The Latest

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  Deep Dive

  Biotech M&A is picking back up. Here are the latest deals.

  At $43 billion, Pfizer’s planned buyout of Seagen is the largest pharmaceutical industry acquisition since 2019.

  Updated March 13, 2023

  Deals

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  Karuna’s schizophrenia drug success draws a royalty buyer

  PureTech Health will sell some of its royalty interest in Karuna’s drug, known as KarXT, after its second successful late-phase trial this week.

  Deals

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  Moderna inks second genetic medicine deal in a month

  The biotech plans to use Generation Bio’s nonviral delivery technology to get nucleic acid-based therapies to immune cells and into the liver.

  Gene Therapy

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  FDA approves new antifungal as concerns grow over drug-resistant fungus

  Rezzayo is the first new treatment for candidemia and invasive candidiasis to win FDA approval in years.

  FDA

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  Moderna CEO defends price of COVID shot at Senate hearing

  Stéphane Bancel said his company's planned quadrupling of the vaccine’s price covers the higher costs of commercial sales. Sen. Bernie Sanders called it part of industry’s “unprecedented level of corporate greed.”

  Drug Pricing

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  Deep Dive

  After a record run, fewer biotechs are going public. Here’s how they’re performing.

  The pace of biotech IPOs so far this year is the slowest in at least five years, lagging behind even last year's torpid clip. Only four drugmakers have priced new stock offerings.

  Updated March 3, 2023

  Biotech

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  Biohaven strikes a deal to take TYK2 drugs in a new direction

  The rebooted biotech plans to test whether blocking TYK2 in the brain could help treat neurological diseases, licensing a compound from China-based Hangzhou Highlightll Pharmaceutical.

  Biotech

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  Emerging biotech

  At EpiBiologics, a pair of Genentech alumni wants to make next-gen protein degraders

  Armed with a $50 million Series A round, the startup is building off of research from a lab run by protein engineering pioneer Jim Wells.

  Biotech

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  U.S. government again rejects call to seize Xtandi rights

  The Biden administration plans to review federal “march-in” rights and consider whether price could be a reason to take control of patents for drugs developed with government funding.

  Drug Pricing

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  Novo partners with Dewpoint to mine an emerging field for new drugs

  The companies will collaborate to identify compounds that could treat insulin resistance by targeting shape-shifting cellular droplets known as biomolecular condensates.

  Pharma

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  FTC wades into dispute between Supernus, generic competitor

  The agency, which is taking a closer look at the pharma industry, submitted a brief to federal court in a case it says could have “significant implications” for Parkinson’s patients.

  Marketing

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  A biotech stumbles in its bid to challenge Novo’s obesity drug

  Altimmune’s drug aided weight loss in a Phase 2 trial, but also came with side effects that could hamper its ability to compete with Novo Nordisk’s Wegovy. 

  Biotech

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  Gilead’s Yescarta extends survival in lymphoma study

  The results, the first for a CAR-T therapy, are further evidence supporting the use of the complex therapies earlier in a patient’s disease course. 

  Gene Therapy

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  Karuna’s schizophrenia drug succeeds in a second late-stage trial

  The results add to a growing body of evidence that Karuna’s drug, known as KarXT, could be a valuable new option for patients living with the brain disorder.

  Updated March 20, 2023

  Clinical Trials

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  Flush with cash, BioNTech buys into an immunotherapy to rival Yervoy

  The COVID-19 vaccine maker is paying $200 million to secure rights to an experimental CTLA-4 inhibitor that privately held OncoC4 designed to have fewer side effects.

  Biotech

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  ALS drug development

  FDA staff signal support for Biogen ALS drug, but highlight data hurdles

  In documents released Monday, agency staff appeared inclined to approve Biogen’s tofersen, which failed in its main trial. Gathering confirmatory evidence of its benefit could be difficult, however.

  Updated March 20, 2023

  FDA

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  Illumina, facing Icahn challenge, ‘moving quickly’ on resolution for Grail

  The DNA-sequencing company said the activist investor hasn’t offered any better solutions for satisfying regulators’ concerns about the acquisition.

  Deals

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  Takeda, chasing Bristol Myers, unveils awaited TYK2 drug data

  "This is why we did the deal," said Takeda R&D chief Andy Plump, referring to his company's $4 billion acquisition of the medicine from startup Nimbus Therapeutics.

  Clinical Trials

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  FDA reversal sets up high-stakes hearing on Sarepta gene therapy

  The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held.

  Biotech

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  Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach

  The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo.

  Pharma

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  Sanofi joins other diabetes drugmakers in cutting insulin prices

  The pharma is the last of the three major insulin suppliers to reduce U.S. list prices, responding to persistent criticism and policy changes that will affect Medicaid rebate payments.

  Drug Pricing

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  CMS lays out plans for negotiating drug prices

  The guidance fills in details for one of the central pharmaceutical provisions of the Inflation Reduction Act, signaling how the agency will use its new authority.

  Drug Pricing

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  Esperion in dispute with Daiichi over drug milestone payment

  The companies disagree over what qualifies for a payment of up to $300 million that’s associated with inclusion of heart data on the cholesterol drug’s label.

  Biotech

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  US names first drugs to face price hike penalty

  Gilead’s cancer cell therapies Yescarta and Tecartus were among the slate of 27 drugs singled out by CMS for rebates under a provision of the IRA.

  Drug Pricing

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  Healthcare companies may turn to big banks after SVB’s fall

  SVB’s unraveling created a hole in life sciences financing that could be filled by bigger banks, but might hamper access to quick, short-term cash for startups.

  Biotech

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