PCSK9 race heads to the finish line with Amgen's evolocumab application

Amgen has taken another big step in its head-to-head race with Sanofi and Regeneron, filing its application for the prospective cholesterol blockbuster evolocumab and backing it up with more positive data from the latest in a long string of major clinical studies.

Two new biotech IPOs help set the stage for the fall parade

The crossover round is alive and well. Just a few days after Dermira put out the word that a consortium of backers had come up with a $51 million C round, the company rolled out a $75 million IPO. And the news, along with a fresh, $86 million filing from Rhythm Pharmaceuticals, helps set the stage for a new round of fall biotech IPOs that will once again test investors' appetite for risk.

The Ebola vaccine game plan takes shape as GSK, agencies hit the gas

Initially, GSK officials had sounded distinctly skeptical about whether the vaccine could be ready in time to help contain the outbreak. But this morning there was a distinct can-do attitude in its approach to the crisis.

Back on the 'hot' list, Achillion shares spike (yet again) on takeover talk

Ted Tenthoff, an analyst for Piper Jaffray, was clearly pumped about the prospects of an Achillion buyout when a reporter from Bloomberg reached him.

What's the #1 biotech hub for VCs? (It's still not Boston)

Biotech investing is sizzling right now, and despite all the attention that the Boston hub gets, the Bay Area is still number one.

Parkinson's play Civitas Therapeutics files for an $86M IPO

The S-1 prominently features Civitas' successful Phase IIb study for an inhaled formulation of levodopa, a "rescue" treatment for Parkinson's patients.

Thinking 'big,' Arch Venture gathers $400M-plus to back a new wave of biotechs

Arch Venture Partners has joined a lineup of top venture groups which has been making hay while the market sun shines on biotech IPOs. The VC has marshaled more than $400 million for its new investment fund--its eighth--that will now be available to back a new wave of cutting-edge life science companies, often starting from scratch.

Grabbing a quick $55M venture round, Bellicum Pharma ponders an IPO

Just 8 months after extending its last round with a $15 million raise, Houston-based Bellicum Pharmaceuticals has lured in a whole new group of backers to add $55 million to fuel its work. And the strategic financing allows the biotech to stare down a shot at an IPO while the window remains open.

After a string of gene therapy licensing deals, ReGenX says it's time to shine

ReGenX Biosciences is one of the most intriguing gene therapy biotechs you never heard of. And now the executive team in charge intends to start changing that.

Novartis CEO predicts a looming biosimilars boom

Novartis' big generics operation at Sandoz has been one of the leaders in the field of biosimilar development. So when the chief lays out a timetable on the adoption of these long-awaited knockoffs of some of the industry's biggest biologics, FierceBiotech listens.

Alkermes closer to launching once-monthly schizophrenia drug into a crowded market

Alkermes has taken another step toward the market with its long-acting version of the schizophrenia drug Abilify, filing for an approval with the FDA as it lays the foundation for a hoped-for launch in 2015.

Civitas nails $55M venture round for a PhIII Parkinson's study

Civitas Therapeutics has nailed down a substantial $55 million venture round aimed at getting its lead program for Parkinson's through Phase III and onto the market. The Chelsea, MA-based biotech is developing CVT-301, a fast-acting rescue formulation of levodopa that can be self-administered through an inhaler.

Banking on its R&D rep, Calithera looks to raise $80M in IPO

About 5 years ago, Susan Molineaux and the executive team at Proteolix decided the time was ripe to grab a buyout deal from Onyx, which would push ahead on its lead drug program to win an approval for Kyprolis, which in turn inspired the big Amgen acquisition. Now, about four years after launching their next venture, Molineaux and the team at Calithera think this is the right time to go public.

Pfizer and Merck extend heavyweight immuno-oncology pact to lung cancer

Merck and Pfizer have struck a deal to add the immuno-oncology superstar pembrolizumab to Xalkori for ALK-positive cases of advanced non-small cell lung cancer.

UPDATED: Kite Pharma spikes on its second take of CAR-T cancer study

Kite Pharma has once again demonstrated just how hot experimental CAR-T technology is in the cancer field. The Santa Monica, CA-based biotech reported Monday evening in a trial update that 12 of 13 evaluable patients with advanced B cell malignancies demonstrated a complete or partial response after being treated with its chimeric antigen receptor (CAR) T cell therapy.

Aldea raises $24M to push alcohol-poisoning antidote to the clinic

Aldea Pharmaceuticals closed a $24 million round of Series B equity financing to support the development of a drug designed to mitigate the severe--and sometimes deadly--effects of alcohol poisoning.

No deal: Report asserts that Roche has dropped any plans for Chugai buyout

The news that Roche struck a deal to buy InterMune for $8.3 billion reportedly came at the expense of Chugai's investors.

J&J snaps up Covagen and its protein-antibody fusion platform

Johnson & Johnson's Innovation Center in London has stepped in to help coordinate the acquisition of Covagen, a Swiss protein drug developer that's been working on an IL-17A anti-inflammatory for psoriasis in a very crowded field.

The real 'exclusive' at Merck: R&D is back in the saddle, baby

Reuters has the "exclusive" this morning that the FDA may approve Merck's PD-1 immuno-oncology superstar pembrolizumab for melanoma some weeks ahead of the October 28 PDUFA date. Then again, they may not, but it's looking good, according to the wire service.

Allergic reactions force Regado to pull the plug on PhIII anticoagulant study

Regado Biosciences just got called for its third strike by the safety board. The biotech, which raised tens of millions of dollars to fund a go-it-alone clinical program for an experimental anticoagulant, says the board called on Regado to shutter its Phase III study after determining that the serious allergic reactions investigators had recorded in the study made it impossible to go on.