The Latest
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Purdue Pharma lays off 350, cutting remainder of sales force
The layoffs mark an end to the Oxycontin maker's direct marketing of its prescription medicines to doctors.
Marketing -
SponsoredDisruptive innovation – the impact on clinical trials
Senior pharma executives weigh in on how the industry is experiencing a digital disruption, impacting the entire spectrum of drug development.
Clinical Trials -
Anika shares slump on Phase 3 miss
The regenerative medicine company's osteoarthritis treatment failed to meet its goal, spurring investor worries about approval in the U.S.
Clinical Trials -
Opioid supply levels decline in most states, report finds
States that passed laws to limit opioid prescriptions, such as Maine, appeared to have the biggest reductions.
Regulatory / Compliance -
Roche buys out Foundation Med in $2.4B bet on targeted cancer treatment
Over the past half year, Roche has spent $6 billion on investments aimed at building a lead in the industry's shift toward more personalized medicine.
Mergers and Acquisitions / Deals -
Vertex opens doors to new research site in San Diego
Research at the new complex, which is one of three hubs for the biotech, will focus on cystic fibrosis as well as other therapeutic areas, including pain.
Clinical Trials -
340B audits target hospitals more than pharma, sparking lawmaker criticism
The drug discount program has become a flash point between the two industries amid changes made by the Trump administration.
Regulatory / Compliance -
How badly does Alexion want its Soliris follow-on? Enough to use a rare fast pass
In submitting ALXN1210, the rare disease biotech used one of its priority review vouchers to hasten an approval decision from regulators.
Regulatory / Compliance -
Ziopharm shares tumble as clinical hold delays CAR-T
The FDA put a halt to the company's Phase 1 trial before it even began, seeking more information on the company's manufacturing plans.
Clinical Trials -
Solid finds its footing as FDA lifts trial hold
Shares rose on news the biotech will resume enrollment into a Phase 1/2 study of its experimental gene therapy for DMD.
Clinical Trials -
Gottlieb lays out FDA plans to speed generic reviews, spur label updates
The agency is set to launch a new review tool aimed at reducing the number of cycles of application review.
Drug Discovery -
Valeant hit with CRL for key dermatology drug
While the pharma seems hopeful of a quick resolution, the red light from the FDA is a blow to Valeant's plans to turn around its dermatology business.
Clinical Trials -
ObsEva's endometriosis win puts it back in investors' good graces
The biotech is now looking to take two doses of linzagolix into Phase 3 for pain associated with the condition.
Clinical Trials -
Cytokinetics says early SMA treatment shows promise
Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.
Clinical Trials -
AMAG divests Cord Blood Registry for $530M
The sell-off of the stem cell firm will tighten AMAG's focus on pharmaceuticals and help pay down debt.
Mergers and Acquisitions / Deals -
ColumnPrescribed Reading: J&J sells off units; another Alzheimer's defeat
Big pharma extended its string of divestitures and portfolio streamlining this week. Meanwhile, manufacturers can't seem to beat Alzheimer's disease.
Clinical Trials -
Lilly's Olumiant delivers positive Phase 2 lupus data
The trial win is likely welcome news for Lilly and partner Incyte in light of the drug's narrow and disappointing approval in rheumatoid arthritis.
Clinical Trials -
Mylan preps for rejection of Advair copy
The generic drugmaker faces another regulatory setback for its copycat version of the blockbuster GSK lung drug.
Regulatory / Compliance -
Bluebird's changes to LentiGlobin begin to pay off
The gene therapy continued to show promise in two genetic blood disorders, but questions of durability remain.
Clinical Trials -
Nonprofit pharma picks up coveted PRV
Securing approval for its river blindness drug also hands Medicines Development for Global Health a coveted regulatory fast pass.
Marketing -
Gene-editing biotechs drop as cancer concerns weigh on CRISPR
Shares in Editas, Intellia and others fell after two studies found CRISPR/Cas9 technology seems to work best in cells at higher risk of becoming cancerous.
Corporate News -
Recipharm to pay $60M for Sanofi manufacturing plant
All 450 staff employed at the Sanofi site will transfer over to the Swedish CDMO, which hopes to expand its contract business with the buy.
Manufacturing -
GSK touts two-drug HIV therapy, intends to file this year
Success of the doublet should help GSK better compete with Gilead, its main competitor in the HIV market.
Clinical Trials -
Sage licenses out depression drug in Asia, adding to cash warchest
Inking a deal with Shionogi for rights to SAGE-217, the biotech will earn $90 million upfront just as it preps for a potential market launch of brexanolone.
Mergers and Acquisitions / Deals -
Galmed stock jumps sky-high on mixed results for NASH drug
While the company touted the drug's impact on liver fat, a closer look at the study results raises questions about how effective the treatment really is.
Clinical Trials