Bio Pharma Dive

Social health: The future of healthcare marketing

Bio Pharma Dive

Approximately 79% of patients look to connect through social media to find answers to their health questions

A biotech startup raises $117M to deliver gene therapies in a new way

Bio Pharma Dive

Flagship Pioneering, the biotech incubator that created Moderna, is helping fund Ring Therapeutics, a startup hoping to disrupt gene therapy development through the use of a different viral vector

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Bluebird preps for split by selling manufacturing plant to well-funded startup

Bio Pharma Dive

The startup manufacturing specialist National Resilience, which raised $800 million when it launched last year, will pay Bluebird $110 million for the North Carolina facility, bringing its North American network up to 10

Bristol Myers withdraws Opdivo in liver cancer as fallout from FDA meeting continues

Bio Pharma Dive

With the decision by Bristol Myers, each of the two accelerated cancer drug approvals an FDA advisory panel voted to overturn in April have now been voluntary withdrawals

Drugs 230

BioNTech, WHO hatch plan to bring mRNA vaccines to Africa

Bio Pharma Dive

Responding to criticism, the German biotech plans to develop a malaria shot and build manufacturing infrastructure on the continent

Caribou raises $304M in one of gene editing's most lucrative IPOs

Bio Pharma Dive

The IPO is several times larger than what CRISPR Therapeutics, Intellia and Editas raised several years ago, and ranks well ahead of a more recent offering from gene editing startup Beam

A biotech's eye gene therapy faces longer odds as serious side effects pile up

Bio Pharma Dive

Five trial participants with diabetic macular edema who received Adverum Biotechnologies' treatment experienced side effects never before reported for an eye gene therapy

5 FDA decisions to watch in the third quarter

Bio Pharma Dive

The agency is under pressure to grant full approvals to two coronavirus vaccines and faces important questions on how to handle the next Alzheimer's drugs after Aduhelm. A safety review of several arthritis medicines, meanwhile, is ongoing

Merck rebounds to win a milestone immunotherapy approval in early breast cancer

Bio Pharma Dive

The FDA reversed an earlier decision to make Keytruda the first immunotherapy available for patients with early-stage breast cancer and also gave the drugmaker a full approval in advanced disease

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Regeneron, AstraZeneca team up on targeted drugs for obesity

Bio Pharma Dive

After screening 650,000 people, Regeneron unearthed a mutation associated with lower weight. AstraZeneca aims to help the biotech make a drug based on its findings

Drugs 208

Bluebird, with little fanfare, is first to bring a second gene therapy to market

Bio Pharma Dive

The approval of Skysona for a genetic brain disease is a milestone for one of gene therapy's pioneering companies, but isn't expected to turn Bluebird's financial fortunes around

A well-funded cancer drug startup brings on GSK's Axel Hoos as CEO

Bio Pharma Dive

Hoos, who led cancer R&D at GSK, will take over as head of Scorpion Therapeutics, a new biotech company that's raised $270 million in venture funding since launching last October

Drugs 251

Trends shaping biopharma's role in the healthcare ecosystem

Bio Pharma Dive

Four trends are shaping the healthcare ecosystem. These present new opportunities for biopharma

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A pharma merger's impact ripples across West Virginia as Viatris plant closes

Bio Pharma Dive

One of the country's oldest and largest drug manufacturing plants will shut down Saturday, a casualty of the 2019 merger between Mylan and Pfizer's Upjohn unit. The impact will be felt by a West Virginia city for years to come

Pfizer, responding to criticism, presses case for COVID-19 booster shots

Bio Pharma Dive

Pfizer previously predicted booster shots would be needed within a year. But the spread of the transmissible Delta variant may mean a booster is needed "a little earlier," CEO Albert Bourla said Wednesday

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Merck details an immunotherapy 'milestone' in early breast cancer

Bio Pharma Dive

Three months after a rare FDA rejection, Merck has data showing Keytruda can slow the return of triple-negative breast cancer but not, as of yet, proving whether the drug extends lives

Drugs 231

Amgen pays $900M for Teneobio and bets bigger on next-gen antibody drugs

Bio Pharma Dive

The acquisition is the third Amgen has made since March and broadens its ability to develop bispecific antibodies, a drug class of intense interest to big biotech

FDA flags rare side effect in new warning on J&J's coronavirus vaccine

Bio Pharma Dive

The agency said the benefits of vaccination with J&J's shot still "clearly outweigh" the risks, which now include very rare cases of a immune-driven condition known as Guillain-Barré

Major health centers, insurers push back against Aduhelm

Bio Pharma Dive

The Cleveland Clinic and Mount Sinai won't yet administer the controversial Alzheimer's drug, while UnitedHealth's CEO said the insurer would need more time to iron out coverage

Drugs 226

Celldex pins its hopes for a comeback on skin disease drug

Bio Pharma Dive

After several setbacks, most notably the failure of a brain cancer vaccine, Celldex has a chance at reinvention should early drug results pan out for the 16-year-old biotech

Biogen executives attack Aduhelm criticism, blaming 'extensive misinformation'

Bio Pharma Dive

The company responded forcefully to controversy roiling around the Alzheimer's drug's approval, defending its data and interactions with the FDA

Drugs 209

In first, FDA approves KRAS-blocking cancer drug from Amgen

Bio Pharma Dive

For decades, scientists have tried unsuccessfully to target the KRAS gene, which is often mutated in lung, colon and pancreatic cancers. Lumakras is the first drug proven effective

Gene therapy for Fabry: early stages, promising results

Bio Pharma Dive

Three companies are testing their gene therapies in early clinical trials, with initial results due later this year. Others are in preclinical stages and aim to follow soon

J&J predicts faster coronavirus vaccine sales amid debate over boosters

Bio Pharma Dive

The pharmaceutical company expects $2.5 billion in sales from its shot this year, despite concerns over protection against variants and significant manufacturing setbacks

Sales 194

Lilly wagers up to $1B on a biotech's plan for a new type of insulin

Bio Pharma Dive

Rival Novo Nordisk has jumped ahead in developing an injectable drug that responds to changes in blood sugar. An acquisition of Protomer Therapeutics could help Lilly close the gap

Prime Medicine raises $315M to fuel 'search-and-replace' gene editing work

Bio Pharma Dive

Formed around research from the Broad Institute's David Liu and Andrew Anzalone, Prime has attracted significant funding from a wide range of high-profile biotech backers

Moderna founder launches new biotech, looking to cure diseases through 'endless RNA'

Bio Pharma Dive

Laronde comes equipped with $50 million in funding from Flagship Pioneering and a goal to upend how diseases are treated with long-lasting RNA medicines

RNA 269

In historic move, FDA approves a closely watched and controversial Alzheimer's drug

Bio Pharma Dive

With the decision, the agency cleared the way for what many predict will become a lucrative and highly sought-after option — though fierce debate continues over whether the medicine, Biogen's aducanumab, actually benefits patients' daily lives

How real-time data keeps infectious disease studies moving in times of crisis

Bio Pharma Dive

One COVID-19 study, 1,000 seniors — ahead of schedule. Find out how eSource made it happen

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FDA seeking more consistency from cell, gene therapy developers, top official says

Bio Pharma Dive

A number of drugmakers have recently faced development delays after the FDA's asked for more information on how they measure the potency of their products

FDA revises labeling of Biogen's Alzheimer's drug to emphasize early treatment

Bio Pharma Dive

The approval of Aduhelm last month, already highly controversial, was made more so by the agency's decision to clear the drug for an exceptionally broad group of patients. New prescribing information more closely matches clinical testing

Drugs 205

Biohaven CEO on migraine drug's fast launch, TikTok ads and battling big pharma

Bio Pharma Dive

Sales of Nurtec ODT during the second quarter were double what Wall Street expected. CEO Vlad Coric explained to BioPharma Dive how the biotech did it, despite being far smaller than its chief rival

Sales 195

FDA approves first CAR-T cell therapy for multiple myeloma

Bio Pharma Dive

Approval of Bristol Myers Squibb and Bluebird bio's Abecma expands use of CAR-T treatment beyond leukemia and lymphoma

FDA rejects a biotech's kidney drug, but some analysts still see a 'sliver of hope'

Bio Pharma Dive

The agency wants Ardelyx to run another trial to show its drug affects clinical outcomes for patients with chronic kidney disease. Analysts think this could be accomplished, but would take some time

Trials 153

Data is becoming the healthcare ecosystem entry fee

Bio Pharma Dive

Biopharmaceutical companies have an opportunity to work alongside new healthcare ecosystem entrants for mutual benefit and better customer value

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Gilead matches Bristol Myers in showing benefit to earlier CAR-T treatment

Bio Pharma Dive

A study of Gilead's Yescarta found the cell therapy dramatically outperformed chemotherapy and stem cell transplant in treating lymphoma, a result that could support much broader use of the drug

Drugs 214

Bristol Myers pays Agenus $200M for drug aimed at top immunotherapy target

Bio Pharma Dive

The pharma acquired rights to an experimental antibody medicine that blocks a protein, called TIGIT, that's become a focus for several cancer drugmakers

An AstraZeneca spinout scores a buyout option from Arena

Bio Pharma Dive

The potential acquisition marks a fast turnaround for Aristea, one of several biotechs formed from programs AstraZeneca decided not to advance internally

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Integrating sourcing, packaging, labelling and distribution for efficient clinical kitting

Bio Pharma Dive

Efficient execution of clinical trials requires the provision of medicines and all other critical materials to be carefully delivered on time to clinical sites or patient's homes

Moderna puts seasonal flu vaccine ambitions to the test

Bio Pharma Dive

Having proved mRNA's might in COVID-19, the biotech company aims to develop similar vaccines for other respiratory illnesses caused by influenza, RSV and metapneumovirus

AstraZeneca still eyes US vaccine filing despite another delay

Bio Pharma Dive

The company now expects to file for full approval by year’s end and has a variant-specific shot in advanced testing. But the long-term prospects for AstraZeneca's new vaccine business are unclear

How biopharma innovation may benefit from more inclusive print communications

Bio Pharma Dive

Medical advancements are evolving at a rapid pace, and so is public consumption of information

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Alzheimer's Association, insurers press Medicare for coverage rules on Aduhelm

Bio Pharma Dive

Days after the FDA narrowed the target population for Biogen's drug, the patient advocacy group said it's urging Medicare to adopt a nationwide policy. Payers are seeking guidance, too

Drugs 189