AbbVie is rolling out its second snapshot of promising Phase III data for its hepatitis C cocktail, demonstrating that the vast majority of patients taking the therapy were cleared of the virus after 12 weeks of dosing.
AstraZeneca and Bristol-Myers Squibb are heading back to the FDA with the once-spurned dapagliflozin, claiming they've addressed the diabetes drug's cancer risks, but agency staff remains wary of the novel treatment's dangers.
The pharma giant is recruiting new patients while expanding the program with a new Phase III study for early-stage patients--without changing the dosing regimen.
Novo Nordisk noted today that the Danish Financial Supervisory Authority informed it of its decision to call in the cops after concluding that Novo Nordisk didn't obey the letter of the law as written in Section 27 (1) of the Danish Securities Trading Act.
After a touch-and-go review from FDA staff, Takeda's inflammatory bowel disease drug had an easier time convincing an agency advisory panel of its safety and efficacy. But while an FDA committee took little issue with vedolizumab's risk profile, Takeda may have a hard time convincing regulators to make its treatment an early option for patients.
Bristol-Myers Squibb will go into its Wednesday panel session for the lipodystrophy drug metreleptin with an agency review that offers a grudging concession on signs of efficacy for a subgroup of patients along with some serious questions about potential safety issues and a number of criticisms for the way the clinical trial program was designed and executed.
Swiss biotech startup Covagen landed a new round of venture backing today that could reach up to $63 million, enough to cover a Phase II program for its lead anti-inflammatory drug along with some follow-up work in oncology.
Novartis CEO Joe Jimenez says the pharma giant easily has enough cash on hand to keep the dividends flowing to investors while reserving up to $6 billion for new bolt-on buyouts. In an interview with the Swiss newspaper Schweiz am Sonntag, which was picked up by Reuters, Jimenez says that the sweet spot for deals lies in the $2 billion to $4 billion arena--modest for a company of that size.
Carl June and the Novartis/Penn team weren't the only players to grab the spotlight at the global gathering of hematology experts at the big American Society of Hematology meeting in New Orleans. Several companies touted new data for their therapies over the weekend, and FierceBiotech focused on a roundup of the news related to some top contenders in the field.
Biogen Idec is sticking close to its research home in Cambridge, MA, in its latest neurodegenerative drug development pact. The big biotech is teaming up with the neighboring Proteostasis Therapeutics on a potential new approach for attacking toxic proteins implicated in the development of Alzheimer's and Parkinson's diseases.
University of Pennsylvania researcher Carl June is back with another impressive round of results for a much larger group of patients in what is fast becoming a race to the finish line with one of the most promising new leukemia therapies in the clinic.
The FDA has stamped its approval on sofosbuvir for hepatitis C, perhaps one of the most anticipated new drugs of the year. Gilead's therapy, which will be marketed as Sovaldi, will open the door to a new generation of treatments that don't require interferon--freeing patients from an arduous regimen tied to a host of nasty side effects.
Just over a month after crossing the T's on a $535 million acquisition by Cubist Pharmaceuticals, Optimer Pharmaceuticals is shedding 177 jobs in the U.S. and Canada, New Jersey's Star-Ledger reports.
Ariad Pharmaceuticals seemed to dodge a bullet last month when the European Medicines Agency chose not to follow its U.S. counterpart, letting the troubled Iclusig stay on the market. Now, the regulator is reopening the books on Ariad's cancer drug, reviving concerns about the company's sole product and sending its shares down about 10%.
Geron got an early gift from its friends at the Mayo Clinic, as a release of upbeat imetelstat results sent its shares skyward Friday morning, rising as much as 30% in premarket trading on news its myelofibrosis drug triggered complete remission in some patients.
Novartis' in-development multiple myeloma candidate LBH589 hit its primary endpoint of staving off cancer progression in a late-stage study, the company said, stoking hopes the Swiss drugmaker can take first place among a new class of treatments.
One of the first deals Flemming Ornskov struck as the new CEO of Shire has soured quickly. The company says that its therapy for dry eye, lifitegrast, missed one of two key endpoints in a Phase III study, raising some serious questions about its future.
Well-traveled biotech luminary Michael Foley has agreed to head up a new translational research effort that unites minds at Weill Cornell Medical College, the Rockefeller University and Memorial Sloan-Kettering Cancer Center with the mission of turning exciting lab work into promising drug candidates.
With pressure growing on Big Pharmas to be more transparent with their drug data, Pfizer says it plans to start unlocking the data vaults, with special plans to allow easy access for patients in studies to check out their personal info.