News

Sarepta's flash firing tightens the focus on a heavily scrutinized company

Sarepta Therapeutics' terse dismissal of its top scientist on Thursday has led to a swirl of rumors and anonymous-sourced reports of boardroom clashes, incompatible personalities and a possible coup attempt, bringing to light worrisome details on a company already under the microscope.

Sarepta science officer Krieg 'terminated' quietly

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

Keryx touts its kidney drug with an FDA decision around the corner

Keryx Biopharmaceuticals' in-development Zerenex helped reduce dangerous buildups of phosphorus in patients on kidney dialysis, meeting its goals in a Phase III study as the company awaits final word from the FDA.

Two more biotechs limp onto Wall Street with discounted debuts

Another hoped-for big week of biotech IPOs has come up well short, with two entrants downsizing their ambitions to make it out and a third reportedly thwarted by some bad timing.

Novo's blockbuster diabetes combo nears EU approval

A committee of European Medicines Agency advisers is recommending approval for Novo Nordisk's combination of a long-acting insulin and its blockbuster GLP-1 drug Victoza, setting the stage for a near-term approval of what's expected to be the diabetes giant's next big therapy.

Biotech IPOs sputter amid downsizings, disappointments and white flags

Six biotechs were expected to go public this week, eyeing nearly $400 million combined, but that potential has so far amounted to one deeply discounted offering, one bottom-of-the-range debut and one outright cancelation.

Sarepta slips after new CSO is quickly pushed out

So what happened to Sarepta's ($SRPT) new chief scientific officer? Hired just 7 months ago, the biotech issued a one-liner in an 8-K this morning stating simply that Art Krieg had been "terminated."

Big Pharma to share abandoned drugs, Actelion M&A rumors resume, Gaza war threatens IPOs

In this week's EuroBiotech Report, events in Gaza and Ukraine have cast a shadow over Europe, with sections of the Israeli biotech industry among the many groups indirectly affected by the fighting. And more.

Purdue earns a nod--and a quick slap--for abuse-resistant painkiller

The FDA has approved a new pain drug from Purdue Pharma that's intended to throw up a line of defense against the abuse of an extended-release reformulation of OxyContin. But all the approval seems to have accomplished is triggering some added eye-rolling from some of the experts fighting abuse.

Israel's Atox banks $23M to fight flesh-eating bacteria

Israeli drug developer Atox Bio has raised a $23 million E round to support its treatment for rare, tissue-destroying bacteria, paving the way for late-stage work.

A new VC player debuts with global plans to invest $150M in biotech startups

Over the last few years there's been something of a shakeout among biotech venture investors. There are fewer big players, but with IPOs taking flight again, established venture groups are rolling out new funds collectively worth billions of dollars. And now a pair of Asian pharma companies is bankrolling a rare operation: a brand new VC organization--Remiges Ventures--that plans to go hunting for biotech startups in the U.S. and Europe.

FDA opens the door for a Novartis biosimilar of Amgen's Neupogen

The FDA accepted Novartis' application to sell a knockoff of Amgen's biological treatment Neupogen, making the company a pioneer among those looking to capitalize on a soon-to-come U.S. market for biosimilars that is expected to explode.

UPDATED: Gilead picks up blockbuster FDA blood cancer approvals for idelalisib

Gilead said today that the FDA has approved its PI3k inhibitor idelalisib for three types of B-cell blood cancers following its early Phase III success last fall on impressive leukemia data. EvaluatePharma analysts estimate this drug could earn $1.2 billion a year by 2020, making it one of the top therapies in late-stage development.

Inovio vs. Feuerstein, Round II: Biotech claims PhII success for VGX-3100

Shares of Inovio Pharmaceuticals jumped about 20% this morning after the biotech said it had hit the mark on the primary endpoint for its mid-stage study of VGX-3100, an experimental therapy designed to eliminate precancerous cervical lesions.

UCB inches toward the FDA with its latest epilepsy contender

A new epilepsy treatment from Belgian drugmaker UCB helped reduce the rate of seizures in a Phase III trial, the company said, setting the stage for an FDA application and a shot at widening its footprint in the field.

Shire inks a $225M rare disease deal on the eve of life with AbbVie

Shire has signed a $225 million agreement to brighten its future in rare diseases, bolstering a major selling point for AbbVie as the two prepare for a $54.7 billion merger.

Eagle Pharma nabs FDA OK for hyperthermia drug

Eagle Pharmaceuticals ($EGRX) has nabbed an FDA approval for its new-and-improved formulation of dantrolene sodium, which will be sold as Ryanodex, for potentially lethal cases of malignant hyperthermia.

Sofinnova closes $500M venture fund, keeps late-stage focus

Sofinnova Ventures has evolved rapidly over the past decade to suit the times, from a diversified early stage biotech and IT investor to focusing solely on later stage biotech. And LPs seem to think it is making all the right moves; it has closed a ninth fund at $500 million, the hard cap for the fund that was initially targeting $425 million.

Puma shares triple on positive PhIII neratinib data, plans to file for approval

Shares of Puma Biotechnology soared more than 220% after the markets closed on Tuesday as investors cheered the biotech's positive Phase III numbers for a late-stage study of their lead drug neratinib (PB272). 

We're looking for 2014's Fiercest women in biotech

Our annual top women in biotech report spotlights women in the life sciences industry, academia and regulatory roles who are outstanding members of the field. Our nomination form for this year's...