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

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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

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

FDA decision nears on Aimmune's contested peanut allergy drug

Palforzia is one of two products under review by the FDA that are aimed at desensitizing people highly allergic to peanuts.

By Jonathan Gardner • Jan. 24, 2020

Epizyme drug granted approval by FDA for rare cancer

Five years after buying back rights from Eisai, Epizyme won approval for its first-ever drug. 

By Ned Pagliarulo • Updated Jan. 24, 2020

Roche strengthens case for SMA drug with new study data

Results showed the oral drug can help improve motor function in babies with the severest form of a rare degenerative muscular disease.

By Jonathan Gardner • Jan. 23, 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

5 biopharmas to watch as the decade's last earnings kick off

Biogen faces down analysts one more time on its aducanumab plans, while two biotechs could give early glimpses into their first-ever drug launches. 

By Ned Pagliarulo , Jacob Bell • Jan. 21, 2020

After big year, RNAi drugmakers compete to prove what comes next

"We are in the first out of the first inning of the lifespan of RNAi," said Arrowhead CEO Christopher Anzalone. Two RNAi drugs are now approved, but the field still has much to prove.

By Andrew Dunn • Jan. 17, 2020

BioNTech rescues cancer biotech Neon in bargain buyout

The all-stock deal, worth $67 million, valued Neon at a 86% discount to the cell therapy developer's IPO price of $16 per share.

By Ned Pagliarulo • Jan. 16, 2020

Orchard isn't for the picking, Biohaven's Allergan headache, and who's on Vascepa?

Amarin CEO John Thero had one question for investors eager to hear about his company's plans for its heart pill, while Orchard made a case for independence.

By Jacob Bell • Jan. 16, 2020

Nektar quickly drops opioid drug after FDA panel rejection

After a decade of research, the biotech said it will withdraw its application for oxycodegol and make no further investment in the drug.

By Kristin Jensen • Jan. 15, 2020

Galapagos finds a new normal at biotech's biggest dealmaking event

Though the Belgian drug company is tied to a 10-year, $5 billion research pact with Gilead, its CEO says there's still some "wheeling and dealing" left to do.

By Jacob Bell • Jan. 15, 2020

Neuroscience's decade, a biotech's 'crown jewel,' and Ionis gets selective

Roche, maker of the last decade's top cancer drugs, is betting that neuroscience R&D can make strides in the 2020s — an outlook that contrasts with research retreats by the pharma's peers. 

By Andrew Dunn , Jacob Bell • Jan. 15, 2020

Astellas swoops in for Adaptimmune deal a day after positive data

For $50 million, the Japanese pharma signed up for three programs in a deal that could net Adaptimmune hundreds of millions more if all goes to plan. 

By Jonathan Gardner • Jan. 14, 2020

Alexion's neuro bet, Rubius' trial troubles and biotech's gene therapy milestones

On the first day of the JPM conference, Alexion mapped out ambitious plans in neuroscience, while Rubius did its best to explain delays in testing its first drug.

By Jacob Bell , Andrew Dunn • Jan. 14, 2020

BioMarin sets gene therapy sights beyond hemophilia

At the JPM conference, the biotech announced a manufacturing lift and a new trial start that affirm its ambitions in gene therapy go beyond its closely watched hemophilia A treatment.

By Jacob Bell • Jan. 13, 2020

Biogen finds $75M home for Pfizer Alzheimer's drug

Having stepped back from neuroscience research, Pfizer will sell off an early-stage therapy to Biogen, which has made the space its central focus.

By Jonathan Gardner • Jan. 13, 2020

Incyte turns to German Morphosys to refresh cancer pipeline

A licensing deal for Morphosys' near-to-market lymphoma drug will pad a pipeline that was recently weakened by a surprising study setback for Incyte. 

By Ned Pagliarulo • Jan. 13, 2020

Blueprint wins 1st FDA approval with targeted cancer drug

The Boston-area biotech advanced Ayvakit from initial human testing to regulatory approval in just four years, a rapid timeline reflective of the drug's gene-targeted profile.

By Ned Pagliarulo • Jan. 10, 2020

5 biotech trends to follow in 2020

Enthusiasm for new drugs and burgeoning companies will collide with an election year spotlight.

By Ned Pagliarulo • Jan. 9, 2020

Moderna, though early in development, prepares its vaccine for market

The vaccine just began mid-stage testing, but Moderna is already preparing for the next steps, which include a large Phase 3 study and hiring of sales associates.

By Jacob Bell • Jan. 9, 2020

Solid cuts one-third of staff, goes all in on delayed gene therapy

Re-starting a halted muscular dystrophy trial is Solid's priority as it puts a second drug and an assistive device on the backburner.

By Jonathan Gardner • Jan. 9, 2020

Lilly looms over Blueprint as the biotech files targeted cancer drug

Positive results in certain lung cancer patients support Blueprint's decision to submit pralsetinib, a RET-inhibitng drug, for approval in the first quarter.

By Jacob Bell • Jan. 8, 2020