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

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

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

Colon cancer proves tougher target for Amgen's KRAS drug

A much lower response rate in colorectal cancer than in lung could signal the two tumor types respond differently to blocking KRAS with AMG 510.

By Ned Pagliarulo • Sept. 28, 2019

Cancer immunotherapy boom showing no sign of slowdown

A new report from the Cancer Research Institute found nearly 3,900 drugs in preclinical and clinical development, up 91% from just two years ago. 

By Ned Pagliarulo • Updated Sept. 27, 2019

Investors conclude there are probably better NASH drugs than Enanta's

The biotech's stock plummeted more than 18% Thursday as data showed its FXR agonist barely cleared the threshold for success in a Phase 2 study.

By Jacob Bell • Sept. 26, 2019

Medicines Co. gets cholesterol confirmation

The biotech secured positive results from two more Phase 3 trials of inclisiran, clearing a final step before submitting the PCSK9 drug to the FDA.

By Jonathan Gardner • Sept. 25, 2019

Clovis shares plunge after downgrade raises questions on path forward

A Wall Street analyst was skeptical of a preclinical deal that adds R&D costs while the company fights for market share in ovarian cancer.

By Jonathan Gardner • Sept. 24, 2019

Alder's migraine drug attracted plenty of dealmakers. The company, not so much

A new regulatory filing affirms the theory that, in neuroscience, risk-sharing partnerships are more appealing than all-out acquisitions.

By Jacob Bell • Sept. 24, 2019

Amag fights activist investor's bid for board seats

After increasing its stake to 10%, a hedge fund has launched a board bid as Amag works to commercialize a female libido pill.

By Jonathan Gardner • Sept. 23, 2019