Biotech

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. 04, 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. 04, 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. 04, 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

Pfizer and BioNTech coronavirus vaccine gets boost from German data

As the race to bring a vaccine to market accelerates, the companies unveiled new clinical results and a deal that promises the U.K. 30 million doses of a successful shot.

By Jonathan Gardner • July 20, 2020

Sponsored by Parexel Biotech

Opportunities for biotechs in precision medicine

Exploring the promise of precision medicine in helping biotechs bring new therapies to patients.

By Angela Qu, MD, PhD, Vice President, and Arlene Hughes, PhD, Senior Director • July 20, 2020

A startup launches with big plans to develop antibody drugs for coronaviruses

Larger drugmakers like Regeneron have led the way in developing antibody drugs for COVID-19. Adagio Therapeutics aims to prove it can follow suit, with an eye to future coronavirus outbreaks as well.

By Ben Fidler • July 16, 2020

Researchers publish long-awaited study data on Moderna coronavirus vaccine

The results support the biotech's earlier claim of positive results, but don't show whether the vaccine protects against infection. Still, "we're so hungry for a vaccine we're trying to read the tea leaves," said vaccine expert Paul Offit.

By Ned Pagliarulo • UPDATED: July 14, 2020 at 6:33 p.m.

Preventive studies for Eisai, Biogen Alzheimer's drug could add years to amyloid debate

Two late-stage trials will assess the companies' experimental drug BAN2401 in people without Alzheimer's symptoms but with biological signs of the disease.

By Jonathan Gardner • July 14, 2020

Blueprint, eyeing an independent future, gets $775M in new Roche alliance

The deal, which gives Roche rights to Blueprint's lead drug pralsetinib, is another bet by the Swiss drugmaker on targeted cancer therapies.

By Ben Fidler • UPDATED: July 14, 2020 at 9:34 a.m.

India clears a psoriasis drug for COVID-19, and a tiny US biotech's shares soar

An emergency approval for Biocon's drug Alzumab in India could lead its U.S. partner, Equillium, to start broader trials in coronavirus disease.

By Ben Fidler • July 13, 2020

Beigene, already flush with cash, raising $2B from investors

Amgen, which last year partnered with the Chinese biotech, will invest another $420 million in the company to maintain its roughly 20% stake. 

By Ned Pagliarulo • July 13, 2020

Big pharma, battling COVID-19, looks to 'buy time' on another health crisis: superbugs

Facing an alarming scarcity of new antibiotics, about two dozen of the world's largest drugmakers are backing a fund meant to develop two to four by 2030.

By Jacob Bell • July 09, 2020

In the hunt for ALS treatments, researchers find promise in silencing genes

Two studies published in the New England Journal of Medicine, including one that tested a Biogen drug, provide some evidence that a decades-long effort to develop genetic medicines for ALS is starting to pay off.

By Jacob Bell • July 08, 2020

Biogen submitted its Alzheimer's drug for approval. Now what?

The later-than-expected filing is just the first of many hurdles Biogen faces in trying to get aducanumab approved. Some analysts on Wall Street don't have high hopes for the drug's chances.

By Jacob Bell • July 08, 2020

US buys up early supply of Regeneron's COVID-19 antibody cocktail

A $450 million grant will help Regeneron scale up manufacturing of its drug, which is among the front-running antibody therapies for COVID-19.

By Jonathan Gardner • July 07, 2020

Regeneron advances COVID-19 antibody cocktail into late-stage trials

The launch of a Phase 3 prevention study accelerates work on antibody-based drugs, which could offer strained healthcare systems a "bridge" to a vaccine.

By Jonathan Gardner • July 06, 2020

Bellus shares plummet as cough drug fails Phase 2 test

While Bellus plans to do more testing, the negative readout now puts it further behind Merck in the race to develop a drug for refractory chronic cough.

By Jacob Bell • July 06, 2020