FDA approval of UCB’s Bimzelx gives the Belgian drugmaker a contender in the crowded plaque psoriasis therapies market. In the rare disease generalized myasthenia gravis, the agency approved Zilbrysq, a UCB drug with advantages over two blockbuster AstraZeneca drugs addressing the same target.

Thermo Fisher Scientific is acquiring Olink, a company that provides proteomics analysis tools and services used in drug discovery research. Olink’s growing revenue will help shore up a Thermo Fisher business segment whose sales have fallen due to declining Covid-19 testing demand.

Roche is paying $50 million up front to begin a drug R&D alliance with Monte Rosa Therapeutics, a biotech whose molecular glue technology could address targets previously deemed undruggable. It’s Roche’s second such deal in the past month.

The KBP Biosciences drug Novo Nordisk is acquiring has reached Phase 3 testing as a potential treatment for uncontrolled hypertension and advanced chronic kidney disease. It’s the latest in a string of business deals aimed at expanding the Novo Nordisk pipeline beyond diabetes.

Pfizer lowered its revenue projections for 2023, a change it attributed to declining demand for its Covid-19 vaccine, Comirnaty, and antiviral drug, Paxlovid. Citing this revenue decline, Pfizer is implementing a companywide cost-cutting plan projected to save $3.5 billion.

The FDA’s digital health advisory committee will discuss technologies such as artificial intelligence and machine learning, virtual reality, and digital therapeutics as well as topics like decentralized clinical trials and patient-generated health data. Committee member nominations are due in December.

Pfizer’s new FDA-approved ulcerative colitis drug Velsipity comes from its $6.7 billion Arena Pharmaceuticals acquisition. The small molecule will compete against blockbuster Bristol Myers Squibb drug Zeposia, which addresses the same target.

European Union regulators ordered Illumina to divest Grail. Illumina is appealing antitrust findings in Europe and the U.S., but the DNA sequencing giant revealed that divesting all or part of Grail is an option even if it wins both legal challenges.

BioNTech gains rights to a MediLink Therapeutics antibody drug conjugate that targets tumors expressing the HER3 protein. The deal comes six months after the German company entered the ADC field by acquiring rights to two therapeutic candidates from DualityBio.

A study testing Novo Nordisk’s semaglutide in chronic kidney disease is ending early after an interim analysis met efficacy goals. Detailed results are not yet available, but they could support expanding use of the GLP-1 agonist, which is far and away Novo Nordisk’s top-selling product.

Formed by Baidu founder and CEO Robin Li, BioMap uses artificial intelligence technology to glean insight into proteins to guide biologic drug discovery. The startup is the latest company to join a growing list of Sanofi partners as the pharmaceutical giant continues investing in AI-enabled drug discovery.

Bayer opens its new cell therapy manufacturing facility as it prepares a Parkinson’s disease cell therapy for Phase 2 testing. The new 100,000 square foot facility also has space for manufacturing other cell therapies in the pharma giant’s pipeline.

Despite an affirmative FDA advisory committee vote, the agency declined to approve Alnylam Pharmaceuticals’ Onpattro for treating the heart complications caused by a rare, inherited protein disorder. But Alnylam has other drugs candidates for the disease, including one expected to post Phase 3 data in the first half of 2024.

Acquiring Mirati Therapeutics brings Bristol Myers Squibb Krazati, one of two FDA-approved therapies addressing a KRAS cancer mutation. The deal comes as BMS looks to add revenue-generating products as patent expirations loom for several of its cancer products.

Takeda Pharmaceutical drug Exkivity failed the confirmatory study required of its 2021 accelerated approval. Our recap of other recent regulatory developments includes a partial clinical hold on a cancer drug, a Covid-19 vaccine authorization, and several drug approvals in the U.S. and beyond.

Precede Biosciences’ liquid biopsy platform yields insight into the genes and pathways in diseased tissue. Based on Dana-Farber Cancer Institute research, the startup aims to support biopharma drug R&D as it also develops the technology for clinical care applications.

The Orchard Therapeutics acquisition comes as the biotech’s gene therapy for metachromatic leukodystrophy approaches a March 2024 FDA decision. The ex vivo gene therapy is already commercialized in Europe, marketed as Libmeldy.

Iambic Therapeutics brings together software engineers and drug-hunting scientists, all sharing the goal of using artificial intelligence to optimize properties of small molecule drugs. The startup will apply its Series B financing to a cancer drug pipeline that includes two candidates on track for the clinic in 2024.

Novavax’s updated version of its Covid-19 vaccine is now FDA authorized for use in the U.S., joining the approved shots from Moderna and partners Pfizer and BioNTech. Novavax said its protein-based vaccine will be available in coming days.

Acquiring Point Biopharma gives Eli Lilly a pipeline of radiopharmaceuticals, including one for prostate cancer that could rival Novartis’s Pluvicto. The deal comes ahead of an expected Phase 3 data readout for that Point therapeutic candidate.

Novartis’s iptacopan met the first of two main goals in its pivotal study in immunoglobulin A nephropathy, and the pharma giant plans to seek accelerated FDA approval next year. The drug could challenge two available therapies for the rare kidney disorder.

The FDA awarded marketing authorization for a new Invitae test that uses next-generation sequencing to assess multiple genes to identify variants indicating a person’s predisposition for certain cancers. The regulatory action creates a new regulatory classification making Invitae’s test the predicate device for future cancer tests.

Avalyn Pharma aims to improve treatment of idiopathic pulmonary fibrosis with inhalable versions of two older oral drugs and it’s now headed for mid-stage testing backed by a Series C financing. Other recent biotech industry financings raised money for research in cancer, immunology, and rare genetic diseases.

Preliminary weight loss and safety data for Structure Therapeutics’ drug candidate suggest it’s competitive with other oral GLP-1 targeting contenders from big pharma companies. The data are from a small study and a short time frame, but Structure was able to leverage the encouraging preliminary results into a private placement of securities.

Sanofi dominates the market for therapies that treat Pompe disease, a rare enzyme deficiency. The FDA has approved an Amicus Therapeutics combination treatment for patients inadequately served by the Sanofi products.

NurOwn, BrainStorm Cell Therapeutics’ experimental stem cell therapy for ALS, did not win the backing of an independent panel of FDA advisors. Many advisory committee members said they want to see more data from another clinical trial, the same guidance the FDA has given the biotech for nearly three years.

Ionis Pharmaceuticals’ olezarsen has Phase 3 results showing the therapy handily beat a placebo at reducing fat levels in the blood due to a rare, inherited metabolic disorder with no FDA-approved drugs. Ionis plans early 2024 submissions for what could become the first medicine it commercializes without a partner.

Intercept Pharmaceuticals’ acquisition by Alfasigma comes three months after the FDA again rejected the biotech’s drug as a treatment for the fatty liver disease NASH. But Intercept still has rare liver disease assets, and Italy-based Alfasigma says acquiring the company will help it expand in gastroenterology and hepatology.

Novo Nordisk is paying Valo Health $60 million up front to gain three preclinical cardiovascular disease programs. Milestone payments for those programs and others covered under the artificial intelligence drug discovery pact could reach up to $2.7 billion.

Scynexis said no adverse events or contamination problems have been reported for Brexafemme, an antifungal approved for treating vaginal yeast infections. The biotech said the risk of cross-contamination stems from the processes of the small molecule’s third-party manufacturer.