CDC panel backs COVID-19 boosters for Moderna, J&J vaccine recipients

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  Deep Dive

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

  Sixteen cell or gene therapy developers have gone public so far this year, surpassing the 13 that IPO'd last year as well as the combined total from 2019 and 2018.

  UPDATED: Oct. 21, 2021 at 9:19 a.m.

  Biotech

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  Sponsored by Vetter Pharma

  Emerging therapeutic oligonucleotides – analytical challenges accepted

  A relatively new class of parenteral drug products on the market - therapeutic oligonucleotides – poses new challenges to the pharmaceutical manufacturing process.

  Manufacturing

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  CDC panel levels playing field for new Merck, Pfizer pneumonia vaccines

  New guidance for the rival shots didn't favor Pfizer's, as analysts had expected, giving Merck a better chance to gain ground in one of the most lucrative market opportunities for vaccines.  

  Pharma

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  Gates Foundation pledges $120M to bring Merck COVID-19 drug to lower-income countries

  Anticipating regulatory clearance of the pill, the group aims to speed access by investing in the manufacturing of generic versions of the drug.

  Manufacturing

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  J&J foresees end to not-for-profit sales of coronavirus vaccine

  The drugmaker plans to switch over to a commercial business model late next year or early in 2023, said Jennifer Taubert, head of J&J's pharma division.

  Pharma

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  Atea, Roche change plans for oral COVID-19 drug after trial setback

  A closely watched competitor to Merck's molnupiravir failed a Phase 2 study, prompting its makers to change their strategy in a move that could delay an answer on the drug's efficacy until late next year.

  Biotech

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  Deep Dive

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

  FDA advisers supported offering a third dose of Moderna's vaccine in some cases, which could clear the way for the agency to soon authorize a booster shot for millions more Americans.

  UPDATED: Oct. 15, 2021 at 12:11 p.m.

  Pharma

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  Sage, Biogen detail plans to get their newer depression drug approved

  Following discussions with the FDA, the companies plan to submit zuranolone for approval in major depressive disorder and postpartum depression over the next roughly year and a half.

  Marketing

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  Boehringer Ingelheim takes next step in development of cystic fibrosis gene therapy

  Drugs from Vertex can effectively treat the lung disease in as much as 90% of patients. Gene therapy could be a solution for the remaining 10%, but the path forward is challenging.

  Pharma

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  Biogen's closely watched ALS drug comes up short in late-stage study

  Though the study's primary goal was missed, Biogen claimed there were some signs its drug, tofersen, could slow the disease's progression. The company is now engaging with regulators to discuss tofersen's future.

  Biotech

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  Esperion lays off nearly half its workforce as heart drug sales disappoint

  The company hopes a "streamlined" sales force can turn around a drug launch that's failed to meet expectations amid tough competition from rival medicines.

  Pharma

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  Deep Dive

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

  The acquisitions of Adamas Pharmaceuticals and Flexion Therapeutics add to a recent string of dealmaking, and offer mid-double-digit premiums to two biotechs developing brain drugs.

  UPDATED: Oct. 12, 2021 at 10 a.m.

  Deals

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  Boehringer wins 'interchangeable' status for Humira copy, strengthening competitive threat

  The interchangeable approval could help to boost adoption of Boehringer's biosimilar when it launches in mid-2023, a date set via settlement with AbbVie.

  Marketing

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  FDA panel endorses second shot for adults who received J&J vaccine

  Agency advisers unanimously supported offering a second dose of J&J's coronavirus vaccine to adults who previously received it, though guidance could change as regulators evaluate mixing boosters.

  UPDATED: Oct. 15, 2021 at 4:03 p.m.

  Pharma

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  AstraZeneca immunotherapy combo extends survival in liver cancer trial

  The results are a rare positive result for AstraZeneca's experimental drug tremelimumab, which has come up short in a handful of other studies and cancer types.

  Pharma

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  Biden reportedly weighing former FDA chief Califf to again lead agency

  The Washington Post reported the administration was "closing in" on Califf, citing sources. The White House declined to comment and Califf could face opposition from Senate Democrats if chosen. 

  FDA

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  FDA advisers unanimously back Moderna booster shot for many Americans

  But the committee members remain opposed to broad use of boosters in healthy young adults, for whom the benefits of an additional shot are less clear.

  FDA

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  Merck advantage grows as FDA approves Keytruda for first-line cervical cancer

  The company's immunotherapy is the only drug of its type cleared for advanced cervical cancer. Others are being tested, however. 

  Pharma

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  NIH study finds mixing COVID-19 boosters increases immune response

  Results suggested Pfizer's and Moderna's vaccines may serve as a more potent booster for those who initially received Johnson & Johnson's shot, although data are limited and preliminary.

  Pharma

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  Intellia looks to eye diseases in latest deal

  The gene editing company will take a 10% stake in SparingVision, a young biotech that will use Intellia's CRISPR technology to develop treatments for up to three ocular targets.

  Deals

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  Lilly drug cleared by FDA for wider use in breast cancer

  Verzenio now has an expanded approval for treatment of a common form of early cancer, although the label granted by FDA places some limits on use.

  Marketing

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  FDA staff take neutral stance on Moderna, J&J boosters ahead of two-day meeting

  Advisers are discussing an authorization of Moderna's booster on Thursday, with a vote on recommendations to the FDA expected this afternoon. 

  FDA

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  CRISPR touts new results as fresh questions surround 'off-the-shelf' CAR-T

  The biotech's lymphoma treatment initially seems as potent as earlier cell therapies, but its effects waned, adding to doubts about off-the-shelf CAR-T.

  UPDATED: Oct. 13, 2021 at 9:55 a.m.

  Biotech

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  CureVac scraps its first COVID-19 vaccine and pivots to a second

  The German biotech has abandoned plans to seek approval of the shot in Europe, citing tough competition, waning demand and the progress of a second candidate it's developing with GlaxoSmithKline. 

  Biotech

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  Takeda takes aim at a biotech's gene therapy work

  For an upfront payment of $45 million, Takeda gains access to as many as eight programs from Poseida Therapeutics and a potential method of delivering gene therapies without the help of viruses.

  Deals

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  AstraZeneca builds case for long-acting COVID-19 drug, but is it too late?

  The British drugmaker could soon become the first with both a marketed vaccine and treatment for COVID-19, a notable achievement. Yet competition has blunted the potential impact of each of them.   

  Pharma

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