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.
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 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 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.
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.
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.
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' 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.
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.
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.
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.
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.
Roche is taking a hard look at partner Chugai Pharmaceutical, according to a report, considering whether to pay about $10 billion to buy the remaining shares of the company.
Gilead Sciences convinced an panel of arbitrators that rival Roche had no legitimate claims on Sovaldi, its record-setting hepatitis C treatment, but the antiviral pioneer still faces patent spats with a host of challengers looking to cash in on next-generation combo therapies for the disease.
Teva Pharmaceutical is rolling its troubled CNS drug laquinimod into a mid-stage study in Huntington's disease, looking to expand the potential of a treatment marked by clinical and regulatory setbacks.
Dutch drug developer ProQR Therapeutics is swinging for a $75 million Wall Street debut to fund its work on a treatment for cystic fibrosis, looking to compete with market leader Vertex Pharmaceuticals.
Biotech Achillion Pharmaceuticals is working to get its name on the short list of blockbuster hepatitis C contenders, revealing promising Phase II data for a combination of its antiviral with Gilead Sciences' leading Sovaldi.
The latest batch of Israeli biotechs to hit Nasdaq hasn't been doing so well. But that hasn't deterred Foamix Pharmaceuticals from joining the tail end of the big biotech rush into the public markets.
Basilea CEO Ronald Scott offered that the next best step for the biotech may be to just sell the Basel-based company to a U.S.-based biopharma company interested in a quick tax inversion deal that would allow a buyer the chance of trading American taxes for a sweeter deal in Switzerland.