Regulatory

BMS-Hengrui deal strikes panic in Washington

Tue, 02 Jun 2026 12:00:00 -0400

On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.

China launches long-awaited drug data protection rules

Tue, 02 Jun 2026 12:00:00 -0400

China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.

Fulcrum drops work on SCD drug pociredir; stock plummets

Tue, 02 Jun 2026 12:00:00 -0400

Shares of Fulcrum Therapeutics Inc. (NASDAQ:FULC) fell 54% after the company said it is discontinuing work on sickle cell disease (SCD) candidate pociredir, its only clinical-stage candidate, and reviewing strategic alternatives in the wake of the U.S. FDA’s safety concerns regarding the drug target.

FDA clears Shionogi’s Xocova as first COVID-19 prevention pill

Tue, 02 Jun 2026 12:00:00 -0400

The U.S. FDA approved Shionogi & Co. Ltd.’s Xocova (ensitrelvir) as the first oral post-exposure prophylactic option in the U.S. to prevent COVID-19, with the decision coming ahead of a PDUFA target date of June 16.

China deals highlight biopharma evolution, reports LEK

Tue, 02 Jun 2026 12:00:00 -0400

In 2025, China’s outbound life sciences and biopharma deals reached nearly $100 billion, about 12 times the level seen in 2021, underscoring how quickly global appetite for Chinese assets has accelerated, according to a recent report by L.E.K. Consulting.

FDA advises leveraging what’s already known in gene therapy R&D

Tue, 02 Jun 2026 12:00:00 -0400

Rather than reinventing the wheel for every gene therapy that uses genome editing, the U.S. FDA is advising sponsors on leveraging existing knowledge, be it publicly available or platform-based, to more efficiently advance their products across multiple stages of development.

FDA approves IND for Iovance’s TIL therapy IOV-5001

Tue, 02 Jun 2026 09:00:00 -0400

Iovance Biotherapeutics Inc. has received IND clearance from the FDA for IOV-5001, a next-generation interleukin-12 (IL-12)-tethered tumor-infiltrating lymphocyte (TIL) therapy.

Voyager’s tau-targeted gene therapy VY-1706 gains IND approval

Tue, 02 Jun 2026 09:00:00 -0400

Voyager Therapeutics Inc. has obtained IND clearance from the FDA for VY-1706, the company’s investigational gene therapy for the treatment of Alzheimer’s disease.

Policy, aka politics, to have bigger role in US grants?

Mon, 01 Jun 2026 12:00:00 -0400

The Trump administration’s efforts to ensure U.S. federal grants align with its policies may soon be coming to fruition. The White House Office of Management and Budget released a proposed rulemaking to revise its Guidance for Federal Financial Assistance.

China launches long-awaited drug data protection rules

Fri, 29 May 2026 12:00:00 -0400

Replimune tries again with melanoma drug post FDA shakeup

Fri, 29 May 2026 12:00:00 -0400

Industry watchers will be tracking closely Replimune Group Inc.’s latest attempt to secure U.S. FDA approval of its advanced melanoma candidate, RP-1 (vusolimogene oderparepvec). The company announced Friday it had reached alignment for resubmitting the twice-rejected BLA with the agency, which it said has pledged to prioritize the review.

BMS-Hengrui deal strikes panic in Washington

Fri, 29 May 2026 09:00:00 -0400

FDA accepts IND for Rest Therapeutics’ early PTSD candidate

Fri, 29 May 2026 09:00:00 -0400

The FDA has accepted the IND application from Rest Therapeutics SAS for RST-101, the company’s lead investigational candidate for the early treatment of post-traumatic stress disorder (PTSD).

TROP2 ADCs progress into first-line for lung, breast cancers

Thu, 28 May 2026 12:00:00 -0400

Multiple updates on TROP2-directed antibody-drug conjugates (ADCs) for lung and breast cancers highlight both progress made and opportunities for improvement for the targeted class of cancer therapeutics.

TROP2 ADCs progress into first-line for lung, breast cancers

Thu, 28 May 2026 12:00:00 -0400

FDA’s VRBPAC faces complex COVID-19 landscape

Thu, 28 May 2026 12:00:00 -0400

Landing on the right COVID-19 vaccine formulation for the coming season is becoming more complicated against a backdrop of low vaccination rates, young children with little to no immunization, declining surveillance data and a new SARS-COV-2 lineage slowly emerging.

Abbott receives CE mark for dual glucose, ketone sensing systems

Thu, 28 May 2026 12:00:00 -0400

Abbott Laboratories received CE mark approval for two dual glucose and ketone sensing systems, bringing to the market sensors that could be transformational to the lives of people with diabetes at risk of diabetic ketoacidosis.

Elzonris this: FDA clears Abbvie’s Decnupaz in BPDCN

Thu, 28 May 2026 12:00:00 -0400

Payoff for the November 2023 buyout of Immunogen Inc. came for Abbvie Inc. in the form of U.S. FDA clearance for the CD123-targeting antibody-drug conjugate Decnupaz (pivekimab sunirine) to treat adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an ultra-rare, aggressive and quick-killing hematologic malignancy.

BMS-Hengrui deal strikes panic in Washington

Wed, 27 May 2026 12:00:00 -0400

Newcelx submits pre-IND package for NCEL-101 to FDA

Wed, 27 May 2026 09:00:00 -0400

Newcelx Ltd. has submitted a pre-IND briefing package to the U.S. FDA to support a proposed first-in-human trial of NCEL-101 in combination with tegoprubart, an investigational anti-CD40L monoclonal antibody being developed by Eledon Pharmaceuticals Inc.

Kennedy offers emergency immunity for use of MCM in hantavirus

Tue, 26 May 2026 12:00:00 -0400

Acknowledging that the spread of the Andes virus and the resulting disease, hantavirus pulmonary syndrome, “constitutes a credible risk of a future public health emergency,” U.S. Health and Human Services Secretary Robert Kennedy is issuing a declaration to provide liability protection for manufacturers, distributors and providers using favipiravir as a medical countermeasure (MCM) against the virus.

FDA adcom to consider next iteration of COVID-19 vaccines

Tue, 26 May 2026 12:00:00 -0400

What would normally be a routine meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee May 28 may be more carefully watched given the overall turmoil surrounding vaccines in the U.S. The only task before the adcom is to recommend the COVID-19 vaccine formula for the upcoming season. That conversation will include looking at the effectiveness of the four FDA-approved vaccines currently in use in the U.S.

China’s new IIT rules expected to wipe out ‘gray market’

Tue, 26 May 2026 11:00:00 -0400

New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies.

Biotle’s FcRn inhibitor BTL-203 cleared for clinic in China

Tue, 26 May 2026 09:00:00 -0400

Biotle has received a clinical trial notice from China’s National Medical Products Administration (NMPA) for its IND application for BTL-203, the company’s bispecific FcRn inhibitor being developed for the treatment of multiple autoimmune diseases.

Lilly’s oral GLP-1 milestone highlights a steady April for FDA approvals

Fri, 22 May 2026 12:00:00 -0400

The U.S. FDA granted 14 approvals in April 2026, down from March’s 19 but broadly in line with the historical range for the month.

China’s new IIT rules expected to wipe out ‘gray market’

Fri, 22 May 2026 12:00:00 -0400

New regulations tighten regulatory oversight of China’s investigator-initiated trials (IITs) but legitimize the pathway that will be open to other modalities beyond cell and gene therapies.

EMA poised to be 4th regulator approving Boehringer’s Jascayd lung drug

Fri, 22 May 2026 12:00:00 -0400

As generic versions of its blockbuster drug Ofev (nintedanib) start to hit the market, Boehringer Ingelheim GmbH looks to have swerved the patent cliff, with European and Japanese regulators both approving a potential replacement, Jascayd (nerandomilast), this week. At its monthly meeting, the EMA’s Committee for Medicinal Products for Human Use also recommended Novartis AG’s Vijoice (alpelisib) be given conditional approval in the treatment of PIK3CA-related overgrowth spectrum disorders.

Henlius gains Australian trial clearance for HLX-3902

Fri, 22 May 2026 09:00:00 -0400

Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors.

Scribe’s STX-1150 for hypercholesterolemia cleared for clinic

Fri, 22 May 2026 09:00:00 -0400

Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand.

FDA clears Qihan Biotech’s CAR T therapy QT-019C for clinic

Thu, 21 May 2026 09:00:00 -0400

Hangzhou Qihan Biotech Co. Ltd. has obtained IND clearance from the FDA for QT-019C, a universal allogeneic CAR T-cell therapy for autoimmune diseases. QT-019C cell injection is an off-the-shelf allogeneic CAR T-cell therapy engineered from healthy donor leukapheresis products to stably express two distinct CARs targeting CD19 and BCMA.