New hires:
Apnimed hired former Pfizer exec Graham Goodrich as chief commercial officer and Ted Harding as chief human resources officer.
BenevolentAI hired former LEO Pharma and Bayer executive Joerg Moeller, MD, PhD to serve as its CEO.
Tris Pharma named Franchesca Fowler as chief compliance officer and VP, general counsel.
Former Edelman executive Stacy Sommer joined TrendyMinds as chief services officer.
Transgene added James Wentworth as chief business officer.
Kyruus Health introduced Harshit Shah as its chief technology officer.
Healthcare identity resolution company Throtle named former PulsePoint exec Chris Neuner as president.
Actio Biosciences appointed Samuel Collins, MBBS, PhD, MBA as chief medical officer.
Executive elevations:
The Weber Shandwick Collective named Laura Schoen as chief healthcare officer, among a series of other promotions at the network.
Healthcare agency QBFox Healthcomm promoted Mark Vespole to SVP, group account supervisor.
Colgate-Palmolive handed its Asia-Pacific chief marketer, Yves Briantais, a global creative role.
Claims management company Sedgwick promoted Kimberly George to global chief brand officer.
Board appointments:
Citius Pharmaceuticals nominated Wyeth Pharmaceuticals and Pfizer alum Robert J. Smith to its board of directors.
San Francisco-based AI-supported clinical assistant Suki named six executives to its advisory board.
Trade group New Hampshire Life Sciences signed Novocure and Novo Nordisk as its inaugural founding members.
Departures:
Johna Norton announced her plans to retire as EVP of global quality at Eli Lilly.
PDS Biotech announced the retirement of Lauren V. Wood, MD as chief medical officer. She will be succeeded by Kirk V. Shepard, MD.
FDA:
The agency granted full approval of Johnson & Johnson’s Balversa for treating locally advanced or metastatic bladder cancer with select genetic alterations.
In a complete response letter, the agency denied approval for a newer formulation of tesamorelin that Theratechnologies proposed as a treatment to reduce excess abdominal fat in patients with HIV and lipodystrophy.
The agency added boxed warnings of hypocalcemia to Amgen’s Prolia.
The agency warned the public not to purchase or use tianeptine products, including Neptune’s Fix.
Clinical-stage Ensysce announced the agency granted Breakthrough Therapy Designation for PF614-MPAR.
Cybin received FDA clearance for a Phase 2a study of a psychedelic drug.
Layoffs:
San Diego-based LunaDNA will cease operations on January 31.
Ikena Oncology initiated cash reduction measures including laying off 35% of its staff to support assets IK-930 and IK-595.
Deals:
GenEdit signed a multiyear collaboration deal with Genentech, of which it will receive an upfront payment of $15 million and is eligible to receive up to $629 million in milestone payments.
Novo Nordisk licensed an experimental obesity pill from EraCal Therapeutics in a deal worth roughly $255 million.
Merck entered into a $220 million research collaboration with Unnatural Products.
Coherus divested its ophthalmology franchise to Sandoz for $170 million.
AC Immune regained global rights to anti-amyloid beta antibody crenezumab and anti-Tau antibody semorinemab following termination of collaboration agreements with Genentech and Roche.
Culmination Bio announced a multi-year research and development partnership with Merck.
Naya agreed to buy Florida Biotechnologies in an effort to grow its presence in the gene therapy space.
Pharmacy benefit manager (PBM) Liviniti added Mark Cuban Cost Plus Drug Company to its network of pharmacies.
Single Pass signed a biopsy device distribution deal with Mermaid Medical Group.
Vivtex entered into a research collaboration with Astellas Pharma.
Walgreens is exploring a sale of specialty pharmacy company Shields Health Solutions, according to media reports.
Funding rounds:
CG Oncology raised $380 million in its initial public offering (IPO).
Kura Oncology said it expects gross proceeds from its oversubscribed private placement to total $150 million, before offering expenses.
ArriVent BioPharma plans to sell more than 8.33 million shares for net proceeds of about $135.7 million in its IPO.
Synnovation Therapeutics launched with $102 million.
LB Pharmaceuticals closed a $75 million Series C funding round.
Oncology biotech Accent Therapeutics raised $75 million in a Series C funding.
CalciMedica announced a private placement of up to $55 million.
Sano Genetics raised $11.4 million to support its precision medicine ambitions.
Nutex Health announced a $10 million registered direct offering of common stock and warrants.
Clinical-stage biopharma Azitra filed for a public offering of 3 million shares.
Industry news:
Cathy Fink and Michelle Anderson launched CLF•A Collective, a healthcare marketing and communications consultancy.
Collette Douaihy, global chief creative officer of health at Dentsu Health, will serve as the Pharma Lions President at the 2024 Cannes Lions. Additionally, Wendy Chan, health creative lead for Asia Pacific (APAC) at Edelman, will serve as the Health & Wellness Lions President.
Gilead Sciences said its Phase 3 EVOKE-01 of Trodelvy study did not meet its primary endpoint in patients previously treated metastatic non-small cell lung cancer.
An experimental gene therapy from Eli Lilly restored the hearing of a child who was born deaf.
Tyson Foods dropped CVS Health’s Caremark and chose PBM startup Rightway to manage drug benefits for its 140,000 employees starting this year.
Abbott’s medical device sales helped boost its net sales and meet quarterly expectations, but the company forecast weak earnings for the rest of the year.
Scientists at Dana-Farber Cancer Institute are “moving to” retract one paper and correct others amid an expanding investigation of data manipulation.
The Library of Congress launched a website for Americans to share their COVID-19 stories.
Initial findings from a Phase 3 efficacy trial suggest Ionis Pharmaceuticals’ RNA-targeted treatment, given monthly or bimonthly, cut angioedema attacks more than placebo.
Saudi Crown Prince Mohammed bin Salman bin Abdulaziz Al-Saud launched the National Biotechnology Strategy.
Samsung Biologics said its net profit fell 21.4% in Q4 2023 due largely to a one-off factor.
Novartis’ Lutathera reduced the risk of disease progression or death by 72% in treating patients with advanced gastroenteropancreatic neuroendocrine tumors.
Johnson & Johnson’s sales rose 7.3% to $21.4 billion during Q4 2023, according to its latest earnings report. The healthcare giant announced that it reached a tentative agreement with 42 states and Washington, D.C. to resolve investigations into whether the company misled consumers about the safety of its talc-based products.
BioNTech and Duality Biologics announced the first patient with metastatic breast cancer has been treated in a Phase 3 trial evaluating antibody-drug conjugate candidate BNT323/DB-1303.
New York Mayor Eric Adams announced the city plans to wipe out more than $2 billion in medical debt for up to $500,000 residents.
AstraZeneca’s Imfinzi in combination with transarterial chemoembolisation and bevacizumab reduced the risk of disease progression or death by 23%.
Supergoop named Digitas, a 2023 MM+M Agency 100 honoree, its U.S. media agency of record.
Zurich-based Biognosys announced its expansion to the U.S. with a new proteomics facility in Massachusetts.
Thayers is continuing its partnership with X Games Aspen as its official skincare sponsor.
Silo Pharma said its Alzheimer’s disease therapeutic SPC-14 showed positive efficacy in small animals.
Sagimet Biosciences announced a therapeutic being tested for nonalcoholic steatohepatitis (NASH) and liver fibrosis showed statistically significant improvement versus placebo on two primary endpoints in a one-year, Phase 2b trial.
Global life sciences marketing agency Ramarketing announced a strategic rebranding effort.
Bristol Myers Squibb released results from the Phase 3 CheckMate -8HW study showing a combination of Opdivo and Yervoy improved progression-free survival in certain metastatic colorectal cancer patients.
Amid a recall of its AirFit and AirTouch continuous positive airflow pressure devices, ResMed released its latest earnings report.
Discount prescription provider Optum Perks unveiled a telehealth offering.
The Department of Health and Human Services barred former Theranos CEO Elizabeth Holmes from federal health programs for nine decades.
A federal appeals court upheld “Pharma Bro” Martin Shkreli’s lifetime ban from working in the pharma industry.
