News

UPDATED: After a 6-year delay, Medicines Co. bags FDA approval for once-troubled antibiotic

More than 5 years after The Medicines Company bagged Targanta and its troubled antibiotic oritavancin for the bargain basement rate of $42 million plus potential bonus payments, the biotech has finally nailed down an elusive FDA approval of the product for skin infections caused by Gram-positive bacteria, including MRSA.

Boehringer walks away from an anti-inflammatory deal with Orexo

Boehringer Ingelheim has handed back the rights to a drug development project targeting pain and inflammation, ending a long-standing partnership with Orexo.

Regeneron hits the gas on R&D, pouring cash into a blockbuster pipeline

Regeneron has again dialed up its R&D budget, spending more and more on a slew of late-stage assets that promise to line its pockets and an emerging crop of early drugs the Big Biotech believes can beat a path to blockbuster status.

In a surprise twist, Treasury takes aim at Big Pharma's tax inversion deals

Tax inversions are one of the hottest trends in biopharma. But with lawmakers unable so far to reach a deal on new legislation, the Obama administration is signaling that it wants to put a stop to it--now. And it's looking for a way to go it alone, leaving lawmakers on the sidelines.

Sarepta leaps into Ebola spotlight with a shelved therapy

With Tekmira's alternative-track treatment on hold, Sarepta CEO Chris Garabedian has jumped into the media blitz surrounding the Ebola outbreak in Africa, offering to provide the small stock still on the shelves and order up fresh supplies of the Phase I drug.

Auris pulls off a $56M IPO to bankroll its ear treatments

Auris Medical had to dial up its offering and take a deep discount to make its way to Wall Street, but the biotech still managed to come away with $56.4 million to support two late-stage ear therapies for inner ear disorders.

Cytori shares slammed as safety concerns halt stem cell trials

Cytori Therapeutics hit the brakes on a pair of clinical trials to find out why three patients in the study suffered from "cerebrovascular" events after they were treated with the biotech's experimental stem cell treatment. The San Diego-based biotech's shares plunged more than 30% in after-hours trading after putting out word of the hold in a late release.

The top 15 late-stage blockbusters in the pipeline

In recent years it's been the big biotechs in the U.S. which have registered approvals for the drugs most likely to succeed on the market. But in reviewing EvaluatePharma's recent picks for top Phase III drugs, it's interesting to see some prominent positions among the Big Pharma crowd. Read the full report >>

Takeda preps for 'stringent' R&D as a new boss takes the reins

Christophe Weber, Takeda's anointed next CEO, sees a brighter future through specialization for the Japanese drugmaker, promising to focus only on therapeutic areas where it can lead, leaving behind losing programs.

Mapp Bio stays mum during Ebola media storm

A few days ago Mapp Biopharmaceutical was an obscure little biotech with a handful of staffers. Now the private company is a central player in a drama involving two Americans whose lives may have been saved by Mapp's experimental antibody cocktail after they were stricken by Ebola.

Juno stuffs its CAR-T war chest with another $134M fundraise

Superlatively well-funded biotech startup Juno Therapeutics has bagged another $134 million in venture cash, bringing its 12-month total north of $300 million as it races to advance a new therapeutic approach that could transform cancer treatment.

How big is Novartis' LCZ696 heart drug? Experts bet on a key number

In the pharma business, you're only as good as your next big blockbuster. And in Novartis' case, the next big cardio blockbuster--LCZ696--looks very good, indeed.

Japanese researcher found dead amid a swirling stem cell research scandal

One of the authors of a controversial and now-retracted paper purporting a stem cell breakthrough has been found dead in what appears to be a suicide, according to numerous reports, following an investigation that has alarmed researchers and rattled one of Japan's most respected institutions.

Insmed shares shrivel as PhIII Arikayce plan chills hopes for quick OK

The news at Insmed tends to run hot and cold for investors. When their experimental antibiotic Arikayce hits trouble, its stock price goes cold and shrivels. Good news runs hot on the market. On Monday, though, the share price plunged after the biotech laid out plans for a lengthy pair of late-stage studies, squashing hopes for a quick dash to the FDA for an early approval.

Roche's pRED buys out Santaris in $450M RNA acquisition

Roche's European-based R&D arm pRED has closed a deal to buy Denmark's Santaris Pharma, paying $250 million upfront with another $200 million up for grabs in potential milestones if the research pays off. The deal marks a big increase in Roche's bet on RNA-targeting drugs, a research sector it exited with great fanfare several years ago as experts debated the potential for the field.

Enumeral banks $21.5M for immuno-oncology R&D

Biotech startup Enumeral Biomedical has pulled off a deal that gives it $21.5 million in financing and access to public markets, paving the way for early-stage work on some cancer immunotherapies.

Fecal-transplant specialist Rebiotix nabs $25M round

Roseville, MN-based Rebiotix says it raised $25 million in a Series B, designed to fund pivotal work on its lead fecal-transplant program for RBX2660.

Biotechs find themselves in R&D spotlight as Ebola hits the headlines

A month ago, Tekmira shares took a deep dive after the FDA placed a clinical hold on its Ebola therapy, the RNAi therapy TKM-Ebola, citing concerns about cytokine release--a condition which can spur a fatal noninfectious fever in the worst cases. The Canadian biotech's shot up more than 12% on Monday morning on speculation that the FDA would put the treatment back on its fast track.

PTC wins EU approval for its DMD drug as Phase III data pend

After missing a key trial goal and getting a rare second chance from EU regulators, PTC Therapeutics' ataluren is now the world's first approved therapy for Duchenne muscular dystrophy, picking up a conditional European OK as the company awaits results from a late-stage study.

Bristol-Myers is seeding a new crop of biotech spinouts, buyout options included

Bristol-Myers Squibb has formed a new joint venture with Boston-based Allied Minds that will hunt the groves of academia in an enterprising approach to launching new biotechs and bagging new drug candidates.