Biotech

Pfizer, BioNTech are first to seek full FDA approval of a coronavirus vaccine

The milestone filing could pave the way for the shot's use beyond the pandemic and give employers the legal heft to require vaccination, a key step toward herd immunity in the U.S.  

By Jonathan Gardner • May 07, 2021

Two biotechs team up to bring CRISPR to 'natural killer' cell therapy

A wide-ranging alliance between CRISPR Therapeutics and Nkarta is the latest sign of interest in a fast-emerging form of cancer immunotherapy.

By Ben Fidler • May 06, 2021

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Trendline

The BioPharma Dive Outlook on 2021

M&A appears to be ticking higher after a slow 2020, while a series of setbacks has renewed questions around gene therapy. Several key clinical trial readouts also loom. Here's what to watch in biotech and pharma this year.

By BioPharma Dive staff

Pharma erupts as Biden administration backs waiver of vaccine patent rights

The shift in U.S. policy might not undermine future research as the drug industry claims. Easing patent protections, though, isn't likely to translate to an immediate boost in vaccine supply.

By Jonathan Gardner , Ned Pagliarulo • May 06, 2021

CSL closes deal for UniQure gene therapy in hopeful sign for M&A

Completion of the buyout eases concerns the arrangement might be held up by the FTC, which has signaled it will step up scrutiny of life sciences deals.  

By Kristin Jensen • May 06, 2021

Dyno, in demand for its gene therapy work, raises $100M for fast expansion

After inking three pharma deals within a year of launching, the Harvard spinout has the backing of Andreessen Horowitz and several other top investors.

By Jonathan Gardner • May 06, 2021

Roger Perlmutter, former Merck research chief, resurfaces to lead a small biotech

Months after leaving his post as Merck's top scientist, Perlmutter has become CEO of Eikon Therapeutics, which plans to use Nobel Prize-winning microscope technology to discover new drugs.

By Ben Fidler • May 05, 2021

Adagio, flush with cash, launches large study of next-gen COVID-19 antibody

The privately held biotech believes its drug might treat or prevent infections from existing variants and future coronavirus strains, which could make it a competitor to marketed therapies from Regeneron and Eli Lilly. 

By Kristin Jensen • May 05, 2021

Esker, a new biotech startup, launches with plans to make targeted immune drugs

Led by a former MyoKardia executive, Esker Therapeutics is developing a drug that could eventually compete with one of Bristol Myers Squibb's most closely watched candidates.

By Jonathan Gardner • May 05, 2021

Sage braces for make-or-break depression data

The biotech's latest earnings call focused less on revenue and more on an experimental drug for depression that's close to having important study results.

By Jacob Bell • May 04, 2021

Sarepta's second-gen Duchenne drug shows signs of topping its first

An experimental Duchenne drug developed with a newer technology may be more potent than Sarepta's marketed treatment Exondys 51. But early data also brought new safety concerns.

By Jonathan Gardner • May 03, 2021

Roivant valued at $7B in blank-check merger, bucking SPAC slowdown

Vivek Ramaswamy's unusual biotech holding company will go public through a deal with Montes Archimedes Acquisition Corp. that nets Roivant $611 million.

By Ben Fidler • May 03, 2021

Avrobio changes course after FDA closes path for speedy gene therapy approval

The FDA recently converted its clearance for a standard Fabry treatment to a full approval, complicating Avrobio's plans to seek an accelerated OK for its rare disease therapy. 

By Ned Pagliarulo • May 03, 2021

A serious side effect puts a biotech's eye gene therapy in limbo

Adverum Biotechnologies has unmasked a Phase 2 study in which a trial participant suffered severe inflammation and vision loss — a finding that could threaten the program’s future in multiple eye diseases.

By Ben Fidler • April 29, 2021

Moderna plans to triple coronavirus vaccine production next year

The biotech aims to double capacity at plants in Switzerland and Spain, and by 50% at U.S. sites. The total number, however, will depend on the mix of primary and booster doses.

By Jonathan Gardner • April 29, 2021

Wall Street fears Amgen's tough first quarter is just the start

Product sales fell by 5% in the first quarter, keeping the pressure high for Amgen to deliver on expectations for its KRAS cancer drug Lumakras.

By Jacob Bell • April 28, 2021

Under pressure, Biogen will allow some patients early access to experimental ALS drug

Biogen plans to start a compassionate use program in July that would let a small group of patients with rapidly progressing disease access its drug.

By Jacob Bell • April 27, 2021

Vertex moves pain drug into mid-stage testing

VX-548 is Vertex's latest attempt to show that blocking a certain sodium channel can offer a new, non-addictive way to treat pain.

By Jacob Bell • April 26, 2021

Coronavirus vaccine makers Oxford, Novavax follow up with a promising malaria shot

A vaccine co-developed by the U.K. academic center and the Maryland biotech could be the first to meet the WHO's efficacy target for a malaria vaccine.

By Ben Fidler • April 23, 2021

As review of its Alzheimer's drug wraps up, Biogen prepares for an uncertain launch

On an earnings call Thursday, executives shed more light on how they intend to address some of the challenges that would come with selling a controversial drug like aducanumab.

By Jacob Bell • April 22, 2021

With money pouring into biotech, Versant raises another $950M

Versant's announcement comes as biotechs continue to rake in record levels of cash, supporting a wave of new drug company startups. 

By Jacob Bell • April 21, 2021

The next 2 months in biotech and pharma will be busy. Here's what to watch.

New developments could come soon for two coronavirus vaccines while, a bit further off, the fate of Biogen's Alzheimer's drug hangs in the balance. Important data are expected, too, for Vertex and Sarepta.

By Ben Fidler , Ned Pagliarulo , Jacob Bell • April 20, 2021

Bluebird to withdraw gene therapy from Germany after dispute over price

The biotech will cut staff, primarily in Europe, after negotiations with German health authorities resulted in a price lower than Bluebird had sought. 

By Ned Pagliarulo • April 20, 2021

Vertex bets another $900M on CRISPR treatment for blood diseases

Vertex and CRISPR Therapeutics are tweaking their partnership so that the larger biotech will cover 60% of the costs — and receive 60% of the future profits — related to a gene editing therapy for sickle cell disease and beta thalassemia.

By Jacob Bell • April 20, 2021

Positive data in hand, TG Therapeutics readies MS drug for FDA review

If approved, TG's drug would join Roche's fast-selling Ocrevus and Novartis' newer entrant Kesimpta as one of a newer class of multiple sclerosis therapies.

By Jonathan Gardner • April 19, 2021

A startup raises $336M to make a better antibody drug for COVID-19

Adagio Therapeutics, a well-financed spinout of antibody developer Adimab, could challenge Regeneron and Eli Lilly if its drug candidate proves protective in clinical tests.

By Ben Fidler • April 19, 2021