Two years after the FDA's shock rejection of Novo Nordisk's next-generation insulin, the Danish drugmaker has convinced U.S. regulators to change their tune, setting the stage for a market duel with Sanofi.
Novo Nordisk's in-development weekly diabetes treatment met its goals in a second Phase III trial, beating AstraZeneca's Bydureon in a 56-week study.
The European Medicines Agency is moving toward approving a trio of novel medicines from Roche, Boehringer Ingelheim and Gilead Sciences, handing down positive recommendations for each.
Late last year GlaxoSmithKline set its sights on reorganizing and downsizing its R&D group, laying off hundreds of staffers in North Carolina as it concentrates research in the Philadelphia area and around Stevenage in the U.K. And now it's taking the ax to a satellite lab in France.
AbbVie is backing out of a roughly $1.4 billion deal with Galapagos, picking an internal rheumatoid arthritis treatment over the one it licensed from the Belgian biotech.
In this week's EuroBiotech Report, AstraZeneca spinout Albireo hired Ron Cooper, a 30-year veteran of Bristol-Myers Squibb, as its CEO, while Sir Greg Winter-founded Bicycle Therapeutics persuaded Kevin Lee to swap a top rare disease R&D post at Pfizer for a chance to lead its nascent operations. And more.
With a combo of its lead cancer drugs already designated as a breakthrough worthy of VIP treatment at the FDA, Aduro Biotech has now added in-house checkpoint inhibitors to the mix. The Berkeley, CA-based biotech announced Thursday after the markets closed that it is acquiring the Dutch biotech BioNovion for $32 million evenly divided between cash and stock.
Mark Fishman, head of Novartis' $10 billion research operation, is retiring next year, making way for an award-winning Harvard oncologist after 13 years at the helm.
Having spent 7 years building up a pipeline of bile acid modulators from its base in Gothenburg, Sweden, AstraZeneca spinout Albireo is now swinging its center of gravity to Boston, MA. The shift follows the appointment of ex-Bristol-Myers Squibb executive Ron Cooper as CEO.
Just weeks after a group of castaways from the big GlaxoSmithKline reorg in North Carolina started their own biotech, Phoundry, focusing on establishing a pipeline of new peptide therapies, they've found a buyer for the company. Boston-based Intarcia says it is acquiring Phoundry with an eye to beefing up its work related to the ultra-extended-release diabetes therapy ITCA 650.
GlaxoSmithKline got a positive opinion from European regulators on its new treatment for severe asthma, setting the stage for a likely approval later this year.
Concert Pharmaceuticals, at work on a modified version of Vertex Pharmaceuticals' star cystic fibrosis therapy, said its treatment lasted longer than the reference drug in a small, early-stage trial, stoking hopes for future clinical success.
One of the original players in the development of Amgen's cancer therapy talimogene laherparepvec (T-Vec), now up under review at the FDA, has started a new biotech focused on oncolytics drug development. And the U.K. company attracted a $30 million startup round from a transatlantic group of venture players to get started with a splash.
Nextera has landed a research collaboration that could put it on the map. The deal gives Johnson & Johnson a chance to take a closer look at Nextera's immunological technology platform with a view to bagging an exclusive global license for its use in rheumatoid arthritis research.
San Diego-based Conatus Pharmaceuticals has scored another big surge in its stock price after a short, small midstage study provided bragging rights to a success in treating an indicator for liver damage that afflicts patients suffering from NASH and hepatitis C.
Bicycle Therapeutics has become the latest biotech to convince a Big Pharma R&D chief to jump ship for the chance to lead a startup. The R&D chief in question is Kevin Lee, who took over as CEO of the British biotech this week after spending the previous three years leading rare disease research at Pfizer.
Boehringer Ingelheim has finalized the crowdsourced chronic obstructive pulmonary disease (COPD) R&D team it has spent the past 9 months putting together with BioMed X. The partners have tapped the University of Stuttgart's Renata Jurkowska to lead the initiative, which is an attempt by Boehringer to draw on expertise outside of its walls to better understand the epigenetics of COPD.
Malin is looking for near-term paydays in its portfolio. The plan is to start delivering a return to the shareholders who helped it amass a €372 million ($415 million) investment war chest by taking some of the businesses it has backed public.
Martin Shkreli and his biotech, Turing Pharmaceuticals, are out at BIO. FierceBiotech learned today that the BIO board opted to kick him out of the industry organization after an intense controversy erupted over Shkreli's move to boost the price of Daraprim by more than 5000%.