Roche, Biogen sign royalty deal for late-stage lymphoma drug

Roche will pay royalties to Biogen on glofitimab, part of a long-standing collaboration between the two companies that’s resulted in Rituxan and Ocrevus.

By Jonathan Gardner • Updated Dec. 26, 2022

Madrigal shares triple on positive NASH study results

The company said its experimental drug helped patients with the fatty liver disease while also improving fibrosis. One analyst called the readout a “major win” for Madrigal and the NASH field.

By Jacob Bell • Dec. 19, 2022

Explore the Trendline➔

Cell therapy

The continued emergence of CAR-T therapy has fueled research into next-generation approaches and new applications, such as its use in autoimmune diseases.

By BioPharma Dive staff

Nimbus CEO Jeb Keiper on negotiating a $4B deal and building an unorthodox biotech startup

Days after inking one of the largest deals for an unapproved drug, the CEO spoke with BioPharma Dive about the company’s unusual origins and decision to remain private — for now. 

By Ben Fidler • Dec. 16, 2022

Sio Gene Therapies to dissolve after years of setbacks

Having failed to find a buyer or potential partner, the biotech company has opted instead to shut down and liquidate its assets.

By Delilah Alvarado • Dec. 15, 2022

A San Diego startup sees covalent biologics as the next frontier in cancer drugs

Enlaza claims to be the first biotech to build a pipeline of protein drugs that can grab their target via covalent binding, a twist on previous drugmaking methods.

By Gwendolyn Wu • Dec. 15, 2022

For ALS patients, doctors, a new medicine reignites concerns about healthcare access

Relyvrio, a drug developed by Amylyx Pharmaceuticals, is in high demand in ALS clinics across the U.S. Though some patients are already getting it, insurance coverage and out-of-pocket costs remain a source of anxiety.

By Jacob Bell , Shaun Lucas • Dec. 15, 2022

Cytokinetics heart drug voted down by FDA panel

Following years of development, the biotech’s heart failure drug now faces another hurdle in its regulatory path forward, after a group of FDA advisers took issue with its trial evidence. 

By Delilah Alvarado • Dec. 14, 2022

GSK gives Wave a lift with genetic medicine deal

A four-year agreement between the companies comes with $170 million in cash and equity for Wave, which in recent years has dealt with clinical setbacks.

By Kristin Jensen • Dec. 14, 2022

Mirati’s KRAS-blocking cancer drug approved by FDA

Cleared for a certain kind of mutated lung cancer, the medicine will challenge Amgen’s similarly acting treatment Lumakras.

By Ned Pagliarulo • Dec. 13, 2022

Moderna vaccine succeeds in early-stage skin cancer study with Merck’s Keytruda

The positive data are the most significant findings for the mRNA developer’s pipeline of experimental treatments outside of infectious diseases, where it has reaped billions from COVID-19 vaccine sales. 

By Jonathan Gardner • Dec. 13, 2022

Black Diamond spins out new biotech to develop cancer drugs

Months after restructuring and trimming its workforce, the company has teamed up with its original investors to form an antibody drug developer called Launchpad Therapeutics.

By Delilah Alvarado • Dec. 13, 2022

Flagship’s Lovisa Afzelius on creating a successful biotech and a ‘very different’ startup market

Even with a shaky market for drug startups, the Apriori CEO and Alltrna cofounder said Flagship will continue its approach of betting on cutting-edge, and unproven, science.

By Gwendolyn Wu • Dec. 13, 2022

Roche’s hemophilia gene therapy holds steady with longer-term data

Roche’s subsidiary Spark has offered few updates on its hemophilia A treatment since being acquired in 2019. New data at ASH show the therapy can maintain levels of a key blood-clotting protein for years. 

By Jonathan Gardner • Dec. 12, 2022

Clovis files for bankruptcy

Perhaps best known for its marketed PARP inhibitor Rubraca, the cancer drugmaker is now in the process of reorganizing its debt and selling off assets.

By Jacob Bell • Dec. 12, 2022

[Podcast] Thinking Big for Small and Mid-Sized Biotechs

This podcast series explores how to help small and mid-sized companies get innovative treatments to the people who need them.to help small and mid-sized companies get innovative treatments to the people who need them.

By BioPharma Dive's studioID • Updated Dec. 15, 2022

Biopharma trends leaders should consider for 2023

What healthcare trends biopharma leaders should pay attention to in 2023 and how to set yourself up for success.  

By Tom Langan, President and Chief Commercial Officer, Veradigm • Dec. 12, 2022

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.

By Delilah Alvarado • Dec. 9, 2022

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. 

By Gwendolyn Wu • Dec. 8, 2022

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.

By Delilah Alvarado • Dec. 7, 2022

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. 

By Jonathan Gardner • Dec. 6, 2022

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.

By Christopher Newman • Dec. 6, 2022

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.

By Gwendolyn Wu • Dec. 6, 2022

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.

By Gwendolyn Wu • Dec. 6, 2022

Biotech veteran Jeff Jonas on leaving Sage, guiding new biotechs and his ‘personal odyssey’

In an interview with BioPharma Dive, the longtime industry executive discussed becoming a biotech investor and his plans for Abio-X, a new incubator with $150 million to spend on startups. 

By Ben Fidler • Dec. 6, 2022

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.

By Delilah Alvarado • Dec. 5, 2022