Exelixis prostate cancer data could help stave off competitive threats

As Pfizer makes inroads against Cabometyx in kidney cancer, Exelixis said it will ask the FDA next year for approval in prostate disease.

By Jonathan Gardner • Feb. 11, 2020

Bayer, looking to grow pharmaceutical sales, seeds new research center

The German drugmaker is transferring a "large part" of its small molecule research unit in Berlin to contract developer and manufacturer Nuvisan, with the aim of building a new facility on Bayer's R&D campus.

By Jacob Bell • Feb. 11, 2020

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

In Alzheimer's, a plan to treat patients earlier doesn't work out for Lilly, Roche

Results from the DIAN-TU study chip away at the amyloid hypothesis' foundation, just as Biogen prepares to file its drug aducanumab for approval.

By Jonathan Gardner • Feb. 10, 2020

Biohaven misses a chance to prove it's more than migraine

One of Biohaven's late-stage drugs proved no better than placebo in a type of severe anxiety — a lost opportunity for the company to showcase a pipeline beyond its lead migraine therapy.

By Ned Pagliarulo • Feb. 10, 2020

Biogen dips as Alzheimer's drugs from Lilly, Roche fail again

Analysts have said that, should the DIAN-TU study miss, it may further paint Biogen's aducanumab and the positive Phase 3 data it generated as an "artifact of luck" within a series of failed amyloid-targeting drugs.

By Jacob Bell • Feb. 10, 2020

Innovations shaking up clinical trial patient recruitment

 From voice assistants to study-specific patient portals, discover the newest innovations for clinical trial sponsors to leverage. 

Feb. 10, 2020

In small study, hints of promise for 'natural killer' cell therapy

None of the 11 patients treated with the CAR NK treatment experienced the severe immune reactions or neurotoxicity that are associated with CAR-T.

By Ned Pagliarulo • Feb. 6, 2020

Sanofi MS drug results set stage for extensive late-stage testing

The drug, a type of enzyme inhibitor that's proven valuable in cancer treatment, will soon head into four late-stage studies across various types of MS.

By Jacob Bell • Feb. 6, 2020

Implementing risk-based quality management: The importance of scalability

Regulators insist on making better use of advancements such as centralized monitoring and analytics to more efficiently maintain quality and safety standards.

Feb. 6, 2020

Regeneron partners with US government to develop coronavirus treatment

The biotech hopes to replicate its past success in quickly advancing a treatment for Ebola. But, as that experience showed, proving a new antiviral isn't easy.

By Ned Pagliarulo • Updated Feb. 4, 2020

Antiviral drugmakers GSK, Gilead join fight against coronavirus' spread

Gilead will work with Chinese authorities to test its drug remdesivir in a randomized study, while GSK is providing its adjuvant platforms to groups partnered with CEPI.

By Ned Pagliarulo • Feb. 3, 2020

US cancels trial after finding vaccine doesn't prevent HIV

Research into preventive treatments will continue, however, as an NIH leader declared a vaccine "essential" to ending the widespread disease.

By Jonathan Gardner • Feb. 3, 2020

Preventive Alzheimer's trial data due within weeks, Lilly says

Lilly's top scientist, however, set low expectations that solanezumab will show a benefit for patients with genetic mutations that drive early and severe disease.

By Jonathan Gardner • Jan. 30, 2020

Big pharma backed away from brain drugs. Is a return in sight?

Biotech executives see a new era of neuroscience breakthroughs on the horizon. But in a historically challenging space, it's hard to pinpoint what would cause big pharma to dive back in — and what ripples that would create.​

By Jacob Bell • Jan. 29, 2020

Decibel CEO steps down as company pares workforce

The Third Rock-backed company put an acting executive in place as it repositions for development in gene therapy and regenerative medicine.

By Jonathan Gardner • Jan. 29, 2020

Pfizer lays out gene therapy aspirations

With more Phase 3 trials on the near horizon, the big pharma plans to add one new gene therapy project per year to its pipeline.

By Jonathan Gardner • Jan. 28, 2020

Acceleron soars on blood pressure data despite lengthy road to market

While the biotech's drug succeeded in a mid-stage study of pulmonary arterial hypertension patients, analysts think a potential approval is four years off, at least.

By Jacob Bell • Jan. 28, 2020

J&J launches vaccine efforts as coronavirus spreads

The pharma says it has the manufacturing capacity to produce a vaccine at scale should its scientists hit upon a construct that appears effective. 

By Ned Pagliarulo • Updated Jan. 27, 2020

Ipsen pauses studies of drug for rare bone disease

The decision makes a mid-2020 approval and launch, which Ipsen expected when it acquired the drug, less likely.

By Jacob Bell • Jan. 24, 2020

Safety risks highlighted in FDA letter on Sarepta's Vyondys

In rejecting Vyondys last August, one FDA official wrote that, without confirmatory trials for either of Sarepta's muscular dystrophy drugs, it's difficult to judge whether they're worth the risk.

By Jonathan Gardner • Jan. 22, 2020

Drug trial success a consolation prize for Akcea, Ionis

Although Novartis chose not to license Akcea and Ionis' high triglyceride drug, positive data could open up new development opportunities.

By Ned Pagliarulo • Jan. 22, 2020

BeiGene cancer drug data sets up China duel with Merck

Merck's Keytruda won the first PD-1 approval in China for a type of lung cancer, but Beigene's tislelizumab could make a run.

By Jonathan Gardner • Jan. 21, 2020

A biotech startup launches with unusual goal: invent new drugs, and sell them for less

Founded by venture capitalist Alexis Borisy, EQRx will launch with $200 million in funding to prove out a vision as daunting as it is ambitious.

By Ned Pagliarulo • Jan. 13, 2020

3 myths that may be sabotaging your clinical trial enrollment effort

Survey insights from patients, physicians, and study sponsors reveal missed opportunities for enrollment success. 

Jan. 13, 2020

Ultragenyx boosted by trial data for 2nd gene therapy

One analyst called the results, which sparked a 30% jump in Ultragenyx's stock price, better than expected. The biotech is now preparing a Phase 3 trial.

By Jonathan Gardner • Jan. 10, 2020