Industry News

Biotechnology Industry News

Takeda and Alkermes both took data…

September 8th, 2025|FierceBiotech|

Takeda and Alkermes both took data from their orexin receptor 2 (OX2R)-selective agonists to Singapore this morning as the race to get a new class of narcolepsy drug approved heats up.

Junshi has announced that its…

September 8th, 2025|FierceBiotech|

Junshi has announced that its IL-17 antibody hit the goals of a phase 3 psoriasis trial in China, setting up the biopharma to seek national approval.

BioNTech and its new partner…

September 7th, 2025|FierceBiotech|

BioNTech and its new partner Bristol Myers Squibb have trotted out the first global data for their PD-L1xVEGF bispecific in small cell lung cancer. BioNTech’s chief medical officer, Özlem Türeci, M.D., described the findings as

Servier is souping up its…

September 5th, 2025|FierceBiotech|

Servier is souping up its neurology pipeline with a clinical-stage candidate for a rare genetic disease sourced from U.K. biotech Kaerus Bioscience. The French pharma is offering as much as $450 million for KER-0193, a

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.