In major surprise, FDA rejects high-profile therapies from BioMarin, Gilead

BioMarin's hemophilia gene therapy Roctavian and Gilead's arthritis drug filgotinib were widely expected to win approvals from the FDA, which demanded more study data from both drugmakers.

By Ned Pagliarulo , Ben Fidler , Jacob Bell • Updated Aug. 19, 2020

Momenta shift to new drugs pays off with $6.5B buyout by J&J

Once a leader in biosimilar development, Momenta pivoted toward developing treatments for autoimmune diseases, including one that drew J&J's interest.

By Jonathan Gardner • Aug. 19, 2020

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

A cure for hemophilia seemed closer than ever. For many patients, it’s now further out of reach

The surprise rejection of BioMarin's hemophilia A gene therapy delayed a decades-long mission to fix the rare bleeding disorder.

By Jacob Bell • Updated Aug. 19, 2020

Gilead expands Tango alliance, continuing a busy year of cancer deals

A $145 million payment to broaden a partnership with Tango Therapeutics is the latest in a series of deals Gilead has made to grow its oncology business.

By Jonathan Gardner • Aug. 18, 2020

Commercial and regulatory strategy considerations for biotech

Important considerations for biotech companies in early-stage development. 

By Alberto Grignolo, Corporate Vice President, Parexel; Sheela Hegde, Partner and Managing Director in Parexel’s Health Advances subsidiary; and Leslie DeVos, VP, Regulatory Consulting, Parexel • Aug. 18, 2020

CureVac grabs $213M in US IPO, adding to year's record pace

Biotechs have raised nearly $10 billion from 45 initial public offerings this year, with CureVac's fueling the development of a coronavirus vaccine.

By Ben Fidler • Aug. 14, 2020

CanSino rides coronavirus vaccine progress to lucrative Shanghai market debut

The biotech, which has quickly advanced its coronavirus shot to late-stage trials, raised nearly $750 million through the listing.

By Ned Pagliarulo • Aug. 13, 2020

FDA gives speedy approval to another Duchenne drug

The nod for NS Pharma's Viltepso is the third time the agency has cleared a Duchenne drug based on the likelihood, rather than proof, it can help patients.

By Ben Fidler • Updated Aug. 13, 2020

A hedge fund bets on a biotech startup to bring new drugs to China

The unusual startup already has partial rights to multiple drugs developed by MyoKardia and affiliates of BridgeBio, and plans to acquire many more. 

By Ben Fidler • Aug. 11, 2020

Seres finds the microbiome data it's been waiting for

The biotech's value more than quadrupled after reporting pivotal data that, according to executives, "substantially exceeded" what's needed for approval.

By Jacob Bell • Aug. 10, 2020

FDA agrees to review Biogen's Alzheimer's drug

The agency's decision kicks off a historic and dramatic regulatory review, as significant lingering questions surround aducanumab's approval chances.

By Jacob Bell • Aug. 7, 2020

Editas, AbbVie rework gene editing deal as pioneering CRISPR trial resumes

Development of EDIT-101, the first CRISPR-based therapy to be used in a company-led trial to alter genes within a person's body, will now move forward under Editas' sole ownership.

By Ben Fidler • Aug. 7, 2020

Biogen makes a billion-dollar bet on Parkinson's drugs

In one of its biggest deals to date, Biogen plans to take an equity stake in Denali Therapeutics to gain access to new treatments for Parkinson's disease.

By Jacob Bell • Aug. 6, 2020

Moderna sets high price in early coronavirus vaccine supply deals

Early preorders for small quantities of Moderna's shot set a price per dose of $32 to $37, although the biotech plans to charge less in larger agreements.

By Ned Pagliarulo • Aug. 5, 2020

With first results, Novavax takes step forward in coronavirus vaccine race

Early-stage results appear to show that Novavax's shot passed its first meaningful test, helping the Maryland biotech keep pace with larger competitors.

By Ben Fidler • Aug. 4, 2020

FDA rejects a peanut allergy treatment, sinking a small biotech's shares

Given the long list of requirements in the FDA's rejection letter, DBV Technologies likely has years of work ahead to win approval of Viaskin Peanut.

By Jacob Bell • Aug. 4, 2020

Amarin decides to go it alone in Europe, as uncertainty clouds heart drug's US future

Chief executive John Thero said the company decided against "multiple proposals" for sales partnerships on Vascepa in Europe. Doing so, however, keeps the pressure on Amarin to deliver.

By Ben Fidler • Aug. 4, 2020

Pfizer spinoff Cerevel to raise $445M in merger with blank-check company

Deals involving so-called special purpose acquisition companies, or SPACs, have boomed, offering the neuroscience-focused Cerevel an unorthodox, and lucrative, path to go public.

By Ned Pagliarulo • July 30, 2020

Gilead's second act in cell therapy gets its first approval

The FDA approval of Tecartus, for mantle cell lymphoma, means two products have now emerged from Gilead's 2017 buyout of Kite Pharma.

By Jacob Bell • July 24, 2020

Moderna, pacing a global vaccine race, loses a key patent fight

A patent board ruled that Arbutus Biopharma invented a technology Moderna uses to deliver its vaccines, which may have implications for its industry-leading coronavirus shot. 

By Jonathan Gardner • July 24, 2020

On eve of first big coronavirus vaccine study, trial leaders brace for 'unprecedented' task

Researchers will need millions of volunteers to find the roughly 150,000 required for the five Phase 3 trials expected this year. Here's what lies ahead for them.

By Ben Fidler • July 24, 2020

Coronavirus vaccines speed ahead, but experts fear not everyone will take them

Gaining trust will be a tough task as public health officials gear up for one of the biggest immunization campaigns in decades. 

By Jonathan Gardner • July 23, 2020

Biogen points to COVID-19 for disappointing drug launch

Sales of Vumerity, a key new product in Biogen's plan to bolster its multiple sclerosis drug business, have been slow since it launched in December.

By Jacob Bell • July 22, 2020

At a pivotal moment, Biogen loses another top executive

Just weeks after Biogen submitted its closely watched Alzheimer's drug to the FDA, the company announced its CFO Jeff Capello will depart next month.

By Jacob Bell • July 22, 2020

Gilead adds to string of cancer drug deals with Tizona stake

An upfront payment of $300 million gives Gilead a nearly 50% stake in Tizona Therapeutics and the exclusive option to acquire it later, depending on how promising the biotech's immunotherapy looks.

By Jacob Bell • July 21, 2020