News

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.

A renal cancer study fails and stock plunges, but Bionomics stays upbeat

If you take some time with Bionomics' release on the Phase II study of their lead cancer drug you'll see that the trial failed, with progression-free survival for a combo use of the therapy with Afinitor tracking closely to the same PFS rate for renal cancer as a control arm which was treated with Afinitor only. The investment community apparently managed to accomplish the heavy lifting, though, pushing shares for the Australian penny stock company down 30% after the data drop.

C3 Jian gets a $60M round from some unconventional investors

LA-based C3 Jian has rounded up some players in the dental industry to provide a $60.5 million D round designed to get its lead therapy to prevent tooth decay through a mid-stage study while advancing a follow-up program produced with the biotech's platform technology.

Biogen hits an FDA speed bump with its next-gen MS drug

The FDA said it needs three more months to consider Biogen Idec's Plegridy, an injectable multiple sclerosis treatment, delaying an expected midyear launch for the company's latest entrant in its blockbuster MS franchise.

Meet RestorGenex, a biotech mosaic from Celgene founder Barer

Nearly three years removed from his Celgene retirement, Sol Barer is working to get another biotech off the ground, piecing together four drugmakers into a whole called RestorGenex and setting out to make a difference in dermatology, ocular diseases and women's health.

AstraZeneca signs up for MD Anderson's 'moon-shot' immuno-oncology project

MD Anderson's popular "moon-shot" immuno-oncology research project has won over another big industry player looking to play catch-up in the hottest race in cancer drug R&D. AstraZeneca's biologics arm, MedImmune, has become the latest Big Pharma player to join a team that has already attracted Pfizer and J&J.

Eager biotechs eye $133M in IPOs as a frenzied quarter closes

Three more drug developers are angling to go public in the waning days of a bustling first quarter for biotech IPOs, swinging for a combined $133 million to bankroll their programs. Agile Therapeutics, Aldeyra Therapeutics and GlobeImmune have all queued up for Wall Street debuts, hoping 2014's bull market lasts long enough to pull off offerings.

Upbeat review of PhII DMD trial earns Prosensa a big boost to shares

After the markets closed last night, Prosensa issued an upbeat self-assessment of its 48-week extension data from a Phase II study of its lead drug drisapersen for Duchenne muscular dystrophy.

Report: Novartis circles a deal to buy Gamida Cell in $600M deal

Israel's Globes is reporting that Novartis is pursuing a deal to buy out Israel's Gamida Cell for "hundreds of millions" of dollars upfront and hundreds of millions more in milestones, adding up to a total of about $600 million.

Biogen gambles on a $17M Atlas biotech launch, buyout option in hand

Biogen Idec is partnering with Atlas Venture on a biotech launch, with the Big Biotech investing in the company, helping on R&D and taking an option to scoop up the entire package at the end of Phase I.

Amgen goes 6-for-6 in Phase III, leading the race for a new cardio blockbuster

Amgen's promising cardio drug aced its 6th late-stage study, the company said, beating out statins in patients with a cholesterol-boosting genetic disorder and widening the drugmaker's lead in a potentially lucrative new field.

Bristol-Myers inks a $650M deal to pair with Five Prime on immuno-oncology gold rush

Bristol-Myers Squibb, a leader in the race to develop new immuno-oncology therapies, is pairing up with Five Prime Therapeutics to come up with a second set of cancer therapies that target two undisclosed immune checkpoint pathways in a deal worth up to $350 million.

Informa purges Elsevier unit staff in wake of buyout

Just a few months after Informa swooped in to buy out Elsevier Business Intelligence and plug it into its own operations, word is spreading that the company purged the staff last week.

Intercept scores a PhIII win for lead drug following Friday night frights

On Friday night Intercept Pharmaceuticals managed to rattle investors with a 10-K filing flagging a collection of serious cardiac adverse events recorded in a study of its lead drug OCA. But come Sunday morning, the biotech balanced out that bitter taste with an announcement that its Phase III trial had ended with positive data, setting up a regulatory filing for approval.

Chimerix started the week as a punching bag, then pulls off a TKO

Chimerix will evidently have no trouble finding the 20 patients it is recruiting for the pilot study of its antiviral brincidofovir. And it still isn't willing to provide its therapy under the FDA's "compassionate use" regulations.