Valneva SE has struggled to get its COVID-19 vaccine on the market, but efforts to get the first Lyme disease vaccine in years approved appear firmly on track after partner Pfizer Inc. invested €90.5 million (US$94.9 million) in the project. New York-based Pfizer has been working with Saint-Herblain, France based Valneva on the Lyme disease vaccine since April 2020, when the big pharma bought into the development program for the vaccine candidate codenamed VLA-15 for $130 million.

No ‘may’ about it when it comes to COVID-19 pediatric vaccines

Instead of “Mother, may I” for COVID-19 vaccines for children 6 months through 5 years of age, the U.S. CDC is saying the correct response is “I should.” That was the recommendation June 18 from the CDC’s Advisory Committee on Immunization Practices. CDC Director Rochelle Walensky wasted no time in endorsing the recommendation, which came just a day after the FDA had authorized the vaccines from Moderna Inc. and Pfizer Inc.-Biontech SE for that pediatric age group. The CDC’s endorsement paves the way for the U.S. to begin a nationwide rollout of the vaccines for the youngest children this week.

Strong deal-making dominated by Sanofi, BMS

While Pfizer Inc. remains active with mergers and acquisitions, Sanofi SA and Bristol Myers Squibb Co. are major players in the top six biopharma deals of 2022. So far this year, the industry has announced 769 deals, including licensings, joint ventures and collaborations, valued at $88.9 billion. They represent fewer deals than each of the last two years, yet overall deal value is 23% above 2021 and 18% above 2020. The industry has also completed 42 M&As in 2022 for a combined value of $23.4 billion, which is significantly down from each of the last two years.

US FTC zeroing in on exclusionary rebate schemes

The U.S. FTC isn’t waiting to complete its investigation into potentially anticompetitive practices of pharmacy benefit managers (PBMs) to crack down on some of those schemes. The agency last week adopted an enforcement policy statement putting PBMs and drug companies on notice that certain rebate and fee practices that block patient access to lower-cost drugs, including biosimilars, may be illegal. “When we see illegal rebate practices that foreclose competition and raise prescription drug costs for families, we won’t hesitate to bring our full authorities to bear,” FTC Chair Lina Khan said. The crackdown could give the biosimilar industry the boost it needs to capture more of the U.S. market.

Cancer ultimatum: Ultimovacs’ universal cancer vaccine posts strong survival data

New data from the phase I study of Ultimovacs ASA’s lead candidate showed positive two-year overall survival data for the cancer vaccine. UV1, combined with the checkpoint inhibitor Keytruda (pembrolizumab, Merck & Co. Inc.) for treating malignant melanoma, demonstrated a 24-month survival rate of 73% in all 30 patients in the study. In March, the ongoing trial produced a 33% complete response rate and an objective response rate of 57%. Three-year overall survival data is expected before the year ends from the first cohort of 20 patients. The Oslo-based company’s shares (OSE:ULTI) had a strong day, closing 11.8% higher at NOK 73 (US$7.38).

UK signs on to subscription-style plans for new Pfizer, Shionogi antibiotics

An agreement has been reached in the U.K. to pay a fixed annual fee for two antibiotics, regardless of how often the drugs are prescribed, in a bid to prevent their overuse and slow the development of antimicrobial resistance.

Ratio Therapeutics emerges with $20M financing, taking mathematical approach to radiopharmaceuticals

In the last decade, Bayer AG and Novartis AG have shown that radiopharmaceutical technology can produce marketable drugs, with Xofigo (radium-223 dichloride) and Lutathera (lutetium [177Lu] oxodotreotide), respectively approved for prostate cancer and neuroendocrine tumors. Now Ratio Therapeutics Inc., of Boston, has emerged from stealth mode with more than $20 million in seed financing, and development alliances with Bayer and Lantheus Holdings Inc. plus its own technology intended to harness the tumor-killing power of alpha particles.

Also in the news

3Z, Abbvie, Addex, Basilea, Biontech, Boehringer, Boundless, Codexis, Cyclerion, Cytokinetics, Excellthera, Hansa, HKSTP, Jatt Acquisition, Kazia, LG Chem, Moderna, Mydecine, Myovant Sciences, Novartis, Obseva, Pfizer, Rhythm, Sana, Scholar Rock, Sierra, Sinomab, Sirnaomics, Theramex, Vyne, Zhittya Genesis Medicine, Zura