Latest Biotechnology, Pharmaceutical and Healthcare News from BioPharmaDive

20:20 EDT 19th June 2018 | BioPortfolio

Here are the most relevant search results for "BioPharmaDive" found in our extensive news archives from over 250 global news sources.

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Showing News Articles 1–25 of 1,000+ from BioPharmaDive

Tuesday 19th June 2018

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.

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.

Electronic platforms drive improvements in vaccine study efficiency and data quality

Electronic diary (eDiary) cards are helping sponsors overcome the unique data collection challenges associated with vaccine trials.

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.

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.

Monday 18th June 2018

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.

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. 

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.

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.

Cytokinetics says early SMA treatment shows promise

Investors, however, were not so convinced, sending shares in the biotech sliding Monday morning.

Friday 15th June 2018

Prescribed 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.

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.

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.

Thursday 14th June 2018

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.

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.

Mylan preps for rejection of Advair copy

The generic drugmaker faces another regulatory setback for its copycat version of the blockbuster GSK lung drug.

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. 

FDA hits Taiwan Biotech with warning letter

Taiwan Biotech was urged to call in a consultant to remedy the cGMP violations flagged by the FDA. 

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. 

Solving the challenges of high-viscosity biopharma mixing with effective design choices

Designing a processing system to handle high-viscosity BioPharma products can be a demanding process, and there are many challenges to consider. However, the better you understand the nature of these challenges, the better you will be able to optimize your quality and productivity. 

BridgeBio launches another biotech, focused on gene disorders

CoA Therapeutics, the second subsidiary BridgeBio has rolled out this month, aims to create drugs for diseases linked to coenzyme-A deficiencies.

Wednesday 13th June 2018

Phase 2: Big Pharma expands its blockchain experiment

Two drug distributors and four pharmas have signed onto the MediLedger Project, aiming to create a blockchain-based approach to product traceability.

Biosimilars could still pack revenue-busting punch, analyst suggests

Uptake of the few copycat biologics launched in the U.S. has been slow. Yet a Leerink analyst expects a typical biosimilar will erode 20% of branded drug sales in the first year post-launch. 

Big pharma shows no signs of 'massive' drug price cuts

The nation's largest drugmakers have yet to voluntarily bring down prices on their drugs as President Trump claimed they would — and recent exchanges with lawmakers signal such reductions may not be coming.

Flex calling it quits after trial stop

Safety concerns for its lead candidate are forcing the company to abandon development and pursue strategic options. 

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