Deals:

Vertex Pharmaceuticals announced its biggest M&A play yet, acquiring Alpine Immune Sciences for $4.9 billion.

Merck scooped up biotech startup Abceutics for $208 million. 

Novartis agreed to a licensing and asset-sale agreement with clinical-stage biotech Arvinas that is potentially worth more than $1 billion.

CG Life, a 2023 MM+M Agency 100 honoree, acquired digital agency Toolhouse.

Ginkgo Bioworks expanded its research partnership with Novo Nordisk.

Predictive marketing and PR agency Hahn acquired health communications agency MedVoice PR.

Ascend Advanced Therapies, a 4BIO Capital portfolio company, acquired the contract, manufacturing and controls team and site in Alachua, Florida, from Beacon Therapeutics

Leila Bahbah, Perrigo U.S. Women’s Health Brand Lead, talks with MM+M about how birth control medication Opill partnered with the WNBA.

Atlantic Health System announced a commercial partnership with FeelBetter, an AI-powered tool for physicians.

MoonLake Immunotherapeutics signed a three-year technology partnership with Komodo Health.

FDA:

The agency approved Bristol Myers Squibb and 2seventybio‘s cell therapy Abecma in less severely affected patients with a type of blood cancer.

BrainStorm Cell Therapeutics announced that it is moving forward with a Phase 3b study for NurOwn and has agreed to a Special Protocol Assessment with the FDA.

The FDA expanded the label for Johnson & Johnson and Legend Biotech’s multiple myeloma CAR-T therapy Carvykti.

Endo Pharmaceuticals sued the FDA over the approval of a generic version of its Adrenalin injections to treat allergic reactions.

The agency approved ViiV Healthcare’s Dovato (dolutegravir/lamivudine) to treat HIV infections in patients above the age of 12 years old.

The FDA approved Daiichi Sankyo and AstraZeneca’s Enhertu for adults with unresectable or metastatic human epidermal growth factor receptor 2-positive solid tumors.

The agency agreed to review Stealth BioTherapeutics’ rare disease drug for Barth syndrome.

Supernus Pharmaceuticals announced the FDA issued another complete response letter for its Parkinson’s therapy, SPN-830.

Under a proposal the FDA is drafting, the broad ban on gay and bisexual men donating sperm would be replaced with more pointed screening questions to assess HIV risk, according to The Wall Street Journal.

Layoffs:

Novartis plans to shrink its global development team by up to 680 roles. The drugmaker also temporarily paused enrollment of early breast cancer patients into clinical trials for Kisqali.

Sanofi is closing natural killer cell company Kiadis nearly four years after purchasing it for $357 million.

Funding rounds: 

TORL BioTherapeutics announced a $158 million Series B-2 financing effort.

Acrivon raised $130 million in funding.

Nvelop Therapeutics launched with $100 million in seed funding.

Seaport Therapeutics also launched with $100 million from a Series A funding round.

Biolinq raised $58 million in a financing round.

RenovoRx announced an $11.1 million private placement.

The National Institute for Innovation in Manufacturing Biopharmaceuticals unveiled $10 million in planned project activities through the Institute’s Project Call 7.1.

Industry news:

AstraZeneca said its blockbuster cancer drug Imfinzi helped improve overall and progression-free survival in patients with limited-stage small cell lung cancer. The British pharma giant also increased its 2024 dividend by 7%.

A vaccine from Pfizer showed potential to protect adults ages 18 to 59 who are at increased risk of getting severely sick from RSV in a late stage clinical trial.

The Department of Justice filed a complaint under the False Claims Act against Regeneron Pharmaceuticals for Medicare reimbursement fraud.

Bristol Myers Squibb said its recently acquired KarXT showed efficacy that was maintained through one year in an open-label extension.

Philips is barred from resuming production of its sleep apnea machines at U.S. facilities until it meets a number of safety requirements as part of a recent settlement.

Ionis Pharmaceuticals presented pivotal rare disease data on olezarsen as builds toward the first solo launch.

Moderna’s personalized cancer vaccine developed with Merck showed benefits in an early study.

UCB launched Make HStory, a patient-focused educational campaign to raise awareness of hidradenitis suppurativa, a chronic, inflammatory skin condition.

Cedars-Sinai expanded its virtual healthcare offerings for children and Spanish speakers in California through its mobile app Cedars-Sinai Connect. 

Crosby Marketing Communications, 2023 MM+M Agency 100 honoree, launched the More Donors, More Hope campaign in support of the Health Resources and Services Administration.

Allergan Aesthetics, an AbbVie company, launched two products from SkinMedica.

Synchron said it will begin recruiting human participants in a large trial.

Former Horizon Therapeutics chief communications officer Geoff Curtis launched a consultancy.

Femtech health and wellness brand Elvie is shining a light on serious pregnancy and postpartum challenges as part of a report and campaign unveiled in Times Square.

Alnylam Pharmaceuticals’ RNAi therapy passed a second Phase 2 hypertension test and is undergoing a third trial.

Nutrafol launched its More to Hair campaign, created in partnership with creative agency Mischief, to grow awareness of the daily habits that may contribute to hair loss. 

Nxera Pharma joined the World Orphan Drug Alliance.

Theratechnologies confirmed its full-year revenue guidance between $87 million to $90 million.

MM+M is hosting its third annual Media Summit on Wednesday, November 6 in New York City.

See last week’s edition of Rx Rundown.