Biotech

AstraZeneca puts $55M into Accent as pharmas continue push to drug RNA

The deal follows similar pacts involving Merck, Biogen, Roche and others, reflecting growing interest by pharmaceutical companies in the emerging field. 

By Ben Fidler • June 04, 2020

COVID-19 studies of malaria, blood pressure pills come under scrutiny

The Lancet and The New England Journal of Medicine issued "statements of concern" regarding two high-profile trials they published, citing gaps in a database used by the authors.

By Jonathan Gardner • UPDATED: June 4, 2020 at 4:27 p.m.

Biotech IPOs near last year's pace, despite COVID-19 pandemic

A successful IPO from Pliant Therapeutics is the first of five potential offerings by biotechs this week, suggesting activity is picking up following earlier coronavirus-related disruption.

By Ben Fidler • June 03, 2020

Regeneron expands Intellia gene editing deal as its post-Sanofi future emerges

Regeneron and Intellia will grow their alliance and work on hemophilia, an already competitive space that includes several experimental gene therapies. 

By Jonathan Gardner • June 01, 2020

Details lacking, but new remdesivir data point to a benefit for 'moderate' COVID-19 patients

The results suggest that Gilead's drug may help a broader swath of patients with coronavirus disease, though the magnitude of benefit is unclear. 

By Jacob Bell • June 01, 2020

Lilly wins first-ever FDA approval for drug that can spot Alzheimer's 'tau tangles'

Tauvid, which identifies the size and spread of tau protein clusters in the brain, could help Alzheimer's researchers as they shift away from a long-dominant focus on amyloid beta.

By Jacob Bell • May 29, 2020

With new Allogene data, same promise, questions surround 'off the shelf' CAR-T

Updated results from Allogene at ASCO's virtual meeting are encouraging, but still don't show whether its allogeneic approach can match autologous CAR-T.

By Ben Fidler • May 29, 2020

Novartis teams with Mass. Eye & Ear to join coronavirus vaccine chase

The Swiss pharma has become the latest large drugmaker to enter the worldwide race to develop a vaccine for COVID-19, tapping a project developed by gene therapy experts at the Massachusetts Eye and Ear Hospital.

By Jonathan Gardner • May 28, 2020

U.K. grants early access to Gilead's remdesivir for COVID-19 patients

Supplies of the antiviral drug are tight, however, with many of the doses donated by Gilead reserved for use in the U.S. 

By Kristin Jensen • May 27, 2020

Gilead puts $375M into Arcus in latest push to broaden cancer business

The alliance, inked two months after a $5 billion buyout of cancer biotech Forty Seven, extends Gilead's effort to establish itself as a major player in oncology.

By Ben Fidler • May 27, 2020

Deep Dive

Venture capital found its footing in biotech. Then came the virus.

There's been no better time for venture firms to invest in drug startups than the past few years. But when a virus upended the world, it raised new questions about what types of investors and investments would succeed moving forward.

By Jacob Bell • May 26, 2020

Intercept shares fall as FDA again delays closely watched NASH drug

The FDA has asked for more data on obeticholic acid, which could be the first-ever marketed medicine for non-alcoholic steatohepatitis. The latest delay means the drug likely won’t be approved by the agency's June 26 deadline.

By Jonathan Gardner • May 22, 2020

Sunovion crowds a new group of Parkinson's drugs, with uncertain sales prospects

Kynmobi has become the fourth drug the FDA has approved since late 2018 for the "off" episodes Parkinson's disease patients experience. The coronavirus pandemic may complicate an already challenging launch.

By Ben Fidler • May 22, 2020

AstraZeneca, Merck race past Clovis as PARPs break into prostate cancer

The approvals of Lynparza and Rubraca within days of one another mark the arrival of PARP inhibitors as treatments for prostate cancer — a role that could grow in the coming years.

By Ben Fidler • May 20, 2020

More questions than answers as Moderna's coronavirus vaccine speeds ahead

Preliminary results from a Phase 1 study were enough to add $5 billion to Moderna's market capitalization. But they don't answer key questions about the vaccine's safety and effectiveness. 

By Jonathan Gardner • May 19, 2020

Biotech companies raise cash as coronavirus updates lift stocks

Eight publicly traded drugmakers, including Moderna, announced plans Monday to raise nearly $3 billion via offerings of new stock and debt.

By Ned Pagliarulo • May 19, 2020

Moderna delivers first human data for a coronavirus vaccine

The first volunteers who received low or medium doses of Moderna's vaccine produced what look to be meaningful immune responses, but it's unclear whether that will lead to disease prevention.

By Ben Fidler • May 18, 2020

Safety questions linger as Pfizer preps Duchenne gene therapy for final test

New data presented at the American Society of Gene & Cell Therapy's yearly meeting show promise, but also side effects that haven't been seen with a rival treatment from Sarepta.

By Ben Fidler • May 15, 2020

Ousted BARDA director: Hydroxychloroquine push distracted government scientists

Safety concerns led to a clash over how widely to distribute the malaria pill for use against COVID-19, Rick Bright testified to Congress Thursday. 

By Jonathan Gardner • May 14, 2020

Cancer biotech stocks shift on glimpse of ASCO data

Data from Allogene was well received by investors, but several other biotechs saw their market value erode following release of ASCO study abstracts.

By Ned Pagliarulo • May 14, 2020

Allogene gives first look at an 'off the shelf' cell therapy for lymphoma

Donor-derived cell therapy has been a goal for drugmakers since CAR-T arrived several years ago. New data from Allogene could offer "proof of concept."

By Ben Fidler • May 13, 2020

Activist investor pushes Alexion to sell after Portola deal

Elliot Advisors cited Alexion's buyout of Portola, which triggered a sell-off last week, as reason to ask the biotech's board to solicit bids from larger pharmas.

By Jonathan Gardner • May 12, 2020

Dyno spins out of Harvard's laboratories with an aim to make gene therapy better

The startup announced collaborations with Novartis and Sarepta, both leading gene therapy makers, that could be worth $2 billion in total. 

By Jonathan Gardner • May 11, 2020

After trial failure, Enanta narrows its focus to NASH

The biotech's main drug missed its goal in a mid-stage study of patients with a liver disease known as PBC.

By Jacob Bell • May 07, 2020

Orchard lays off a quarter of its staff amid major shift

The gene therapy developer has given up on plans to build a new manufacturing facility and is adjusting its clinical resources to focus on more common diseases.

By Kristin Jensen • UPDATED: May 8, 2020 at 10:35 p.m.