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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Micrograph]. Retrieved from Flickr.

    NIH licenses COVID-19 technologies to WHO-backed program

    The agreement, which covers three experimental vaccines as well as several key patents, will be royalty free for products sold in 49 low-income countries.

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    Sarah Silbiger via Getty Images

    BridgeBio sale of FDA voucher good news for Bluebird, other biotech sellers

    The drugmaker was able to get $110 million for its voucher, a kind of regulatory fast pass. Other vouchers have sold for similar amounts, boding well for Bluebird, which plans to sell two that it hopes to get this year.

    FDA
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers acquires BridgeBio drug aimed at emerging cancer target

    The pharma will pay $90 million to license BridgeBio's experimental candidate, joining a lengthening list of large drugmakers aiming to treat cancer by blocking a protein called SHP2.

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    SciePro via Getty Images

    Taiho, chasing larger rivals, buys back rights to Cullinan cancer drug

    The deal hands $275 million upfront to Cullinan, whose medicine is being developed for a genetic driver of lung tumors that's become a top target for drugmakers.

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    Permission granted by Bristol-Myers Squibb

    Key Bristol Myers drug holds up in long-term psoriasis study

    Deucravacitnib, forecast by Bristol Myers to hit $4 billion in peak sales, is under FDA review with an approval decision due by September. The agency's view of its safety will be key to its future.

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    iStock via Getty Images

    Roche cancer immunotherapy fails another trial, casting doubt on emerging drug class

    A treatment combination involving Roche's anti-TIGIT medicine tiragolumab missed its goal in a Phase 3 lung cancer study that was viewed as a proof point for the drug class.

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    Maddie Meyer via Getty Images

    Moderna's finance head is out as former employer conducts investigation

    Jorge Gomez, who officially took the CFO reins Monday, lasted one day on the job. His departure comes as Gomez's previous company, Dentsply Sirona, looks into financial allegations against current and former executives.

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    Permission granted by Sekar Kathiresan

    In first, Verve gets clearance to test base editing inside the body

    Regulators in New Zealand have allowed human testing to proceed, another milestone for the gene editing technology. Verve plans to soon ask for approval to begin testing in the U.S. and U.K., too. 

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    Sarah Silbiger via Getty Images

    With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

    The proposed changes could have a notable impact on cell and gene therapy developers, many of which are advancing rare disease therapies that rely on speedy approval pathways.

    FDA
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    Permission granted by Moma Therapeutics

    Against a historic market downturn, Moma Therapeutics raises $150M for precision cancer research

    The biotech's Series B round, which kicked off early this year, should fund its work on "molecular machines" until at least 2024, according to CEO Asit Parikh.

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    Dan Kitwood via Getty Images

    Pfizer to acquire Biohaven in $11.6B bet on biotech's migraine drugs

    The deal, which hands Pfizer full rights to the biotech's fast-selling Nurtec ODT, could provide a much needed spark for the sector after months of stock market declines. 

    Updated May 10, 2022
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    Mario Tama via Getty Images

    J&J ends hepatitis B, HPV vaccine work with Bavarian Nordic

    The companies' hepatitis B program never reached clinical testing, while J&J said it would no longer develop an HPV vaccine because of the "widespread uptake" of effective shots from other companies.

  • Former Novartis exec joins ADC Therapeutics as CEO after brief stint as Rafael head

    Ameet Mallik takes over for founder Chris Martin at helm of the antibody drug developer after a seven-month run leading Rafael Holdings, which reported a clinical trial setback last October.

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    Jacob Bell / BioPharma Dive

    Clay Siegall, founding Seagen CEO, takes leave amid domestic violence accusation

    The company's board is investigating the allegation, which Siegall, who has led Seattle's largest biotech for 24 years, denied. Chief Medical Officer and former Merck executive Roger Dansey was named interim CEO.

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    Novartis

    Novartis suspends production of two radiopharmaceutical drugs over quality concerns

    Due to potential issues in manufacturing, the pharma is halting deliveries of two cancer drugs, Lutathera and Pluvicto, in the U.S. and Canada, a setback for a business in which the company has invested heavily.  

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    Jon Cherry via Getty Images

    FDA places stricter limits on J&J's COVID-19 vaccine after review of rare side effect

    The agency is limiting use to adults who either can't or won't take another authorized vaccine after collecting more data on a rare and unusual clotting syndrome that has weighed on the shot's uptake.

    FDA
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    Jacob Bell / BioPharma Dive

    AstraZeneca and Daiichi set to broaden use of breast cancer drug, challenging Roche

    The FDA cleared Enhertu for second-line use in HER2-positive disease, the latest inroads the partners have made against Roche’s dominant portfolio of breast cancer medicines.

    FDA
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    Getty Images: Edited by BioPharma Dive

    Intercept sells international rights to liver drug in $400M deal

    Advanz Pharma will obtain rights to Ocaliva outside the U.S., handing its maker an upfront payment nearly equivalent to its market value.

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    Elizabeth Regan / Industry Dive

    Argenx drug succeeds in trial, beats sales forecasts

    The biotech reported positive results from a study meant to expand Vyvgart's use to another immune disorder, while sales from the drug's first quarter on the market exceeded expectations.

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    Permission granted by Biogen

    Biogen, having scrapped Aduhelm, tries to convince investors of turnaround plan

    Though executives claimed that inking deals and derisking research programs are priorities, analysts questioned whether any meaningful strategic changes will occur in the near term. 

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    Maddie Meyer via Getty Images

    Moderna vaccine sales surpass expectations as company looks to fall boosters

    The trajectory of COVID-19 vaccine sales is now harder to predict amid questions about the rollout of additional doses and whether purchasing in the U.S. might shift from the federal government to private payers.

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    utah778 via Getty Images

    Spero to lay off 75% of workforce, change strategy after FDA challenges study results

    Agency statisticians took a different view of the Phase 3 results the biotech was relying on to support approval of a new antibiotic, an announcement that triggered the sector's latest restructuring.

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    Regeneron

    Regeneron tries to shake off fall in COVID drug sales with first quarter earnings

    Partnerships and profit-sharing deals helped Regeneron overcome the sudden loss of U.S. revenue for its coronavirus antibody, which was withdrawn from the market as omicron spread.

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    Permission granted by Biogen

    Biogen CEO to step down as company pulls back from Alzheimer's drug

    Michel Vounatsos, Biogen's CEO since 2017, will be replaced as the company "substantially" eliminates the commercial workforce around Aduhelm, which has generated paltry sales in the face of resistance from insurers and doctors.

    Updated May 3, 2022
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    libre de droit via Getty Images

    Pfizer cleared to restart hemophilia gene therapy trial

    While a voluntary pause in dosing new patients will remain in place, the FDA's decision puts the study back on track to deliver data in 2023.