News

Boehringer's stumble is InterMune's gain in lung drug race

InterMune watched its shares jump more than 15% after Boehringer Ingelheim posted some mixed results for its rival idiopathic pulmonary fibrosis treatment, all while the biotech has nearly tripled in value over the past 30 days.

Versartis grabs $126M in an upsized IPO to fund its orphan drug

A month removed from raising $55 million in Series E cash, Versartis has hauled in $126 million more in an IPO, filling its coffers and planning to take its growth hormone deficiency treatment all the way to market.

EU smiles on Lilly and Boehringer's FDA-rejected diabetes drug

European regulators are recommending approval for Boehringer Ingelheim and Eli Lilly's latest diabetes offering, shrugging off a manufacturing issue that spiked the drug's FDA approval and putting the pair in line for third place in a new class of treatments.

Novo says Tresiba's down but not out of the blockbuster diabetes race

Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.

Biogen's Scangos joins Agilent board

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)...

UPDATED: Merck, Endocyte score crucial EMA OK for conditional approval of vintafolide

Endocyte and its Big Pharma partner Merck won the support of the Committee for Medicinal Products for Human Use at the EMA for conditional approval of the biotech's lead drug in Europe, winning over regulators with mid-stage data demonstrating that vintafolide successfully delayed disease progression for ovarian cancer.

Partnerless Aveo is back on the hunt as Biogen returns a cancer drug

With the departure of Astellas and now Biogen Idec, Aveo Oncology is fresh out of collaborators, sending the struggling biotech back to the partnering table as it looks to advance an early-stage cancer drug.

Harvard team fingers missing protein as a key to Alzheimer's

The team concluded that a protein called REST--particularly active in the brains of fetuses and now emerging as a key gene regulator in older brains--also appears to protect neurons in the elderly.

Pfizer snags a 'breakthrough' tag for its meningitis vaccine in a race with Novartis

Pfizer picked up the FDA's breakthrough therapy designation for an in-development vaccine against meningococcal disease, a common cause of meningitis, lighting the path for an accelerated approval as the drugmaker looks to expand its vaccine portfolio beyond the blockbuster Prevnar 13.

J&J trumpets early success for 3-month Invega Sustenna PhIII schizophrenia trial

J&J wrapped a Phase III study of a 3-month formulation of Invega Sustenna early after an independent monitoring group called it on positive efficacy data. That's good news for J&J as well as Alkermes, which provided their NanoCrystal delivery tech for the new-and-improved therapy.

Biotechs bag $170M in IPO cash as a booming quarter winds down

Drug developers Akebia Therapeutics and MediWound banked a combined $170 million in their Wall Street debuts, stacking cash for their lead programs and taking advantage of a banner quarter for biotech IPOs.

Geron sinks as liver risks plague another imetelstat trial

A week after the FDA put a halt to Geron's in-house studies of the cancer drug imetelstat over toxicity concerns, the agency stepped in on a Mayo Clinic-run trial of the same treatment, citing familiar dangers and imposing a partial clinical hold.

Sanofi launches a vaccine R&D program with blockbuster Prevnar 13 in its sights

Sanofi has put Pfizer on notice that it's going after the blockbuster pneumococcal conjugate vaccine market and Prevnar 13. France's pharma giant is partnering with SK Chemicals in South Korea to ramp up a global vaccine program, kicking off with a $23 million upfront payment from Sanofi in a deal designed to split research costs and share profits from around the world.

GlaxoSmithKline's cancer vaccine MAGE-A3 suffers its second PhIII flop

Once a top Phase III program at the pharma giant, MAGE-A3 failed to hit a pair of primary endpoints for non-small cell lung cancer, its second failure since the melanoma flop that occurred in the first hurdle of the study reported last fall.

McKinsey's four drug launch flavors: Good, bad, ugly and misguided

What's the probability of a good drug launch? About one in three, according to a new McKinsey & Co. analysis.

With a $300M buyout fund, Maravai sets out to make a biotech splash

Private equity outfit GTCR has recruited two industry veterans and put up $300 million to create Maravai Life Sciences, a buyout-focused firm out to make some deals.

The FDA vs. the flash mob: Hard questions as parents demand unproven drugs

Last week the parents of 7-year-old Josh Hardy managed to whip up a media tempest big enough to get the biotech Chimerix and the FDA to work out a pilot study so that their child could be treated after their compassionate use request was denied, alongside many others. Now the parents of another young boy afflicted by a terrible disease are using some interesting PR tactics in an attempt to achieve a much larger goal.

Novo touts a PhIII hemophilia win as it chases Biogen, Bayer

In the race to win FDA approval for a long-acting hemophilia A treatment, Novo Nordisk said its factor VIII therapy came through in a Phase III study, helping the Danish drugmaker play catchup in a three-way contest with Biogen Idec and Bayer.

Bristol-Myers partner Alder Bio looking for $115M IPO haul

What does $190 million in R&D spending get you? In the case of Alder Biopharmaceuticals, it got a blockbuster $1.35 billion development deal with Bristol-Myers Squibb and an in-house migraine drug headed into a Phase IIb study. It also takes the biotech to the threshold of an IPO it detailed today, which is designed to raise $115 million to fund operations through 2015.

Proteon sets out on its own after Novartis waves off a $550M deal

Five years after optioning the right to buy Proteon Therapeutics for up to $550 million, Novartis has walked away from the table despite what Proteon says was a successful study of its blood vessel-dilating drug, leaving the biotech to fend for itself as it prepares for Phase III.