Gilead buys into multiple myeloma cell therapy with Arcellx deal

The Latest

• 

  Deep Dive

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

  AstraZeneca’s acquisition of Neogene is its third biotech buyout this year, expanding its capabilities in cell therapy, gene editing and bispecific antibodies.

  Updated Dec. 2, 2022

  Deals

• 

  Sponsored by Allucent

  When it comes to small populations, biotechs need to think big

  Maria-Cruz Morillo, global therapeutic operations lead for rare diseases at Allucent, discusses the unique challenges of rare disease drug development and how the right expertise can help.

  Clinical Trials

• 

  Biotech layoffs claim more jobs at Sensei, Instil, TherapeuticsMD

  Cell therapy Instil Bio will cut 60% of its staff and Sensei Bio will reduce its headcount by 40%. TherapeuticsMD, meanwhile, is laying off all its employees days after announcing a deal to sell off its drug portfolio.

  Biotech

• 

  Pharvaris, pushing through trial pause, sees shares surge with new study results

  Though the FDA halted testing of the biotech’s pill for hereditary angioedema in August, enough patients were already enrolled to accrue results that sent shares soaring. 

  Clinical Trials

• 

  FDA clears updated Omicron boosters for youngest children

  Pfizer's reformulated vaccine is now authorized for children 6 months to 4 years of age who have not completed its primary series, while Moderna's updated shot is cleared as a booster for those 6 months to 5 years old.

  FDA

• 

  Emerging biotech

  Dantari emerges with a new way to make cancer drug conjugates

  As the success of drugs like Enhertu catalyzes new investment in antibody-drug conjugates, the California startup is launching with plans to develop more potent versions of the targeted cancer medicines. 

  Biotech

• 

  Deep Dive

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

  Just 20 drugmakers have priced an initial public offering this year, less than one-fifth last year’s total of 104, according to BioPharma Dive data.

  Updated Dec. 5, 2022

  Biotech

• 

  Relmada sinks further as depression drug fails second large trial

  The company claimed an “unplausible” placebo response caused both studies to fail and is making substantive changes to its other remaining late-stage trial as a result. 

  Clinical Trials

• 

  Prometheus shares soar on new data for inflammation drug

  Having scored positive results in two key studies for ulcerative colitis and Crohn’s disease, Prometheus now intends to advance the drug, called PRA023, into pivotal testing.

  Clinical Trials

• 

  Esperion, without data, says cholesterol pill lowered heart risk in study

  The large cardiovascular outcomes trial is a major test for Esperion, which has struggled to sell its drug Nexletol since winning U.S. approval in 2020.

  Marketing

• 

  Emerging biotech

  Immune drug developer Apogee emerges as first spinout of biotech Paragon

  The new biotech launches with $169 million in venture funding and plans to advance its first drug into clinical testing next year.

  Biotech

• 

  Karuna switches CEOs ahead of FDA filing for schizophrenia drug

  Former Allergan commercial executive Bill Meury will take over for longtime CEO Steve Paul as the company prepares to seek U.S. approval of the treatment, known as KarXT, next year.

  Biotech

• 

  Gene editing

  Trailing rivals, Editas shares first study data for sickle cell treatment

  Editas said its gene editing therapy appeared safe and was well tolerated in two patients. The data comes five months after U.S. regulators lifted a partial hold on the trial.

  Gene Therapy

• 

  MEI, Kyowa stop lymphoma drug trials after FDA meeting

  The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

  Pharma

• 

  Emerging biotech

  Star Therapeutics launches Vega, growing its galaxy of drug startups

  The second startup to emerge from Star’s “hub-and-spoke” model aims to develop a Hemlibra-like antibody drug for the blood clotting disorder von Willebrand disease.

  Biotech

• 

  With $81M, Entact Bio takes a new approach to fixing helpful proteins

  Entact Bio aims to develop medicines that can enhance helpful proteins, rather than block harmful ones, a twist on the usual drugmaking playbook.

  Biotech

• 

  Gene therapy safety

  Verve shares slide after company reveals details on FDA trial hold

  In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks.

  FDA

• 

  Novartis prostate cancer drug succeeds in study key to company’s sales hopes

  The positive results could help Novartis secure approval for earlier use of the radiopharmaceutical drug Pluvicto, potentially broadening the number of eligible patients by several times the current market.

  Clinical Trials

• 

  J&J drops out of hunt for Horizon, leaving Sanofi and Amgen to bid

  The two remaining suitors said they would make cash bids if they move forward with offers, for which they must declare “firm intent” by Jan. 10 under Irish takeover rules.

  Pharma

• 

  With new data, Nkarta builds case for ‘natural killer’ cell therapy

  The updated study results add to evidence that such therapies may help treat B-cell lymphomas. But it’s still unclear how long their effects could last. 

  Clinical Trials

• 

  TherapeuticsMD to offload drugs to Australia’s Mayne after failed buyout

  After a private equity takeover unraveled this summer, the women’s health company is selling its drug portfolio to Mayne Pharma in a $153 million deal.

  Biotech

• 

  Gene editing

  FDA lifts pause on Beam plans to test base editing cancer therapy

  The FDA’s decision is a step forward for a type of drugmaking known as “multiplex editing,” which involves editing several genes simultaneously.

  Gene Therapy

• 

  Rigel wins US approval of rival drug to Servier leukemia treatment

  The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

  FDA

• 

  J&J’s Duato to replace departing Gorsky as board chair

  The board reshuffling will consolidate Duato’s leadership of J&J as the company absorbs a big medtech acquisition and nears a planned spin out of its consumer health division.

  Pharma

• 

  FDA approves first microbiota-based treatment

  The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

  FDA

• 

  Roche study failure gives Alzheimer’s researchers new clues in drug quest

  Detailed clinical trial data for Roche's gantenerumab showed treatment cleared far less toxic protein from patients' brains than expected, potentially explaining its divergent result from Eisai’s lecanemab.

  Clinical Trials

More stories