Fibrogen, AstraZeneca confirm roxadustat's heart safety months after confusing first readout

Pooled data from seven studies showed the red blood cell-boosting pill to be as safe as placebo and safer than Epogen on some heart measures in kidney disease patients.

By Jonathan Gardner • Nov. 8, 2019

FDA approves first drug for anemia tied to rare blood disorder

Developed by Celgene and biotech partner Acceleron, Reblozyl is one of five drugs Bristol-Myers Squibb highlighted in its $74 billion buyout of Celgene. 

By Ned Pagliarulo • Updated Nov. 8, 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

Sarepta tries softer approach to resolve FDA setback

Departing from the combative tack taken by Sarepta with Exondys 51, CEO Doug Ingram appears to be reading from a new playbook in handling Vyondys 53's rejection.

By Jonathan Gardner • Nov. 8, 2019

AnaptysBio shares collapse after 'worst case scenario' for key drug

Etokimab, an anti-inflammatory drug key to AnaptysBio's future, missed its goal in a Phase 2 study, a result that erased $700 million from the company's value. 

By Ned Pagliarulo • Nov. 8, 2019

Celgene's last hurrah at ASH a defining moment for Bristol-Myers' buyout

With pivotal data for a Celgene CAR-T therapy expected soon, the clock is ticking on a timeline that will determine whether Bristol-Myers pays billions more to the biotech's shareholders.

By Jonathan Gardner • Nov. 7, 2019

Trump administration sues Gilead over HIV drug patents

Accused of unfairly profiting from government research, Gilead said it will ask the district court to stay HHS' suit until the U.S. Patent Office reviews the disputed patents.

By Ned Pagliarulo • Updated Nov. 7, 2019

Biogen broadens biosimilar bet to go after top-selling eye drugs

A new deal with existing biosimilar partner Samsung Bioepis gives Biogen exclusive rights to market copycat versions of Lucentis and Eylea.

By Ned Pagliarulo • Nov. 6, 2019

Regenxbio hit with FDA clinical hold, pushes back gene therapy timelines

It's the second trial hold for the gene therapy field in recent weeks, after the FDA partially suspended a Novartis study testing the SMA treatment Zolgensma.

By Andrew Dunn • Nov. 6, 2019

Regeneron defends bid to challenge Merck in lung cancer

Merck's Keytruda is far and away the leading immunotherapy for treating lung cancer. In typical fashion, Regeneron thinks its rival drug can compete. 

By Ned Pagliarulo • Nov. 5, 2019

Shifting the biomanufacturing paradigm - intensifying upstream processes

Game-changing technologies to intensify upstream processes.

Nov. 5, 2019

Aveo's cancer drug runs into a skeptical FDA

The regulator told the Cambridge, Massachusetts-based biotech to hold off on filing its cancer drug, sending shares in the company down 40%. 

By Andrew Dunn • Nov. 4, 2019

China approves Alzheimer's drug, inviting fresh debate in field with few successes

Developed by a little-known Shanghai drugmaker, the therapy joins a short list of approved Alzheimer's treatments. Yet how well it works is an open question.

By Ned Pagliarulo • Updated Nov. 4, 2019

Amgen exits neuroscience R&D as pharma pulls back from field

About 180 roles, primarily based in Cambridge, Massachusetts, will be affected by the decision, which comes several months after a setback in Alzheimer's.

By Andrew Dunn • Oct. 30, 2019

CF Foundation puts half a billion dollars toward drugs for all patients

About 90% of cystic fibrosis patients can take one of Vertex's drugs. The remaining 10% have no options — something the foundation wants to change.

By Jacob Bell • Oct. 30, 2019

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

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