News

AstraZeneca's new antibiotic comes through in Phase III

AstraZeneca's antibiotic combination treatment beat out standard meropenem in treating complicated infections, the company said, setting the table for a near-term shot at regulatory approval.

Bristol-Myers, Celgene pair an immuno-oncology star with a rising chemotherapy

Bristol-Myers Squibb and Celgene are joining forces on a cancer combination treatment, testing the former's highly anticipated immunotherapy in tandem with an on-the-market chemo drug against a host of tumor targets.

MorphoSys bets on Emergent BioSolutions' cancer contender in $183M deal

German drug developer MorphoSys is pairing up with Emergent BioSolutions to get its hands on an early-stage prostate cancer treatment, signing a deal worth up to $183 million for a promising antibody.

Could buying Salix get Valeant off of Allergan's scent?

Allergan, working to fend off a hostile approach from Valeant Pharmaceuticals, is reportedly taking a look at the smaller Salix Pharmaceuticals, weighing a multibillion-dollar deal that could render it unattainable--or at least drive up its asking price.

Amicus sets sights on approval as rare disease pill clears Phase III

Amicus Therapeutics has come a long way in two years, shaking off a clinical misstep on the way to a second Phase III success for its rare disease treatment. Now the biotech is preparing to make its case to regulators, hoping to win approval for a new approach to Fabry disease.

Sanofi wins FDA's blessing for an oral Gaucher drug

Sanofi's rare ailment-focused Genzyme unit won FDA approval for a new Gaucher disease treatment, providing an oral alternative to its own trailblazing intravenous therapy.

Sanford-Burnham poaches a GSK exec to bridge academia and Big Pharma

Back in January, the prestigious Sanford-Burnham Medical Research Institute amended its ethos, promising to more closely marry its work to therapeutic development and become a partner of choice for drugmakers. Now, the 38-year-old organization has chosen the leader to get it there, convincing GlaxoSmithKline's Perry Nisen to take the reins as its new CEO.

Merck KGaA's cancer vaccine endures another clinical failure

Tecemotide, Merck KGaA's 9-lived cancer vaccine, has flunked another clinical trial, missing its main goal in a Japanese study and casting further doubts on the program's future.

Dermira pockets $51M to bankroll skin treatments

Well-funded biotech Dermira has landed a $51 million C round to support its late-stage dermatology pipeline, rallying some high-profile investors as it dials up R&D spending and builds out its management team.

Lilly grabs a 'tentative' FDA OK for insulin treatment, but Sanofi still blocks its path

Eli Lilly has won a "tentative" FDA approval for its knockoff of Sanofi's Lantus, but don't look for it at a pharmacy anytime soon. The insulin glargine injection--to be marketed as Basaglar eventually in the U.S.--faces an automatic 30-month stay after Sanofi filed a suit against Lilly and its partner Boehringer Ingelheim claiming patent infringement.

Novartis slashes ante, inks another Gamida Cell buyout pact in $635M leukemia deal

Novartis is forging ahead with a prospective stem cell biotech buyout, agreeing to pay $35 million to grab a sizable equity stake in Gamida Cell while executing a short term option deal that will allow the pharma giant the right to gobble up the company for another $600 million split up between a $165 million upfront payout with the rest up for grabs in development and sales milestones.

Amgen successfully hits another PhIII goal line with kidney dialysis drug

Amgen successfully wrapped its second Phase III study for AMG416, its late-stage drug for secondary hyperparathyroidism that's now one final study away from a prospective regulatory filing.

Pfizer hands in an early application for the blockbuster contender palbociclib

As expected, Pfizer has submitted an early FDA application for palbociclib, beating a quick path to market with a breakthrough breast cancer treatment that could peak at nearly $3 billion a year.

Novo Nordisk accepts a $90K slap on the hand for delaying news of Tresiba setback

Danish financial regulators took a dim view of Novo Nordisk's decision to spend the weekend pondering the FDA's February 2013 snub to Tresiba before spreading the news of the agency's complete response letter and the major delay that would be triggered by its demand for a new study. And today Novo said it had decided to accept a $90,000 fine to close the books on the incident, not the least bit chastened at the slap on the hand.

Struggling Eisai files its thyroid cancer drug lenvatinib in U.S., EU

Still suffering from the loss of patent protection on its big Alzheimer's drug Aricept, Japan's Eisai said today that the company had fired off a pair of applications for its new cancer drug to U.S. as well as European regulators.

Novartis circles back with new terms for a stem cell biotech buyout--report

Novartis' on-again, off-again deal to buy out Israeli stem cell therapy developer Gamida Cell is reportedly back on again--though the pharma giant has apparently renegotiated the old $600 million pact to include a smaller upfront buy-in and one of its favored option agreements.

Are they or aren't they? Chugai spurns reports of Roche takeover talks

With M&A deals percolating around the global biopharma industry, investors bought in to the story anyway, driving up Chugai's stock price to record levels on the market buzz as fresh press reports added to the speculative frenzy.

Biogen scores fresh MS advance with blockbuster Plegridy OK

Billing it as the most important new innovation in the interferon drug class in a decade, Biogen Idec nailed down the FDA's approval of Plegridy, a new multiple sclerosis drug that patients can easily inject themselves with once every two weeks.

Novo chief Sorensen preps for showdown as Lilly's dulaglutide nears diabetes market

The executive team here at the rapidly expanding headquarters of Novo Nordisk doesn't pull many punches. CEO Lars Rebien Sørensen is a competitive sort who tends to be blunt, aggressive and forward-thinking; projecting a confident attitude that is reflected by the rest of the execs and right down the line to 40,000 rank-and-file employees around the world.

Chikungunya vaccine shows antibody response in Phase I trial

Following recent outbreaks in the Pacific and Caribbean, chikungunya virus has made its way to the U.S.--and drug developers have taken note of its continued spread.