Novo scores a game-changing diabetes approval, reversing an embarrassing rejection

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's weekly diabetes drug clears another Phase III hurdle

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.

Roche, Boehringer and Gilead line up for EU drug approvals

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.

Troubled GlaxoSmithKline to shutter R&D facility in France

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 dumps Galapagos' arthritis drug and presses on with its own

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.

Stephen Ubl planning move from AdvaMed to PhRMA: Reports

Welcome to this week's Chutes and Ladders, our roundup of hirings and retirings throughout the industry. Please send the good word--or the bad--from your shop to Eric Sagonowsky (email) or...

Albireo, Bicycle Therapeutics name Big Pharma execs as CEOs; Nextera lands J&J collaboration

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.

Aduro adds checkpoint inhibitors to a 'breakthrough' mix in $32M buyout

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.

Novartis' top scientist is stepping down after 13 years, making way for a Harvard luminary

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.

AstraZeneca's NASH spinout shifts focus to Boston as ex-BMS exec takes charge

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.

Intarcia nabs GSK castoff Phoundry, beefs up diabetes pipeline

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's asthma injection heads for EU approval

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 Pharma's CF drug tops Vertex's top-seller in early study

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.

Next-gen oncolytics upstart Replimune grabs a $30M transatlantic venture round

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.

J&J signs up to assess Nextera's tech platform in rheumatoid arthritis

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.

Conatus soars (again) after heralding positive data from a small liver study

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 names Pfizer rare disease chief as CEO

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 finalizes team for crowdsourced COPD R&D initiative

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 plots IPOs for portfolio companies over next 12 months

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.

BIO boots Martin Shkreli's Turing out after pricing controversy erupts

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%.