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

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

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

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

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

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

What could help biotech close out 2019 stronger? Analysts pick 3 events to watch

Biotech generally underperformed the market so far this year. Updates from Amgen, Roche and Novartis could deliver a needed boost, analysts at Credit Suisse say.

By Andrew Dunn • Sept. 4, 2019

Vertex to buy preclinical biotech for $950M, searching a Type 1 diabetes cure

Acquiring Semma Therapeutics fulfills CEO Jeffrey Leiden's promise that Vertex would explore "potentially larger" deals than it's done in the past.

By Andrew Dunn • Sept. 3, 2019

UniQure stays a step ahead in hemophilia B

Seeing high interest from patients and study investigators, uniQure is enrolling six more participants than planned in its Phase 3 gene therapy study.

By Ned Pagliarulo • Sept. 3, 2019

Medicines Co.'s cholesterol drug looks good to take on PCSK9 rivals

Data show inclisiran more or less matched Repatha and Praluent on cholesterol lowering, but the drug will need a smart launch, and possibly a partner, to compete.

By Jonathan Gardner • Updated Sept. 3, 2019

Alexion shares slide on Amgen patent challenge to top-seller

A surprise decision by the U.S. patent office to review three patents held by Alexion on its drug Soliris renewed fears of earlier-than-expected competition.

By Ned Pagliarulo • Aug. 30, 2019

Amgen puts its KRAS hopes on 'Navy Seals' team of drug hunters

Found in many solid tumors, mutant KRAS is cancer research's white whale. Amgen's drug looks the most promising to emerge from decades of failed efforts, but others are close behind. 

By Ned Pagliarulo • Aug. 30, 2019

Amyloid's last hope? Prevention studies next big test for Alzheimer's research

The DIAN-TU trial, studying patients genetically predisposed to Alzheimer's, could help decide the fate of what's been the dominant hypothesis of the disease's cause.

By Jonathan Gardner • Aug. 29, 2019