Boehringer gets respiratory boost with batch of Spiolto nods in EU

Carly Helfand When Boehringer Ingelheim's COPD drug Stiolto Respimat won U.S. approval early last month, the company's head of pharma marketing and sales, Allan Hillgrove, acknowledged ...

Alexion gets EU green light for a pair of rare disease drugs

Damian Garde European regulators are recommending approval for two rare disease treatments from Alexion, a victory for the biotech as it works to expand its stable of commercialized ...

Third Rock eyes a Cambridge, MA, beachhead as biotech gets priced out

Damian Garde As growing demand for lab space in Cambridge, MA, threatens to price out startups, biotech foundry Third Rock Ventures is looking to make a splash in the neighborhood to ...

Argos gets a $40M China deal for AGS-003

John Carroll China's Lummy HK and the China BioPharma Capital I Fund have agreed to acquire $ 10 million worth of Durham, NC-based Argos Therapeutics stock in exchange for rights ...

Eisai gets EMA nod for Lenvima just weeks after FDA approval

Eric Palmer Eisai has gotten its second dose of good news in as many months. Weeks after getting an FDA approval for its thyroid cancer drug Lenvima, the struggling Japanese drugmaker ...

Third Rock’s faded Ember gets resuscitated in merger deal

Damian Garde Ember Therapeutics, a Third Rock Ventures-founded biotech startup that closed its doors late last year, is getting a second chance thanks to a small New York drug developer. FierceBiotech ...

New Zohydro formula gets FDA’s blessing, but abuse-deterrent label has to wait

Carly Helfand Since its FDA approval, the all-hydrocodone painkiller Zohydro has sparked outrage from officials and advocates trying to fight the tsunami of opioid addiction. But with ...

Esperion gets out from under the FDA and speeds toward Phase III

Damian Garde Ann Arbor, MI, biotech Esperion Therapeutics finally resolved the FDA snag standing in the way of its ambitious plans for a new cholesterol drug, clearing the company to ...

Vertex gets 500-patient boost with FDA’s newest Kalydeco nod

Carly Helfand Vertex will start the new year with a group of new eligible patients for cystic fibrosis drug Kalydeco, thanks to a Monday green light from the FDA. The agency has OK'd ...

Sanofi’s U.S. sales team gets its close-up–and a promised makeover

Tracy Staton Sanofi's U.S. diabetes sales team is under a worldwide spotlight–and not because it's time to take a bow. FiercePharma News

Boehringer gets NICE nod for Pradaxa for DVT/PE in U.K.

Eric Palmer Boehringer Ingelheim has completed a trifecta of approvals for its blood thinner Pradaxa for deep vein thrombosis and pulmonary embolism. The U.K. cost watchdog NICE has ...

Impax gets products, manufacturing with $700M deal for allergy-drug makers

Carly Helfand Back in August, Impax Laboratories CEO Fred Wilkinson told investors on a conference call that the company was "well-positioned to execute on a number of transactions." ...
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