ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.

BeiGene welcomes the return of the immunotherapy’s rights as an opportunity to make it the backbone of its solid tumors strategy. But Novartis cedes an opportunity to gain a competitor to established cancer immunotherapies from Merck and Bristol Myers Squibb.

Magnet Biomedicine builds on decades of molecular glue research from its scientific co-founder, Harvard University Professor Stuart Schreiber. The startup is developing drugs that take these glues beyond the biotech industry’s current focus on targeted protein degradation.

The Coalition for Epidemic Preparedness Innovations, or CEPI, has pledged up to $90 million to BioNTech’s messenger RNA vaccine candidates for mpox. This research could help advance the scientific understanding of the application of mRNA technology to Orthopoxviruses, which includes mpox, formerly known as monkeypox.

FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.

RayzeBio’s IPO will support pivotal testing of a targeted radiopharmaceutical for cancer patients who progress after treatment with Novartis’s Lutathera. Neumora will apply its IPO cash toward Phase 3 testing of a depression drug with a novel mechanism of action.

Allogeneic cell therapy hasn’t caught up to autologous cell therapy yet, and the disappointing data so far has soured the entire allogeneic field for at least one venture capitalist. The cell therapy debate was one of the topics covered during a panel discussion at the Biopharm America conference.

Pharmaceutical industry observers say CVS Health’s creation of Cordavis, a new biosimilar drugs company, is part of a strategy to make its move into this market as profitable as possible.

Avalon BioVentures unveiled new portfolio company Arialys Therapeutics. The startup’s lead program, an antibody from Astellas Pharma, is a potential treatment for anti-NMDA receptor encephalitis (ANRE), a rare autoimmune inflammatory disorder.

The FDA said the updated messenger RNA vaccines from Pfizer/BioNTech and Moderna will protect against the omicron subvariants now prevalent in circulation. Left out of the FDA decision is Novavax, whose protein-based vaccine is still under regulatory review.

Moderna and Immatics aim to see if the combination of their respective technologies can lead to better cancer treatments spanning multiple therapeutic modalities. Milestone payments to immunotherapy developer Immatics could top $1.7 billion.

Seagen and Nurix are bringing their respective technologies together to develop a new class of cancer drugs called degrader antibody conjugates. Nurix CEO Arthur Sands says the multi-year, multi-target collaboration expands the reach of each company’s technology.

By revealing how tumors interact with immune cells, Noetik aims to identify new targets for new cancer drugs. The startup and its artificial intelligence-driven platform are supported by $14 million in seed financing.

Gene therapy biotech Kriya Therapeutics has acquired Tramontane Therapeutics, a startup focused on metabolic diseases. Tramontane brings a gene therapy that’s a potential one-time treatment for the fatty liver disease NASH.

Peanut allergy therapy Palforzia, which Nestlé acquired in a multi-billion dollar deal, has been sold to allergy product company Stallergenes Greer. Palforzia was the first FDA-approved drug for peanut allergy, but its sales were hampered by the Covid-19 pandemic.

Startup Star Therapeutics will use the Series B funding to support clinical development of a drug candidate for von Willebrand disease, a bleeding disorder. The capital will also support the formation of new biotech subsidiaries developing antibodies with therapeutic applications in hematology and immunology.

Intarcia Therapeutics’ GLP-1 agonist product candidate for type 2 diabetes now belongs to i2o Therapeutics, which will make the treatment’s case for approval at an upcoming FDA advisory committee meeting. The startup’s $46 million Series A financing is one of several recently announced funding rounds.

Amgen and the Federal Trade Commission are settling the lawsuit the regulator filed to block the pharmaceutical giant’s $28 billion Horizon Therapeutics acquisition. As part of the settlement, Amgen agrees not to “bundle” its products with Horizon’s drugs in negotiations with health plans.

Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines.

Novo Nordisk is expanding its cardiometabolic drug pipeline with the acquisition of Embark Biotech, a startup developing drugs for a novel target that can suppress appetite and boost calorie burning in cells. Embark’s science comes University of Copenhagen research on a novel fat cell target.

The Apellis Pharmaceuticals restructuring will save up to $300 million. It comes as the biotech continues its inquiry into the cause of a rare inflammatory complication reported in a small number of patients who received its geographic atrophy drug, Syfovre.

Bristol Myers Squibb drug Reblozyl is now approved as a first-line therapy for anemia caused by myelodysplastic syndromes, a group of blood cancers. It’s the third indication for the drug, which analysts project could top $4 billion in peak sales.

A Bayer cell therapy for Parkinson’s disease has met primary and secondary goals of its first test in humans, and the pharmaceutical giant is now planning for a larger Phase 2 clinical trial expected to begin enrollment in the first half of next year.

Abcam’s acquisition comes two months after its board announced the exploration of strategic alternatives that could include the sale of the company. Danaher beat out at least 20 companies that were potential buyers of the life sciences tools and antibody development firm.

Genesis Therapeutics recently joined the growing list of AI-powered drug discovery startups receiving venture funding this year. The company closed a $200 million Series B financing round, taking its total funding to date to more than $280 million.

Imugene gains global rights to Precision BioSciences’ most advanced program, an allogeneic cell therapy for advanced cases of blood cancer. Precision will now focus on in vivo gene editing therapies, some of which is partnered with Novartis and Eli Lilly.

Gilead Sciences is partnering with Tentarix Biotherapeutics, a startup developing multifunctional antibody drugs that it calls “Tentacles.” Tentarix’s technology offers the potential to selectively address targets in cancer and inflammation.

Oncology is already a big piece of Pfizer’s drug lineup. The portfolio is expanding to multiple myeloma with FDA approval of Elrexfio, a bispecific antibody that targets the cancer protein BCMA.

Zynerba Pharmaceuticals’ lead drug candidate is designed to bring the therapeutic effect of cannabinoids without also causing euphoric effects. The synthetic cannabinoid in a topical gel formulation includes none of the psychoactive compounds from the cannabis plant.

Johnson & Johnson’s Akeega is approved for treating advanced prostate cancer with a BRCA mutation. The drug, which interferes with a way cancer cells repair themselves, will compete against recently approved drugs from Pfizer and partners AstraZeneca and Merck.