Bio Pharma Dive

Bluebird wins FDA approval of gene therapy for rare brain disorder

Bio Pharma Dive

The therapy, called Skysona and cleared to treat cerebral adrenoleukodystrophy, is the product of more than a decade of work by Bluebird. It will cost $3 million

FDA, NIH initiative aims to speed development of drugs for ALS, other brain diseases

Bio Pharma Dive

The public-private partnership plans to bring together scientific experts, private entities and patient groups to better understand certain neurodegenerative disorders and find new treatments

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Back-to-back gene therapy approvals give Bluebird shot at survival

Bio Pharma Dive

The FDA's clearances of Zynteglo and Skysona are a boost to Bluebird, and could help lift the research field after a series of setbacks. But selling the high-priced therapies will be a challenge

J&J opens new research hub near San Francisco

Bio Pharma Dive

The roughly 200,000-square-foot facility will house about 400 employees and more than double the size of the drugmaker’s presence in San Francisco

2022 Research: The Rapid Rise of Ocean Freight Visibility

Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.

Third Harmonic boosts biotech with sector’s top IPO in four months

Bio Pharma Dive

The startup’s $185 million initial public offering is the largest for the sector since early May and potentially a sign of renewed investor interest in young biotechs

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AstraZeneca claims positive results for its “add-on” drug for rare blood disease

Bio Pharma Dive

The drug, meant to complement other treatments for paroxysmal nocturnal hemoglobinuria, comes via Alexion, which had acquired it from Achillion in 2019

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Alnylam, Regeneron to advance NASH drug after early signs of potential

Bio Pharma Dive

A gene discovery four years ago led to a partnership between the companies, which plan to start a Phase 2 study later this year after encouraging early data

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How a top FDA official’s words helped push a closely watched ALS drug toward approval

Bio Pharma Dive

Comments by Billy Dunn, head of the FDA’s neuroscience office, played a major role in a vote by an advisory panel Wednesday in support of the medicine, which is in the final stages of regulatory review

Vesalius Therapeutics, a buzzy, Flagship-backed startup, cuts jobs six months after public launch

Bio Pharma Dive

When the company debuted in March, it announced plans to hire 200 employees over two years. Now, it’s laid off nearly half its staff in a year when the biotech sector has experienced a sharp market downturn

Sangamo presses ahead with Fabry disease gene therapy

Bio Pharma Dive

Preliminary results from a Phase 1 study show Sangamo’s treatment to be safe and suggest it is working as intended, leading the biotech to move into the trial’s next phase

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Optimizing pharmaceutical innovation

Bio Pharma Dive

Elevate pharma product development and marketing through collaboration with physician experts

Intellia offers first look at CRISPR drug for rare swelling disorder

Bio Pharma Dive

Preliminary study results show the biotech’s gene editing treatment could reduce markers and symptoms of hereditary angioedema, though the data come from few patients and follow-up remains limited

FDA advisers back microbiota-based treatment for gut infection

Bio Pharma Dive

Committee members voted in support of Rebiotix’s treatment for recurrent C. diff infections of the intestines, a condition with no regulated options after antibiotics fail

Biotech startup Ocean pivots from IPO to SPAC merger

Bio Pharma Dive

The blank-check deal gives Ocean another route to public markets after it struggled to price an initial public offering it revealed back in June 2021

Acelyrin sets hopes high for arthritis drug with $300M fundraise

Bio Pharma Dive

The well-funded startup is planning Phase 3 trials for a drug it claims could be superior to top-selling medicines from Novartis and others

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Mandatory COVID Vaccination Policy Template

The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.

Atlas Venture’s Bruce Booth on testing the IPO waters and putting the ‘tech’ in biotech

Bio Pharma Dive

In a wide-ranging conversation with BioPharma Dive, Booth, a prolific builder of new biotechs, said he’s starting to see positive signs for startups considering an IPO or private financing

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Alnylam details anticipated results from heart disease drug trial

Bio Pharma Dive

Fuller data from Alnylam’s APOLLO-B trial confirm the success reported by the company last month, but won’t end a debate on the degree of benefit offered by its drug

Bluebird gene therapy approved by FDA for rare blood disease

Bio Pharma Dive

The regulator cleared the biotech’s medicine Zynteglo for transfusion-dependent beta thalassemia, giving patients a powerful new treatment option. But it will come at a very high cost of $2.8 million in the U.S.

Bristol Myers gets FDA approval for new type of psoriasis drug

Bio Pharma Dive

Sotyktu has been on the pharma’s top pipeline candidates and its clearance continues a string of positive regulatory news for the company

Pfizer follows GSK with positive Phase 3 results for RSV vaccine

Bio Pharma Dive

In a pre-planned interim data analysis, Pfizer said its shot was strongly protective against severe disease and plans to submit the results to regulators this fall

Relay impresses with early study data for targeted cancer drug

Bio Pharma Dive

Updated data released ahead of the ESMO medical conference suggest Relay’s medicine could be more effective than others like it in treating a type of bile duct cancer

Moderna follows Pfizer in asking FDA to approve updated COVID shot

Bio Pharma Dive

The companies are moving quickly to supply vaccines targeting currently circulating omicron variants in time for the Biden administration's planned fall vaccination campaign

Pfizer brings mRNA flu vaccine into Phase 3 testing

Bio Pharma Dive

The trial, expected to enroll 25,000 adults, is the second late-stage test of an mRNA flu shot to begin this year, following the June start of a Moderna study

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Psychedelic clinical trials: What sponsors should know when designing new protocols

Bio Pharma Dive

With regulators and lawmakers seemingly on board, sponsors have more opportunities than ever to pursue clinical research in this high-velocity area

Roche to pay $250M for Good Therapeutics and its targeted drug technology

Bio Pharma Dive

The team behind the Seattle-based startup will launch a new company, Bonum Therapeutics, after the sale to Roche is completed

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Drugging RNA with pills: small molecules for a big frontier

Bio Pharma Dive

A handful of startups have formed in recent years with plans to target RNA with small molecules. Many have caught the attention of big drugmakers

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After safety setbacks, job cuts, Imara sells its top drug to a startup

Bio Pharma Dive

The biotech, which has lost nearly all of its value since going public in 2020, reached a deal to sell a drug it tested in sickle cell disease to Cardurion Pharmaceuticals, a richly funded startup focused on cardiovascular research

Regeneron answers rivals with data for new version of top-selling eye drug

Bio Pharma Dive

A high-dose form of Eylea, administered less frequently, matched the original in late-stage testing, an important step in the company’s plan to defend its bestseller against competition

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Backed by $40M, a biotech startup targets cancer with help from the immune system

Bio Pharma Dive

After several years in stealth, 3T Biosciences is launching publicly with plans to develop newer types of T cell receptor-based treatments

Next-generation RNA technologies: making longer-lasting drugs with a broader reach

Bio Pharma Dive

At least 10 biotechnology startups are trying to use RNA molecules in new ways to make medicines. Here’s a look at where they stand

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Beam details reasons for FDA hold on base editing cancer therapy

Bio Pharma Dive

The regulator has asked Beam for a range of technical data before it can start testing the blood cancer treatment in humans

Alnylam drug succeeds in key heart disease study, boosting company

Bio Pharma Dive

The success of Alnylam's treatment in a trial known as APOLLO-B could pave the way for the biotech to reach consistent profitability, should the FDA sign off on a planned approval application

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A biotech startup gives Merck its next shot at Alzheimer’s

Bio Pharma Dive

Boston-based Cerevance uses samples of healthy and diseased human brain tissue to find new targets for central nervous system diseases

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‘Treg’ cell therapy: bringing CAR-T to autoimmune disease

Bio Pharma Dive

At least seven companies, including five richly funded startups, are developing cell-based treatments for inflammatory conditions, making it one of biotech’s most competitive fields

How a small UK biotech ended up in Gilead’s hands

Bio Pharma Dive

MiroBio, which was spun out of the University of Oxford three years ago, drew Gilead’s interest with its autoimmune disease research

Merck backs radiopharmaceutical startup Aktis, joining other high-profile backers

Bio Pharma Dive

The pharma contributed to an $84 million round for the new cancer drugmaker, which attracted Novartis and Bristol Myers Squibb in an earlier fundraise

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Roche digs into off-the-shelf cell therapy with Poseida deal

Bio Pharma Dive

The pharma has now signed two alliances with allogeneic drug developers since September, signalling its interest in CAR-T treatment alternatives

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CDC backs updated COVID shots from Pfizer, Moderna

Bio Pharma Dive

One day after the FDA’s authorization, the CDC recommended the companies’ omicron-targeted vaccines for most adults and children over 12 years old

FDA names new head to vaccine review office

Bio Pharma Dive

David Kaslow, the lead scientist at a global public health nonprofit, will succeed Marion Gruber, who retired last fall amid her dissent on the timing of COVID-19 vaccine boosters

Mitochondrial drugs, with a twist: Pretzel Therapeutics launches with $72.5M in funding

Bio Pharma Dive

Scientists at Pretzel believe fixing mutated mitochondrial DNA with a mix of small molecule therapies and gene editing could be key to solving a number of hard-to-treat diseases