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FDA

Puma wins a big round in fight for neratinib OK as experts offer a crucial thumbs up

Immuno-oncology, New Products

Pioneering Merck makes another breakthrough with PD-1 star Keytruda, grabbing first OK for a cancer biomarker

Workforce

Novartis swings the ax again, this time aiming at 250 job cuts in the US

Latest

NEWAerie shares shoot up as investigators take another big step to an NDA with 2nd positive glaucoma PhIII →

The FDA refuses to lift a clinical hold on Cel-Sci’s PhIII drug →

Ge Li’s fast-growing WuXi Biologics sets the stage for a $513M IPO →

Zai Lab CEO Samantha Du is raising a $150M biotech fund →

Hard charging Neurocrine hit with a sudden setback as Tourette study flops →

Ludwig Hantson is cleaning house at Alexion, booting R&D chief Martin Mackay and other execs →

Pfizer grabs a solid endorsement from FDA insiders for their knockoff of Amgen’s flagship drug Epogen →

Top News

Adam Koppel and Jeff Schwartz are done raising capital. Now they have $720M to do some serious deals at Bain

John Carroll

Trump administration doubles down on slashing the budget at NIH, FDA — with a user fee hike for biopharma

John Carroll

Regeneron, Sanofi win a delayed OK for rheumatoid arthritis IL-6 heavyweight sarilumab

John Carroll

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Protocols

Quick hits from around the biopharma web

May 24

ImmunoGen gets $25M upfront for ADC therapy; miRagen adds European orphan drug designation; Pierre Fabre buys some preclinical immunotherapies

May 23

AstraZeneca cheers a success for PhIII benralizumab study; TP raises $45M for cancer drug

May 22

Ablynx grabs a €15M milestones payment from Merck KGaA; EyeGate surges on Valeant payout

May 19

Astellas, Pfizer scrap a PhIII breast cancer study using Xtandi; New $30M fund will back Israeli biotech startups

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Thumbs Up/Down

May 19

A father's plea: The FDA needs to make sure that Juno's lethal disaster isn't repeated

May 5

Puma's fresh shiner, what the biotech IPO surge tells us, and the trouble with cancer R&D

Apr 28

Scott Gottlieb will push to publish CRLs; Marathon's demise offers the industry a cautionary tale

Apr 21

Don't let a slump in biopharma deals get you down — yet; The controversy on drug prices is taking a toll

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Special Reports

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House GOP Health Bill Would Add 23 Million Uninsured, Cut $119 Billion in Deficit Through 2026, CBO Says

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CBO Says GOP Health Plan Will Cut Deficit by $119 Billion

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Five charged with insider trading related to U.S. health agency

ENDPOINTS NEWS

Novartis swings the ax again, this time aiming at 250 job cuts in the US

Forbes

FDA Panel Votes 12 To 4 to Approve Puma's Breast Cancer Drug

ENDPOINTS NEWS

Hard charging Neurocrine hit with a sudden setback as Tourette study flops

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Follow Marco

Puma wins a big round in fight for neratinib OK as experts offer a crucial thumbs up

Pioneering Merck makes another breakthrough with PD-1 star Keytruda, grabbing first OK for a cancer biomarker

Novartis swings the ax again, this time aiming at 250 job cuts in the US

Latest

NEWAerie shares shoot up as investigators take another big step to an NDA with 2nd positive glaucoma PhIII →

The FDA refuses to lift a clinical hold on Cel-Sci’s PhIII drug →

Ge Li’s fast-growing WuXi Biologics sets the stage for a $513M IPO →

Zai Lab CEO Samantha Du is raising a $150M biotech fund →

Hard charging Neurocrine hit with a sudden setback as Tourette study flops →

Ludwig Hantson is cleaning house at Alexion, booting R&D chief Martin Mackay and other execs →

Pfizer grabs a solid endorsement from FDA insiders for their knockoff of Amgen’s flagship drug Epogen →

Top News

Protocols

Thumbs Up/Down

Special Reports

The 15 top R&D spenders in the global biopharma business: 2016

Top 10 pipeline blowups, setbacks and snafus in H1 2016

Where the money is: Biotech’s megahubs command VC's billions

Deep dives

What’s a biotech CEO worth? The top 15 pay packages puts a spotlight on performance — usually

A biotech billionaire tops the list of the 15 highest paid R&D execs in biopharma

The top 15 spenders in the global drug R&D business: 2017

Planning a clinical supply program? Don’t overlook primary packaging.

Alzheimer’s: Learning From a Legacy of Bitter Setbacks

The top 15 would-be blockbusters in the pipeline prepping for a 2017 launch

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Latest

Hot This Week

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