In major surprise, Biogen will ask FDA to approve Alzheimer's drug aducanumab

New data from two trials halted earlier this year found the drug reduced clinical decline, Biogen said in an announcement that reverberated throughout the Alzheimer's research community. 

By Jacob Bell • Oct. 22, 2019

Seattle Genetics stock hits record high on well-placed breast cancer bet

Positive results for tucatinib should help the Seattle biotech in its quest to expand beyond Adcetris, currently its only approved drug.

By Ned Pagliarulo • Oct. 21, 2019

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

Mirati data to test whether biotech can challenge Amgen in KRAS quest

Shares in Mirati soared this year, driven higher by optimism the drugmaker can replicate Amgen's KRAS success. Data due Oct. 28 will give the first look at whether Mirati's candidate holds promise. 

By Ned Pagliarulo • Oct. 18, 2019

Merck's Ebola vaccine wins key European vote

Erevebo has already been administered to 274,000 people, and data indicate it is effective against the virus currently causing an African outbreak.

By Jonathan Gardner • Oct. 18, 2019

Lilly cancer drug pipeline hit by trial setback

Pegilodecakin, an immunotherapy acquired in the pharma's $1.6 billion deal for Armo BioSciences, failed to extend survival in patients with pancreatic cancer. 

By Ned Pagliarulo • Oct. 16, 2019

Reata surprises with positive data in challenging rare disease

There are no FDA-approved drugs for Friedreich's Ataxia, an uncommon neurological disorder. Reata looks closer to changing that with its latest data.

By Jacob Bell • Oct. 15, 2019

ProQR eye-disease data lend confidence that pivotal trial will succeed

The positive data also helps to keep the Netherlands drugmaker ahead of gene-editing specialists Editas and its partner, Allergan.

By Jonathan Gardner • Oct. 10, 2019

After more than a year, Gilead finds new chief medical officer

Coming from Roche's Genentech, Merdad Parsey​ will oversee clinical development and medical affairs starting Nov. 1.

By Jacob Bell • Oct. 7, 2019

Sarepta, in shadow of FDA setback, marks gene therapy progress

The biotech released the first functional data from a trial of an experimental gene therapy treating a different type of muscular dystrophy than Exondys 51.

By Jonathan Gardner • Oct. 4, 2019

Arbutus stops early hepatitis B study on safety concerns

Shares in the Pennsylvania biotech shed a quarter of their value Friday, putting the company down more than 70% for the year.

By Ned Pagliarulo • Oct. 4, 2019

Amicus rare disease data build hope for approval

The real test of the Pompe disease therapy, however, will be an enrolling Phase 3 study that's set to read out data in 2021.

By Jonathan Gardner • Oct. 2, 2019

FDA knocks back AstraZeneca's respiratory ambitions

The rejection of AstraZeneca's triple respiratory inhaler puts the company further behind its U.K. rival, GlaxoSmithKline.

By Jonathan Gardner • Oct. 1, 2019

Seattle Genetics makes case it can be more than Adcetris

Known best for its approved antibody drug conjugate, the biotech impressed at ESMO with positive results from two experimental drugs.

By Ned Pagliarulo • Sept. 30, 2019

Novartis, Lilly drugs set new survival bar in breast cancer

Study results detailing the survival benefit to Kisqali and Verzenio could help persuade more doctors to prescribe the targeted drugs. 

By Ned Pagliarulo • Sept. 29, 2019

AstraZeneca, Merck strengthen lead in PARP drug class

AbbVie appears back on track with rival veliparib, but until it's approved Lynparza looks set to be a preferred option in first-line ovarian cancer.

By Jonathan Gardner • Sept. 28, 2019

Colon cancer proves tougher target for Amgen's KRAS drug

A much lower response rate in colorectal cancer than in lung could signal the two tumor types respond differently to blocking KRAS with AMG 510.

By Ned Pagliarulo • Sept. 28, 2019

Cancer immunotherapy boom showing no sign of slowdown

A new report from the Cancer Research Institute found nearly 3,900 drugs in preclinical and clinical development, up 91% from just two years ago. 

By Ned Pagliarulo • Updated Sept. 27, 2019

Pfizer's new JAK drug works, but class safety concerns linger

While effective, the class has come under regulatory scrutiny for increasing patients' risk of blood clots and cardiovascular events.

By Jacob Bell • Sept. 27, 2019

Investors conclude there are probably better NASH drugs than Enanta's

The biotech's stock plummeted more than 18% Thursday as data showed its FXR agonist barely cleared the threshold for success in a Phase 2 study.

By Jacob Bell • Sept. 26, 2019

First-of-its-kind trial in ALS spurs hope for brutal disease

A so-called platform study will test five drugs at once, a design that experts say could become a model in rare disease drug development. 

By Andrew Dunn • Sept. 25, 2019

FDA warning slowed immunotherapy use in bladder cancer

Doctors appeared to shift their prescribing following an FDA decision to limit the approvals of Keytruda and Tecentriq in the tumor type, new research found.

By Ned Pagliarulo • Sept. 25, 2019

Medicines Co. gets cholesterol confirmation

The biotech secured positive results from two more Phase 3 trials of inclisiran, clearing a final step before submitting the PCSK9 drug to the FDA.

By Jonathan Gardner • Sept. 25, 2019

Cancer centers stretching to keep up with pharma's oncology interest

Empty trials, bandwidth constraints and lingering issues with enrollment criteria are on display amid a boom in cancer drug research.

By Jacob Bell • Sept. 23, 2019

Merck, Pfizer execs explain how they tap sites for cancer trials

The decisions hinge on a trial's phase and tumor type but are also affected by certain medical experts and the companies' history with a site.

By Jacob Bell • Sept. 23, 2019

Is the future of diabetes treatment better drugs or better care?

Drug manufacturers are trying to push the boundaries of glucose control, but cost concerns could rein in ambitions.

By Jonathan Gardner • Sept. 23, 2019