News

GSK's R&D staff hit with trade rumors spurred by Novartis' cancer pact

GlaxoSmithKline hasn't spelled out exactly how its big deal with Novartis will impact individual workers. But the rumor mill has it that more than 100 investigators in cancer R&D in Collegeville, PA, are about to become Novartis workers.

Novartis, GSK deal puts the spotlight on a narrowing R&D focus

The big trend in Big Pharma R&D has been to cut back significantly in key areas where they felt they faced extraordinarily high risks--a particular problem in the central nervous system field, where trial failures have been more the norm than the exception.

Spectrum touts PhII cancer data, plans NDA

Shares of Spectrum Pharmaceuticals surged on the news that its experimental injectable drug for blood cancer looked promising in a Phase II study.

Amgen beats a path to the FDA, looking for an early approval of leukemia drug

Amgen is getting aggressive with one of its midstage leukemia drugs. In its earnings call with analysts the big biotech's R&D chief called out blinatumomab, saying that recent Phase II data might warrant an early approval.

Kala reels in $22.5M to get its next-gen eye drops into PhIII

Kala Pharmaceuticals, co-founded by MIT biotech luminary Robert Langer, has closed a $22.5 million B round, cash the company says will help advance its novel approach to eye treatments.

Shooting for IPO glory, Alder cites trial success with migraine drug

A few weeks after Seattle-based Alder Biopharmaceuticals spelled out plans to raise $115 million in an IPO designed to propel them into the ranks of a fully diversified biotech company, the biotech has released some key data points from its proof-of-concept study on its experimental migraine therapy.

Allergan fashions a poison pill as raiders at Valeant promise to gut R&D

Allergan didn't waste any time in coming up with a poison pill to help thwart a hostile, $46 billion takeover attempt by Valeant CEO J. Michael Pearson and his hedge fund ally William Ackman. The board issued a shareholder rights plan on Tuesday evening giving its general investors the right to buy discounted shares once someone accumulates a threatening stake in the company of 10% or more.

Epizyme jumps on $4M payday

Shares of Cambridge, MA-based Epizyme jumped 10% this morning after the company announced that it had won a $4 million payment from GSK after hitting the third of the three histone methyltransferase targets in their collaboration.

VC groups put up $165M for a trifecta of biotech rounds

A Detroit-based biotech has landed a $59.5 million round to continue its work on a nucleic acid-based DNAi cancer therapy now in a mid-stage trial. ProNAi Therapeutics CEO Mina Sooch says that's enough cash to get the company through 2016, with plans to pursue partnership talks as well as a discussion with the FDA about potential ways to accelerate the approval process for their lead therapy.

AbbVie heads to the FDA with its hep C combo in a race with Gilead, Merck

AbbVie has submitted an FDA application for its promising all-oral hepatitis C treatment, expecting approval this year as it prepares for a three-way race with perceived leaders Gilead Sciences and Merck.

GlaxoSmithKline punts its cancer R&D work in Big Pharma swap and shop

Novartis, GlaxoSmithKline and Eli Lilly have hammered out a pact to swap, sell and partner on a group of four different divisions, realigning the corporate and marketing landscape for each of the big three pharma players. 

Analysts brace for a brawl as Valeant moves ahead with $46B Allergan bid

Activist investor William Ackman has allied himself with biopharma raider Michael Pearson at Valeant to buy out Allergan, the maker of Botox, which has been actively hunting down its own buyouts, according to a report Monday evening from The Wall Street Journal.

FDA OKs Lilly's blockbuster hopeful ramucirumab for stomach cancer

The bull case for Eli Lilly and its long-stunted R&D operation rests largely on a potential string of FDA approvals for the much-hyped ramucirumab, and the Indiana drugmaker picked up its first, clearing the treatment to treat stomach cancer.

Aastrom surges after acquiring Sanofi's cell therapies

A little more than a year after reorganizing the company and slashing staff in the wake of a Phase III failure, Ann Arbor, MI-based Aastrom Biosciences has acquired Sanofi's cell therapy and regenerative medicine business for the low, low purchase price of $6.5 million--$4 million payable in cash and $2.5 million in a promissory note.

Former Creighton professor named chief medical officer at 23andMe

Welcome to this week's Chutes and Ladders, our roundup of hirings and firings throughout the industry. Please send the good word--or the bad--from your shop to Michael Gibney (email | Twitter)...

Sarepta rockets up after mapping a shortcut to the FDA with DMD hopeful eteplirsen

After keeping investors on a roller coaster ride of speculation for months, Sarepta says it now plans to shoot for an accelerated approval of its Duchenne muscular dystrophy drug eteplirsen. The biotech says it will file for an early approval by the end of this year after launching a slate of new clinical trials to get the data that the FDA is looking for.

Zafgen tees up an $86M IPO for eye-catching obesity drug

Zafgen has been turning heads with some jaw-dropping results from its mid-stage studies for a promising new obesity drug. And now the biotech hopes to parlay its eye-catching, if risky, technology into an $86 million IPO.

Say what? Pfizer's $101B buyout pitch to AstraZeneca sparks a megadebate

Pfizer has reportedly made overtures offering to buy the struggling pharma giant AstraZeneca for $101 billion, setting the stage for what could be the first megamatchup in pharma land in years.

FDA lifts its hold on Juno's cutting-edge cancer drug after deaths trigger delay

The FDA has lifted a clinical hold placed on a study at Memorial Sloan-Kettering of Juno Therapeutics' cutting-edge approach to treating cancer using genetically tailored T cells, FierceBiotech has learned.

Nasdaq volatility delays IPO, Almirall pulls drug over price, Topotarget to merge as PDUFA nears

Welcome to this week's edition of our EuroBiotech Report, in which we have news of how the rise and fall of U.S. biotech and med tech stocks is shaping decisions in Europe.