Regulatory & PolicyFour FDA officials used an FDA Voices editorial to signal stricter oversight of foreign trial sites, including more resources for inspections, added reviewer training and earlier discussions with sponsors about foreign data provenance. The policy message is broader than any one country, but it arrives amid rising concern about data integrity and human subject protections as trial activity in China has expanded.
Dr. Alex Morgan·Sep 3, 2026
Healthcare InvestmentRoche’s Genentech is licensing access to DualityBio’s Dupac payload platform as more patients receive first-line antibody-drug conjugates such as Enhertu and Trodelvy and then progress. DualityBio will take candidates into the clinic before Genentech assumes sole responsibility for development after phase 1a, combining Genentech’s portfolio reach with China-based early-stage development economics.
Dr. Alex Morgan·Aug 28, 2026 Regulatory & PolicyThe documents, obtained by The Associated Press and The Guardian, include a letter in which Kennedy proposed studying Samoa's MMR vaccines after the deaths of two children who had received them. The Department of Health and Human Services said the Samoa visit was unrelated to vaccines and called claims that Kennedy lied to Congress false and defamatory.
Dr. Alex Morgan·Aug 28, 2026 
AI in Drug DiscoveryAccording to an SEC filing, draft copies of three posters were made publicly available via the ERS website on Aug. 25, nearly two weeks before the Sept. 7 embargo expired. The episode gave investors an early look at ongoing clinical data for golukibart, two days before a scheduled lock-up expiry reshaped the share register.
Dr. Alex Morgan·Aug 27, 2026 
Healthcare InvestmentSomeit Sidhu has brought a third biotech-focused SPAC to market just two months after pairing JATT II with Talawar Therapeutics. The new vehicle is targeting data-driven life sciences businesses, highlighting that even in a cooler SPAC market, sponsors still see openings around platform-heavy biotech stories.
Dr. Alex Morgan·Aug 27, 2026 
Biopharmaceutical IndustryThe approval covers adults and children age 8 and older with glycogen storage disease type Ia and positions Genglycos as an adjunct to nutritional management that can reduce daily cornstarch intake. For Ultragenyx, the decision is both a product launch and a platform validation point after years of investment in gene therapy.
Dr. Alex Morgan·Aug 22, 2026 
Regulatory & PolicyReps. John Moolenaar and Ben Cline reportedly asked Acting FDA Commissioner Kyle Diamantas to reject clinical data from China unless a trial site has recently undergone an FDA audit, and to review products already approved using clinical results from China. The pressure comes after at least three patient deaths were reported over the last few months in trials in China, including a Duchenne muscular dystrophy study run by HuidaGene.
Dr. Alex Morgan·Aug 21, 2026 
Biopharmaceutical IndustryThe collaboration gives Sandoz ex-China rights to an initial group of biosimilars, with Henlius responsible for development and manufacturing. For Sandoz, the deal ties near-term pipeline expansion to a business line that grew 22% in the second quarter while its larger generics unit was flat.
Dr. Alex Morgan·Aug 18, 2026 
AI in Drug DiscoveryThe article frames cell and gene therapy as an ecosystem problem rather than a component problem, arguing that isolated work on vectors or gene-editing tools misses the bigger constraint. Its central claim is that AI’s value lies in processing and connecting live operational data across the therapy lifecycle, provided companies share more non-IP information about what fails.
Dr. Alex Morgan·Aug 18, 2026 
Biopharmaceutical IndustryChina’s National Medical Products Administration approved ivonescimab with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer last Wednesday. At the same time, updated HARMONi-6 data posted to the label showed degradation in progression free survival, complicating the case for Summit Therapeutics as it tries to translate Chinese momentum into a U.S. approval strategy.
Dr. Alex Morgan·Aug 18, 2026 
Biopharmaceutical IndustryAbelZeta said rights to prizlon-cel were returned in July, ending J&J’s hold on a large B cell lymphoma asset it had licensed for $245 million upfront through its former Janssen subsidiary. The strategic signal is not about the quality of a single early dataset so much as how large pharmas are pruning external cell therapy bets while adding capital to newer priorities such as in vivo CAR T.
Dr. Alex Morgan·Aug 17, 2026 
Regulatory & PolicyThe U.S. Court of Appeals for the Fifth Circuit sided with the Texas Medical Association on two central disputes over the qualifying payment amount, or QPA, used in No Surprises Act arbitration. By rejecting the use of “ghost rates” and requiring bonus and incentive payments to be counted, the court challenged a methodology providers have argued favored payers.
Dr. Alex Morgan·Aug 14, 2026 