New hires:
Madrigal Therapeutics announced three new members of its leadership team, with Mark Barrett joining as chief business officer, Clint Wallace joining as chief human resources officer and Tina Ventura joining as chief investor relations officer.
Biotech CytoDyn hired Jacob Lalezari MD as CEO and Mitchell Cohen as interim CFO.
Havas Health & You appointed Afshan Rizvi Hussain as MD and global rare disease lead for the network.
Sexual wellness company Satisfyer selected Jeff Garlow to serve as president.
OneChain Immunotherapeutics appointed Dr. Stefanos Theoharis as CEO.
Microbiome science company Seed Health hired Charles Fulford as chief creative officer.
Precision dosing software company DoseMe named Siegfried Bräuer as director of international sales.
Vivodyne appointed Elliot Menschik, MD, PhD as chief technology officer.
Virtual and community-based primary care solution Pair Team hired Nate Favini, MD, MS as its chief medical officer.
Executive elevations:
Greenough Communications named Nikki Festa O’Brien as CEO
Board appointments:
Minds + Assembly, a 2023 MM+M Agency 100 honoree, appointed Adam Cossman to its board of directors.
Tome Biosciences added Dr. Daniel Curran, who was most recently head of rare genetics and hematology at Takeda Pharmaceuticals, to its board of directors.
Ted Love, MD joined Gilead Sciences’ board of directors.
Graeme Pitkethly was nominated as a candidate to the Sandoz board of directors. Additionally, François-Xavier Roger announced he is stepping down from the board of directors.
Nonprofit healthcare alliance DirectTrust is seeking nominations for new board directors.
Stand Up To Cancer added 10 scientists to its scientific advisory committee.
Departures:
The Food and Drug Administration’s principal deputy commissioner of food and drugs Janet Woodcock officially retired.
FDA:
Kite, a Gilead Sciences company, announced the agency approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta.
The agency granted Daiichi Sankyo and AstraZeneca’s antibody drug conjugate (ADC) Enhertu priority review for treating adults with unresectable or metastatic HER2 positive solid tumors, regardless of where the cancer started in the body.
The agency told Ascidian Therapeutics it can begin the first clinical tests of a therapy that “rewrites” RNA to correct roughly two-thirds of the genetic typos responsible for an inherited form of vision loss called Stargardt disease.
The agency rejected Defender Pharma‘s motion sickness nasal gel candidate.
Johnson & Johnson submitted a supplemental Biologics License Application to the agency for approval of a Darzalex Faspro-based regimen for treating patients with transplant-eligible, newly diagnosed multiple myeloma.
The agency approved Takeda Pharmaceuticals’ approved Gammagard Liquird as an intravenous immunoglobulin therapy to improve neuromuscular disability and impairment in adults with chronic inflammatory demyelinating polyneuropathy.
Eli Lilly sent its schizophrenia drug Zyprexa Relprevv to uncertified pharmacies and did not follow required safety procedures for the drug, according to the FDA.
The agency warned the public against copycat eye drops from South Moon, Rebright and FivFivGo because of the risk of infection.
BioNTech and DualityBio received a Fast Track Designation for its next-generation ADC candidate, BNT325/DB-1305.
The agency published a draft guidance on collecting demographic data for clinical trials and clinical studies.
Layoffs:
Hookipa Pharma announced it was slashing 30% of its workforce and that Roche terminated a collaboration and licensing agreement.
Strand Therapeutics laid off roughly 18% of its employees.
Novavax said it will cut 12% of its global workforce.
Cell therapy biotech Catamaran Bio recently announced a decision to commence wind-down.
Weight loss startup Noom announced its latest round of layoffs, including coaches and engineers.
Deals:
Cardinal Health announced it will buy Specialty Networks for $1.2 billion in cash.
Gilead Sciences made an additional $320 million equity investment in Arcus Biosciences, upping its stake in the company to 33%.
Kiora Pharmaceuticals announces strategic partnership with Théa Open Innovation, in which it will receive an upfront payment of $16 million and up to $285 million upon the achievement of pre-specified clinical developments.
Regeneron Pharmaceuticals announced it will buy 2seventy bio’s experimental cell therapies for $5 million upfront.
Oxford Biomedica completed its acquisition of ABL Europe.
Funding rounds:
Vaxcyte’s pricing for a $750 million funding round is one of the largest public offerings in recent biotech memory.
Fractyl Health set the terms for a $110 million initial public offering (IPO).
COUR Pharmaceuticals closed a $107 million Series A financing round.
Halia Therapeutics closed a $30 million Series C financing round.
Checkpoint Therapeutics reported a $14 million registered direct offering.
Imaging AI marketplace platform Carpl raised $6 million in a funding round.
Adipo Therapeutics completed a $1.9 million bridge funding round.
Industry news:
Publicis Health agreed to pay $350 million as part of a multistate settlement regarding its role in the prescription opioid crisis.
The Supreme Court announced it will hear oral arguments on how patients can access abortion pill mifepristone on March 26.
Novo Nordisk’s sales rose 36% at constant exchange rates to 232.3 billion Danish kroner.
Attorney General Merrick Garland will undergo back surgery this weekend.
Thanks to less-than-expected returns of oral COVID-19 treatment Paxlovid by the federal government, Pfizer recorded a surprise profit in Q4 2023.
Walmart launched Optical Virtual Try-On, which will allow customers to virtually “try on” frames and purchase prescription eyewear online as part of its augmented reality and virtual reality offerings.
Vertex Pharmaceuticals reported positive results for two Phase 3 trials testing the efficacy and safety of pain compound VX-548 compared to either placebo or opioid-based treatment.
Sarepta Therapeutics announced its experimental drug for Duchenne muscular dystrophy was more effective in increasing levels of a key protein than its bestselling medicine Exondys 51.
Novartis reported an earnings miss per consensus analyst expectations for Q4 despite a strong effort in 2023.
Thermo Fisher Scientific reported a year-over-year decline in revenue during Q4 2023 but still exceeded analysts’ estimates.
Though Roche’s group sales rose 1% at CER, they fell 7% in CHF. The company’s core operating profit fell as well, down 1% at CER and 13% in CHF.
Teva Pharmaceutical announced it will divest its active pharmaceutical ingredient unit to focus on its core business.
Insilico Medicine collaborated with University of Toronto biochemist and molecular geneticist Igor Stagljarto test AI-designed molecules against “undruggable” cancer targets.
Takeda Pharmaceuticals’ quarterly revenues rose 4.6% year-over-year to 3.2 trillion yen, but otherwise most metrics dropped, some by double digits.
Bristol Myers Squibb’s Opdivo failed for a second time in a late-stage kidney cancer trial.
Abbottdebuted the Protality brand of high-protein nutrition shakes.
Philips Respironics announced that it came to an agreement on the terms of the consent decree around its domestic sleep business as well as the 2021 CPAP and ventilator recall with the Department of Justice.
Mercksaw sales grow 6% year-over-year to $14.6 billion. For the full year, sales inched up 1% to $60.1 billion.
Telehealth clinic service Pelagoselected SolComms as its AOR.
Veeva Compass launched products to accurately project all medicines and help biopharma brands reach more HCPs and their patients.
The Substance Abuse and Mental Health Services Administration issued a final rule on opioid use disorder treatment.
In Q4 2023, Sanofi’s sales grew 9.3% at constant exchange rates, hitting €10.9 billion, while its business earnings per share increased 8.2% at CER. However, the drugmaker reported a quarterly net loss of €555 million and a negative EPS of €0.44.
PatientPoint received an accreditation from the Media Rating Council.
GSK’s RSV vaccine Arexvy contributed £1.2 billion in sales, with its vaccine sales rising 25% year-over-year.
Alvotech announced positive top-line results from a study for AVT03, a proposed biosimilar for Prolia and Xgeva.
Quest Diagnostics reported a 90% surge in net income as part of its Q4 2023 earnings report.
Physician consulting service Atropos Health announced an integration with Google Cloud’s Healthcare Data Engine.
