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

Explore the Trendline➔

Emerging biotech

New biotechs continue to emerge despite a challenging market environment that has forced venture firms to build their drug startups more cautiously.

By BioPharma Dive staff

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

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

Clovis shares plunge after downgrade raises questions on path forward

A Wall Street analyst was skeptical of a preclinical deal that adds R&D costs while the company fights for market share in ovarian cancer.

By Jonathan Gardner • Sept. 24, 2019

Alder's migraine drug attracted plenty of dealmakers. The company, not so much

A new regulatory filing affirms the theory that, in neuroscience, risk-sharing partnerships are more appealing than all-out acquisitions.

By Jacob Bell • Sept. 24, 2019

Amag fights activist investor's bid for board seats

After increasing its stake to 10%, a hedge fund has launched a board bid as Amag works to commercialize a female libido pill.

By Jonathan Gardner • Sept. 23, 2019

3 Akcea execs, including CEO, leave in a 'disconcerting surprise'

"It's hard to see this abrupt transition as not being disruptive to the ongoing Tegsedi launch," noted one analyst, referring to the biotech's antisense drug.

By Andrew Dunn • Sept. 23, 2019

Focusing on cystic fibrosis, Translate Bio to raise $90M

The fundraising follows Translate's inking of a five-year manufacturing deal with AMRI, aimed at supporting development of its mRNA products.

By Kristin Jensen • Sept. 18, 2019

Alexion's CFO steps down in surprise departure

Known for his 'legendary caution,' Paul Clancy will be succeeded by Alexion's head of business development Aradhana Sarin.

By Ned Pagliarulo • Sept. 18, 2019

Vertex hits a biomarker bump on road to new drug

Following an FDA workshop, analysts believe Vertex will need to show its drug for AAT deficiency offers some functional benefit rather than just a biomarker effect.

By Jacob Bell • Sept. 17, 2019

Acceleron dealt pipeline setback

The biotech's muscular dystrophy drug ACE-083 failed a Phase 2 trial, putting the spotlight for Acceleron more firmly on Celgene-partnered luspatercept.

By Jonathan Gardner • Sept. 17, 2019

Lundbeck buys into migraine, acquiring Alder for $2B

The Danish pharma has blockbuster ambitions for Alder's CGRP drug, but the already competitive migraine market is poised to become more so next year.

By Andrew Dunn • Sept. 16, 2019

Aimmune's peanut allergy drug secures FDA panel support, along with criticism

Winning the advisory committee's backing is a major step toward approval, but experts pressed Aimmune with questions on the drug's safety.

By Andrew Dunn • Sept. 13, 2019

Vertex makes headway in UK reimbursement

Scotland has agreed to cover two Vertex drugs, Orkambi and Symkevi, which may bode well for resolving a dispute over the company's prices.

By Jacob Bell • Sept. 12, 2019

In a 'make or break' moment, Tocagen falls short

The San Diego biotech's lead drug failed to extend survival in a pivotal study for an aggressive type of brain tumor, setting back the company's plans. 

By Andrew Dunn • Sept. 12, 2019

Reata's new CFO on M&A, weathering a recession and biotech's quirks

Manmeet Soni helped execute multi-billion dollar sales as CFO of Ariad and Pharmacyclics. He's now moving from Alnylam to a small, Texas-based biotech.

By Andrew Dunn • Sept. 12, 2019

Moderna marks progress toward goal of coaxing medicine from body's cells

Preliminary data suggest Moderna could reach its lofty ambitions for mRNA. "Any protein under the sun we can make," CEO Stéphane​ Bancel told BioPharma Dive.

By Ned Pagliarulo • Sept. 12, 2019

Survey suggests Ionis is losing battle against Pfizer and Alnylam

Physician preferences between the company's respective drugs appear to be emerging in the year since Ionis' Tegsedi won approval. 

By Jacob Bell • Sept. 10, 2019

Medicare would negotiate prices for 250 drugs under House Democrats' plan

Speaker Nancy Pelosi's proposal also finds common ground with the president in pegging U.S. prices to an international index.

By Jonathan Gardner • Sept. 10, 2019

Amgen update shows promise, limits of KRAS cancer drug

A 54% response rate among lung cancer patients will encourage, but several relapses could temper sky-high expectations for AMG 510. 

By Ned Pagliarulo • Sept. 8, 2019

Roivant offloads biotech stakes in $3B alliance with Japanese pharma

The deal transfers ownership in five Roivant subsidiaries to Sumitomo Dainippon, along with a stake in Vivek Ramaswamy's parent company. 

By Jonathan Gardner • Sept. 6, 2019

Alexion suffers another Soliris patent setback

Just a week after the U.S. patent office took up an Amgen challenge, Alexion now faces patent struggles in Europe as well.

By Andrew Dunn • Sept. 6, 2019

With third pharma deal, IFM's unorthodox approach paying off

An inflammatory disease partnership with Novartis is IFM's second this year with the Swiss pharma and follows a 2017 deal with Bristol-Myers Squibb. 

By Ned Pagliarulo • Sept. 5, 2019

Aclaris to lay off 86 employees in restructuring to extend cash

The biopharma is moving away from selling its dermatology products and will focus on its immuno-inflammatory pipeline, company execs said Thursday.

By Kristin Jensen • Sept. 5, 2019