Bio Pharma Dive

AstraZeneca, Oxford coronavirus vaccine prevents COVID-19, though study results raise questions

Bio Pharma Dive

Data from two late-stage trials showed the shot to be, on average, 70% effective against COVID-19, an encouraging finding. The lower dose tested, however, outperformed a higher dose

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Stem cell therapy for ALS fails a large clinical trial

Bio Pharma Dive

The therapy's developer, Brainstorm Therapeutics, blamed the setback on better-than-expected results from placebo-treated patients. The biotech still sees a path forward, however

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UniQure's gene therapy for hemophilia B meets first goal in key study

Bio Pharma Dive

The results are first to emerge from a late-stage test of a hemophilia B gene therapy, and show UniQure's treatment can restore clotting protein levels to mild or even near normal levels

How Gilead finally spent its money

Bio Pharma Dive

This year, the biotech spent about $27 billion trying to become a leader in cancer research. Executives who spoke to BioPharma Dive said there's still work to be done

Coronavirus vaccine from Pfizer, BioNTech prevents COVID-19, early results show

Bio Pharma Dive

An interim analysis conducted after 94 cases of COVID-19 in Pfizer and BioNTech's large study found their vaccine to be more than 90% effective

Moderna's vaccine can last for weeks in a refrigerator, expanding an edge on rivals

Bio Pharma Dive

Pharmacies and doctor's offices should be able to store Moderna's shot on site, a crucial advantage for the mass immunization challenge that lies ahead

Pfizer invests in Homology and adds to its gene therapy ambitions

Bio Pharma Dive

Along with an equity investment, Pfizer will get first dibs on any potential transaction involving Homology's lead programs, which the biotech is developing for a rare metabolic disorder

The meeting that could change Alzheimer's treatment

Bio Pharma Dive

On Friday, a panel of experts and FDA staff will weigh in on a closely watched Alzheimer's drug from Biogen. Their feedback could affect how the disease is treated for years to come

Drugs 277

Hospitals scramble to get ready for coronavirus vaccines

Bio Pharma Dive

Facilities are preparing ultra-cold storage capabilities and reviewing secruity plans as they brace for their role in distributing potentially multiple shots

Eli Lilly wins FDA emergency clearance for COVID-19 antibody drug

Bio Pharma Dive

The Food and Drug Administration cleared the company's synthetic antibody treatment, but short supplies and logistical challenges could limit its initial impact

Moderna says vaccine prevents COVID-19 in large study, adding to hopes for several protective shots

Bio Pharma Dive

Several effective vaccines will likely be needed to end the pandemic. Moderna's study results, which are equally strong as those reported by Pfizer and BioNTech last week, make that outcome more likely

FDA gene therapy holdups suggest closer scrutiny by agency

Bio Pharma Dive

Requests for more data on manufacturing, clinical holds and a surprise rejection have led to questions of a tougher standard at the agency. Officials, however, point to a large and fast-advancing pipeline

Gene therapy for Duchenne muscular dystrophy: Nearing final tests

Bio Pharma Dive

Sarepta and Pfizer are advancing their experimental treatments into late-stage trials, while others are accelerating research in what's become one of gene therapy's most active fields

AstraZeneca cancer drug found ineffective for treating COVID-19

Bio Pharma Dive

The setback follows disappointing results from companies like Novartis and Sanofi, which have also sought to repurpose existing drugs for COVID-19

Drugs 237

Biogen surges as FDA reviewers appear supportive of Alzheimer's drug approval

Bio Pharma Dive

Documents made public ahead of a key advisory meeting Friday revealed an FDA more willing than expected to accept Biogen's controversial case for approval of aducanumab

Drugs 254

Sarepta, continuing its gene therapy push, helps launch a startup

Bio Pharma Dive

The biotech has joined a group of investors to form a new gene therapy developer led by one of its longtime executives and backed with $107 million

New coronavirus vaccine data back up Pfizer, BioNTech claims of strongly effective shot

Bio Pharma Dive

Reaching the main goal of their large trial, Pfizer and BioNTech reported 162 cases of COVID-19 among participants who received a placebo, and just 8 for those who were vaccinated

Trials 216

Merck to pay almost $3B for VelosBio, broadening antibody cancer drug push

Bio Pharma Dive

Buying VelosBio is Merck's second investment in so-called antibody-drug conjugates since September, reflecting the drug class' fast turnaround

Pfizer, BioNTech's strong results give lift to other coronavirus vaccines

Bio Pharma Dive

The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial

Amgen cuts Cytokinetics loose after heart drug disappointment

Bio Pharma Dive

The smaller biotech vowed to push forward, although the pill's inability to prevent heart failure death may complicate its plans to win approval

Drugs 187

Bristol Myers bet pays off as psoriasis drug beats Amgen rival in study

Bio Pharma Dive

While full data were not disclosed, the trial's outcome signals competition for Amgen's Otezla, which Celgene was forced to divest last year as a result of its acquisition by Bristol Myers

Trials 245

Gilead's Veklury becomes first FDA-approved drug for COVID-19

Bio Pharma Dive

The U.S. regulator granted a full approval after allowing emergency use earlier this year. New results from an WHO study, however, raise questions about the drug's ultimate effectiveness

5 questions ahead of next week's FDA meeting on coronavirus vaccines

Bio Pharma Dive

Normally staid affairs, next Thursday's advisory committee meeting could be historic and set expectations for how the FDA will approach any future vaccine approval

Moderna close to having results from key coronavirus vaccine trial

Bio Pharma Dive

Coronavirus' fast accelerating spread in the U.S. has sped up Moderna's timeline for its late-stage vaccine study, which now has sufficient COVID-19 cases for a first look at results

Bristol Myers taps machine-learning biotech for help finding ALS drugs

Bio Pharma Dive

The companies hope Insitro's technology can lead to a deeper understanding of how ALS progresses and, in turn, help them discover better treatments

Drugs 251

Ligand binding program considerations – the value of preclinical to clinical bioanalytical expertise

Bio Pharma Dive

Careful selection of a partner CRO can deliver advantages and accelerate your drug development program

Drugs 208

Early signs of survival benefit raise optimism around a small biotech's ALS drug

Bio Pharma Dive

Newly published data show that, after joining a clinical trial, patients who were given a drug from Amylyx Pharmaceutcials lived a median 6.5 months longer than those who didn't

Facing vaccine doubts, US grapples with building confidence in coronavirus shots

Bio Pharma Dive

The CDC, for example, doesn't support vaccine mandates for healthcare workers or essential employees, an agency official told experts convened by the FDA Thursday

Pharmacquired: Splashy deals belie a shallow pool of heart drugs left to acquire

Bio Pharma Dive

Recent deals for MyoKardia and The Medicines Co. may be hard to follow, since venture investors and big pharma acquirers have largely ignored cardiovascular drugs

Atea, riding interest in COVID-19 drugs, pulls off one of 2020's top biotech IPOs

Bio Pharma Dive

The Boston startup's initial public offering is the fourth-largest in biotech this year, according to data compiled by BioPharma Dive

Drugs 234

With Eli Lilly data, another drug emerges to stop breast cancers from returning

Bio Pharma Dive

The highly anticipated results could signal a change in how some patients with the most common form of breast cancer are treated — and drive up the costs of care

Drugs 278

Bluebird faces delay for sickle cell gene therapy as rivals inch closer

Bio Pharma Dive

The setback for Bluebird's LentiGlobin comes amid a string of manufacturing-related delays for gene therapy developers

Biogen's all-important Alzheimer's drug enters the review gauntlet

Bio Pharma Dive

On Nov. 6, aducanumab will go before a panel of experts who will review it and make recommendations to the FDA. Meanwhile, the drug has also caught the attention of a powerful cost watchdog group

Drugs 265

Record numbers of biotechs are going public. Here's how they're performing.

Bio Pharma Dive

Initial public offerings have fueled biotech's boom. A new database built by BioPharma Dive will help you keep track of them as they happen

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Lilly backs a biotech's spinout and places a small bet on protein degradation

Bio Pharma Dive

An alliance with BeyondSpring spinout Seed Therapeutics makes Eli Lilly the latest pharma company to dive into the fast-emerging drug research field

Intellia cleared to start key CRISPR drug study in UK

Bio Pharma Dive

The trial would be the first test of a systemically administered gene editing treatment that uses the Nobel Prize-winning technology to alter DNA

AstraZeneca, Oxford vaccine study allowed to restart in UK

Bio Pharma Dive

Six days after a worrisome illness in a U.K. study participant led to a worldwide pause in vaccinations, the country's drugs regulator and an independent committee allowed testing to resume

Lilly, with new data, seeks emergency clearance for COVID-19 antibody drug

Bio Pharma Dive

The pharma is the first to seek emergency approval for this kind of treatment, and may quickly follow up with a second request after reporting promising data for a two-drug combination

FDA advisers vote against Biogen's Alzheimer's drug, leaving its future in doubt

Bio Pharma Dive

In a tense meeting Friday, a group of independent experts found Biogen and the FDA's case for aducanumab unpersuasive, voting overwhelmingly against the drug

Drugs 214

Pfizer says coronavirus vaccine study still on track for October readout

Bio Pharma Dive

Importantly, the study committee hasn't had reason to pause vaccinations in the trial, something AstraZeneca and the University of Oxford recently reported in tests of their vaccine

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