Deals:
Gilead Sciences announced a research collaboration, option and license agreement with Merus N.V. to discover novel dual tumor-associated antigens targeting trispecific antibodies – which could exceed more than $1.5 billion.
Sandoz bought the Cimerli (ranibizumab-eqrn) business from Coherus Biosciences for $170 million.
Bayer bought the exclusive license to commercialize BridgeBio Pharma’s transthyretin amyloid cardiomyopathy treatment candidate acoramidis in Europe.
Elsevier signed a multi-year agreement with Iktos to drive drug discovery with AI capabilities.
Healthcare marketing agency SCF Group acquired CareContent, a woman-owned, Chicago-based content creation company.
Armata Pharmaceuticals secured a $35 million credit agreement with Innoviva.
Health and human services software vendor Healthy Together bought Kinsa Health.
FDA:
The FDA approved Johnson & Johnson’s bispecific antibody Rybrevant (amivantamab-vmjw) for treating locally advanced non-small cell lung cancer in combination with carboplatin and pemetrexed.
The agency approved AbbVie’s Juvederm Voluma XC for treating temple hollows.
The FDA cleared the first over-the-counter continuous glucose monitor from Dexcom.
Advisors to the agency unanimously recommended the FDA approve trivalent flu vaccines for the 2024-2025 season.
The FDA approved Eyenovia and Formosa Pharmaceuticals’ clobetasol propionate 0.05% eye drops for the treatment of post-operative inflammation and pain after eye surgery.
The agency approved Hugel America’s neurotoxin injection letibotulinumtoxinA-wlbg for the treatment of frown lines.
The FDA approved two of Sandoz’s biosimilars to denosumab, a bone drug developed by Amgen.
Layoffs:
Gritstone announced it will lay off 40% of its workforce.
Sumitomo Pharma said it will lay off another 400 employees in North America.
Moderna laid off manufacturing workers at its Burlington and Norwood sites in Massachusetts.
Pfizer shut down construction of Seagen’s 270,000-square-foot facility in a business park in Everett, a move that is expected to impact 120 employees.
Funding rounds:
Akero Therapeutics launched a $300 million stock offering.
San Francisco biotech Alumis raised $259 million in venture capital.
BridgeBio Pharma launched a $250 million stock offering.
Sionna Therapeutics raised $182 million in a Series C funding round.
FogPharma raised $145 million in a Series E financing round.
Achieve Life Sciences announced the pricing of up to $124.2 million of shares in a direct offering and concurrent private placement.
Nocion Therapeutics raised $62 million in a Series B funding round.
Boundless Bio filed to go public as the San Diego-based startup approaches early safety and efficacy data for its first clinical attempt at a unique take on treating cancer.
Morehouse School of Medicine announced Team SAMBAI was awarded a $25 million grant funded by Cancer Research UK and the National Cancer Institute.
Biotech firms inked 204 deals in Q4 2023, down 24% year-over-year, according to data from Pitchbook.
Industry news:
Novo Nordisk’s Ozempic cut the risk of patients developing advanced kidney disease or dying from kidney or heart complications. The Danish drugmaker’s stock also hit a record high as it presented data from amycretin, one of the next generation of GLP-1 drugs.
Bayer said it will hold off on plans to break up and instead focus on improving the operating performance, resolving litigation and paying off debt.
A federal judge in Delaware ruled in favor of the Biden administration in a case brought by AstraZeneca seeking to overturn parts of the drug price negotiations established by the Inflation Reduction Act.
CVS and Walgreens both said they’ve received certification to dispense the abortion pill mifepristone and will start making the medicine available this month in a limited number of states where it’s legal.
Boehringer Ingelheim announced it will cap out-of-pocket costs for its inhaler products for chronic lung disease and asthma at $35 per month starting June 1.
A federal judge ruled that NYU Langone Health doesn’t own the use of the color purple in branding and advertising as part of a legal fight with Northwell Health.
The White House held a roundtable on pharmacy benefit managers that was attended by Federal Trade Commission Chair Lina Khan, billionaire entrepreneur Mark Cuban and Kentucky Governor Andy Beshear, among others.
Mark Cuban Cost Plus Drug Company will begin manufacturing its own generic medications.
Perrigo announced Opill, the first oral contraceptive approved for over-the-counter use in the United States, will be available in stores and online this month.
Tonix Pharmaceuticals named Eversana Intouch as the brand’s launch strategy and commercialization partner for Tonmya, an early-stage drug in development for the management of fibromyalgia.
Rosy started off as a sexual wellness app but recently announced the launch of Quickies, a digital feature to connect patients with healthcare professionals (HCP) and other evidence-based resources.
Seres Therapeutics reported that Vowst generated $10.4 million in net sales in Q4 2023.
GSK said a study showed its experimental drug Blenrep helped extend survival in patients with a type of blood cancer without symptoms worsening.
Project Ronin, a cancer-focused software startup co-founded by Oracle chairman Larry Ellison, is shutting down.
As part of a Phase 2 trial, Roche and Alnylam Pharmaceuticals announced their experimental drug against high blood pressure was shown to work when used in combination with the standard of care.
Amring changed its name to Nordic Pharma.
Fitness training startup Humango has hired Finn Partners, a 2023 MM+M Agency 100 honoree.
Finn Partners, a 2023 MM+M Agency 100 honoree, announced the formation of its Global Health Impact Group to address corporate and NGO client communication priorities in Africa, Asia, Europe and the Americas.
Gilead Sciences said a study indicated Biktarvy demonstrated high rates of viral suppression in people with HIV and comorbidities.
Biogen said data from Spinraza showed promise reducing neurodegeneration patients living with spinal muscular atrophy.
EyePoint Pharmaceuticals reported growth in Q4 2023 amid ongoing strategic shifts.
American Indian Cancer Foundation re-upped its sixth annual Blue Beads campaign for colorectal cancer awareness in conjunction with Exact Sciences and Mayo Clinic.
Apogee Therapeutics reported its antibody treatment, APG777, had an approximate half-life of 75 days and achieved biological targets for roughly three months.
OptimizeRx’s platform is now connecting providers with Walmart’s specialty pharmacies of the community.
Stevanato Group’s quarterly revenue increased 10% to €320.6 million.
See last week’s edition of Rx Rundown.
