Bio Pharma Dive

US calls for pause in J&J coronavirus vaccine rollout after rare blood clotting cases

Bio Pharma Dive

The FDA and CDC recommended halting vaccinations while they investigate six cases of unusual blood clots in women given the company's shot

5 takeaways from AACR, one of the year's top meetings on cancer drugs

Bio Pharma Dive

The American Association for Cancer Research's virtual conference featured new data on an emerging immunotherapy target, a new kind of cell therapy and a KRAS reboot

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

Bio Pharma Dive

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

Drugs 212

FDA faces backlash after seeking more data on an experimental ALS therapy

Bio Pharma Dive

The ALS Association demanded the FDA "move with the urgency" other agencies have in reviewing a drug from Amylyx Pharmaceuticals

Drugs 238

5 FDA approval decisions to watch in the second quarter

Bio Pharma Dive

A long-awaited reckoning for Biogen’s Alzheimer’s drug and the review of AstraZeneca’s coronavirus vaccine are among the top FDA decisions expected before the end of June

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

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

Bio Pharma Dive

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

A year with COVID-19: The impact of data on pharma marketing

Bio Pharma Dive

Learn how three pharma brands used data to validate and adjust their promotional spend in 2020

Sanofi buys an mRNA startup in another bet on 'off-the-shelf' cell therapy

Bio Pharma Dive

Tidal Therapeutics is the second biotech developing more convenient cell therapies that the French pharma has recently acquired, part of a broader expansion in oncology

CDC panel delays decision on J&J vaccine, extending pause over rare side effect

Bio Pharma Dive

Advisers to the agency agreed to wait for more data before recommending new guidance, but aim to reconvene quickly to decide on whether vaccinations with J&J's should be resumed, and for whom

Moderna watches for 'waning immunity' as new data show durable vaccine protection

Bio Pharma Dive

Updated study results show Moderna's coronavirus vaccine was strongly protective against COVID-19 through six months. But executives outlined contingency plans in case those effects fade

Roche stops giving Huntington's disease drug in closely watched study

Bio Pharma Dive

A disappointing recommendation from outside data reviewers raises doubts about the DNA-targeting drug's benefits and puts pressure on Roche's partner, Ionis Pharmaceuticals

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FDA advisers reassert case against approval of Biogen's Alzheimer's drug

Bio Pharma Dive

In a new editorial, three of the agency's advisers reiterated that they see "no persuasive evidence to support approval of aducanumab at this time "

Drugs 233

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

Bio Pharma Dive

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

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

Bio Pharma Dive

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

FDA authorizes J&J's one-shot coronavirus vaccine

Bio Pharma Dive

The agency's emergency clearance makes J&J's vaccine the third available in the U.S., adding much-needed reinforcements at a critical time

As COVID-19 becomes a business, vaccine makers confront thorny pricing questions

Bio Pharma Dive

Yearly vaccinations could be required after the pandemic ebbs. Will drugmakers change how they approach pricing their shots

Researchers lay out hypothesis for rare side effect linked to AstraZeneca vaccine

Bio Pharma Dive

The EMA has reiterated the benefits of the shot outweigh the risks, but the safety concerns are another hurdle to the vaccine's rollout in Europe

Europe's drug regulator links J&J's vaccine to rare clots as US pause continues

Bio Pharma Dive

The EMA reiterated the vaccine's benefits outweigh its risks but recommended a warning be added to highlight the rare, but serious side effect. Regulators in the U.S. are expected to soon make a similar decision

Bristol Myers gets late-stage win in test of new type of immunotherapy

Bio Pharma Dive

When given together with Opdivo, Bristol Myers' new drug kept skin cancers from progressing, a rare clinical victory for a combination of immunotherapies that puts the pharma a step ahead of several rivals

Drugs 233

Drugmakers flock to Vineti's fix for a cell, gene therapy problem

Bio Pharma Dive

A group of drug companies, including Novartis, Takeda and Roche's Genentech, have agreed to collaborate with Vineti to usher in new identification standards for complex medicines

Bristol Myers finally wins FDA approval for cancer cell therapy

Bio Pharma Dive

Delays tied to factory inspections had pushed an FDA decision on Breyanzi past a key deadline, allowing Bristol Myers to avoid paying billions of dollars in payouts to investors

Crucial data on AstraZeneca's vaccine are coming. Here's what we may learn.

Bio Pharma Dive

Results from previous trials have raised questions about the vaccine and how well it works. Data from a large U.S. study could help clear up the confusion

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FDA turns back Keytruda, delaying immunotherapy's arrival in early cancer

Bio Pharma Dive

Merck & Co.'s 's drug could've been the first immunotherapy approved in the so-called neoadjuvant setting. Its rejection might indicate a higher bar for others with similar ambitions

Drugs 220

Lilly asks FDA to revoke clearance of first COVID-19 antibody drug

Bio Pharma Dive

The request comes less than six months after the FDA authorized Lilly's bamlanivimab, reflecting the spread of virus variants that can elude the drug

Relay buys AI startup to aid unorthodox drug discovery quest

Bio Pharma Dive

The $85 million acquisition is an unusual and early step for a company like Relay, which went public last July and only just began clinical testing of its lead drugs last year

Drugs 173

Bluebird to withdraw gene therapy from Germany after dispute over price

Bio Pharma Dive

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

How Rocket Pharma quietly became one of gene therapy's high flyers

Bio Pharma Dive

An unconventional strategy is behind the rise of Rocket, a New Jersey biotech whose executives boldly talk of turning into the "Genentech of gene therapy "

Gene therapy for hemophilia: So close, yet so far away

Bio Pharma Dive

Significant setbacks for pace-setting programs from BioMarin and UniQure have renewed questions about gene therapy’s promise, and its safety

FDA lays out shortened path for testing vaccines against new coronavirus variants

Bio Pharma Dive

Lengthy trials won't be needed for updating shots against emerging viral strains, the agency told developers in newly published guidance

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Rivals J&J, Merck are latest to team up to boost production of coronavirus vaccines

Bio Pharma Dive

Merck will lend J&J the use of two separate facilities in the unusual agreement, which was brokered by the Biden administration and could help double supply of the one-dose shot

New CAR-T therapy from Bristol, Bluebird effective but too costly, ICER finds

Bio Pharma Dive

The influential drug cost watchdog recommended a discount of between 37% and 54% to the $419,500 list price the companies charge for Abecma, a multiple myeloma cell therapy cleared by the FDA in March

Drugs 202

Pfizer set to double weekly production of coronavirus vaccine

Bio Pharma Dive

The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday

Gilead stops Veklury study, citing enrollment challenges, changing treatment

Bio Pharma Dive

The company said a multi-day infusion treatment that must be administered in healthcare settings no longer addresses an unmet need of non-hospitalized COVID-19 patients

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Ionis cuts jobs at a former spinout and inks new deal with Sobi

Bio Pharma Dive

Some seven months after acquiring the rest of Akcea Therapeutics, Ionis is laying off most of its subsidiary's staff and turning to Sobi to sell its drugs

Drugs 201

Vaccine makers prepare response as coronavirus mutations raise alarms

Bio Pharma Dive

So far, both Pfizer's and Moderna's vaccines appear to work against more transmissible variants, but preparation is underway for the day they don't

Vertex begins human testing for diabetes cell therapy

Bio Pharma Dive

While Vertex is confident in the therapy, which came via the $1 billion acquisition of Semma Therapeutics, it will still be a few years before the company has a good read on its effects in Type 1 diabetes patients

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Sanofi, in unusual move, to help Pfizer, BioNTech make coronavirus vaccine doses

Bio Pharma Dive

The French drugmaker, having hit delays with its own coronavirus shot, agreed to manufacture over 100 million doses of Pfizer and BioNTech's vaccine for supply in Europe

The Apple Watch in clinical trials: Current uses and future possibilities

Bio Pharma Dive

Why the Apple Watch will likely be one of the top choices for use by sponsors, CROs and clinical trial teams wishing to use wearables in their trials

J&J says single dose of coronavirus vaccine 66% effective in large trial

Bio Pharma Dive

The vaccine's efficacy was higher in the U.S., but lower in Latin America and South Africa, where new, more infectious virus variants are circulating

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AstraZeneca's coronavirus vaccine possibly linked to rare blood clots, EMA says

Bio Pharma Dive

Europe's drug regulator affirmed the benefits of vaccination outweigh the risks, but recommended the shot's label be updated to warn of the newly established side effect

Merck gives an early peek at COVID-19 drug results

Bio Pharma Dive

Initial results from a mid-stage study indicate the antiviral drug, molnupiravir, is safe. But whether it's hitting the study's main goal remains unclear

Drugs 238

A biotech shelves its Huntington's drugs after trial failures

Bio Pharma Dive

Two drugs developed by Wave Life Sciences didn't appear to have an effect on disease-causing proteins, another setback for Huntington's research after disappointing results last week from Roche and Ionis