News

Amgen notches positive PhIII results for top cancer drug

Once again, Amgen's R&D chief Sean Harper has Roger Perlmutter to thank for a positive late-stage outcome on one of the Big Biotech's top cancer prospects.

Amgen's big Asian push triggers $75M heart drug pact for Japan

Amgen's new Asia strategy is paying off for one of its development partners. Shares of Cytokinetics surged 18% this morning after Amgen agreed to hand over $25 million in cash and up to $50 million in royalties in exchange for the Japanese rights to a heart drug now on the threshold of Phase III testing.

Top AstraZeneca exec bows out to helm a biotech

AstraZeneca's announcement early this year that Peter Greenleaf would be "promoted" from the head of MedImmune to the top job in the company's big Latin American division raised a few eyebrows around the industry.

Dermira scores $35M venture round for dermatology pipeline

Less than 2 years after grabbing a $42 million A round, Dermira's team of biotech veterans has gone back to the venture well for $35 million more to advance a slate of dermatology treatments for acne and inflammatory skin conditions.

Alzheimer's drug market starts to shrivel as caseload explodes

According to analysts, the Alzheimer's drug market peaked last year at $10.2 billion and will now slide 1.5% per year until 2017, when the cash returns will slide to about $9.5 billion.

Takeda's Millennium Pharmaceuticals R&D rejig unfolds

Last month, Millennium CEO Deborah Dunsire stepped down and company veteran Anna Protopapas stepped in as president of the company, which will no longer operate as autonomously as it had before the reorganization. The reorganization will also come at the expense of an undisclosed number of jobs.

GlaxoSmithKline's research chief in China fired for data fraud

The head of GlaxoSmithKline's R&D operation in China has been fired while another researcher has resigned following a company probe into allegations that data on interleukin-7 research published in Nature Medicine was "misrepresented" by company researchers.

Elan drops lawsuit against Royalty Pharma, assesses other inquiries

Elan has ditched a complaint against Royalty Pharma in a U.S. District Court, having filed the lawsuit against Royalty for lacking disclosures in its takeover bid last week. Ireland-based Elan is claiming a victory because it dropped the lawsuit after Royalty responded with additional disclosures in its latest and increased bid to acquire Elan.

Agios selling $86M IPO to fund its first cancer drug trials

Cambridge, MA-based Agios Pharmaceuticals has raised a pile of cash from venture groups and Celgene in recent years. And now it's headed to the public market to see if it can raise $86 million more in an IPO, pitching a drug development platform that has yet to undergo testing in the clinic.

Hunt for 2013 Fierce 15 begins… Release the biotech hounds!

Calling everyone from the global biotech community. We've begun seeking nominations for FierceBiotech's 2013 class of Fierce 15 companies, and our editors would like to give readers a voice in the selection process. It's really easy: Just fill out our online nomination form here.

Sanofi finally nears the goal line for MS drug Lemtrada

Lemtrada, Sanofi's "new" drug for multiple sclerosis, helps demonstrate just how plagued the drug-development process can be, with a series of false starts and sudden stops as it was handed off from one company to the next. Today, Reuters' Ben Hirschler chronicled the 25-year R&D odyssey, which is expected to be capped soon with a European approval followed soon after by an FDA decision.

Gilead gains FDA's inside track for hep C drug sofosbuvir

The FDA announced that regulators are providing a priority review for the treatment, potentially lopping four months off of the review process.

Shire chief focuses on deal-making, trials with eye to revving up sales

After whetting analysts' expectations on the deal-making front, he executed a series of small deals for experimental ophthalmology treatments--which fit well with his own professional background.

Dynavax tumbles after FDA blocks shortcut on hepatitis B vax salvage operation

Shares of Dynavax Technologies took a fresh dive this morning after the biotech announced the FDA had provided some fresh insights into the safety data it wants to see before it can approve the hepatitis B vaccine Heplisav, likely adding to the delay before the biotech can try again in seeking an approval.

FDA blasts Aveo one last time for 'uninterpretable' cancer study

Days after the Cambridge, MA-based biotech whacked close to two thirds of its staff as it scrambled to stay afloat in the wake of a scathing regulatory assessment of its lead drug, the developer says that the FDA has handed over the expected rejection notice for tivozanib as a treatment for kidney cancer.

UPDATED: AstraZeneca bags another PhIII therapy in $1.15B Pearl buyout

The Pearl Therapeutics buyout gives AstraZeneca's late-stage development director Briggs Morrison a Phase III respiratory therapy just days after the pharma giant was forced to throw in the towel on the rheumatoid arthritis drug fostamatinib.

Roche rejects option on autism drug from struggling Seaside

Seaside Therapeutics has suffered a string of setbacks recently. Swiss drug giant Roche has passed on taking an option on Cambridge, MA-based Seaside's lead drug candidate arbaclofen, which the biotech startup revealed last month flunked a Phase II autism study and Phase III trial in Fragile X patients. 

Forest prepares to negotiate with investor Icahn on board positions

Forest Laboratories faces another proxy battle as its annual investor meeting this summer looms. Icahn, the company's second largest shareholder, has been highly critical of the company's leadership.

Forrester is Verastem CEO after Westphal steps down

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

Canada's Medicago reports positive early data for H7N9 vaccine

Global concern is growing over the outbreak of H7N9 avian influenza in China. So far, 133 cases of H7N9 sickness have been confirmed, and at least 37 deaths are deaths are thought to have been caused by the disease.