Industry News

Biotechnology Industry News

Partners Daiichi Sankyo and Merck…

September 5th, 2025|FierceBiotech|

Partners Daiichi Sankyo and Merck & Co. are sharing phase 2 data for their investigational antibody-drug conjugate, findings the partners think will help score accelerated approval in pre-treated small cell lung cancer.

The FDA’s ongoing effort to…

September 5th, 2025|FierceBiotech|

The FDA’s ongoing effort to establish a culture of “radical transparency” saw the agency publish another haul of complete response letters yesterday.

Braveheart Bio has waded into the…

September 5th, 2025|FierceBiotech|

Braveheart Bio has waded into the fight for a heart disease market, paying $65 million upfront for a rival to Bristol Myers Squibb’s Camzyos and Cytokinetics’ aficamten.

BioNTech’s HER2 antibody-drug…

September 5th, 2025|FierceBiotech|

BioNTech’s HER2 antibody-drug conjugate has beaten Roche’s Kadcyla in a phase 3 breast cancer trial, positioning the company’s partner Duality Biologics to seek approval for the candidate in China.

The German pharma giant has found…

September 4th, 2025|FierceBiotech|

The German pharma giant has found a new pipeline leader in David Weinreich, M.D., who is joining the company as global head of R&D and chief medical officer for its healthcare unit. Weinreich, who will

The Food and Drug Administration…

September 4th, 2025|FierceBiotech|

The Food and Drug Administration today announced a plan to publicly release complete response letters at the same time they are issued to sponsoring companies, part of what the agency calls a push toward “radical

Enveda has closed its second $150…

September 4th, 2025|FierceBiotech|

Enveda has closed its second $150 million financing round of the year. The series D round, which moves Enveda’s total funding beyond $500 million, positions the biotech to advance a crop of programs into the

A phase 3 trial of Sanofi’s…

September 4th, 2025|FierceBiotech|

A phase 3 trial of Sanofi’s eczema prospect amlitelimab has hit its primary and key secondary endpoints. Yet, with the data falling short of analyst expectations, shares in the company opened down 9% in Paris.

An interim analysis reported in…

September 3rd, 2025|FierceBiotech|

An interim analysis reported in June showed that Amgen's Zai Labs-partnered bemarituzumab made improvements in overall survival, but the final analysis tells a different story.

Gilead Sciences’ Kite Pharma has…

September 3rd, 2025|FierceBiotech|

Gilead Sciences' Kite Pharma has cut off a collaboration with Shoreline Biosciences, ending a research collaboration on off-the-shelf cell therapies that was valued at more than $2.3 billion.

After becoming the first group to…

September 3rd, 2025|FierceBiotech|

After becoming the first group to therapeutically edit human RNA in October 2024, Wave Life Sciences has released more data from an ongoing alpha-1 antitrypsin deficiency clinical trial—and investors appear less enthused this time around.

The FDA has outlined a new review…

September 3rd, 2025|FierceBiotech|

The FDA has outlined a new review process for drugs and biologics designed to treat ultra-rare genetic diseases that would allow a single-arm trial, plus other supportive data, to serve as pivotal evidence.

Treeline Biosciences has surfaced…

September 3rd, 2025|FierceBiotech|

Treeline Biosciences has surfaced from secrecy to reveal the harvesting of a $200 million series A extension and the picking of some ripe clinical programs. The extra cash brings the Massachusetts-based oncology outfit’s total funding

Valneva has reported phase 2 data…

September 3rd, 2025|FierceBiotech|

Valneva has reported phase 2 data on the third booster dose of its Pfizer-partnered Lyme disease vaccine candidate, ticking off another task for a prospect that could reach regulatory review next year.

Novartis has returned to Argo…

September 3rd, 2025|FierceBiotech|

Novartis has returned to Argo Biopharmaceutical with $160 million in upfront cash to explore various cardiovascular meds in the Chinese biotech’s siRNA pipeline.

After throwing down $70 million…

September 2nd, 2025|FierceBiotech|

After throwing down $70 million upfront to partner on Black Diamond Therapeutics’ solid tumor candidate earlier this year, Servier is pulling out its checkbook to ink yet another oncology licensing deal.

Boston-based Radiance Biopharma is…

September 2nd, 2025|FierceBiotech|

Boston-based Radiance Biopharma is doling out $15 million in cash and offering more than $1 billion in milestones for licensing rights to a bispecific antibody-drug conjugate from a Chinese drug developer.

Cytokinetics spent Labor Day…

September 2nd, 2025|FierceBiotech|

Cytokinetics spent Labor Day weekend in Spain, sharing a big phase 3 win for its lead cardio candidate at the European Society of Cardiology Congress in Madrid. A daily pill of small molecule aficamten improved