Sarepta and BioMarin race for an FDA tag that could be worth $350M-plus

Rivals Sarepta Therapeutics and BioMarin ​Pharmaceutical are in line to become the next recipients of an FDA coupon for a fast review, each potentially picking up a sellable asset that recently brought in $350 million on the open market.

Vernalis cuts the cord on a late-stage pain drug after a trial flop

An in-development pain treatment from Vernalis missed its main goal in a proof-concept study, leading the U.K. drugmaker to back away from a drug it once believed could bring in more than $500 million a year.

GlaxoSmithKline flips an MS project to Novartis for up to $1B

Novartis is paying GlaxoSmithKline as much as $1 billion for the rights to a mid-stage multiple sclerosis treatment, betting it can develop an heir to the blockbuster Gilenya, soon to lose patent protection.

Baxalta bets on 'external innovation' to meet its $8.5B goal and ward off Shire

Baxalta is hoping to launch 20 new drugs by 2020, and the nearly 2-month-old company is taking a decentralized approach to R&D on the way there, relying on partners to handle early-stage work before finishing projects itself.

Norway opens $120M cancer hub; Summit hits goal in DMD trial; Sobi rises on long-term data

Welcome to the latest edition of our weekly EuroBiotech Report. Oncology has long been a strong suit for Norway. With a 60-year old cancer registry, the legacy of breakout biotech success Algeta and a clutch of immuno-oncology upstarts to its name, the country has the credentials to make an impact on R&D.

Aisling plots a new $500M biotech fund

Aisling Capital is raising a new fund, looking to gather up to $500 million for a new wave of life science investments, according to a report in Fortune.

FierceBiotech Radio on Addyi's approval, Allergan's M&A future, and a biotech lawsuit

FiercePharma's Carly Helfand and FierceBiotech's Damian Garde discuss the controversial FDA approval of the first libido drug for women, what Allergan should buy next, and Retrophin's lawsuit against former CEO Martin Shkreli.

Samsung, Biogen lining up a $1B IPO for biosimilar joint venture: WSJ

Looking to join the biotech gold rush on Wall Street, Samsung is reportedly lining up a shot at a $1 billion raise for its growing biosimilars development group, a joint venture set up with Biogen as a junior partner in the deal.

Drugs just don't get rejected much anymore, report says

Picking apart biopharma's protracted boom, analysts tend to focus on investors' ongoing appetite for risk, readily available early-stage funding and the vibe that getting drugs approved is simply much easier than it once was. Forbes, with the help of BioMedTracker, has run the numbers on that last point, finding that the FDA has been green-lighting new drugs at an escalating rate for the past few years.

Hunting an FDA cancer drug OK and a partner, little Telesta raises $28M

Telesta Therapeutics has rounded up $28.6 million to help it see if it can push an experimental bladder cancer drug through to an FDA approval. Consonance Capital Investors, Boxer Capital of Tavistock Life Sciences and Omega Funds all joined in the round for the publicly-traded Telesta. Some of the senior execs and board members also chipped in.

Macrocure shares crushed after PhIII regenerative med study flops

Macrocure's plan to break into regenerative medicine has slammed into a brick wall. The biotech reported that its Phase III study for repairing venous leg ulcers looks like a near certain loser, putting the company under a cloud at a critical moment.

Controversial Valeant Pharma swoops in with a $1B Addyi buyout

A little more than a day after little Sprout Pharmaceuticals won a controversial FDA approval to market Addyi (flibanserin) as a new drug that can help inspire sexual desire among women, Valeant Pharmaceuticals announced a deal to acquire the one-drug company in a $1 billion buyout.

Norway steps up immuno-oncology ambitions with opening of $120M park

Norway has opened the doors at its NOK 1 billion ($120 million) bet on cancer R&D. The investment has enabled the creation of Oslo Cancer Cluster Innovation Park, a site housing hospitals, Big Pharma and an incubator for the next generation of Norwegian oncology startups.

MAb patent cliff threatens to blow a hole in U.K. research budget

The United Kingdom's Medical Research Council (MRC) is bracing itself for a big hit to its budget. For years, MRC has benefited from income relating to its discovery of monoclonal antibodies (mAbs) in the 1970s, but the upcoming wave of patent expirations is set to disrupt this cash cow.

Sobi shares tick up as data support long-term use of hemophilia B drug

Swedish Orphan Biovitrum has posted data to support the long-term use of its Biogen-partnered hemophilia B drug, Alprolix. And with Sobi now set to commercialize the drug in its home territory if the European Medicines Agency (EMA) looks favourably on its submission, shares in the company were buoyed by the news.

Summit rolls DMD drug toward PhII after coming through early test

Summit Therapeutics has posted top line data on a Phase Ib trial of its Duchenne muscular dystrophy (DMD) drug, SMT C1100. And with the candidate living up to expectations in terms of therapeutic plasma levels, the drugmaker is preparing to advance into an open label Phase II trial.

Lundbeck to advance schizophrenia drug solo after taking an ax to early-stage pipeline

Lundbeck has initiated a rejig of its pipeline, taking an ax to undisclosed early-stage assets in order to funnel cash into what it sees as its most promising candidates. The schizophrenia drug Lu AF35700 is among the beneficiaries of the reshuffle, with Lundbeck using its reorganized balance sheet to advance the therapy through development unpartnered.

A biotech startup grows out of GlaxoSmithKline's discarded NC R&D

GlaxoSmithKline is laying off nearly 1,000 employees in North Carolina in an effort to trim its R&D costs, cutting deep into the biotech ecosystem in Research Triangle Park. But a handful of ex-GSK researchers have swiftly moved on, starting up a biotech to develop peptide therapies of their own.

Reborn Akari grabs $75M in financing for another Soliris rival

Six months after Celsus Therapeutics' stock price collapsed on the mid-stage failure of its lead therapy, Geneva-based Volution Immuno Pharmaceuticals has stepped in with a reverse merger deal, lining up $75 million in fresh financing from some A-list investors and flipping the company into the public market with a new name and ticker symbol on Nasdaq.

Intarcia's diabetes-treating implant tops Januvia in a head-to-head test

Intarcia Therapeutics' matchstick-sized device for diabetes beat out Merck's blockbuster drug Januvia in a Phase III trial, burnishing its case for FDA approval next year.