Biotech: Page 2

Moderna's vaccine may have an edge when immunization programs roll out

A rival shot from Pfizer and BioNTech needs to be stored at colder temperatures and doesn't last as long in a refrigerator, which may limit its use.

By Jonathan Gardner • Aug. 26, 2020

A new biotech forms to revive Amgen's old heart drug

Founders of Dutch biotech Dezima have created NewAmsterdam Pharma and bought back the cholesterol drug they sold to Amgen in 2015.

By Ben Fidler • Aug. 26, 2020

Explore the Trendline➔

Trendline

Inside the global race for a coronavirus vaccine

Some 29 vaccine candidates are now in clinical studies. Early results from five leading efforts are encouraging, suggesting researchers are on the right track despite rapid acceleration of testing.

By BioPharma Dive staff

Moderna says its coronavirus vaccine sparks immune response in older people

An initial look at the vaccine's effects on the elderly shows those in their 70s had similar responses to those under 55, Moderna told a government panel.

By Jonathan Gardner • Aug. 26, 2020

Freenome raises $270M to run pivotal trial of colorectal cancer blood test

The 14,000-person study could set the company up to compete with Exact Sciences and Guardant Health for the colorectal cancer screening market.

By Nick Paul Taylor • Aug. 26, 2020

Sarepta, after two dramatic approvals, gets an FDA review for next Duchenne drug

Sarepta's first two medicines were both cleared in controversial fashion. Will its third attempt go more smoothly?

By Jonathan Gardner • Aug. 25, 2020

New data lead Ovid, Takeda to push seizure drug into final testing

The partner companies found that, when tested in two types of rare epilepsy, their drug seems to perform better in one. But they see a path forward in both. 

By Jacob Bell • Aug. 25, 2020

Moderna joins other vaccine leaders in European supply talks

The deal would designate up to 160 million doses of Moderna's shot for the European Union, which has worked aggressively of late to bolster its supply.  

By Jonathan Gardner • Aug. 24, 2020

Proteostasis bows out of cystic fibrosis drugmaking through Yumanity merger

The biotech's plans to challenge Vertex Pharmaceuticals have fallen short, leading to a merger with a neuroscience-focused startup. 

By Jacob Bell • Aug. 24, 2020

Deep Dive

Relay Therapeutics set out to change how drugs are designed. Can it continue what Vertex began?

Vertex pioneered a more precise way of developing drugs. Relay, which has raised nearly $1 billion since its founding, thinks it can go one step further. 

By Ned Pagliarulo • Aug. 24, 2020

Coronavirus vaccine Pfizer, BioNTech chose for late-stage testing appears safer than first

Preliminary data showed the pair's second experimental shot caused less fever, without compromising potency, when compared to an earlier version.

By Jonathan Gardner • UPDATED: Aug. 21, 2020 at 9:30 a.m.

BioMarin's gene therapy rejection didn't shock everyone

The FDA's decision not to approve Roctavian raises the question of why BioMarin was able to submit the hemophilia A therapy in the first place.

By Jacob Bell • Aug. 20, 2020

Mylan launches copy of Biogen's top drug despite ongoing court battle

Mylan's launch of a generic copy of the multiple sclerosis drug Tecfidera comes earlier than expected, and risks a court siding with Biogen on a key patent.

By Ben Fidler • Aug. 19, 2020

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 at 11:26 a.m.

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

Deep Dive

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

Even before the FDA surprisingly rejected BioMarin's Roctavian, doctors and patients had expected access to gene therapy would remain limited for quite some time.

By Jacob Bell • UPDATED: Aug. 19, 2020 at 12:05 p.m.

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

Sponsored by Parexel Biotech

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 at 11:41 a.m.

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. 07, 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. 07, 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. 06, 2020