Mirati keeps pace with Amgen in hunt for KRAS cancer drug

Initial trial results showed Mirati's closely watched KRAS inhibitor led to responses in patients with lung and colon cancers, although data remain early.

By Ned Pagliarulo • Oct. 28, 2019

Pharmacquired: Eylea could be in trouble, but that doesn't make Regeneron a buyer

A rival medicine from Novartis and potential changes to Medicare aren't likely enough for Regeneron to reverse its decades-long aversion to M&A.

By Jacob Bell • Oct. 25, 2019

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Rubius' roller coaster ride set to accelerate with first clinical results

Since an IPO last July, shares in the platform biotech have fallen by nearly two-thirds. Can the first glimpse at clinical results, expected soon, spur a rebound?

By Andrew Dunn • Oct. 24, 2019

With massive debt looming, Acorda to lay off about 120 in restructuring

Even with the cost-cutting, Wall Street analysts still raised concerns over the biotech's liabilities, with $345 million in debt coming due in 2021.

By Andrew Dunn • Oct. 24, 2019

Vertex clears its biggest commercial hurdle: UK insurance coverage

After months of testy negotiations, Vertex and English health authorities have created a reimbursement plan for the company's cystic fibrosis drugs.

By Jacob Bell • Oct. 24, 2019

Alkermes to lay off 160 in cost-cutting restructure

Shares have fallen by more than a third since the start of 2019, a slide the company hopes to correct with plans to cut costs and curtail future hiring.

By Kristin Jensen • Oct. 23, 2019

In major surprise, Biogen will ask FDA to approve Alzheimer's drug aducanumab

New data from two trials halted earlier this year found the drug reduced clinical decline, Biogen said in an announcement that reverberated throughout the Alzheimer's research community. 

By Jacob Bell • Oct. 22, 2019

Vertex wins speedy approval for cystic fibrosis triplet

With Trikafta cleared by the Food and Drug Administration, Vertex estimates its drugs can treat as much as 90% of patients with the lung condition. 

By Jacob Bell • Oct. 21, 2019

Seattle Genetics stock hits record high on well-placed breast cancer bet

Positive results for tucatinib should help the Seattle biotech in its quest to expand beyond Adcetris, currently its only approved drug.

By Ned Pagliarulo • Oct. 21, 2019

Mirati data to test whether biotech can challenge Amgen in KRAS quest

Shares in Mirati soared this year, driven higher by optimism the drugmaker can replicate Amgen's KRAS success. Data due Oct. 28 will give the first look at whether Mirati's candidate holds promise. 

By Ned Pagliarulo • Oct. 18, 2019

Reata surprises with positive data in challenging rare disease

There are no FDA-approved drugs for Friedreich's Ataxia, an uncommon neurological disorder. Reata looks closer to changing that with its latest data.

By Jacob Bell • Oct. 15, 2019

Glenmark spin-out aims to challenge Amgen, others in cancer bispecific field

Newly launched as Ichnos, the spin-out company is led by former Gilead oncology chief Alessandro Riva. 

By Ned Pagliarulo • Oct. 15, 2019

Pelosi drug plan would save $370B, but could reduce R&D, forecasters say

Pharma would respond to Pelosi's proposal by raising list prices, keeping some drugs off foreign markets, and cutting R&D spending, according to the CBO.

By Jonathan Gardner • Oct. 14, 2019

Revance CEO stepping down over 'misjudgment'

Dan Browne, who has led Revance for the past 17 years, will be replaced by board member and former Zeltiq CEO Mark Foley.

By Ned Pagliarulo • Oct. 14, 2019

Five Prime's restructuring claims more jobs

Roughly 70 jobs will be eliminated, leaving a "small research group" to develop the California biotech's three wholly-owned drugs.

By Jacob Bell • Oct. 11, 2019

Gene therapy biotechs caught in manufacturing crunch

Rising demand for contract manufacturing services could push companies to invest more in their own capabilities despite the high cost.

By Ned Pagliarulo • Updated Oct. 11, 2019

Reata buys drug rights back from AbbVie for $330M before readout

"It shows our confidence, but we'll have to see how the data plays out," the biotech's CFO told BioPharma Dive.

By Andrew Dunn • Oct. 10, 2019

Arbutus stops early hepatitis B study on safety concerns

Shares in the Pennsylvania biotech shed a quarter of their value Friday, putting the company down more than 70% for the year.

By Ned Pagliarulo • Oct. 4, 2019

Gilead's follow-on PrEP drug gets broad label, but with a notable exclusion

The FDA approved Descovy to prevent HIV infection in adults and adolescents, but not for cisgender women.

By Jacob Bell • Oct. 4, 2019

Gene therapy stocks have taken a beating. Their recovery may be slow

Share prices of at least 26 gene therapy biotechs were down on the year in October, a sign of some investor uncertainty on how the drugs will be sold.

By Jacob Bell • Oct. 3, 2019

Tocagen to lay off two-thirds of company after R&D setback

After a brain cancer study missed its goal last month, the San Diego biotech said it will keep only 30 employees in order to extend its cash runway.

By Andrew Dunn • Oct. 3, 2019

Amicus rare disease data build hope for approval

The real test of the Pompe disease therapy, however, will be an enrolling Phase 3 study that's set to read out data in 2021.

By Jonathan Gardner • Oct. 2, 2019

NewLink's two-decade run ends in reverse merger, layoffs

Following the collapse of the biotech's oncology prospects last year, NewLink will now merge with privately held Lumos Pharma.

By Andrew Dunn • Oct. 1, 2019

Biogen's R&D head is out, following string of clinical setbacks

Chief Medical Officer Alfred Sandrock is, effective immediately, taking on the duties of Michael Ehlers, who's set to leave Biogen on Oct. 11.

By Jacob Bell • Oct. 1, 2019

Seattle Genetics makes case it can be more than Adcetris

Known best for its approved antibody drug conjugate, the biotech impressed at ESMO with positive results from two experimental drugs.

By Ned Pagliarulo • Sept. 30, 2019