AbbVie's blockbuster weighed down by safety concerns for a similar Pfizer drug

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  Deep Dive

  Heart attacks struck Sek Kathiresan's family. He's devoted his life to stopping them.

  After several family members had early heart attacks, Kathiresan vowed to understand why they happen. His research journey has changed medical practice and led to a new biotech startup, Verve Therapeutics, that seeks to prevent them.

  Biotech

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  Lilly drug becomes first COVID antibody cleared for use in young children

  The emergency clearance from the FDA allows for treatment of mild and moderate disease as well as prevention in those exposed and at high risk.

  Pharma

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  Former Immunomedics executive charged with insider trading around trial data

  Usama Malik, chief financial officer of Immunomedics from 2017 to late 2020, is charged with tipping his partner and several relatives of positive study results for the biotech's breast cancer drug.

  Biotech

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  Sobi buyout breaks down

  Three months after proposing a roughly $8 billion acquisition of Sobi, the investment firms Advent International and GIC have withdrawn their offer.

  Deals

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  Novartis pays $150M for access to UCB's Parkinson's drug

  UCB's experimental pill is one of the most advanced projects that's aimed at blocking accumulation of an abnormal protein in patients' brains.

  Pharma

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  Deep Dive

  Biotech M&A, while far from recent heights, is picking back up. Here are the latest deals.

  Recordati, a private equity-owned Italian pharmaceutical firm, is buying the U.K.'s EUSA Pharma for an enterprise value of nearly $850 million. 

  Updated Dec. 2, 2021

  Deals

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  Early tests suggest Vir, GSK antibody could hold up versus omicron

  But more complete testing, which would give a better sense of the drug's potency against the variant, is still ongoing as researchers work to assess omicron's threat.

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  A startup led by Novartis veteran raises $80M to develop gene therapies for the brain

  AviadoBio, which was built around research from the lab of Christopher Shaw at King's College London, is backed by venture firms NEA and Monograph Capital.

  Biotech

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  Facing challenges, Deciphera cuts workforce by a third

  The Massachusetts biotech is eliminating 140 positions as it looks to cut costs following disappointing study results for its sole commercial product.

  Biotech

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  Regeneron warns its antibody drug may be less potent versus omicron

  While Regeneron is still testing its treatment against the variant, the biotech is readying contingency plans, including second-generation versions of its drug.

  Biotech

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  Deep Dive

  Coronavirus vaccines are rolling out quickly. Here's where the pipeline stands.

  Fuller data in hand, Pfizer and BioNTech plan to soon seek full U.S. approval for their vaccine in 12- to 15-year-olds. 

  Updated Nov. 24, 2021

  Pharma

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  Vaccine makers move quickly to confront omicron threat

  Several companies, including Pfizer and Moderna, are already at work adapting their coronavirus shots to the newly identified variant, which experts worry could more readily evade vaccine protection.

  Pharma

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  Blueprint, taking aim at larger drugmakers, becomes a biotech buyer

  A $250 million acquisition of startup Lengo Therapeutics has given Blueprint a lung cancer drug that could compete with medicines from Takeda and J&J.

  Biotech

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  New Merck study results raise questions about its COVID pill

  Final trial data for molnupiravir were less convincing than what Merck previously reported and could alter how the FDA views the drug, which will be evaluated at a meeting Tuesday.

  Pharma

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  With safety a concern, Merck, Gilead pause study of HIV drugs

  Out of an "abundance of caution," the companies halted enrollment in a trial evaluating the combination of Merck's islatravir and Gilead's lenacapavir.

  Clinical Trials

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  Deep Dive

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

  Vigil Neuroscience and Bionomics, which just outlined their IPO plans, could become the eighth and ninth neurological drug developers to go public in 2021, a total that would eclipse each of the previous three years. 

  Updated Nov. 23, 2021

  Biotech

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  Takeda wins US approval for new CMV treatment

  The antiviral drug, which has been a top research focus of Takeda for years, is the first to be cleared by the FDA for post-transplant CMV infections that are resistant to other treatments.

  Pharma

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  GSK dives into NASH, RNA interference with Arrowhead deal

  GSK has secured rights to a genetic medicine in early-stage human testing for NASH, a disease thought to affect millions of people that has proven to be a tough target for drugmakers. 

  Deals

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  AstraZeneca, after years of delays, opens UK hub meant to recharge drug research

  Formally unveiled five years after originally planned, the $1 billion headquarters will become the British drugmaker's second-largest R&D center by headcount.

  Pharma

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  Pfizer, BioNTech to seek full approval as COVID-19 vaccine efficacy holds up in young teens

  Four months after vaccination, no 12- to 15-year-olds in the companies' clinical trial developed COVID-19, compared to 30 who received a placebo.

  Pharma

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  Deep Dive

  A three-decade monopoly: how Amgen built a patent thicket around its top-selling drug

  Through high-stakes litigation, aggressive patenting practices and a bit of luck, Amgen will likely stretch Enbrel's monopoly until 2029, more than 30 years after it was approved.

  Pharma

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  Novo to acquire Dicerna for more than $3B amid RNA drug resurgence

  The acquisition would give Novo Nordisk ownership of one of the oldest and largest developers of RNA interference drugs, along with a web of potential royalty streams. 

  Updated Nov. 18, 2021

  Deals

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  Neurocrine stocks up on a biotech's psychiatric drugs

  A new deal with Sosei Heptares hands Neurocrine a "broad portfolio" of drugs for schizophrenia, dementia and other neuropsychiatric disorders.

  Deals

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  Bluebird, after delays, gets speedy FDA review for beta thalassemia gene therapy

  The regulator will decide whether to approve Bluebird's treatment by next May, but its evaluation is beginning more than a year later than the biotech hoped.

  Biotech

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  FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

  Soon after the FDA's authorization, a panel of CDC advisers followed with similar recommendations for third doses in adults over 18 years old. 

  Updated Nov. 20, 2021

  Pharma

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