• Biogen
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    Biogen to pay $900M to settle lawsuit over MS drug outreach

    A former Biogen employee sued in 2012, alleging the company paid physician fees to encourage prescribing of its drugs. Biogen did not admit wrongdoing as part of the settlement.

    By Sept. 27, 2022
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    Optimizing pharmaceutical innovation

    Elevate pharma product development and marketing through collaboration with physician experts

    Sept. 19, 2022
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    Courtesy of Sanofi

    Sanofi, AstraZeneca secure EMA support for RSV drug in babies

    If authorized by the European Commission, the companies’ antibody medicine would become the first cleared for broad use in newborns and infants. 

    By Sept. 16, 2022
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    Permission granted by Bristol-Myers Squibb

    Bristol Myers gets FDA approval for new type of psoriasis drug

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

    By Updated Sept. 12, 2022
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    Sarah Silbiger via Getty Images

    FDA names new head to vaccine review office

    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.

    By Sept. 9, 2022
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    Getty Images

    FDA holds back Alvotech’s Humira biosimilar over manufacturing issues

    The company received a complete response letter, but still expects to win approval of the copycat drug in time to launch it in the U.S. next year.

    By Sept. 6, 2022
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    Joe Raedle/Getty Images via Getty Images

    Funds for free COVID-19 vaccines could run out as early as January, HHS says

    The commercial market for COVID-19 vaccinations could be similar to that for seasonal flu shots and other vaccines, an official with the department said.

    By Sydney Halleman • Aug. 31, 2022
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    Jacob Bell / BioPharma Dive

    Incyte secures second approval for targeted cancer drug

    Sold as Pemazyre, the drug, which blocks well-known cancer proteins known as FGFRs, is now also cleared for use in certain patients with very rare and aggressive blood cancers.

    By Aug. 29, 2022
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    24K-Production via Getty Images
    Sponsored by Worldwide Clinical Trials

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

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

    Aug. 29, 2022
  • Glass vials of Moderna COVID-19 vaccine.
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    Gabriel Kuchta via Getty Images

    Moderna sues Pfizer, BioNTech over COVID-19 vaccine technology

    The biotech claims its rivals’ vaccine Comirnaty, one of the world’s top-selling pharmaceutical products, infringes on two patents covering its messenger RNA technology.

    By Aug. 26, 2022
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    Jacob Bell

    Novartis begins plans to spin off generic drug business

    After reviewing multiple options including a possible sale, the Swiss drugmaker said spinning off Sandoz would give the division “greater freedom to operate” and capitalize on newly growing sales.

    By Aug. 25, 2022
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    Gilead breaks through with first approval for new HIV drug

    European authorities cleared Gilead’s long-acting shot for patients whose HIV infection is resistant to other drugs. An FDA decision is expected by December.

    By Aug. 22, 2022
  • A child plays EndeavorRx on a tablet. The digital therapeutic intended to improve attention in kids with ADHD.
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    Permission granted by Akili Interactive

    Digital medicine company Akili gets cold market reception after blank-check merger

    After spiking on news of the merger’s close, shares in the ADHD treatment developer fell sharply in trading.

    By Elise Reuter • Updated Aug. 23, 2022
  • Transmission electron micrograph of a SARS-CoV-2 virus particle, isolated from a patient.
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    National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from Flickr.

    US plans shift to private market sales of COVID-19 vaccines, drugs

    The federal government will begin the transition as early as this fall, clearing the way for drugmakers to control sales and distribution of their medicines.

    By Aug. 17, 2022
  • Glass vials of Moderna COVID-19 vaccine.
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    Gabriel Kuchta via Getty Images

    UK approves Moderna’s two-pronged COVID-19 booster

    Britain’s drug regulator is the first public health authority to clear a vaccine designed to fight omicron as well as the original strain of the virus. 

    By Aug. 15, 2022
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    Pfizer’s new pneumococcal vaccine meets study goal in children

    Pfizer, which competes with Merck in this market, plans to ask the FDA for an expanded approval of its 20-valent shot later this year.

    By Aug. 12, 2022
  • In this photo illustration, packages and pills of Zantac sit on a table on September 19, 2019 in New York City.
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    Drew Angerer via Getty Images

    GSK, Pfizer, Sanofi shares drop amid Zantac litigation concerns

    The companies could face liability related to their sales of the heartburn drug, which was withdrawn from the market in the U.S. and other countries after impurities related to a likely carcinogen were detected.

    By Updated Aug. 11, 2022
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020, in White Oak, Maryland.
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    Sarah Silbiger via Getty Images

    Coherus wins FDA approval for second Lucentis biosimilar, its third drug

    The biotech company secured a valuable interchangeable designation for the copycat medicine, which it plans to launch later this year.

    By Kristin Jensen • Aug. 3, 2022
  • Roche Pharmaceutical Group's office building in Shanghai, China
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    With new data, Roche takes step toward more convenient cancer immunotherapy

    The pharma claimed Phase 3 study success for a subcutaneous version of its drug Tecentriq, a strategy it and rivals Merck and Bristol Myers could use to extend the market life of their lucrative drugs.

    By Aug. 2, 2022
  • A general view of AstraZeneca is seen during Prime Minister Scott Morrison's visit on August 19, 2020 in Sydney, Australia.
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    Lisa Maree Williams via Getty Images

    AbbVie cancer drug sales fall as AstraZeneca competitor gains ground

    Imbruvica, long one of AbbVie’s top-selling medicines, has ceded market share in treating chronic lymphocytic leukemia to AstraZeneca’s Calquence.

    By July 29, 2022
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    Pfizer sales of COVID-19 vaccine, pill beat forecasts as company prepares for future waves

    The company plans to ready a booster shot by the fall that targets the BA.4 and BA.5 strains that are currently most prevalent in the U.S. and other countries.

    By Updated July 28, 2022
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    Courtesy of Teva Pharmaceutical

    Teva reaches deal in principle to settle opioid lawsuits for over $4B

    The generics maker joins other pharmaceutical companies attempting to resolve litigation over their alleged contributions to the opioid epidemic.

    By Kristin Jensen • July 27, 2022
  • Amazon will see you now: reading between the lines of the One Medical acquisition

    The deal’s near-term effects might not be large, but Amazon’s acquisition still threaten’s One Medical’s primary care competitors and others seeking a greater slice of the market, experts said.

    By Rebecca Pifer • July 25, 2022
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    Sean Gallup via Getty Images

    EU speeds approval of monkeypox vaccine as WHO declares public health emergency

    Vaccine maker Bavarian Nordic said it is meeting demand for its shot with production capacity of 30 million doses a year.

    By July 25, 2022
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    Amazon to buy One Medical for $3.9B

    The all-cash deal for the San Francisco-based company follows months of speculation about a potential acquisition, but Amazon as the buyer comes as a surprise.

    By Rebecca Pifer • July 21, 2022