Shire, Takeda get closer to hammering out a deal

Immunotherapies, biosimilars to dominate next week of earnings

AbbVie, Bristol-Myers, Celgene, Roche and others will report first quarter earnings over the coming days. 

Setback for AstraZeneca cancer combo raises MYSTIC stakes

The failure of Imfinzi plus tremelimumab in third-line lung cancer makes an upcoming readout from the MYSTIC study even more important for the pharma.

Lilly's baricitinib wins FDA panel nod, but still dogged by safety issues

Lilly entered the Food and Drug Administration committee meeting on Monday with a fuzzy outlook for its potentially billion-dollar arthritis drug. It left in much the same fashion.

Prothena pulls Phase 3 drug, stock plummets

The Irish biotech scrapped its amyloidosis candidate after a late-stage futility analysis returned disappointing results.

Lilly raises sales forecasts as diabetes drugs outperform

Strengthening uptake of Trulicity, coupled with higher-than-expected revenue from older insulin products, helped the pharma beat market estimates.

Orexigen agrees to sale, but is open to more offers

Company leadership realized it's time to slim down and has accepted an acquisition offer. There's still time, though, for other buyers to submit a bid.

Pfizer's Herceptin copy hits FDA roadblock

Regulators handed Pfizer a Complete Response Letter four months after approving Mylan's copycat version of the breast cancer drug. 

Fresenius dumps $4.3B Akorn merger

The German drugmaker contends an internal probe found FDA data breaches, but Akorn denies any wrongdoing.

Novartis bolsters case for siponimod with new data

The results support Novartis' filing of the drug, which the pharma hopes will secure FDA approval for secondary progressive MS.

Merck antibiotic data positive in Phase 3

The promising data moves the pharma closer to a submission to the FDA.

Biogen, facing questions, turns again to Ionis in $1B research deal

Tapping the discovery expertise of Ionis, however, may not placate investors eager to see Biogen pad its pipeline with more aggressive dealmaking. 

Alnylam, Dicerna settle RNAi trade secrets lawsuit

Two makers of the gene-silencing technology settled a years-long lawsuit days ahead of a scheduled jury trial date. 

Column

Prescribed Reading: Shire on the block; FDA flip-flops

There are potentially multiple suitors looking to take out Shire. Elsewhere, the FDA is making surprise reversals.

GW wins panel backing for Epidiolex, looks to FDA decision

Following an advisory committee's unanimous recommendation for Epidiolex, GW Pharma awaits a June decision on approval by the regulator. 

Shire rejects $62B offer from Takeda, while Allergan weighs bid

The Irish pharma has spurned three offers from the Japanese drugmaker; and now, Allergan confirms it is considering an offer as well. 

UPDATED: April 19, 2018 at 3 p.m.

Out-of-pocket drug costs still murky, report underscores

A recent look by Iqvia at patient drug costs suggests they have, on average, fallen. Whether that's partially because of discounts and rebates remains unclear.

P&G absorbs German Merck's consumer business for $4B

Merck KGaA's consumer health business rose 6% between 2015 and 2017, making it an attractive asset for P&G, which has struggled to deliver growth.

Cosentyx jitters weigh on Novartis

Worries over a slowdown in the immunology drug's sales and a sharp decline in the Swiss pharma's U.S. generics business overshadowed otherwise strong quarterly growth.

Q&A

GE brings antibody know-how to viral vector production

The corporate giant aims to adapt its manufacturing tech for the cell and gene therapy world, a GE exec tells BioPharma Dive. 

Tagrisso wins first-line lung cancer approval, boosting AstraZeneca

Securing the FDA OK is a key step in AstraZeneca's plan to turn Tagrisso into a multi-billion dollar drug franchise.

Lilly's baricitinib to face tough questions at AdComm

FDA staff reviewers raised doubts about the safety of the once-rejected rheumatoid arthritis drug ahead of an advisory committee meeting Monday.