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Novartis’ radiopharma gambit
Novartis is once again making moves in radiopharmaceuticals. It announced this week that it will pay $1 billion upfront to acquire Mariana Oncology and the startup’s peptide-based candidates. The buyout came just a couple days after Novartis expanded its deal with PeptiDream, handing the Japanese partner $180 million to come up with peptides against a slate of new targets for conjugating with radionuclides or other compounds.
Weight loss battle plays out
Supply constraints for GLP-1 drugs continue to dominate conversations around Novo Nordisk and Eli Lilly’s quarterly updates, even as both companies report a spike in sales thanks to unwavering demand. Meanwhile, Amgen offered a surprise update on a Phase 2 trial of its obesity candidate MariTide, sending its own shares up and putting pressure on the two leaders.
Spark co-founder’s new startup
Beverly Davidson is hoping to replicate the success she and the Spark Therapeutics team had. Latus Bio, her new Philadelphia biotech, emerged with $54 million in initial Series A financing to expand to Boston in June and enter human studies in late 2025. The company’s pipeline includes gene therapies for CLN2, Huntington’s disease and a third undisclosed indication.
New tone on IRA?
Days after a New Jersey federal judge tossed their lawsuits against the Inflation Reduction Act, Johnson & Johnson followed Bristol Myers Squibb and filed an appeal. The legal battle is playing out as pharma companies downplayed the legislation’s overall impact on business in first-quarter earnings calls, Nicole DeFeudis writes.
Q1 EARNINGS
- Beyond GLP-1s, Novo Nordisk touted how its broader diabetes portfolio beat its target for a greater global market stake one year early, nabbing a third of the market. And that could still grow: Its once-weekly insulin is set to face FDA adcomm in May, following a review extension.
- Pfizer execs stayed away from some of their bolder promises of recent years and largely stuck to the script in first-quarter update as cost cuts are “largely complete,” Max Gelman writes. The company also disclosed that it trimmed a handful of programs from its pipeline, including an early-stage gene therapy.
- GSK is still riding a vaccine sales wave, which is pushing 2024 forecasts higher, with expansion opportunities for both its RSV and shingles vaccines. On the other fronts, the drugmaker said it will present Blenrep to regulators sooner than previously planned as it eyes a second chance in multiple myeloma.
- Lilly scraps trials of Verzenio, Jardiance and a gene therapy from Prevail
- Moderna sticks to long-term strategy in first-quarter update, ends pact with Metagenomi
- FDA asks for more data on Dupixent in COPD in move that could delay a decision
DEALS
- Japanese drugmaker Ono Pharmaceutical is acquiring cancer-focused biotech Deciphera Pharmaceuticals for $2.4 billion. Through the buyout, Ono — which played a role in developing what became Opdivo — nabs an FDA-approved late-line cancer drug.
- BridgeBio spins out oncology unit with $200M in backing for RAS assets
- Bristol Myers buys into Repertoire’s autoimmune vaccines, giving new life to Flagship startup
- Harmony Biosciences buys small epilepsy biotech for $35M, plus milestones
FINANCING
- MPM BioImpact and Novo Holdings are among a group of investors pouring $103 million into Reunion Neuroscience, a psychedelic biotech that MPM took private last summer.
- In one of JP Morgan’s first biotech bets, Enlaza raises $100M for its permanently binding protein drugs
- Biotech vets raise $67M to develop targeted activators for cancer
CELL/GENE TX
- The FDA OK’d the first-ever human trial of prime editing, Prime Medicine announced, opening the door for testing a new technology that backers hope will widen the array of diseases that can be treated with gene editing.
- Astellas taps Poseida for second CAR-T deal focused on solid tumors
- ICER pushes back on FDA’s potential conversion of Sarepta’s gene therapy to full approval
- FDA decision on Sarepta’s Duchenne gene therapy could come earlier than expected
R&D
- Two of AstraZeneca’s top cancer drugs delivered new data this week. Its Daiichi Sankyo-partnered Enhertu claimed another Phase 3 victory in HER2-low breast cancer, while the blockbuster BTK inhibitor Calquence hit the primary endpoint in a trial for first-line mantle cell lymphoma.
- CG Oncology touts interim Phase 3 bladder cancer data, gears up to compete with ImmunityBio
- J&J showcases more bladder cancer results from ‘pretzel’ drug-device combo
- Lead drug from J&J and Addex’s 20-year collaboration flunks Phase 2 in epilepsy
- As it cuts costs and pipeline, Bristol Myers hands back a cancer drug to Schrödinger
- Merck touts updated 21-valent pneumococcal data weeks ahead of FDA decision: Corrected
- AEON fails another migraine trial, shares halve as company reviews options
PHARMA
- Antitrust regulators at the Federal Trade Commission expanded their campaign on what they call “junk” patents, sending a new round of warning letters to drug companies about their products for obesity, diabetes, asthma, COPD and severe hypoglycemia.
- The House Oversight Committee will mark up the Biosecure Act — a far-reaching bill that, if passed, could force many US biopharma companies to cut ties with WuXi and several other Chinese life sciences contractors — on May 15, Lia DeGroot reports.
- AbbVie puts $161M into new R&D site in Germany, will add 300 jobs
- Boehringer puts a target on Humira, says pushing it off formularies is necessary
- Senator alleges GSK is shirking its commitment to lower inhaler costs
- Senators from both parties introduce menopause research bill
- J&J proposes $6.5B talc settlement plan
FDA+
- The FDA finalized a long-awaited rule that outlines how it will regulate laboratory-developed tests as medical devices, even though some critics say the FDA is overstepping its authority.
- FDA approves X4 Pharmaceuticals’ pill for ultra-rare immunodeficiency disease
- FDA converts Pfizer’s Tivdak to full approval in cervical cancer
- Neurocrine wins approval of Ingrezza ‘sprinkle’ formulation for patients with trouble swallowing
- FDA asks for public input on advisory committee reforms
PEOPLE
- Epigenetic editing startup Chroma lays off staff, focusing on reaching the clinic
- DNA sequencing firm PacBio to lay off workers and shutter San Diego office
HEALTH TECH
- Testifying before lawmakers, UnitedHealth CEO Andrew Witty revealed origins of the cyberattack that paralyzed the US healthcare industry for months and bled some providers dry. While most of the senators’ questions concerned whether UnitedHealth did enough to prevent and respond to the attack, they also drilled into a broader question: Is UnitedHealth too big?
- Walmart exits live and virtual care business, five years after push into care delivery
- Digital health startup Ro’s CEO talks GLP-1 drug pricing, shortages and compounded shots
- CVS is getting pummeled by the very strategy it once planned its future on
- Exclusive: Piction Health raises $6M to cut wait times for skin conditions
MANUFACTURING
- The Federal Trade Commission extended its antitrust review of Novo Holdings’ $16.5 billion purchase of Catalent by potentially another 30 days as it requests additional information.
- WuXi wants to regain client confidence amid claims of IP transfer to Chinese authorities
- Emergent to shut facilities and lay off workers as part of new CEO’s roadmap
- Bipartisan draft bill would pay hospitals more to combat drug shortages
MARKETING
- Patient advocacy groups’ perception of pharma companies fell for the first time since beginning a steady rise five years ago, a sign that the industry may not be able to fully hang on to the improved reputation it’s enjoyed over the last several years, according to a new survey.
- Real Chemistry debuts a one-stop dashboard for all things GLP-1
- Sanofi and Regeneron debut next generation in Dupixent’s asthma campaign