOCENTURY, THE BERNSTEIN REPORT ON BIOBUSINESS
COVER STORY

Cancer: Cost and quality

Payer reforms of cancer care may result in more drug use, depending on how the schemes balance cost-effectiveness and quality outcomes.

STRATEGY

Cancer: Cost and quality

Payer reforms of cancer care may result in more drug use, depending on how the schemes balance cost-effectiveness and quality outcomes.

PRODUCT DISCOVERY & DEVELOPMENT

Learning from Gleevec

Gleevec pathfinder Brian Druker says the drug succeeded because CML can be diagnosed early, part of his 3-pronged approach to cancer.

Ebola realities

Hope that Ebola products might contain the current outbreak is sliding into hype as officials exaggerate how quickly products could be deployed.

EMERGING COMPANY PROFILE

Levicept: Modulating NGF

Levicept hopes its modulation of nerve growth factor may be disease modifying in osteoarthritis without the risks of anti-NGFs.

FINANCE

Broken-field runner

Why Receptos may have room to run after $500M run-up on Phase II MS data

ProQR tests IPO threshold

ProQR's backers, hot disease area could make it exception to preclin IPO rule

Ribomic test in Tokyo

Preclinical RNA play Ribomic looks to become Japan's first biotech IPO of 2014

OrbiMed's Asia 2.0

Why OrbiMed's new $325M Asia fund lacks European LPs

Ablynx's booster shot for U.S. access

Ablynx adds ADRs to increase U.S. investor access

OnCore performance

Ex-Pharmasset execs line up money, assets in OnCore to tackle HBV

Private equity tracks

Biotech investor, banker and analyst personnel changes

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